Abamectin DAR 01 Vol 1 Public

Draft Assessment Report (DAR)
- public version -
Initial risk assessment provided by the rapporteur Member State

The Netherlands for the existing active substance
ABAMECTIN
of the third stage (part A) of the review programme
referred to in Article 8(2) of Council Directive 91/414/EEC
Volume 1
June 2006
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ABAMECTIN - VOLUME 1 - OCTOBER 2005
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European Commission
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ABAMECTIN
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VOLUME 1
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Rapporteur Member State: The Netherlands

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October 2005
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Draft Assessment Report and Proposed Decision of the Netherlands prepared in the context
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of the possible inclusion of abamectin in Annex I of Council Directive 91/414/EEC

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CONTENTS
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Level 1 Statement of the subject matter and purpose of the Monograph 3
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1.1 Purpose for which the monograph was prepared 4
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1.2 Summary and assessment of the steps taken to collectively present the dossier 4
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1.3 Identity of the active substance 4
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1.4 Identity of the plant protection product 7
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1.5 Use of the plant protection product 8
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Level 2 Overall conclusions 12
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2.1.1 Identity 13
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2.1.2 Physical and chemical properties 13
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2.1.3 Details of uses and further information 13
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2.1.4 Classification and labelling 13
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2.2 Methods of analysis
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2.3 Impact on human and animal health 18

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2.4 Residues 41
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2.5 Fate and behaviour in the environment 43

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2.6 Effects on non-target species 79

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Appendix 1 Part 1: Standard terms and abbreviations 140

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Part 2: Organisations and Publications 147

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Part 3: Preparation (formulation) types and codes 149

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Appendix 2 Specific terms and abbreviations 153

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Appendix 3 Endpoints 157

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Level 3 Proposal for the decision 205

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3.1 Background to the proposed decision 206

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3.2 Proposed decision 207

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3.3 Rationale for the proposed decision 207

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Level 4 Demand for further information 209

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4 Demand for further information - data required before inclusion in Annex I can
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be considered 210
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LEVEL 1
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Abamectin
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STATEMENT OF THE SUBJECT MATTER AND PURPOSE OF THE MONOGRAPH

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1.3.3 Chemical name (Annex IIA 1.4)
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IUPAC nomenclature:
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Avermectin B1a
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(10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-6'-[(S)-sec-butyl]-21,24-dihydroxy-
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5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-
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6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-
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hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside
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Avermectin B1b
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(10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6'-isopropyl-
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5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-
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6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-
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hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside
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CA nomenclature:
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Abamectin avermectin B1 lat
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Avermectin B1a 5-O-demethyl-avermectin A1a
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Avermectin B1b 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-avermectin A1a

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1.3.4 Manufacturer's development code number (Annex IIA 1.5)

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Abamectin MK 936
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Avermectin B1a NOA 422601

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Avermectin B1b NOA 421704

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1.3.5 CAS, EEC and CIPAC numbers (Annex IIA 1.6)

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CAS number: 71751-41-2 abamectin

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65195-55-3 avermectin B1a

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65195-56-4 avermectin B1b

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CIPAC number: 495 abamectin

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EINECS number: 265-610-3 avermectin B1a

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265-611-9 avermectin B1b

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ABAMECTIN - VOLUME 1 - OCTOBER 2005 cum
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Table 1.5.3-1: List of representative uses evaluated (abamectin) th
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Crop and/ Member Product F Pests or n tePHI Remarks:
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or State name G Group of (days)
Formulation Application Application rate per treatment
situation or or pests t b
Country I controlled t no
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Type Conc. method growth number interval kg as/hLati
onwater kg as/ha
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of as kind stage & min between i st L/ha
g
(a) (b) (c)
(d-f) (i) (f-h) season max applications Re
min max min max
(l) (m)
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(j) (k) (min)tio min max
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Citrus EU Vertimec F Phyllocnistis EC 18 g/L r1e-a3 7 0.00072– 1500- 0.0216 10
citrella e 0.00135 3000
018 EC
Panonychus tb
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Tetranychus
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urticae
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Lettuce EU Vertimec F Liriomyza
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EC 18 g/L
a nd 1-3 7 0.0018 1000 0.018 7
018 EC
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Lettuce EU Vertimec G Liriomyza EC c k18 g/L 1-4 7 0.0009 1000 0.009 14
018 EC
sp.
a pa
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Tomatoes EU Vertimec F Tetranychus n EC 18 g/L 1-3 7 0.0009 – 1200- 0.0216 3
urticae i o 0.0018 2500
018 EC at
a lu
Liriomyza
Tomatoes EU Vertimec G
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Tetranychus EC 18 g/L 1-5 7 0.0009 – 1200- 0.0216 3
E C
urticae 0.0018 2500
018 EC an Liriomyza
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Remarks: o rm (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between
tf the plants - type of equipment used must be indicated
en (a) For crops, the EU and Codex classifications (both) should be used; where relevant, (i) g/kg or g/l
u m the use situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants,
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(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
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1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds season at time of application th
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application
on possible under practical
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 conditions of use must be provided d
(f) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (l) PHI - minimum pre-harvest interval te
(g) All abbreviations used must be explained (m) r an importance/restrictions
Remarks may include: Extent of use/economic
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1.5.4 Information on authorisation in EU Member States (IIIA 12.1)
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Abamectin is currently registered in several countries of the EU for ornamentals, and a great variety of
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fruits and vegetables.
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LEVEL 2
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Abamectin
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OVERALL CONCLUSIONS
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2 Reasoned statement of the overall conclusions drawn by the Rapporteur Member
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State
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2.1 Identity, physical and chemical properties, details of uses, further information, and
proposed classification and labelling
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2.1.1 Identity
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All points of Section 1, Annex IIA and IIIA have been addressed, and the information supplied is ac-
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ceptable.
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2.1.2 Physical and chemical properties
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Abamectin is a white powder, with a water solubility of 1.21 mg/L. Solubility in organic solvents ranges
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from 0.11 g/L in hexane to 470 g/L in dichloromethane. The compound does not dissociate at pH 1 -
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12. The log KOW is 4.4 at pH 7.2, the vapour pressure is < 3.7 x 10-6 Pa. Abamectin is formulated as an
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emusifiable concentrate. The product is stable upon storage, the shelf life is at least 2 years when
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packed in a high density polyethylene container.

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2.1.3 Details of uses and further information

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Abamectin is a broad spectrum acaricide with additional insecticidal action on a limited number of in-
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sects. The compound can be used by spray treatment on a variety of crops. Proposed uses for the
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purpose of this monograph are citrus, lettuce and tomatoes. The product acts via contact and stomach
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action, by stimulation of γ-aminobutryric acid release, which acts as an inhibitory neurotransmitter.

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This leads to paralysis of affected insects and mites. Arthropods usually become immobilised shortly
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after exposure, although 3-4 days may be required to achieve complete mortality. During this period
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feeding is limited and plant damage is minimal. The product is not systemic in plants, but has a
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translaminar movement. Judged from the toxicity studies with aquatic and terrestrial invertebrates, the
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photoproduct [8,9-Z]-avermectin B1a has similar activity as compared to abamectin or avermectin B1a.
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2.1.4 Classification and labelling

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Justified proposals for classification and labelling of abamectin, relating to physical and chemical
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properties, human health and ecotoxicological effects, according to Directive 67/548/EEC are listed
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below:
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Physical chemical properties

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Based on the result no classification or labelling is proposed.

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Toxicology
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Hazard symbol :T+
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Indications of danger : very toxic
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Risk phrase : R28 “very toxic if swallowed”
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Justification for the proposal: LD50 rat 8.7 mg/kg bw
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Hazard symbol :T+
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Indications of danger : very toxic
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Risk phrase : R26 “very toxic by inhalation”
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Justification for the proposal: LC 50 >0.034 and <0.051 mg/L in the rat
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Hazard symbol :T
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Indications of danger : category 2/ category 3
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Risk phrase : R60 “may impair fertility”/ R62 “possible risk of impaired fertility”
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Justification for the proposal: increased mating time during F1a mating, decreased number of males
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mating during F1b mating, increased duration of cohabitation in the F0 generation, increased number
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of F0 dams with prolonged interestrus and decreased number of F0 females mating, in a rat two-
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generation study, in the absence of general toxicity. Although the effects observed on reproductive
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parameters were not statistical significant in all individual parameters, the overall result appeared to be
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that in the highest dose group less females had litters.

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Hazard symbol :T
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Indications of danger : category 2/category 3

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Risk phrase : R61 “may cause harm to the unborn child”/R63 “posible risk of harm to the
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unborn child”.
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Justification for the proposal: incidences of cleft palate and exencephaly in the absence of general
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toxicity. Although effects observed on developmental parameters were not dose related and/or signifi-
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cant in all individual studies, these effects were observed in almost all studies.
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Safety phrases : S36/S37: Wear suitable protective clothing and gloves.

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S38: In case of insufficient ventilation, wear suitable respiratory equipment.

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S45: If swallowed, seek medical advice immediately and show this container
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or label.
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S53: Avoid exposure – obtain special instructions before use.

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Environment
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The EC50 for invertebrates is lower than 1 mg a.s./L and the substance is not readily biodegradable.
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Therefore, abamectin should be classified as Very toxic to aquatic organisms (R50) and May cause
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long-term adverse effects in the aquatic environment (R53).
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Because of being allocated the R50/53 phrases, abamectin is considered Dangerous for the environ-
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ment and should also carry the following safety phrases:
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S60: This material and its container must be disposed of as hazardous waste
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S61: Avoid release to the environment. Refer to special instructions/Safety data sheet
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Justified proposals for classification and labelling of the preparation VERTIMEC 018 EC, relating to
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physical and chemical properties, human health and ecotoxicological effects, according to Directive
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1999/45/EC are listed below:
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Physical chemical properties
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Based on the result no classification or labelling is proposed.
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Toxicology
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Hazard symbol : Xn
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Indications of danger : harmful

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Risk phrase : R22 “harmful if swallowed”

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Justification for the proposal: LD50 in rat is 300 mg/kg bw

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Hazard symbol : Xn
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Indications of danger : harmful

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Risk phrase : R20 “harmful by inhalation”

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Justification for the proposal: LC 50 in rat is 3.1 mg/L/4h

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Hazard symbol : Xi
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Indications of danger : irritant

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Risk phrase : R36 “irritating to eyes”

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Justification for the proposal: irritating in eye irritation study with rabbits
EC
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Hazard symbol : Xi
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Indications of danger : irritant

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Risk phrase : R43 “may cause sensitization by skin contact”

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Justification for the proposal: positive in GPMT test

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Hazard symbol :T
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Risk phrase : R60 “may impair fertility”/R62 “possible risk of impaired fertility”
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Justification for the proposal: the preparation contains >0.5% abamectin
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Hazard symbol :T
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Risk phrase : R61 “may cause harm to the unborn child”/ R63 “possible risk of harm to the
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unborn child”
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Justification for the proposal: the preparation contains >0.5% abamectin
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Safety phrases : S25: Avoid contact with eyes.
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S26: In case of contact with eyes, rinse immediately with plenty of water and
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seek medical advice.
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S36/S37: Wear suitable protective clothing and gloves.
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S45: If swallowed, seek medical advice immediately and show this container
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or label.
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Environment
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The product Vertimec 018 EC can be classified on the basis of acute formulation toxicity studies. The
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most sensitive species tested showed values smaller than 1 mg formulation/L, hence Vertimec 018 EC
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should be classified Very toxic to aquatic organisms (R50) and May cause long-term adverse effects in
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the aquatic environment (R53).

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Because of being allocated the R50/53 phrases, Vertimex 018 EC is considered Dangerous for the
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environment and should also carry the following safety phrases:

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S60: This material and its container must be disposed of as hazardous waste
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S61: Avoid release to the environment. Refer to special instructions/Safety data sheet
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Glasshouse use: The persistence of harmful effects of foliar surface residues of abamectin on glass-
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house crops is dependent on arthropod species, crop and light intensity. Therefore, recommendations
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on re-introduction periods are most appropriately determined at the Member State level on the basis of
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considerations of crops, species, region and season.

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Field use: Because under field conditions it is not possible to prevent bees from entering the treated
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area, a risk for bees of Vertimec 018 EC cannot be excluded and for field uses the following restriction
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should be put on the label (S-phrase SPe 8) Dangerous to bees.To protect bees and other pollinating
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insects do not apply to crop plants when in flower.Do not use where bees are actively foraging.
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Do not apply when flowering weeds are present.

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2.2.1 Analytical methods for analysis of the active substance as manufactured
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Method AW-211/2 can be used for determination of abamectin. The identity of abamectin can be de-
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termined by IR spectroscopy, Mass Spectoscopy (MS) or liquid chromatography (HPLC). Quantifica-
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tion of avermectin B1a and B1b is performed by HPLC-UV at 254 nm, mobile phase 84 % methanol and
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16 % water, the sum is calculated and reported as abamectin.
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2.2.2 Analytical methods for formulation analysis
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Method AF-1391/1 can be used for determination of abamectin in formulation A 8612 A (Vertimec 018
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EC). The identity of abamectin can be determined by HPLC. Quantification of avermectin B1a and B1b
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is performed by HPLC-UV at 254 nm, mobile phase acetonitrile and 0.1 % aqueous phosphoric acid.
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The sum is calculated and reported as abamectin.
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2.2.3 Analytical methods for residue analysis
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Treated plants, plant products, foodstuffs, feeding stuffs

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Method REM 198.02 is proposed as enforcement method and used as analytical method in super-
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vised trials on citrus, tomato, and lettuce and a processing study on tomato. It includes different ex-
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traction and SPE clean-up steps, depending in the type of material, and quantification using HPLC-
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MS/MS. The analytes avermectin B1a, avermectin 8,9-Z B1a isomer, and avermectin B1b are meas-
sh
ured separately. It is sufficiently validated and has a LOQ of 0.002 mg/kg for the crop groups com-
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modities with a combination of high water and high acid content and fatty dry commodities and 0.01
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mg/kg for special commodity green hops. As method for residue trials: it is sufficiently validated for
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tomato, lettuce, mandarin and orange with a LOQ of 0.002 mg/kg. As abamectin is classified as very
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toxic a validated method in blood is still required.

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A large number of analytical methods was reported, that were used as analytical method in storage
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stability studies and supervised trials: method 91-1, M-073, 1009 Rev.1, 9003, 10001 Rev.1, 8001,
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and 8000/8000 Rev.1. All these methods include extraction, SPE clean-up, and formation of fluores-
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cent derivatives. Quantification using HPLC with fluorescence detection gives no chromatographic
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separation of avermectin B1a and its 8,9-Z isomer and only the sum of both analytes is measured.
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The same applies for avermectin B1b and its 8,9-Z isomer. Methods 91-1, 1009 Rev.1, 9003, 10001
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Rev.1, and 8001 are not sufficiently validated. Generally, information on calibration for avermectin B1a
or
8,9-Z isomer and avermectin B1b, matrix interference data and recovery data are required. All results
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obtained with these methods are considered provisional.

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Residues in body fluids and tissues
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As abamectin is classified as very toxic a validated method in blood is still required.
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Residues in the environment
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Soil
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One analysis method is described for the determination of avermectin B1a, avermectin B1b (NOA
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421704), [8,9-Z]-avermectin B1a (NOA 427011), 8a-oxo-avermectin B1a (NOA 448111), 8a-hydroxy-
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avermectin B1a (NOA 448112), 4,8a-dihydroxy-avermectin B1a (NOA 457464), and 4-hydroxy-8a-oxo-
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avermectin B1a (NOA 457465) in soil. Residues are extracted by shaking three times with acetoni-
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trile/water (70:30, v/v), the extract is brought on a Hydrophylic-Lipophylic Balanced SPE column and
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eluted with dichloromethane. Final determination is performed by LC-MS/MS. The method RAM
st
gi
412/01 is considered valid for concentrations of 0.5 µg/kg and higher. A confirmatory technique is not
Re
n.
considered necessary in view of the specific identification method used.
io
lat
Water
iso
One analysis method is described for the determination of avermectin B1a, avermectin B1b (NOA
in
d
421704), [8,9-Z]-avermectin B1a (NOA 427011), 4"-oxo-avermectin B1a (NOA 426289), and 3"-
ea
er
demethyl-avermectin B1a (NOA 445495) in drinking water, ground water and surface water. Water
tb
samples are diluted with acetonitrile, brought on a HLB SPE column and eluted with acetonitrile. Final
no
determination is performed by LC-MS/MS. The method RAM 413/01 is considered valid at concentra-
ld
ou
tions of 0.05 µg/L and higher. A confirmatory technique is not considered necessary in view of the
sh
specific identification method used.

d
an
ge
Air
a
ck
One analysis method is described for the determination of avermectin B1a and avermectin B1b (NOA
pa
421704) in air. XAD sampling tubes are extracted twice with methanol in an ultrasonic bath, dried, re-
ta
da
dissolved in acetonitrile (60:40, v/v) and filtered over 0.45 µm. Final determination is performed by
n
HPLC-UV at 243 nm. Columns used: Discovery RP Amide C-16, particle size 5 µm, and Inertsil ODS
io
at
II, particle size 5 µm. The method REM 198.01 is valid for concentrations of 0.1 µg/m3 and higher.
alu
ev
Merck method MK 936/23 is suggested as a confirmatory technique (HPLC Fluorescence determina-

EC
tion for avermectin B1 and its 8,9-isomer in cucumbers, Merck USA, 25 October 1989).
n
fa
to
ar
sp
2.3 Impact on human and animal health

m
or
tf
2.3.1 Effects having relevance to human and animal health arising from exposure to the
en
active substance or to impurities contained in the active substance or to their

m
transformation products
cu
do
This toxicological dossier contains studies with the test substance abamectin (code names MK (0)936,
is
CGA 115807). Abamectin is an insecticide comprising of a mixture of avermectin B1a (minimum 80%)
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and avermectin B1b (maximum 20%). This evaluation contains studies performed with abamectin
t
of
technical and specific aspects of the toxicological properties of the 8,9-Z isomer of abamectin B1a, a
is
as
product of abamectin photolysis. Abamectin is the substance under notification, intended to be in-
eb
cluded in Annex I. In 2005, additional data were submitted by the notifier concerning reproductive and
th
on
developmental toxicicity. The additional information is also considered in this evaluation.
e d
nt
ra
Toxicokinetics
eg
Avermectin B1a is absorbed from the gastrointestinal tract of the rat and is distributed throughout all
tb
no
major tissues and organs sampled. Maximum concentrations in blood are achieved within 4-8 h after
t
us
administration. It is rapidly eliminated from the body, almost exclusively in the faeces (more than 92%
m
of the dose within 7 days, urinary excretion accounting for 0.9-1.6% of the dose in males and 0.5-1.0%
n
tio
in females of low and high dose groups). Initially, the rate of excretion was slower in females as com-
ra
st
pared to males. The excretion via expired air accounted for only 0.01% of the dose within 48h after
gi
Re
administration. Tissue half-lives were mostly within the range of 1.2 ± 0.3 days, with the tissue half-
n.
lives of avermectin B1a being lower in males (12 to 17 h) compared to females (13 to 33 h). So, with
io
lat
the exception of dose-dependence for tissue residue levels and excretion by urine, the toxicokinetic
iso
profile is not influenced by sex, dose level or treatment regime.

in
d
The comparison of urinary excretion after oral or i.v. administration indicate almost complete oral ab-
ea
er
sorption, with a calculated bioavailability of 0.86. Intravenous administration confirmed the non biliary
tb
excretion of the majority of absorbed avermectin B1a into the intestinal tract and elimination with the
no
faeces. Avermectin B1a and/or metabolites do not accumulate in liver, kidneys, muscle or fat on re-
ld
ou
peated administration of a low dose. Seven days after the last of 14 daily consecutive doses less than
sh
1% of the total administered dose was present in tissues and organs (except for fat, with more than 10
d
an
times higher levels compared to other tissue reidue levels). A comparative distribution and clearance
ge
study with avermectin B1b following single oral doses showed that the toxicokinetic profile was essen-
a
ck
pa
tially the same as that of avermectin B1a.

ta
The metabolite pattern in urine, faeces and bile is complex, and 11 metabolites were isolated. In fae-
da
ces, avermectin B1a accounted for 24 to 45% of the dose, and the metabolite 3’’-O-desmethyl-
n
io
at
avermectin B1a [=3’’DM] accounted for 19-27%. These major faecal components were not present in
alu
urine. In fat and muscle, avermectin B1a was the major component (92% and 72%, respectively), and
ev
metabolite [3’’DM] acounted for 1.7% and 19% in the fat and muscle, respectively. The major reac-
EC
tions involved in the biotransformation of avermectin B1a in the rat are demethylation, hydroxylation,
n
fa
cleavage of the oleandrosyl ring and oxidation reactions.

to
ar
In rat the 8,9-Z isomer of abamectin B1a is not formed.

sp
The extent of dermal penetration of avermectin B1a is minimal in the rhesus monkey, amounting to
m
or
less than 1% of the applied dose.

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Toxicodynamics
t
of
Acute toxicity
is
as
Abamectin technical is very toxic to the rat by oral administration in sesame oil (LD50 values 8.7 and
eb
th
12.8 mg/kg in males and females, respectively). A subsequent oral study with an aqueous vehicle
on
showed that abamectin was significantly less toxic with this vehicle (LD50 values 232 and 214 mg/kg
e d
in males and females, respectively). However, in the toxicokinetic studies performed with sesame oil
nt
ra
or polyethylene glycol (PEG), there are no indications for this observed difference in toxicity.
eg
Abamectin technical is also very toxic to the rat by the inhalation route (males: LC50 >0.051 mg/L, fe-
tb
no
males: >0.034 mg/L LC 50 <0.051 mg/L).
t
us
In contrast, it has a low order of toxicity by topical application in both the rat (24hr LD50 value >330
m
mg/kg bw, highest dose tested) and the rabbit (24hr LD50 value > 2000mg/kg bw), indicating a low
n
tio
order of percutaneous penetration. This is supported by data in rhesus monkeys which demonstrate
ra
st
that <1% of the applied dose is absorbed through the skin into the systemic circulation.
gi
Re
Characteristic signs of abamectin toxicity, tremors and ataxia, occur in rats after a single low oral dose
n.
and in rats and rabbits after a single very high dermal dose. Abamectin technical is non-irritant to skin
io
lat
and eyes and is not a skin sensitizer.
iso
Based on the acute oral LD50 value observed in the male rat, and the acute inhalation toxicity in the
in
d
female rat, abamectin technical needs to be classified as (R28) “very toxic if swallowed” and (R26)
ea
er
“very toxic by inhalation”, according to the criteria mentioned in Annex VI of Directive 2004/73/EC.
tb
no
Short-term toxicity
ld
ou
An 8-week dietary range-finding study was performed with the rat, and 12,18 and 53-week toxicity
sh
studies in the dog have been performed by dietary, gavage and dietary administration respectively. A
d
an
90-day toxicity study in rats was not conducted. The data from the first 12 weeks of the rat 2-year
ge
a
study are not considered as a 90-day toxicity study, since in a long term toxicity study less parameters
ck
pa
are studied compared to a short term/semichronic toxicity study, and are not intended to replace a 90-
ta
day toxicity study, in contrast to the suggestion of the notifier. However, it is not likely that a 90-day
da
toxicity study will give additional information to the information of the other toxicity studies. Therefore,
n
io
at
a 90-day toxicity study with abamectin is not necessary.

alu
The studies were performed using abamectin technical except the 18 week toxicity study in dogs
ev
which used avermectin B1a.

EC
n
Only the 18 week and 53 week oral toxicity studies with dogs are considered relevant, since the 8
fa
to
week and 12 week study were range finding study, with determination of very few parameters, not
ar
conform OECD guidelines.

sp
In the 18 week oral toxicity study with dogs, a very steep dose-response relationship for avermectin
m
or
B1a in the dog was observed, since the oral NOAEL by gavage is 0.25 mg/kg bw/day and death, clini-
tf
en
cal signs (ataxia, tremors, mydriasis and ptyalism), reduced weight gain and histopathological
m
cu
changes in the liver occurred at 0.5 mg/kg bw/day. In the 53-week oral toxicity dog study with abamec-
do
tin technical in dogs, death occurred at the high dose level of 1.0 mg/kg bw/day, and pupil reactivity
is
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was decreased or absent at the dose level of 0.5 mg/kg bw/day. Based on this effect on pupil reactiv-
t
of
ity, the NOAEL in this study is 0.25 mg/kg bw/day. The results of both these studies show that a simi-
is
as
lar steep dose response exists for abamectin technical.
eb
Therefore, the lowest NOEL in the short-term toxicity studies is 0.25 mg/kg bw/day for both abamectin
th
on
technical and avermectin B1a in the dog.
e d
nt
ra
Genotoxicity
eg
Abamectin technical did not induce gene mutations in either bacterial or mammalian cells at any of the
tb
no
tested concentrations either with or without metabolic activation. There was no evidence of a clasto-
t
us
genic effect at any tested concentration either in vitro or in vivo. It is concluded that abamectin techni-
m
cal and/or its metabolites are not genotoxic.
n
tio
ra
st
Long-term toxicity
gi
Re
Long-term toxicity and carcinogenicity studies were performed in the rat and mouse. There was no
n.
evidence of carcinogenicity in either the rat or the mouse at any of the dose levels employed. The
io
lat
long-term dietary administration of abamectin did not reveal any primary target organ toxicity. Although
iso
clinical signs of neurotoxicity were evident in rats and to a lesser extend in mice, no histopathological
in
d
correlate was evident. The lowest NOAEL determined in long-term toxicity studies was 1.5 mg/kg
ea
er
bw/day in the rat carcinogenicity and toxicity study, based on increased mortality in males and clinical
tb
signs.
no
ld
ou
Reproduction and developmental toxicity

sh
d
In the rat 2-generation reproductive toxicity study, effects were confined to the highest dose group.
an
Effects on reproduction parameters and pups are observed in the absence of general toxicity. In the
ge
a
ck
F0 there was an increased number of dams with prolonged interestrus and increased mating time.
pa
Furthermore, there was a decrease in the number of males and females mating and an increase in the
ta
da
duration of cohabitation, and less females littered. Based on these effects in the highest dose group,
n
the NOAEL for maternal toxicity in this study is 0.12 mg/kg bw/day.
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
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en
m
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In the highest dose group, in both F1 and F2 generation progeny an increase in pup mortality, re-
t
of
tarded weight gain, increased incidence of total litter loss, decreased lactation index were observed
is
as
and an increased incidence in retinal anomaly was observed in F2 pups. Based on these effects in the
eb
highest dose group, the NOAEL for fetal toxicity in this study is 0.12 mg/kg bw/day.
th
on
In the teratogenicity study with rats, maternal toxicity was not observed at the highest dose level, re-
e d
sulting in a NOAEL of 1.6 mg/kg bw/day. In the highest dose group, cleft palate, changed sex ratio and
nt
ra
increased number of fetuses with lumbar rib and lumbar count variation were observed. Based on the
eg
effects observed in the high dosed animals, the NOAEL for fetal toxicity in this study is 0.8 mg/kg
tb
no
bw/day.
t
us
In the teratogenicity study with rabbits, females of the highest dose group of 2.0 mg/kg bw/day showed
m
decreased water and food consumption and weight loss during gestation, and an increased number of
n
tio
resorptions. Based on these effects, the NOAEL for maternal toxicity in this study is 1.0 mg/kg bw/day.
ra
st
The NOAEL for fetal toxicity was also established at 1.0 mg/kg bw/day, based on the occurence of
gi
Re
cleft palate, omphalocele, clubbed fore-feet and delayed ossification at the highest dose level of 2.0
n.
mg/kg bw/day.
io
lat
The lowest NOEL for reproductive effects is 0.12 mg/kg bw/day, observed in the rat two-generation
iso
study.
in
d
In the rat, developmental toxicity was observed in the absence of maternal toxicity. According to the
ea
er
criteria mentioned in Annex VI of Directive 2004/73/EC, abamectin needs to be classified as (T, R61,
tb
category 2) “may cause harm to the unborn child”.

no
Additonal information on reproduction and developmental toxicity (historical control values, overviews
ld
ou
of effects in all studies, literature on estrus cycle and reproduction) provided by the notifier did not re-
sh
sult in changed opinions concerning the effects observed in animals treated with abamectin or the 8,9-
d
an
Z isomer of abamectin. Although effects observed on reproductive and developmental parameters

ge
were not dose related and/or significant in the individual studies, these effects were consistently ob-
a
ck
pa
served in almost all studies. Considering all studies on reproduction and developmental toxicity to-
ta
gether, it cannot be excluded that the observed effects on reproduction parameters, sex ratio and cleft
da
palate are substance-related effects.

n
io
at
alu
Neurotoxicity
ev
Abamectin does not belong to a chemical class which is suspected to cause delayed neurodegenera-
EC
tive effects (organophosphates, carbamates) and studies do not indicate histopathological evidence of
n
fa
central or peripheral nervous system damage. Therefore specific studies on delayed neurotoxicity are
to
ar
not required.
sp
For the present evaluation, no studies on acute and semi-chronic neurotoxicity were submitted. Since
m
or
abamectin induces clinical signs of neurotoxicity in rats, mice and dogs, additional semi-chronic neuro-
tf
en
toxicity studies may give more insight in the mechanism of neurotoxicity and may give more clearance
m
cu
in the steep dose-response of abamectin toxicity.

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Toxicity studies on metabolites
t
of
From studies, not submitted for the present evaluation, it was concluded (by the notifier) that CF-1 mice
is
as
exhibit typical clinical signs of neurotoxicity and are increased susceptible to abamectin toxicity. From
eb
those studies it was suggested that the increased susceptibility of CF-1 mice (compared to CD-1 mice) is
th
on
related to the accessibility of the 8,9-Z isomer to the target organ, and hence to the presence or absence
e d
of P-glycoprotein expression. In order to investigate this suggestion, several studies were performed to
nt
ra
investigate the relation between P-glycoprotein and the increased sensitivity of CF-1 mice to abamectin
eg
and the 8,9-Z isomer and submitted for the present evaluation.
tb
no
t
us
The polar photodegradate of abamectin exhibits a very low order of acute oral toxicity to CF-1 mice
m
since deaths do not occur at dose levels up to 5000 mg/kg. However, since the polar metabolite was
n
tio
not identified, and purity and stability were not determined, the results of this study are less valuable.
ra
st
The acute oral toxicity of the 8,9-Z isomer of avermectin B1a in CF-1 mice has been determined as >
gi
Re
80 mg/kg in both sexes, but has also been reported as between 10 and 20 mg/kg in male CF-1 mice.
n.
Death and clinical signs of intoxication, ataxia and bradypnea, occur at oral dose levels as low as 5
io
lat
mg/kg bw 8,9-Z isomer of avermectin B1a in CF-1 mice. In contrast, no deaths occur in CD-1 female
iso
mice at acute oral dose levels of 162 mg/kg bw 8,9-Z isomer, but death occurs in 100% of animals at
in
d
290 mg/kg bw giving a calculated acute oral LD50 value of the 8,9-Z isomer in CD-1 strain female
ea
er
mice of 217 mg/kg bw. Since the CF-1 mouse exhibits typical clinical signs of neurotoxicity, it is sug-
tb
gested that the increased susceptibility of CF-1 mice is related to the accessibility of the 8,9-Z isomer to
no
the target organ, and hence to the presence or absence of P-glycoprotein expression.
ld
ou
Two preliminary oral toxicity studies with the 8,9-Z isomer in pregnant CF-1 mice established a mater-
sh
nal NOAEL of 0.1 mg/kg bw/day for treatment during organogenesis, based on maternal deaths at
d
an
dose levels of 0.5 mg/kg bw/day and higher. Embryotoxicity, expressed as excess incidences of cleft
ge
palate, occurred at dose levels of ≥ 0.1mg/kg bw/day, resulting in a foetal NOAEL of 0.05 mg/kg
a
ck
pa
bw/day. In an oral developmental toxicity study with CF-1 strain mice, no maternal toxicity was ob-
ta
served at a dose level of 0.06 mg/kg bw/day, whereas fetal toxicity (exencephaly and incomplete ossi-
da
fication) was observed at and above 0.03 mg/kg bw/day, resulting in a NOAELfetal in this study of 0.015
n
io
at
mg/kg bw/day.
alu
In a second embryotoxicity study, a maternal and fetal NOAEL was established at 0.015 mg/kg
ev
bw/day, based on resorptions and exencephaly at and above 0.03 mg/kg bw/day and cleft palate at
EC
n
0.1 and 0.5 mg/kg bw/day.

fa
to
ar
In an investigative study with CF-1 mice, abamectin-sensitive and insensitive female mice were mated
sp
to males of unknown sensitivity, and exposed to the 8,9-Z isomer of avermectin B1a during organo-
m
or
genesis. Marked effects on sensitive mice occurred at the dose tested of 0.2-1.0 mg/kg bw/day, and
tf
en
only one female survived to term with a live litter. Therefore, a NOAEL for developmental toxicity in
m
cu
sensitive CF-1 mice could not be established. Body weight gain was decreased during day 6-16 of
do
gestation in sensitive females, and therefore, the NOAEL for maternal toxicity in sensitive CF-1 mice
is
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was <0.2-1.0 mg/kg bw/day. No effects were seen on insensitive maternal mice at doses up to and
t
of
including 1.5 mg/kg bw/day, but cleft palate was observed at all doses levels at and above 0.5 mg/kg
is
as
bw/day.
eb
In a further study with CF-1 mice of known P-glycoprotein genotype, it was shown that the sensitivity
th
on
of CF-1 foetuses to the induction of cleft palate was governed by their own genotype for the mdr1
e d
gene, which encodes for P-glycoprotein. In this study, a dose level of 1.5 mg/kg bw/day of the 8,9-Z
nt
ra
isomer of avermectin B1a resulted in decreased weight gain during day 6-18 of gestation in all treated
eg
females (genotype f x m: +/+ x +/+, +/- x +/+ and +/- x -/-), as well as in untreated -/- females (mated
tb
no
with -/- males). Since the genotyping of the treated groups resemble more the heterozygous negative
t
us
control group than the homozygous negative control group, the decreased weight gain is considered
m
an effect. The NOAEL in this study is therefore < 1.5 mg/kg bw/day. Cleft palates are elicited in sensi-
n
tio
tive foetuses only. Fetal sensitivity to the induction of cleft palate is influenced by genotype for the
ra
st
mdr-1 gene encoding for the P-glycoprotein, a gene governed by Mendelian inheritance. As further
gi
Re
shown, homozygous positive, heterozygous and homozygous negative genotype foetuses express
n.
decreasing amounts of P-glycoprotein in the brain, placental trophoblasts and yolk sac epithelium.
io
lat
There was an inverse relationship between the amounts of P-glycoprotein expressed in homozygous
iso
positive, heterozygous and homozygous negative genotypes and the incidences of cleft palate (0%,
in
d
41% and 97%, respectively). Therefore, there is a strong correlation between increased incidence of
ea
er
cleft palate and reduced expression of P-glycoprotein. A NOAEL for developmental toxicity in this
tb
study could not be established, and the LOAEL is 1.5 mg/kg bw/day.
no
A developmental toxicity study with the 8,9-Z isomer of avermectin B1a in the CD-1 mouse revealed
ld
ou
no evidence of maternal toxicity up to the highest dose tested of 3.0 mg/kg bw/day. An increased inci-
sh
dence in cleft palate was observed in all treated groups. Athough this effect was not dose-related in
d
an
this study, the effect is considered substance related, since cleft palate is observed in several studies.
ge
Therefore, a NOAEL for developmental toxicity could not be derived, and the LOAEL is 0.75 mg/kg
a
ck
pa
bw/day, in the absence of maternal toxicity.

ta
An oral embryotoxicity study of the 8,9-Z isomer of avermectin B1a in the rat demonstrated neither
da
maternal nor embryotoxic effects at dose levels up to 1.0 mg/kg bw/day (NOAEL).
n
io
at
A female reproduction study in the rat, in which the F1 progeny were exposed in utero and throughout
alu
lactation, showed no effects on parental fertility and reproductive performance at dose levels up to
ev
0.40 mg/kg bw/day (NOAEL). The NOAEL for pup toxicity in this study is 0.12 mg/kg bw/day, based on
EC
an increase in post-natal deaths.

n
fa
A microbial point mutation assay demonstrated that the 8,9-Z isomer of avermectin B1a and/or its me-
to
ar
tabolites is not mutagenic at concentrations up to those producing precipitation on the plates.

sp
m
or
Supplementary studies
tf
en
Dietary administration to pregnant CF-1 mice during organogenesis resulted in clinical signs of neuro-
m
cu
toxicity at time-weighted average maternal dose levels of 0.08 mg/kg bw/day.

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In two studies with pregnant and non-pregnant CF-1 mice, singly orally exposed to abamectin techni-
t
of
cal at day 10, 11 or 12 of gestation, it was shown that the LD50’s in pregnant animals were slightly,
is
as
not statistically significantly lower (LD50 = 19 mg/kg bw and LD50 = 11.8 mg/kg bw in study 1 and 2,
eb
respectively) compared to the LD50’s in non-pregnant mice (LD50 = between 20 and 40 mg/kg bw and
th
on
LD50 = 15 mg/kg bw in study 1 and 2, respectively). Typical clinical signs of neurotoxicity (tremors,
e d
clonic convulsion and bradypnea) occured in both pregnant and non-pregnant animals.
nt
ra
In a study with female CF-1 strain mice, heterozygous (+/-) or homozygous positive (+/+) for the mdr-1
eg
gene (which codes for P-glycoprotein expression), the LD50 for abamectin in homozygous positive
tb
no
(+/+) female mice was 28 mg/kg bw, whereas the LD50 in heterozygous female mice was 14 mg/kg
t
us
bw.
m
In a comparative study with CF-1 mice and CD-1 mice, it was demonstrated that 17% of a random
n
tio
population of CF-1 mice are sensitive to abamectin toxicity, showing signs of neurotoxicity (tremors,
ra
st
ataxia, dyspnea, lateral recumbency, coma) in response to 0.8 mg/kg bw/day abamectin for 4 days.
gi
Re
Sensitive CF-1 individuals were shown not to express P-glycoprotein in the cerebrum, cerebellum and
n.
jejunum, whereas “non-sensitive” CF-1 mice and all CD-1 mice were shown to express P-glycoprotein
io
lat
in these tissues. Control and treated CD-1 mice had similar levels of P-glycoprotein.
iso
In a study with rat fetuses, pups and adults, the developmental expression of P-glycoprotein levels
in
d
was examined. It was demonstrated that the expression of P-glycoprotein on the luminal surface of
ea
er
endothelial cells of cerebral and cerebellar capillaries (and tight-junctions of these endothelial cells) is
tb
lower in neonate rats compared to adult rats. The expression of P-glycoprotein develops to full (adult)
no
extent during the first 20 days. Furthermore the expression of P-glycoprotein in the jejunal epithelial
ld
ou
brush border does not start before Postnatal Day 8. It is suggested that neonate rats, with limited or no
sh
P-glycoprotein expression, have increased susceptibility to abamectin toxicity.

d
an
The expression and localization of P-glycoprotein in the brain during the early development of rats was
ge
examined in a further study. P-glycoprotein was undetectable in the embryo and early stages of post-
a
ck
pa
natal development. It was first detected on postnatal day 7 and then gradually increased to reach a
ta
plateau at levels approximating to those seen in adult rats. There is evidence that P-glycoprotein ex-
da
pression is localized in the brain capillaries, suggesting a role for P-glycoprotein in the blood brain bar-
n
io
at
rier.
alu
A study in the juvenile rhesus monkey showed that the most sensitive indicator of abamectin toxicity in
ev
rhesus monkeys is emesis, which occurs at dose levels at and above 2.0 mg/kg bw. The incidence of
EC
emesis is dose-related and the time of onset generally decreases with increasing dose level. Typical
n
fa
clinical signs of abamectin toxicity, tremors and convulsions, are absent in the rhesus monkey and
to
ar
pupil dilation or decreased pupil constriction occur only at dose levels at and above 6.0 mg/kg bw.
sp
Rhesus monkeys seem to be relative insensitive for the acute effects of abamectin since clinical signs
m
or
of neurotoxicity are confined to transient sedation and marked mydriasis at 24 mg/kg bw. Based on
tf
en
the occurence of emesis at and above 2.0 mg/kg bw, the NOAEL in this study is 1.0 mg/kg bw. The
m
cu
maximum plasma concentrations of abamectin occurred 8 - 24 h after oral administration and plasma
do
concentrations increase with increasing dose, but less than proportionally. Despite increases in
is
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s do
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plasma concentration of abamectin with increasing dose level, the severity of clinical signs did not
t
of
markedly increase. Therefore, the dose-response relationship for abamectin in monkeys appears to be
is
as
much flatter than in rodent species and dogs.
eb
In an antidote study with dogs it was demonstrated that 30 ml ipecac administered within 15 minutes
th
on
of abamectin ingestion (8mg/kg bw) prevented coma and death and reduced the incidence and/or se-
e d
verity of mydriasis, ataxia, tremors and convulsion. However, 3g charcoal or ipecac administered more
nt
ra
than 15 minutes after ingestion, were ineffective in reducing abamectin-induced toxicity.
eg
The few published cases of human poisoning by the intravenous, oral or dermal route show a low sus-
tb
no
ceptibility towards the (neuro-)toxicity of abamectin. Even severely poisoned patients showed an un-
t
us
eventful recovery.
m
n
tio
Conclusion
ra
st
Abamectin is almost completely absorbed in the gastrointestinal tract of the rat (calculated oral
gi
Re
bioavailability is 0.86) and distributed throughout tissues and organs. It is rapidly eliminated from the
n.
body, almost exclusively in the faeces, and does not accumulate in tissues/organs after repeated ex-
io
lat
posure. The major reactions involved in the biotransformation of abamectin in the rat are demethyla-
iso
tion, hydroxylation, cleavage of the oleandrosyl ring and oxidation reactions. Dermal penetration is
in
d
very low, less dan 1% is absorbed through the skin of monkeys.

ea
er
Abamectin is very toxic by the oral and inhalatory route. Repeated dose studies with dogs show a
tb
very steep dose response for clinical signs of toxicity and mortality in dogs. Characteristic for the toxic-
no
ity of abamectin as well as the 8,9-Z isomer are clinical signs of neurotoxicity (tremors, ataxia and my-
ld
ou
driasis) and death, however without histopathological correlates in the tissue of the central and pe-
sh
ripheral nervous system.

d
an
In addition to clinical signs, toxicity of abamectin and the 8,9-Z isomer is also characterized by fetotox-
ge
a
icity, as shown by incidences of cleft palate, exencephaly and changes in sex ratio. These effects are
ck
pa
observed in the absence of maternal toxicity. Since the maternal and foetal NOELs are not the same,
ta
and the foetus is more susceptible, abamectin technical and the 8,9-Z isomer are therefore terato-
da
genic.
n
io
at
alu
From studies, not submitted for the present evaluation, it was concluded (by the notifier) that CF-1 mice
ev
exhibits typical clinical signs of neurotoxicity and are increased susceptible to abamectin toxicity. In the
EC
n
present evaluation, studies demonstrated that the increased sensitivity for cleft palate is determined by
fa
to
the genotyping of the fetus for the mdr-1 gene encoding for P-glycoprotein. There is a correlation be-
ar
sp
m
or
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en
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tween increased incidence of cleft palate and reduced expression of P-glycoprotein in sensitive CF-1
t
of
mice (genotype -/- or +/- for P-glycoprotein expression) and not in CD-1 mice (only genotype +/+ for P-
is
as
glycoprotein expression). Polymorphisms of the mdr-1 gene do exist within the human population that
eb
can result in over- as well as under-expression of P-glycoprotein (Hoffmeyer, et al., 20001; Bernal, et
th
on
al., 20032, not submitted for this evaluation). Therefore, the observed effects in the CF-1 mice are
d
e
considered relevant endpoints for human risk evaluation.
nt
ra
In rats, expression of P-glycoprotein in the brain develops to adult levels during the first 20 days after
eg
birth, and the expression of P-glycoprotein in the jejenum does not start before postnatal day 8. Since
tb
no
neonatal rats have limited P-glycoprotein expression (which is considered in contrast to man, evidence
t
us
not submitted for this evaluation), it is suggested that neonatal rats are increased susceptible for ab-
m
mectin toxicity. Since this susceptible period with limited P-glycoprotein expression after birth is not
n
tio
present in man, effects observed in neonatal rats during lactation are considered less appropriate for
ra
st
human risk evaluation of abamectin and the 8,9-Z isomer.
gi
Re
n.
The relevant NOAEL’s and LOAEL’s derived in the different repeated dose toxicity studies are
io
lat
summarized in the tables 2.3.1-1, 2.3.1-2, 2.3.1-3 and 2.3.1-4.
iso
in
d
ea
er
tb
no
ld
ou
sh
d
an
age
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
1
sp
Hoffmeyer, S., Burk, O., von Richter, O., Arnold, H.P., Brockmoller, J. Johne, A., Cascorbi, I., Gerloff, T., Roots, I., Eichel-
baum, M. and Brinkmann, U. (2000): Functional polymorphisms of the human multidrug-resisitance gene: Multiple sequence
m
variations and correlation of one allele with P-glycoprotein expression and activity in vivo. Proc. Natl. Acad. Sci. USA, 92 (7),
or
3473-3478
tf
2
Bernal, M.L.,Sinues, B., Fanlo, A. and Mayayo, E. (2003): Frequency Distribution of C3435T Mutation in Exon 26 of the MDR1
en
Gene in a Spanish Population. Therapeutic Drug Monitoring, 26: 107-111.

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of
is
Table 2.3.1-1 Short-term toxicity studies
as
Test substance Duration, route Species NOAEL LOAEL Critical effects Reference/
eb
(mg/kg bw/day) (mg/kg bw/day) Notifier
th
Abamectin 8 weeks, oral rat - - Range-finding Gordon,
technical (diet) study (only bw, L.R.
on
(vehicle food (1984b)
d
acetone) consumption
e
and clin. signs)
nt
Abamectin 12 weeks, oral dog - - Range-finding Gordon,
ra
technical (diet) study (only bw, L.R.
eg
(vehicle food (1984c)
tb
acetone) consumption,
no
clin. signs and
pupil respons)
t
us
Avermectin B1a 18 weeks, oral dog 0.25 0.5 Mortality, Robertson,
m
(vehicle sesame (gavage) clinical signs of R.T & Allen,
oil) toxicity (ataxia, H.L. (1976)
n
tio
tremors,
mydriasis,
ra
ptyalism),
st
reduced weight
gi
gain,
Re
histopathologic
n.
al changes in
io
the liver
Abamectin 53 weeks, oral dog 0.25 lat 0.5 Absent or Gordon,
iso
technical (diet) decreased L.R.
(vehicle pupil reflex (1984d)
in
acetone) (death at 1.0

d
mg/kg bw/day)
ea
er
tb
no
Table 2.3.1-2 Long-term toxicity studies

Test substance Duration, route Species NOAEL LOAEL Critical effects Reference/
ld
(mg/kg bw/day) (mg/kg bw/day) Notifier

ou
Abamectin 105 weeks, oral rat 1.5 2.0 Increased Gordon,

sh
technical mortality in L.R.

d
(vehicle males, clinical (1985b)

an
acetone) signs (tremors,

unthrifty
ge
appearance)
a
ck
Abamectin 94 weeks, oral CD-1 4.0 8.0 Increased Gordon,

(vehicle mice mortality in L.R.
pa
acetone) males, reduced (1985c)

ta
body weight
da
gain in males
and females,
n
io
extramedullary
at
haematopoiesis
alu
in spleen of
males
ev
EC
n
fa
to
ar
sp
m
or
tf
en
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Table 2.3.1-3 Reproduction and teratogenicity studies
t
of
Species and test substance Route NOAEL LOAEL Critical effects Notifier
is
mg/kg bw/day mg/kg bw/day Reference
as
Abamectin technical (vehicle Oral 2- 0.12 0.4 Parent: increased Gordon, L.R.
eb
sesame oil) genera- mating time, de- (1984e)
th
tion creased number of
study males and females
on
mating, increased
d
duration of cohabita-
e
tion, increased num-
nt
ber of dams with pro-
ra
longed interesrus,
eg
less females littering
tb
Fetus/pups: increased
no
pup mortality, re-
tarded weight gain
t
us
pups (F1 and F2),
increased incidence
m
of total litter loss,
n
decreased lactation
tio
index, increased inci-
ra
dence of retinal
st
anomaly in the eyes
gi
of pups (F1 and F2)
Re
Abamectin technical (vehicle Oral Maternal: 1.6 >1.6 Cleft palate, lumbar Gordon, L.R.
n.
sesame oil) devel- Developm: 0.8 1.6 rib and lumbar rib (1982a)
io
opmen- count variation
tal study lat
iso
Abamectin technical (vehicle Oral Maternal: 1.0 2.0 Maternal: decreased Gordon, L.R.
sesame oil) devel- Developm: 1.0 2.0 water and food con- (1982b)
in
opmen- sumption and weight

d
tal study loss during gestation,

ea
increased number of
er
resorptions.
Developmental: ceft
tb
palate, omphalocele,
no
clubbed fore-feet and

ld
delayed ossification
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
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en
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Table 2.3.1-4 Summary of studies on metabolites
t
of
Study/species Test article NOAEL LOAEL Major effects Reference
is
dose levels (mg/kg bw) (mg/kg bw)
as
Acute oral toxicity; Polar - Reduced activity Gordon ,
eb
CF-1 strain mice metabolite and bradypnea. L.R. (1984c)
th
LD50 > 48
on
Non-polar
d
metabolite(8,9
e
-Z-isomer)
nt
Acute oral toxicity; 8,9-Z isomer LD50 >80mg/kg Decreased activ- Gordon, L.R.
ra
CF-1 strain mouse ity, bradypnea, (1986h)
eg
ataxia, ptosis
tb
and death.
no
Exploratory acute 8,9-Z isomer LD50 = 217mg/kg in CD- 50 mg/kg in CD- Decreased activ- Lynch, D.
oral toxicity; 1 females 1 females ity, bradypnea, (1996)
t
us
CF-1 & CD-1 mice tremors, urine
staining,
m
hunched posture
n
tio
and death.
LD50 = >10 and <10 mg/kg in Decreased activ-
ra
<20mg/kg in CF-1 males CF-1 males ity, bradypnea,
st
ptosis, tremors,
gi
urine staining
Re
and death.
n.
Oral maternal 8,9-Z isomer Maternal: < 1.5 Maternal: < 1.5 Death. Gordon, L.R.
io
toxicity study; (1986d)
CF-1 strain mice lat
iso
Fetal: < 1.5 Fetal: 1.5 Excess inci-
dences of cleft
in
palate and om-

phalocele.
d
ea
Oral maternal 8,9-Z isomer Maternal: 0.1 Maternal: 0.5 Death. Gordon, L.R.
er
toxicity study; (1986e)

CF-1 strain mice Fetal: 0.05 Fetal: 0.1 Excess inci-
tb
dences of cleft
no
palate and ex-

ld
encephaly.
ou
Oral developmental toxic- 8,9-Z isomer Maternal: 0.06 Maternal: > 0.06 No effects Gordon, L.R.
ity study; (1986f)
sh
CF-1 strain mice Fetal: 0.015 Fetal: 0.03 Exencephaly

d
and incomplete
an
ossification
ge
Oral developmental toxic- 8,9-Z isomer Maternal: 0.015 Maternal: 0.03 resorptions Gordon, L.R.
ity study; (1986g)
a
ck
CF-1 strain mice Fetal: 0.015 Fetal: 0.03 cleft palate and
pa
exencepaly.
Oral developmental toxic- 8,9-Z isomer MaternalInsensitive:1.5 Insensitive: > No effects. Wise, L.D.
ta
ity study; Maternalsensitive: <0.2-1.0 1.50 (1996a)

da
Sub-populations of Sensitive: 0.2- Decreased bw

n
abamectin-sensitive and 1.0 gain during day

io
insensitive Fetal : could not be 6-16 of gestation

at
CF-1 strain mice established (only one Fetal: could not -

alu
litter) be established (cleft palate)

ev
(only one litter)

Exploratory oral develop- 8,9-Z isomer Maternal: <1.50 1.50 Decreased Lankas,G.R.
EC
mental toxicity study; weight gain (1996a)

CF-1 mice of known P- during day 6-18
n
fa
glycoprotein genotype of gestation

to
Developmental: < 1.50 1.50 Excess inci-

ar
dence of cleft
sp
palate in sensi-
m
tive fetuses.
or
Oral developmental toxic- 8,9-Z isomer Maternal: 3.0 Maternal: > 3.0 No effects Wise, L.D.
tf
ity study; (1996b)

en
CD-1 strain mice Fetal: < 0.75 fetal : 0.75 Cleft palate
m
cu
Oral developmental toxic- 8,9-Z isomer Maternal: 1.0 Maternal: > 1.0 No effects. Gordon, L.R.
ity study; (1988b)
do
CD strain rats Fetal: 1.0 Fetal: > 1.0 No effects.

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Study/species Test article NOAEL LOAEL Major effects Reference
t
of
dose levels (mg/kg bw) (mg/kg bw)
is
Oral one-generation fe- 8,9-Z isomer Maternal: 0.40 Maternal: > 0.40 No effects. Gordon, L.R.
as
male reproduction study; (1988c)
eb
CD strain rat pup: 0.12 pup: 0.40 Post-natal death
Microbial genotoxicity 8,9-Z isomer Not mutagenic with and - - Gordon, L.R.
th
study; without activation (1988d)
on
4 x S. typhimurium
+ 3 x E. coli strains
e d
nt
ra
eg
Table 2.3.1-5 Summary of supplementary studies
tb
Study/ species NOAEL LOAEL Effects at LOEL Reference
no
dose levels (mg/kg bw/day) (mg/kg bw/day)
10-day dietary maternal - maternal: 0.08 - maternal: 0.24 Tremors, hunched posture, Gordon, L.R.
t
us
toxicity; CF-1 mice; (time-weighted) (time-weighted) poor condition (1984g)
Acute oral toxicity; LD50 non-pregnant <5 Deaths, tremors, bradypnea Gordon, L.R.
m
Pregnant / non-pregnant mice: >20 and <40 (1986h)
n
tio
CF-1 mice mg/kg bw
ra
LD50 pregnant mice: 5 Deaths, tremors, bradypnea
st
19 mg/kg bw
gi
Acute oral toxicity; LD50 non-pregnant <5 Death, loss of righting reflex, Gordon, L.R.
Re
Pregnant / non-pregnant mice: 15.0 mg/kg bw bradypnea (1986h)
n.
CF-1 mice
io
LD50 pregnant <5 Death, tremors, bradypnea,
mice: 11.8 mg/kg bw lat clonic convulsions
iso
Exploratory acute oral toxic- LD50 (+/+ genotype < 10 Tremors, bradypnea, de- Hall, S. (1997)
ity; female mice): 28 creased activity.
in
CF-1 mice of known geno- mg/kg bw

d
type for P-glycoprotein

ea
LD50 (+/- genotype < 10 Tremors, bradypnea, de-

er
female mice): 14 creased activity, weight loss

mg/kg bw during first week
tb
Exploratory oral toxicity; Results: All CF-1 mice showed tremors and ataxia, but 17% also showed Lankas, G.R.
no
CF-1 / CD-1 mice (dose = dyspnea, lateral recumbence and coma (= sensitive to abamectin toxicity). (1994)
ld
0.8 mg/kg bw for 4 days) All but one sensitive animal had no detectable P-glycoprotein in brain and
ou
small intestine.
All insensitive CF-1 mice evaluated and all CD-1 mice had detectable
sh
P-glycoprotein levels.
d
Control and treated CD-1 mice had similar levels of P-glycoprotein.

an
Exploratory study of P- Results: the expression of P-glycoprotein in the cerebrum and cerebellum is Cukierski, M.A.
ge
glycoprotein development in not fully developed in neonate rats. P-glycoprotein expression reaches adult (1995), Lankas,
rat fetuses and pups. levels by post-natal day 20. Expression of P-glycoprotein in the jejunal G.R. (1996b,
a
ck
epithelial brush border does not start before post-natal day 8. It is suggested addendum)
pa
that neonate rats with limited or no P-glycoprotein expression have an in-

creased susceptibility to avermectin toxicity.
ta
Examination of developmen- Results: P-glycoprotein was first detected at post-natal day 7 in pups, with Matsuoka, Y. et
da
tal expression of P- subsequent increases to plateau at adult levels by post-natal day 28. In the al. (1999)
n
glycoprotein levels in rat adult rat brain, P-glycoprotein was detected predominantly in the membrane
io
pups fraction. Double immunostaining of P-glycoprotein and von Willebrand factor

at
Rats postnatal days demonstrated that P-glycoprotein was co-localised with brain capilliaries,
alu
1,3,7,14,21,28,56,84 exam- suggesting a role for P-glycoprotein in the blood brain barrier.
ev
ined
Oral toxicity and plasma Abamectin: 1.0 Abamectin: 2.0 Emesis Gordon, L.R.
EC
level study in monkeys Plasma Cmax = 8 - 24 h (1985d)

Ivermctin: 1.0 Ivermectin: 2.0
n
fa
Exploratory oral non-specific Results: Ipecac administered within 15 minutes of abamectin ingestion pre- Gordon, L.R.
to
antidote study; vented coma and death, and reduced incidence and/or severity of mydriasis, (1984h)
Dog; ataxia, tremors and convulsion
ar
8 mg/kg bw MK-0936 + Charcoal, or ipecac administered more than 15 minutes after ingestion, were
sp
30 ml ipecac (15min) or ineffective in reducing abamectin-induced toxicity

m
3 g charcoal (30min)
or
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2.3.2 ADI
t
of
No human epidemiological data, volunteer studies or case studies were available which allow the es-
is
as
tablishment of an acceptable daily intake (ADI) for abamectin and/or its 8,9-Z isomer based on human
eb
th
data. The ADI has therefore to be derived from the results of toxicity studies with experimental ani-
on
mals. The calculation of the ADI is based on the highest dose at which no adverse effect is observed
e d
in the most appropriate study in the most sensitive species. Abamectin was tested in several toxicity
nt
ra
studies in rats, mice, dogs and monkeys, providing the basis for the establishment of the ADI. The
eg
relevance of findings in animal studies for human risk assessment is also taken into account. Studies
tb
no
with abamectin technical and the 8,9-Z isomer of avermectin B1a have shown that sensitivity to
t
us
abamectin and the 8,9-Z isomer toxicity is linked to the expression of P-glycoprotein. It has been dem-
m
onstrated that the CF-1 mouse is particularly sensitive to abamectin and the 8,9-Z isomer toxicity and
n
tio
that this sensitivity is related to genotype for the mdr-1 gene encoding for P-glycoprotein expression.
ra
st
Since polymorphism for the mdr-1 gene also exist within the human population, the effects observed in
gi
Re
CF-1 mice are considered relevant for human risk evaluation. The neonatal rat is also sensitive be-
n.
cause the blood-brain barrier is incompletely formed at birth, which is considered in contrast to man.
io
lat
Since such sensitive period with limited P-glycoprotein expresion is not present in man, the effects
iso
observed in neonatal rats are considered less relevant for human risk evaluation.
in
d
For the present establishment of the ADI, a comparison is made between the ADI based on all studies
ea
er
available and the ADI based on the studies excluding the sensitive CF-1 mice. This is done for both
tb
abamectin and the 8,9-Z isomer.

no
ld
ou
abamectin
sh
Considering all studies performed with abamectin available for this evaluation the overall NOAEL of
d
an
0.08 mg/kg bw/day was obtained from a maternal toxicity study with CF-1 mice, with a LOAEL of 0.24
ge
mg/kg bw/day, based on tremors, hunched posture and poor condition. Using this overall NOAEL as a
a
ck
pa
starting point for the establishment of the ADI, application of a safety factor is limited to intraspecies
ta
differences, since interspecies differences are already counted for by considering the sensitive CF-1
da
mice. As a result, application of a safety factor of 10 result in an ADI of 0.008 mg/kg bw/day for
n
io
at
abamectin.
alu
Considering the studies performed with abamectin excluding those performed with CF-1 mice, the
ev
overall NOAEL of 0.12 mg/kg bw/day was obtained from a two-generation study in rats, with a LOAEL
EC
of 0.4 mg/kg bw/day, based on maternal toxicity as expressed by increased mating time, decreased
n
fa
number of males and females mating, increased duration of cohabitation and increased number of
to
ar
dams with prolonged interestrus. Application of a safety factor for inter- and intraspecies differences of
sp
100 results in an ADI of 0.0012 mg/kg bw/day, which is lower than the ADI derived from the sensitve
m
or
CF-1 mice study. Therefore, the ADI for abamectin is 0.0012 mg/kg bw/day.
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8,9-Z-isomer
t
of
Considering all studies performed with the 8,9-Z isomer available for this evaluation, the overall
is
as
NOAEL of 0.015 mg/kg bw/day was obtained from two teratogenicity studies in CF-1 mice, both with
eb
LOAEL’s of 0.03 mg/kg bw/day, based on exencephaly, cleft palate and incomplete ossification. Using
th
on
this overall NOAEL as a starting point for the establishment of the ADI, application of a safety factor is
e d
limited to intraspecies differences, since interspecies differences are already counted for by consider-
nt
ra
ing the sensitive CF-1 mice. As a result, application of a safety factor of 10 result in an ADI of 0.0015
eg
mg/kg bw/day for the 8,9-Z isomer of abamectin.
tb
no
t
us
ADI
m
A comparison of the toxicity of the 8,9-Z isomer of avermectin B1a with that of abamectin in develop-
n
tio
mental toxicity and reproduction toxicity studies in rats shows that they have similar toxicity. Therefore
ra
st
it is appropriate to establish a single ADI for abamectin and its 8,9-Z isomer of avermectin B1a. The
gi
Re
ADI for both abamectin and the 8,9-Z isomer of abamectin is 0.0012 mg/kg bw/day.
n.
io
lat
(Note: the revised ADI established by JMPR in 1997 was also based on the NOAEL of 0.12 mg/kg bw/day from
iso
the two-generation study, but their evaluation was confined to fetal toxicity. Accounting for neonatal hypersuscep-
in
tibility in the rat, a reduced uncertainty factor of 50 was applied. In addition, the NOAEL from the one year dog
d
ea
study of 0.25 mg/kg bw/day was considered, with a uncertainty factor of 100. The ADI was rounded down to 0.002
er
mg/kg bw/day. The CVMP (2002; Committee for Veterinary Medicinal Products) recomended that a revised ADI
tb
no
for abamectin should be based on the NOAEL of 0.25 mg/kg bw/day from the one-year repeated dose study in
ld
dogs. Using a uncertainty factor of 100, this would give a value of 0.0025 mg/kg bw/day.)
ou
sh
d
an
2.3.3 ARfD (acute reference dose)

ge
The calculation of the acute reference dose is based on the highest dose at which no adverse effect is
a
ck
pa
observed in the most appropriate acute toxicity study in the most sensitive species. In acute oral and
ta
inhalation toxicity studies, both abamectin and its 8,9-Z isomer appeared to be very toxic. Clinical
da
signs of neurotoxicity and mortality were observed within a few hours after dosing. Also in repeated
n
io
at
dose toxicity studies, these effects were already seen within a few hours after dosing. In teratogenicity
alu
studies, abamectin and 8,9-Z isomer exposure resulted in fetotoxicity, as shown by cleft palate, exen-
ev
cephaly and resorptions. Since these effects are considered to be induced by a single exposure within
EC
a certain time window, such teratogenic effects are considered relevant for the establishment of the
n
fa
ARfD.
to
ar
For the present establishment of the ARfD, a comparison is made between the ARfD based on all
sp
studies available and the ARfD based on the studies excluding the sensitive CF-1 mice. This is done
m
or
for both abamectin and the 8,9-Z isomer.

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abamectin
t
of
Considering all studies performed with abamectin available for this evaluation, the lowest NOAEL of
is
as
0.08 mg/kg bw/day for acute effects was observed in a maternal toxicity study with CF-1 mice. The
eb
LOAEL in this study was 0.24 mg/kg bw/day, based on tremors, hunched posture and poor condition.
th
on
Application of a safety factor is limited to intraspecies differences, since for interspecies differences is
e d
already counted for by considering the sensitive CF-1 mice. As a result, application of a safety factor
nt
ra
of 10 result in an ARfD of 0.008 mg/kg bw/day for abamectin.
eg
Considering the studies performed with abamectin excluding those performed with CF-1 mice,
tb
no
the lowest NOAEL of 0.5 mg/kg bw/day for acute effects was observed in a 18 week toxicity study with
t
us
dogs (based on effects observed in the first week of the study). The LOAEL in this study was 2.0
m
mg/kg bw/day, based on mortality, ataxia, tremors and mydriasis. Application of a safety factor for in-
n
tio
ter- and intraspecies differences of 100 results in an ARfD of 0.005 mg/kg bw/day, which is lower than
ra
st
the ARfD derived from the sensitve CF-1 mice study. Therfore, the ARfD for abamectin is 0.005 mg/kg
gi
Re
bw/day.
n.
io
lat
8,9-Z isomer
iso
Considering the studies performed with the 8,9-Z isomer available for this evaluation, the lowest
in
d
NOAEL of 0.015 mg/kg bw/day for acute effects was observed in two teratogenicity studies with CF-1
ea
er
mice. The LOAEL’s in these studies were 0.03 mg/kg bw/day, based on exencephaly and cleft palate.
tb
no
already counted for by considering the sensitive CF-1 mice. As a result, application of a safety factor
ld
ou
of 10 result in an ARfD of 0.0015 mg/kg bw/day for abamectin 8,9-Z isomer.

sh
d
an
ARfD
ge
A comparison of the toxicity of the 8,9-Z isomer of avermectin B1a with that of abamectin shows that
a
ck
pa
they have no similar toxicity. Therefore it is not appropriate to establish a single ARfD for abamectin
ta
and its 8,9-Z isomer of avermectin B1a. The ARfD for abamectin is 0.005 mg/kg bw/day, whereas the
da
ARfD for the 8,9-Z isomer of avermectin B1a is 0.0015 mg/kg bw/day.
n
io
at
alu
ev
2.3.4 AOEL
EC
The systemic AOEL is based on the lowest appropriate NOAEL determined in short-term repeated
n
fa
dose oral toxicity studies and an appropriate safety factor (SF).

to
ar
sp
abamectin
m
or
Considering all studies performed with abamectin available for this evaluation, the NOAEL of 0.12
tf
en
mg/kg bw/day in the two generation rat study, with a LOAEL of 0.4 mg/kg bw/day based on maternal
m
toxicity as expressed by increased mating time, decreased number of males and females mating, in-
cu
do
creased duration of of cohabitation and increased number of dams with prolonged interestrus is con-
is
sidered to be the most appropriate. For establishment of an internal AOEL according to the method
Th
:
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NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
35
cu
s do
hi
used by the ECCO, a safety factor of 100 is used. Metabolism studies in the rat showed that orally
t
of
administered abamectin is almost completely absorbed (~86%) and therefore it is not necessary to
is
as
adjust the systemic AOEL. This results in an internal systemic short-term AOEL of 0.0012 mg/kg
eb
bw/day. Since this AOEL is already equal to the ADI, other AOEL derivations will not contribute to its
th
on
reliability and are thus not outlined any further.
e d
nt
ra
8,9-Z isomer
eg
Considering all studies performed with the 8,9-Z isomer available for this evaluation, the lowest
tb
no
NOAEL of 0.015 mg/kg bw/day in a teratogenicity study with CF-1 mice, with a LOAEL of 0.03 mg/kg
t
us
bw/day based on resorptions, cleft palate and exencephaly is considered to be the most appropriate.
m
n
tio
already counted for by considering the sensitive CF-1 mice. For establishment of an internal AOEL
ra
st
according to the method used by the ECCO, application of a safety factor of 10 result in an AOEL of
gi
Re
0.0015 mg/kg bw/day for abamectin. Metabolism studies in the rat showed that orally administered
n.
abamectin is almost completely absorbed (~86%) and therefore it is not necessary to adjust the sys-
io
lat
temic AOEL. This results in an internal systemic short-term AOEL of 0.0015 mg/kg bw/day.
iso
in
d
AOEL
ea
er
A comparison of the toxicity of the 8,9-Z isomer of avermectin B1a with that of abamectin in develop-
tb
mental toxicity and reproduction toxicity studies in rats shows that they have similar toxicity. Therefore
no
it is appropriate to establish a single AOEL for abamectin and its 8,9-Z isomer of avermectin B1a. The
ld
ou
AOEL for both abamectin and the 8,9-Z isomer of abamectin is 0.0012 mg/kg bw/day, equal to 0.084
sh
mg/worker/day (assuming a body weight of 70 kg).

d
an
ge
a
ck
2.3.5 Drinking water limit

pa
According to Council Directive 97/57/EC, exposure to abamectin through drinking water should ac-
ta
da
count for not more than 10% of the ADI. If it is assumed that the average daily consumption of water
n
io
amounts to 2 liter per person of 60 kilogram, a drinking water limit of ((60x 0.0012)/10)/2 mg/l, i.e.
at
alu
0.0036 mg/l can be established.

ev
According to Document 8064/VI/79 of the European Commission, the EU drinking water limit for pesti-
EC
cides of 0.1µg/l is applicable for abamectin.

n
fa
to
ar
sp
2.3.6 Impact on human or animal health arising from exposure to the active substance or to
impurities contained in it
m
or
tf
en
Calculations
m
External operator exposure values without and with personal protective equipment (PPE) were calcu-
cu
do
lated using the UK model and the German model. External operator exposure in greenhouses was
is
calculated using a field study (Mich, 1996) and the Dutch model.
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:
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
36
cu
s do
hi
For risk assessment purposes, the 75th percentile of the UK-model was used (UK-75th), the geometric
t
of
mean of the German model (DE-GM), 90th percentile values derived from the field study (Field study
is
as
Mich-90th) and 90th percentile values of the Dutch model (Dutch-90th). These calculations are pre-
eb
sented in the Supplement 1.
th
on
e d
In Supplement 1external operator exposure values without and with PPE were also calculated using
nt
ra
EUROPOEM. For risk assessment purposes, the 75th percentile of EUROPOEM (EUROPOEM-75th)
eg
was used.
tb
no
t
us
Abamectin is non-volatile, according to the summary of chemical-physical properties the vapour pres-
m
sure of abamectin is < 3.7 x 10-6 Pa (25 oC). The models used to estimate inhalation exposure during
n
tio
mixing, loading and application are based on exposure to non-volatile compounds and are therefore
ra
st
representative for exposure estimation to abamectin.
gi
Re
n.
For bystander exposure during manual or mechanical downward spraying, no formally approved mod-
io
lat
els exist. As an estimate, the draft values proposed for the EUROPOEM II, 2002 model were used.
iso
These values represent the 90th percentile exposure values for bystanders. Since bystanding should
in
d
as much as possible be prevented and will usually occur incidentally, it cannot be assumed that by-
ea
er
standers will be using any kind of personal protective equipment, therefore the use of this equipment
tb
is not considered in bystander risk assessment.

no
ld
ou
For re-entry activities no formally approved models are available. As an estimate, the dislodgeable
sh
foliar residue model (DFR-model) is used (Snippe et al., 2002). Worker exposure in greenhouses will
d
an
be estimated using the Dutch model (van Golstein Brouwers et al., 1996).
ge
a
ck
pa
Both the calculations of bystander exposure and worker exposure in are presented in Supplement 1.
ta
da
Risk assessment
n
io
at
alu
Dermal absorption of abamectin in humans was estimated to be 1%, based on a dermal penetration
ev
study with avermectin B1a in rhesus monkeys (see B.6.1 study 7).
EC
For inhalation exposure the default value of 100% absorption was used.
n
fa
to
ar
The risk index was calculated by dividing the internal exposure by the AOEL-systemic. The basic as-
sp
sumptions, input data and calculations used in the risk assessment for the use of abamectin are fur-
m
or
ther specified in Supplement 1.

tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
37
cu
sdo
hi
Table 2.3.6-1 Operator internal exposure and risk assessment
t
of
Model Route Estimated internal exposure AOEL- Risk-index
is
as
(mg a.s./day) systemic
eb
1
(mg a.s./day)
without PPE with PPE without PPE with PPE
th
on
Mechanical upward spraying on citrus, field use
d
e
th
nt
UK-75 Respiratory 0.0043 0.0043 0.072 0.06 0.06
ra
eg
Dermal 0.025 0.013 0.072 0.35 0.18
tb
DE-GM Respiratory 0.0032 0.0032 0.084 0.04 0.04
t no
us
Dermal 0.024 0.0019 0.084 0.29 0.02
m
n
Manual upward spraying on citrus, field use
tio
ra
th
UK-75 Respiratory -- -- - - -
st
gi
Dermal --- -- - - -
Re
n.
DE-GM Respiratory 0.0076 0.0076 0.084 0.09 0.09
io
lat
Dermal 0.053 0.0013 0.084 0.63 0.02
iso
in
Mechanical downward spraying on lettuce, field use

d
ea
th
UK-75 Respiratory 0.0011 0.0011 0.072 0.02 0.02
er
tb
Dermal 0.026 0.0030 0.072 0.36 0.04

no
ld
DE-GM Respiratory 0.00058 0.00058 0.084 <0.01 <0.01

ou
sh
Dermal 0.016 0.00050 0.084 0.19 <0.01

d
an
Manual downward spraying on lettuce, field use

ge
th
UK-75 Respiratory 0.0022 0.0022 0.072 0.03 0.03
a
ck
pa
Dermal 0.067 0.014 0.072 0.93 0.19

ta
da
DE-GM Respiratory --- -- - - -

n
io
Dermal -- -- - - -
at
alu
Manual downward spraying on lettuce, greenhouse application

ev
EC
th
UK-75 Respiratory -- -- - - -
n
fa
Dermal -- -- - - -
to
DE-GM Respiratory -- -- - - -
ar
sp
Dermal -- -- - - -
m
or
th
tf
Dutch-90 Respiratory 0.009 -- 0.084 0.11 -

en
m
Dermal 0.018 -- 0.084 0.21 -

cu
do
Mechanical downward spraying on tomatoes, field use

is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
38
cu
sdo
hi
t
of
is
as
1
(mg a.s./day)
without PPE with PPE without PPE with PPE
eb
th
th
UK- 75 Respiratory 0.0011 0.0011 0.072 0.02 0.02
on
Dermal 0.029 0.0034 0.072 0.40 0.05
d
e
nt
DE- GM Respiratory 0.00069 0.00069 0.084 <0.01 <0.01
ra
eg
Dermal 0.019 0.00060 0.084 0.23 <0.01
tb
no
Mechanical upward spraying on tomatoes, field use
t
us
th
UK- 75 Respiratory 0.0054 0.0054 0.072 0.08 0.08
m
n
Dermal 0.029 0.016 0.072 0.40 0.22
tio
ra
DE- GM Respiratory 0.0032 0.0032 0.084 0.04 0.04
st
gi
Dermal 0.024 0.0019 0.084 0.29 0.02
Re
n.
Manual upward spraying on tomatoes, field use
io
UK- 75
th
Respiratory --- --
lat - - -
iso
Dermal -- -- - - -
in
d
ea
DE- GM Respiratory 0.0076 0.0076 0.084 0.09 0.09

er
Dermal 0.053 0.0013 0.084 0.63 0.02

tb
no
Manual upward spraying on tomatoes, greenhouse application

ld
th
UK- 75 / Field
ou
th
Respiratory 0.0059 0.0059 0.084 0.07 0.07
sh
study Mich-90
d
Dermal 0.22 0.0074 2.62 0.09

an
0.084
ge
DE- GM / Field
Respiratory 0.0070 0.0070 0.084 0.08 0.08
a
th
study Mich-90
ck
pa
Dermal 0.22 0.0029 0.084 2.62 0.03

ta
th
EUROPOEM-75 /
da
Field study Mich- Respiratory -- -- - - -

n
io
th
90
at
alu
Dermal -- -- - - -
ev
th
EC
n
Dermal 0.043 -- 0.084 0.51 -

fa
to
1
An AOEL of 0.072 mg/day is based on a body weight of 60 kg, and an AOEL of 0.084 mg/day is based on 70 kg body weight.
ar
- : no adequate model available

sp
* : exposure considered to be negligible

m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
39
cu
s do
hi
Table 2.3.6-2 Bystander internal exposure and risk assessment
t
of
Estimated internal AOEL-systemic
is
Model Route Risk-index
as
exposure (mg a.s./day) (mg a.s./day)
eb
Upward spraying on citrus, field use
th
on
th
Europoem II-90 Respiratory 0.0011 0.084 0.01
e d
Dermal 0.0022 0.084 0.03
nt
ra
eg
Downward spraying on lettuce, field use
tb
Europoem II-90
th Respiratory 0.00068 0.084 <0.01
t no
Dermal 0.00018 0.084 <0.01
us
m
n
Downward spraying on lettuce, greenhouse application
tio
ra
Respiratory * -
st
gi
Re
Dermal * -
n.
io
Downward spraying on tomatoes, field use
lat
iso
Europoem II-90
th Respiratory 0.00068 0.084 <0.01
in
Dermal 0.00022 0.084 <0.01

d
ea
Upward spraying on tomatoes, field use

er
tb
Europoem II-90
th Respiratory 0.0014 0.084 0.02
no
ld
Dermal 0.0022 0.084 0.03

ou
sh
Upward spraying on tomatoes, greenhouse application

d
an
Respiratory * -
ge
Dermal * -
a
ck
pa
* : no bystanders should be present during application.

ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
40
cu
do
s
hi
Table 2.3.6-3 Worker internal exposure and risk assessment
t
of
is
as
eb
(mg a.s./day) without
without PPE with PPE with PPE
th
PPE
on
Re-entry in citrus (outdoors)
e d
nt
DFR-model Respiratory -- -- - -
ra
eg
Dermal 0.030 -- 0.084 0.36 -
tb
no
th
Dutch-90 Respiratory -- -- - -
t
us
Dermal -- -- - -
m
n
Re-entry in lettuce (outdoors)
tio
ra
st
gi
Dermal 0.014 -- 0.084 0.17 -
Re
n.
th
Dutch-90 Respiratory -- -- - -
io
lat
Dermal -- -- - -
iso
in
Re-entry in lettuce (in greenhouses)

d
ea
er
tb
Dermal 0.007 -- 0.084 0.08 -

no
th
ld
ou
Dermal 0.0081 -- 0.084 0.10 -

sh
d
Re entry in bush tomatoes (outdoors)

an
ge
Respiratory -- -- - -
a
ck
Dermal * * - -
pa
ta
Re entry in stake tomatoes

da
DFR-model
n
Respiratory -- -- - -
io
(outdoors and in greenhouses)

at
Dermal 0.020 -- 0.084 0.24 -

alu
th
Dutch-90
ev
Respiratory 0.0072 -- 0.084 0.09 -

(only in greenhouses)
EC
Dermal 0.020 -- 0.084 0.24 -

n
fa
to
* : exposure considered to be negligible

--: no adequate model available
ar
sp
m
or
Conclusions
tf
en
• Based on the calculated risk-indices (>1) it is concluded that adverse health effects due to dermal
m
cu
exposure during manual upward spraying on tomatoes during greenhouse application using the
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
41
cu
s do
hi
UK-75th/Field study Mich 90th and the DE-GM/Field study Mich 90th models cannot be excluded for
t
of
the unprotected operator.
is
as
• Safe use for bystanders was identified for upwards spraying on citrus (field use), downward spray-
eb
th
ing on lettuce (field use) and tomatoes (field use), and upward spraying on tomatoes (field use)
on
using the EUROPOEM II 2002 model (90th percentile). No risk assessment was executed for by-
e d
standers for the greenhouse applications, as no bystanders should be present in the greenhouses
nt
ra
during application.
eg
• Safe use for workers was identified for re-entry in citrus (outdoors), in lettuce (outdoors and in
tb
no
greenhouses), in bush tomatoes (outdoors) and in stake tomatoes (outdoors and in greenhouses)
t
us
using the DFR and the Dutch models.
m
n
tio
Based on the risk-assessment, adverse health effects due to unprotected dermal exposure to
ra
st
abamectin can not be excluded. In the ECCO-meetings it was decided to use the German Model to
gi
Re
calculate the risk indices. Using the German Model without PPE, no risk is calculated for mechanical
n.
and manual upward spraying on citrus (field use), mechanical and manual downward spraying on let-
io
lat
tuce (field use), manual downward spraying on lettuce (greenhouse application), mechanical down-
iso
ward spraying on tomatoes (fied use) and mechanical and manual upward spraying on tomatoes (field
in
d
use). For manual upward spraying on tomatoes (greenhouse application), no risk is calculated using
ea
er
the German Model with PPE.

tb
no
ld
ou
2.4 Residues
sh
d
an
2.4.1 Definition of the residues relevant to MRLs

ge
Avermectin B1a was found in almost all plant parts examined and in many cases as the major identi-
a
ck
fied compound. The metabolism of avermectin B1b was not tested but the compound comprises up to
pa
ta
20% of the applied active ingredient, so it is expected to constitute a significant portion of the residues.
da
Several metabolites were formed, of which a few were characterised and/or identified. The levels of
n
io
individual metabolites are primarily below 10% TRR and toxicity is expected to be less than for parent
at
alu
compounds. One non-polar metabolite was identified as the 8,9-Z isomer of avermectin B1a. Its con-
ev
centration does not exceed 10% TRR, but its toxicity was shown to be comparable to that of avermec-
EC
tin B1a. Taking into account their toxicology and presence, it is recommended to include avermectin
n
fa
B1a, avermectin B1b, and the avermectin 8,9-Z isomer into the residue definition for risk assessment.
to
ar
Two of these, avermectin B1b and the avermectin 8,9-Z isomer do not necessarily have to be included
sp
in the residue definition for monitoring. However, an analytical method to determine all three analytes
m
or
separately in a single run is available. And if identical residue definitions are proposed, there is no
tf
en
need to establish conversion factors for each commodity. So the following residue definition of plant
m
products for monitoring is proposed: sum of avermectin B1a, avermectin B1a 8,9-Z isomer, and aver-
cu
do
mectin B1b.
is
Th
:
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NI
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
42
cu
s do
hi
With the currently intended use, no significant residues are expected to occur in livestock feed. There-
t
of
fore, it is considered unnecessary to propose a residue definition for animal products at present.
is
as
However, if new uses are requested that lead to significant residues in livestock feed, the current resi-
eb
due definition for the EU MRLs for abamectine from its use as veterinary medicinal product should be
th
on
considered. A posible problem is the avermectin 8,9-Z isomer, which is not formed in animals so it is of
e d
no concern with veterinary drug use. However, it could enter animal products via livestock feed so it is
nt
ra
potentially of concern with pesticide use.
eg
tb
no
t
2.4.2 Residues relevant to consumer safety
us
m
Avermectin B1a was found in almost all plant parts examined and in many cases as the major identi-
n
tio
fied compound. The metabolism of avermectin B1b was not tested but the compound comprises up to
ra
20% of the applied active ingredient, so it is expected to constitute a significant portion of the residues.
st
gi
Several metabolites were formed, of which a few were characterised and/or identified. The levels of
Re
n.
individual metabolites are primarily below 10% TRR and toxicity is expected to be less than for parent
io
lat
compounds. One non-polar metabolite was identified as the 8,9-Z isomer of avermectin B1a. Its con-
iso
centration does not exceed 10% TRR, but its toxicity was shown to be comparable to that of avermec-
in
tin B1a. Taking into account their toxicology and presence, the following residue definition of plant
d
ea
products for risk assessment is proposed: sum of avermectin B1a, avermectin B1a 8,9-Z isomer, and
er
tb
avermectin B1b.
no
ld
ou
With the currently intended use, no significant residues are expected to occur in livestock feed. There-
sh
fore, it is considered unnecessary to propose a residue definition for animal products at present. How-
d
an
ever, if new uses are requested, that lead to significant residues in livestock feed, the current residue
ge
definition for the EU MRLs for abamectine from its use as veterinary medicinal product should be con-
a
ck
sidered. A possible problem is the avermectin 8,9-Z isomer, which is not formed in animals so it is of
pa
no concern with veterinary drug use. However, it could enter animal products via livestock feed so it is
ta
da
potentially of concern with pesticide use.

n
io
at
alu
ev
2.4.3 Residues relevant to worker safety

EC
Exposure of the worker is discussed under 2.3.4.

n
fa
to
ar
2.4.4 Proposed EU MRLs and compliance with existing MRLs

sp
m
For lettuce, the amount of valid residue trials was too small to propose an MRL. For citrus, a MRL of
or
0.01 mg/kg is proposed. For tomato, a MRL of 0.05 mg/kg is proposed. Because the validation of used
tf
en
analytical methods and confirmation of storage stability is not complete for citrus, citrus has a provi-
m
cu
sional MRL. The current MRL-proposal for tomato is higher than the existing MRL.
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
43
cu
s do
hi
Existing EU MRL MRL-proposal notifier MRL-proposal RMS
t
of
Citrus 0.01 0.010 mg/kg 0.01 mg/kg (provisional)
is
as
Tomato 0.02 0.020 mg/kg 0.05 mg/kg
eb
Lettuce 0.10 0.050 mg/kg not possible
th
on
e d
nt
2.4.5 Proposed EU import tolerances and compliance with existing MRLs
ra
eg
Not applicable. There are no proposed EU import tolerances.
tb
no
t
us
2.4.6 Basis for differences, if any, in conclusions reached having regard to established or
m
proposed CAC MRLs
n
tio
For citrus, the established CAC MRL is equal to the proposed (provisional) EU MRL.
ra
st
For tomato, the existing CAC MRL is 0.02 mg/kg. For the CAC MRLs only the residues of avermectin
gi
Re
B1a and its isomer were taken into account, because residues of avermectin B1b are below LOQ. The
n.
currently proposed MRL of 0.05 mg/kg is higher because of the addition of avermectin B1b residues at
io
lat
the LOQ level to the total residues.
iso
in
d
ea
er
2.5 Fate and behaviour in the environment

tb
no
2.5.1 Definition of the residues relevant to the environment

ld
ou
Soil
sh
d
Relevant residues in soil are avermectin B1a and avermectin B1b, and metabolites [8,9-Z]-avermectin
an
B1a (NOA 427011), 8a-oxo-avermectin B1a (NOA 448111), 8a-hydroxy-avermectin B1a (NOA 448112),
ge
a
4,8a-dihydroxy-avermectin B1a (NOA 457464), and 4-hydroxy-8a-oxo-avermectin B1a (NOA 457465).

ck
pa
Surface water
ta
da
Relevant residues in water are avermectin B1a, avermectin B1b and [8,9-Z]-avermectin B1a.
n
io
Sediment
at
alu
Relevant residues in sediment are avermectin B1a and avermectin B1b, and 4"-oxo-avermectin B1a
ev
(NOA 426289)
EC
n
Groundwater
fa
to
Relevant residues in groundwater are avermectin B1a and avermectin B1b by default.
ar
sp
Air
m
or
Relevant residues in water are avermectin B1a and avermectin B1b by default.
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
44
cu
s do
hi
2.5.2 Fate and behaviour in soil
t
of
is
as
2.5.2.1 Route and rate of degradation
eb
th
Route of degradation
on
Under aerobic conditions, avermectin B1a degrades primarily via hydroxylation or oxidation in the
e d
C-8a-position, resulting in formation of 8a-hydroxy-avermectin B1a (NOA 448112) and 8a-oxo-
nt
ra
avermectin B1a (NOA 448111). At 20 °C, the maximum percentages were 13.4 to 15.7 % of AR for
eg
NOA 448112, and 9.1 to 10.3 % for NOA 488111. In one study, it was shown that 8a-hydroxy-
tb
no
avermectin B1a was present as an equilibrium between the hemiacetal ring and the corresponding
t
us
ring-cleaved aldehyde form, total amount was 20.1 % of AR at ambient temperature. This distinction
m
was not made by the analytical methods used in the other studies. The primary products 8a-hydroxy-
n
tio
avermectin B1a and 8a-oxo-avermectin B1a further degrade via hydroxylation in the C-4 position to
ra
st
4,8a-dihydroxy-avermectin B1a (NOA 457464) and 8a-oxo-4-hydroxy-avermectin B1a (NOA 457465). At
gi
Re
20 °C, both compounds reached maximum levels of 9.9 % of AR.
n.
The degradation pathway is shown in Figure 2.5.2-1.
io
lat
iso
in
d
ea
er
tb
no
ld
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
45
cu
do
s
hi
Figure 2.5.2-1. Degradation pathway of avermectin B1a in soil.
t
of
O
O
is
3"
HO
HO
as
4"
OCH3
O 8,9-Z-isomer of avermectin B1a
H3C O O 3' O O (NOA 427011)
eb
2'
4'
CH3 23
CH3 H
1'
16
22
24
O O O
H3C O O 14
O
th
13 15 17 21
25 26 C2H5 O
12
O H
18 H
photolysis
11 19 20
H3C CH3 H
on
10 O O O O
9
OH OH H
d
avermectin B1a
8 2 3
1
8a
e
6 4
O
(NOA 422601) O 5
CH3
nt
H
OH OH
C48H72O14, MW 873.1
ra
eg
further degradation
tb
O
O
no
O HO
HO
O
HO
8a-hydroxy avermectin B1a O 8a-oxo avermectin B1a
aldehyde form of
t
O O
O
(NOA 448112) (NOA 448111)
us
O O
O O 8a-hydroxy avermectin B1a
H
H
m
O O O
H O O O
O O O
O O
n
O H H
H
tio
H H
H O O O O
O O C48H72O15, MW 889.1 C48H70O15, MW 887.1
ra
OH H OH H
OH H CAS 96722-46-2 CAS 102190-68-1
st
O HO O
O O
gi
HO
H H H
OH OH OH
Re
n.
io
lat
iso
O O
in
HO HO 8a-oxo-4-hydroxy avermectin B1a

4,8a-hydroxy
O avermectin B1a O (NOA 457465)
d
O O (NOA 457464) O O
ea
H H
O O
er
O O O O
O O
H H
tb
H H
O O O O
no
OH C48H72O16, MW 905.1 OH C48H70O16, MW 903.1
HO O
ld
O O
H OH H OH
ou
OH OH
sh
d
an
CO2 and bound residues

a ge
ck
pa
The maximum percentages of metabolites as presented above, represent the net amount resulting
ta
from simultaneous formation and decline. Using the Berkely-Madonna program to model simultaneous
da
n
formation and decline of metabolites, the following "true" formation percentages were obtained: 23 and
io
at
30 % for NOA 448111 and NOA 448112 (both formed from avermectin B1a), 58 % for NOA 457464
alu
(from NOA 448111) and 85 % for NOA 457465 (from NOA 448112).
ev
EC
The degradation pathway is similar under influence of light, but given the results of the aqueous
n
photolysis study it is considered that the [8,9-Z]-isomer of avermectin B1a is also formed in soil under
fa
to
influence of light. It is supposed that this isomer is then further degraded comparable to avermectin
ar
sp
B1a.
m
The formation of bound residues was 39.1 % of AR after incubation for 91 days at 20 °C and further
or
tf
increased to 44.1 % of AR after 196 days. Mineralisation accounted for 12.4 % of AR after 91 days
en
and reached 27.6 % of AR in another study at the end of a 365-days incubation period.
m
cu
do
is
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t.
en
m
46
cu
s do
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No fully anaerobic incubations have been carried out. In two studies, anaerobic conditions were estab-
t
of
lished after a period of aerobic conditions. Under these circumstances, no additional metabolites were
is
as
found.
eb
th
Rate of degradation
on
All laboratory experiments on degradation in soil have been carried out with avermectin B1a, either as
e d
nt
14
C- or 3H-labelled substance. Avermectin B1a is the major compound in abamectin, the other minor
ra
eg
component is avermectin B1b. Both components differ only by having an ethylgroup (B1a) or a methyl-
tb
group (B1b) at the 26-C position. Because the content of avermectin B1a in abamectin is ≥ 80 %, and
no
given the small difference in structure, the laboratory results obtained with avermectin B1a are consid-
t
us
ered representative for abamectin. The field dissipation studies have been carried out with the formu-
m
n
lated product.
tio
ra
st
Laboratory studies
gi
Re
n.
Aerobic biodegradation
io
lat
The rate of degradation of avermectin B1a under aerobic conditions was studied in four laboratory ex-
iso
periments in eight different soil types. Resulting DT50's are summarised in Table 2.5.2-1. Dose levels
in
in all studies were higher than the maximum single field rate, but results from the fourth study indicate
d
ea
that there is no clear relation between dose and degradation rate. Values obtained in the same soil
er
tb
type are averaged. The fourth was performed at ambient temperature, which is supposed to be 20 °C.
no
ld
Table 2.5.2-1. Overview of DT50-values from aerobic laboratory degradation studies with avermectin B1a.
ou
Label Soil type Dose T OM pH pF DT50 DT50, 20 °C

sh
mean per soil

[mg/kg] [°C] [%] [d] [d]
d
14
an
C loam 0.22 20 3.2 7.3 2 18.8 18.8

ge
14
C silt loam 0.1 20 4 7.2 2.5 23.3 23.3
a
14
C silt loam 0.1 10 4 7.2 2.5 50.6
ck
14
C silt loam 0.1 30 4 7.2 2.5 16.6
pa
14
C silt loam 0.1 30 4 7.2 4 24.4
ta
14
C loamy sand 0.125 20 2.4 7.41 2.5 23.6 23.6
da
14
C sandy clay loam 0.125 20 4.3 5.81 2.5 11.2 11.2
n
14
C silty clay loam 0.125 20 2.4 7.92 3.5 49.6 49.6
io
at
3
H sandy loam 0.1 ambient 1.1 6.8 2.5 26.9
alu
3
H sandy loam 1 ambient 1.1 6.8 2.5 22.3
ev
3
H sandy loam 50 ambient 1.1 6.8 2.5 42.6 28.3
14
C sandy loam 1 ambient 1.1 6.8 2.5 15.1
EC
14
C sandy loam 1 ambient 1.1 6.8 2.5 47.0
3
n
H sand 1 ambient 0.6 8 2.5 65.7 65.7

fa
3
H clay 0.1 ambient 1.3 6.8 2.5 34.9
39.6
to
3
H clay 1 ambient 1.3 6.8 2.5 44.9
ar
sp
According to guidance of the FOCUS degradation kinetics working group, an average DT50 should be
m
or
calculated as the geometric mean, because each DT50 is calculated as ln 2/k from the underlying rate
tf
en
constant k. The geometric mean DT50 of avermectin B1a at 20 °C is 28.7 days (range 11.2 – 65.7 days;
m
n = 8; r2 0.9471 - 0.9970).
cu
do
Degradation under cold and warm conditions was determined in one soil type. The DT50 at 30 °C was
is
16.6 days. The actual temperature under cold conditions was 8.6 °C, and the DT50 at 10 °C was esti-
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:
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t.
en
m
47
cu
s do
hi
mated by RMS as 50.6 days using the Arrhenius equation. Moisture content may influence the degra-
t
of
dation rate: at 30 °C, the DT50 under dry conditions (pF 4) is 24.4 days, which is higher than the value
is
as
found at field capacity (16.6 days).
eb
th
on
The degradation rates of metabolites 8a-oxo-avermectin B1a (NOA 448111), 8a-hydroxy-avermectin
e d
B1a (NOA 448112) and 4,8a-dihydroxy-avermectin B1a (NOA 457464) could be obtained from studies
nt
ra
with avermectin B1a. DT50-values were estimated using the Berkely-Madonna program, assuming si-
eg
multaneous decline of avermectin B1a and formation and decline of metabolites. Resulting DT50's are
tb
no
summarised in Table 2.5.2-2.
t
us
Table 2.5.2-2. Overview of DT50-values for metabolites estimated from aerobic laboratory degradation studies with avermectin
m
B1a.
n
Compound Soil type Dose T OM pH pF DT50, 20 °C
tio
parent
ra
[mg/kg] [°C] [%] [d]
st
NOA 448111 loam 0.22 20 3.2 7.3 2 50.6
gi
silt loam 0.1 20 4.0 7.2 2.5 40.5
Re
loamy sand 0.125 20 2.4 7.4 2.5 45.3
n.
silty clay loam 0.125 20 2.4 7.9 3.5 45.4
io
NOA 448112 loam 0.22 20 3.2 7.3 lat
2 30.1
iso
silt loam 0.1 20 4.0 7.2 2.5 26.8
loamy sand 0.125 20 2.4 7.4 2.5 26.9
in
silty clay loam 0.125 20 2.4 7.9 3.5 75.4

d
ea
NOA 457464 loam 0.22 20 3.2 7.3 2 99.0

er
silt loam 0.1 20 4.0 7.2 2.5 48.5

loamy sand 0.125 20 2.4 7.4 2.5 59.5
tb
no
NOA 457465 loam 0.22 20 3.2 7.3 2 173

silt loam 0.1 20 4.0 7.2 2.5 59.8
ld
ou
loamy sand 0.125 20 2.4 7.4 2.5 137

sh
d
Geometric mean DT50-values from aerobic laboratory studies at 20 °C are:

an
NOA 448111: 45.3 days (range 40.5 - 50.6 days; n = 4; r2 0.86 - 0.94)
a ge
ck
pa
ta
NOA 457465: 112 days (range 59.8 - 173 days; n = 3; r2 0.97 - 0.98)
da
n
The maximum laboratory DT50-values for NOA 448112, NOA 457464 and NOA 457465 are higher
io
at
than the trigger of 60 days, and information of field studies should be supplied. Several field studies
alu
ev
have been performed with abamectin, and in two studies soil was analysed for metabolites (see be-
EC
low).
n
fa
Anaerobic biodegradation
to
ar
No data are available from studies in which anaerobic conditions were established during the whole
sp
m
incubation period. In one occasion, such an experiment was carried out, but data were not provided in
or
tf
the report. In two cases, anaerobic incubations were established only after a period of aerobic condi-
en
tions during which substantial degradation had occurred (45 - 80 % of AR). Degradation during the
m
cu
anaerobic phase was negligible, an additional decline of 3 to 10 % of AR was observed.

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t.
en
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Photodegradation
t
of
is
From a soil photolysis experiment, a DT50,photolysis of 12.9 days was obtained after incubation under arti-
as
ficial sunlight with a 12 hours photoperiod at 24.5 °C. This DT50 corresponds to 21.7 days at
eb
th
30 - 50 °N.
on
d
Field dissipation
e
nt
ra
Field dissipation studies were carried out in Switzerland, Southern Germany, Northern France and
eg
Italy. All studies were performed with an emulsifiable concentrate with a nominal abamectin content of
tb
no
18 g/L. A summary of conditions and results is given in Table 2.5.2-3.
t
us
Table 2.5.2-3. Summary of field dissipation studies with abamectin EC 18 g/L
m
Location Soil type Land use Dose Month of average daily DT50
n
abamectin application temperature [°C]
tio
[g as/ha] min max overall [d]
ra
1 2
Vouvry, CH sandy loam bare soil 24.4 May 11.0 21.0 16 1.8
st
2
Wallersdorf-See, Bavaria Silt loam bare soil 24.4 May 6.0 25.6 17 <1
gi
3
Neu-Ulm, Bavaria, D Silt loam bare soil 27 June 11.8 21.8 17 <1
Re
3
Wissembourg, Alsace, F Silt bare soil 27 June 13.4 25.7 17 <1
3
Dugliolo, Po Valley, I loam bare soil 27 April 10 21 13 <1
n.
3
io
Juzancourt, Champagne, F loam bare soil 27 May 12 21 13 <1
1: grass cover after application lat
iso
2: determined as avermectin B1a
3: determined as sum of avermectin B1a and its [8,9-Z] isomer
in
d
ea
The results of the field studies confirm that abamectin is rapidly degraded under field conditions. In the
er
first two studies, samples were also analysed for avermectin B1b, [8,9-Z]-avermectin B1a and hydroxy-
tb
no
and oxo-degradates (NOA 448111, 448112, 457464 and 457465). Levels were always below 0.5
ld
µg/kg (LOD), except for the day of application, when maximum levels of avermectin B1b, [8,9-Z]-
ou
sh
avermectin B1a and 8a-hydroxy-avermectin B1a (NOA 448112) were 0.6 or 0.7 µg/ kg (equivalent to 5 -
d
6 % of the initial concentration of avermectin B1a). These levels are about a factor of four lower than
an
ge
expected on the basis of laboratory DT50's (see Section B.8.3). apparently, the dissipation under field
a
ck
conditions is faster than under laboratory conditions.

pa
ta
da
2.5.2.2 Adsorption, desorption and mobility in soil

n
io
at
Adsorption studies
alu
ev
Batch equilibrium experiments have been performed with avermectin B1a in eight different soils. One
EC
for the soils was a sand with 0.1 % OM, which is considered not relevant for agricultural soils. Adsorp-
n
fa
tion of metabolites 8a-oxo-avermectin B1a (NOA 448111), 8a-hydroxy-avermectin B1a (NOA 448112),
to
4-hydroxy-8a-oxo-avermectin B1a (NOA 457464) and 4,8a-dihydroxy-avermectin B1a (NOA 457465)

ar
sp
was tested in three different soils. Resulting KF, KOM and KOC-values and means are summarised in
m
Table 2.5.2-4.
or
tf
en
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en
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Table 2.5.2-4. KF, KOM and KOC of avermectin B1a and metabolites from batch adsorption studies.
t
of
Compound KF [L/kg] KOC [L/kg] KOM [L/kg]
is
average range average range average range n
as
avermectin B1a 129 18.2 -334 5638 1495 - 7893 3270 867 - 4578 7
eb
NOA 448111 81.7 38.3 - 128 3997 3027 - 5052 2115 1756 - 2319 3
th
NOA 448112 41.1 15.9 - 78.9 1943 1098 - 3104 1127 637 - 1801 3
NOA 457464 35.4 16.9 - 61.3 1732 1082 - 2423 1019 636 - 1426 3
on
NOA 457465 82.3 32.7 - 148 3908 2573 - 5813 1898 1492 - 2267 3
e d
nt
ra
Sorption of avermectin B1a is related to OM-content, linear regression of KF versus % OM gives a re-
eg
gression coefficient r2 of 0.919. There are indications that the sorption of metabolites is related to clay
tb
content. Because the number of soils tested for each metabolite is limited to three, a definitive conclu-
tno
sion with respect to this aspect cannot be drawn.
us
m
Column leaching studies and leaching of aged residues
n
tio
Two column leaching studies with avermectin B1a were submitted, one with aged and non-aged resi-
ra
st
dues, the other with aged residues. The first study was considered not acceptable because of ques-
gi
Re
tions about the mass balance and possible preferential flow patterns. In the second study, avermectin
n.
B1a was aged for 20 days in two soil types. After the ageing period, 39 - 47 % of AR was present as
io
lat
unchanged parent, and metabolites NOA 448111, NOA 448112, NOA 457464 and NOA 457465 were
iso
detected at levels of 8 - 9, 12 - 14, 2 - 4 and 3 % of AR, respectively. Leachates contained 0.5 - 0.9 %
in
d
of the radioactivity applied on the column, maximum of avermectin B1a was 0.2 % of the applied aged
ea
er
residue, metabolites were < 0.1 %. Most of the residual activity was found in the upper layers of the
tb
soil column: 97.1 and 88.4 % of the radioactivity applied on the column was found at 0 - 4 cm depth. In
no
the upper 4 cm, unchanged avermectin B1a accounted for 44.8 and 36.6 % of the aged residue, me-
ld
ou
tabolites NOA 448111 and NOA 448112 for 8.0 % and 14.0 - 14.2 % and metabolites NOA 457464
sh
and NOA 457465 for 2.8 - 3.4 % and 1.6 - 2.3 % of the aged residue, respectively.
d
an
ge
a
ck
Lysimeter studies
pa
Lysimeter studies were not performed but are not considered necessary.
ta
da
n
io
at
2.5.2.3 Predicted environmental concentrations in soil (PECS)

alu
The PECS has been calculated for the proposed use of Vertimec 018 in citrus, lettuce and tomatoes,
ev
EC
based on the maximum application rates of 3 x 21.6 g as/ha for citrus and field grown tomatoes, 3 x 18
n
g as/ha for field grown lettuce, 4 x 9 g as/ha for lettuce under glass and 5 x 21.6 g as/ha for tomatoes
fa
to
under glass, all with a 7-days spraying interval. Crop interception is assumed to be 70 % for citrus,
ar
40 % for lettuce and 50 % for tomatoes, which is the average crop cover used in Steps 1-2 in FOCUS.
sp
The soil bulk density is 1500 kg/m3, the compound is homogeneously distributed over 5 cm soil depth.
m
or
Based on the results of the field dissipation studies, the worst case DT50 for abamectin is 1.8 days.
tf
en
The PECS for metabolites 8a-oxo-avermectin B1a (NOA 448111), 8a-hydroxy-avemectin B1a (NOA
m
cu
448112), 4,8a-dihydroxy-avermectin B1a (NOA 457464) and 8a-oxo-4-hydroxy-avermectin B1a (NOA

do
457465), have been calculated in two ways both based on laboratory values:
is
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:
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t.
en
m
50
cu
s do
hi
1) the standard approach in which the application rate of the parent is corrected for formation rate
t
of
and relative molar mass of metabolites
is
as
2) using the Berkely-Madonna program, assuming simultaneous formation and decline of metabo-
eb
lites.
th
on
Method 1
e d
nt
The "application rate" of metabolites NOA 448111, NOA 448112, NOA 457464 and NOA 457465 was
ra
eg
calculated by correction of the application rate of abamectin with the maximum levels of metabolites
tb
found in the aerobic degradation studies (10.3, 15.7, 9.9 and 9.9 %) and the relative molar masses
no
(1.02, 1.02, 1.04 and 1.03). In this way, the maximum PECS for the metabolites is obtained on the day
t
us
of application. As no DT50,field-values could be derived, the respective geometric mean DT50-values of
m
n
45.5, 35.8, 65.9 and 112 days from the aerobic laboratory degradation studies have been used. In
tio
ra
view of the very low levels of these metabolites found in the field samples only on the day of applica-
st
gi
tion, the average laboratory DT50-values are considered to represent a severe worst case. Resulting
Re
PECS are given in Tables 2.5.2-5 for citrus, 2.5.2-6 and 2.5.2-7 for lettuce and 2.5.2-8 and 2.5.2-9 for
n.
io
tomatoes. lat
iso
in
d
ea
er
tb
no
ld
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
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do
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t.
en
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Table 2.5.2-5. Predicted Environmental Concentrations of abamectin and metabolites in soil (PECS, in mg/kg soil), following
t
of
application of Vertimec 018 to citrus at 3 x 0.0216 kg as/ha per single treatment.
is
as
Days after Single application Single application Multiple application Multiple application
eb
last application actual time weighted average actual time weighted average
abamectin 0 0.00864 0.0093
th
1 0.0059 0.0072 0.0063 0.0077
on
2 0.0040 0.0060 0.0043 0.0065
4 0.0019 0.0044 0.0020 0.0047
d
e
7 0.0006 0.0030 0.0006 0.0032
nt
14 0.0000 0.0016 0.0000 0.0017
ra
21 0.0011 0.0011
eg
28 0.0008 0.0009
56 0.0004 0.0004
tb
100 0.0002 0.0002
no
t
NOA 448111 0 0.0009 0.0024
us
1 0.0009 0.0009 0.0024 0.0024
m
2 0.0009 0.0009 0.0024 0.0024
n
4 0.0009 0.0009 0.0023 0.0024
tio
7 0.0008 0.0009 0.0022 0.0023
ra
14 0.0007 0.0008 0.0020 0.0022
st
21 0.0007 0.0008 0.0018 0.0021
gi
28 0.0006 0.0007 0.0016 0.0020
Re
56 0.0004 0.0006 0.0010 0.0016
100 0.0002 0.0005 0.0005 0.0013
n.
io
NOA 448112 0 0.0014 0.0037
lat
1 0.0014 0.0014 0.0036 0.0037
iso
2 0.0013 0.0014 0.0036 0.0036

4 0.0013 0.0013 0.0034 0.0036
in
7 0.0012 0.0013 0.0033 0.0035

d
14 0.0011 0.0012 0.0029 0.0033

ea
21 0.0010 0.0012 0.0026 0.0031

er
28 0.0008 0.0011 0.0023 0.0029

tb
56 0.0005 0.0009 0.0014 0.0024

no
100 0.0002 0.0007 0.0006 0.0017

ld
NOA 457464 0 0.0009 0.0024

ou
1 0.0009 0.0009 0.0024 0.0024

sh
2 0.0009 0.0009 0.0024 0.0024

4 0.0008 0.0009 0.0023 0.0024
d
7 0.0008 0.0008 0.0023 0.0024

an
14 0.0008 0.0008 0.0021 0.0023

ge
21 0.0007 0.0008 0.0020 0.0022

a
28 0.0007 0.0008 0.0018 0.0021

ck
56 0.0005 0.0007 0.0014 0.0019

pa
100 0.0003 0.0006 0.0009 0.0015

ta
NOA 457465 0 0.0009 0.0025

da
1 0.0009 0.0009 0.0025 0.0025

n
2 0.0009 0.0009 0.0025 0.0025

io
4 0.0008 0.0009 0.0025 0.0025

at
7 0.0008 0.0009 0.0024 0.0025

alu
14 0.0008 0.0008 0.0023 0.0024

ev
21 0.0008 0.0008 0.0022 0.0024

28 0.0007 0.0008 0.0021 0.0023
EC
56 0.0006 0.0007 0.0018 0.0021

n
100 0.0005 0.0007 0.0014 0.0019

fa
to
ar
sp
m
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en
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t.
en
m
52
cu
do
s
thi
of
is
as
field application of Vertimec 018 to lettuce at 3 x 0.018 kg as/ha per single treatment.
eb
th
abamectin 0 0.0144 0.0154
on
1 0.0098 0.0120 0.0105 0.0128
d
2 0.0067 0.0100 0.0071 0.0108
e
4 0.0031 0.0073 0.0033 0.0079
nt
7 0.0010 0.0050 0.0010 0.0053
ra
14 0.0001 0.0027 0.0001 0.0029
eg
21 0.0000 0.0018 0.0000 0.0019
tb
28 0.0013 0.0014
56 0.0007 0.0007
no
100 0.0004 0.0004
t
us
NOA 448111 0 0.0015 0.0041
m
1 0.0015 0.0015 0.0040 0.0040
n
2 0.0015 0.0015 0.0040 0.0040
tio
4 0.0014 0.0015 0.0038 0.0040
ra
7 0.0014 0.0014 0.0037 0.0039
st
14 0.0012 0.0014 0.0033 0.0037
gi
21 0.0011 0.0013 0.0030 0.0035
Re
28 0.0010 0.0012 0.0027 0.0033
56 0.0006 0.0010 0.0017 0.0027
n.
io
100 0.0003 0.0008 0.0009 0.0021
lat
NOA 448112 0 0.0023 0.0061
iso
1 0.0023 0.0023 0.0060 0.0060

in
2 0.0022 0.0023 0.0058 0.0060

4 0.0021 0.0022 0.0056 0.0058
d
ea
7 0.0020 0.0022 0.0053 0.0057

14 0.0018 0.0020 0.0046 0.0053
er
21 0.0015 0.0019 0.0040 0.0050

tb
28 0.0013 0.0018 0.0035 0.0047

no
56 0.0008 0.0014 0.0021 0.0037

100 0.0003 0.0010 0.0009 0.0027
ld
ou
NOA 457464 0 0.0015 0.0041

sh
1 0.0014 0.0014 0.0040 0.0040

2 0.0014 0.0014 0.0040 0.0040
d
an
4 0.0014 0.0014 0.0039 0.0040

7 0.0014 0.0014 0.0038 0.0039
ge
14 0.0013 0.0014 0.0035 0.0038

a
21 0.0012 0.0013 0.0033 0.0036

ck
28 0.0011 0.0013 0.0030 0.0035

pa
56 0.0008 0.0011 0.0023 0.0031

ta
100 0.0005 0.0009 0.0014 0.0025

da
NOA 457465 0 0.0014 0.0042

n
io
1 0.0014 0.0014 0.0041 0.0042

at
2 0.0014 0.0014 0.0041 0.0041

alu
4 0.0014 0.0014 0.0040 0.0041

7 0.0014 0.0014 0.0038 0.0041
ev
14 0.0013 0.0014 0.0035 0.0040

EC
21 0.0013 0.0014 0.0031 0.0039

28 0.0012 0.0013 0.0029 0.0038
n
56 0.0010 0.0012 0.0021 0.0035

fa
100 0.0008 0.0011 0.0011 0.0031

to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
53
cu
do
s
hi
t
of
glasshouse application of Vertimec 018 to lettuce at 4 x 0.009 kg as/ha per single treatment.
is
as
eb
abamectin 0 0.0072 0.0077
th
1 0.0049 0.0060 0.0053 0.0064
on
2 0.0033 0.0050 0.0036 0.0054
4 0.0015 0.0037 0.0017 0.0039
d
e
7 0.0005 0.0025 0.0005 0.0027
nt
14 0.0000 0.0013 0.0000 0.0014
ra
21 0.0009 0.0010
eg
28 0.0007 0.0007
56 0.0003 0.0004
tb
100 0.0002 0.0002
no
t
NOA 448111 0 0.0008 0.0020
us
1 0.0007 0.0007 0.0020 0.0020
m
2 0.0007 0.0007 0.0020 0.0020
n
4 0.0007 0.0007 0.0019 0.0020
tio
7 0.0007 0.0007 0.0018 0.0019
ra
14 0.0006 0.0007 0.0016 0.0018
st
21 0.0005 0.0006 0.0015 0.0017
gi
28 0.0005 0.0006 0.0013 0.0017
Re
56 0.0003 0.0005 0.0009 0.0014
100 0.0002 0.0004 0.0004 0.0010
n.
io
NOA 448112 0 0.0012 0.0030
lat
1 0.0011 0.0011 0.0030 0.0060
iso
2 0.0011 0.0011 0.0029 0.0060

4 0.0011 0.0011 0.0028 0.0058
in
7 0.0010 0.0011 0.0026 0.0057

d
14 0.0009 0.0010 0.0023 0.0053

ea
21 0.0008 0.0009 0.0020 0.0050

er
28 0.0007 0.0009 0.0018 0.0047

tb
56 0.0004 0.0007 0.0010 0.0037

no
100 0.0002 0.0005 0.0004 0.0027

ld
NOA 457464 0 0.0007 0.0020

ou
1 0.0007 0.0007 0.0020 0.0020

sh
2 0.0007 0.0007 0.0020 0.0020

4 0.0007 0.0007 0.0019 0.0020
d
7 0.0007 0.0007 0.0019 0.0020

an
14 0.0006 0.0007 0.0018 0.0019

ge
21 0.0006 0.0007 0.0016 0.0018

a
28 0.0005 0.0006 0.0015 0.0018

ck
56 0.0004 0.0005 0.0011 0.0015

pa
100 0.0003 0.0004 0.0007 0.0013

ta
NOA 457465 0 0.0007 0.0021

da
1 0.0007 0.0007 0.0021 0.0021

n
2 0.0007 0.0007 0.0021 0.0021

io
4 0.0007 0.0007 0.0020 0.0021

at
7 0.0007 0.0007 0.0020 0.0020

alu
14 0.0007 0.0007 0.0019 0.0020

ev
21 0.0006 0.0007 0.0018 0.0020

28 0.0006 0.0007 0.0018 0.0019
EC
56 0.0005 0.0006 0.0015 0.0018

n
100 0.0004 0.0011 0.0011 0.0016

fa
to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
54
cu
do
s
thi
of
field application of Vertimec 018 to tomatoes at 3 x 0.0216 kg as/ha per single treatment.
is
as
eb
abamectin 0 0.0144 0.0154
th
1 0.0098 0.0120 0.0105 0.0128
2 0.0067 0.0100 0.0071 0.0108
on
4 0.0031 0.0073 0.0033 0.0079
d
7 0.0010 0.0050 0.0010 0.0053
e
nt
14 0.0001 0.0027 0.0001 0.0029
ra
21 0.0000 0.0018 0.0000 0.0019
eg
28 0.0013 0.0014
56 0.0007 0.0007
tb
100 0.0004 0.0004
no
NOA 448111 0 0.0015 0.0041
t
us
1 0.0015 0.0015 0.0040 0.0040
m
2 0.0015 0.0015 0.0040 0.0040
4 0.0014 0.0015 0.0038 0.0040
n
tio
7 0.0014 0.0014 0.0037 0.0039
14 0.0012 0.0014 0.0033 0.0037
ra
21 0.0011 0.0013 0.0030 0.0035
st
28 0.0010 0.0012 0.0027 0.0033
gi
56 0.0006 0.0010 0.0017 0.0027
Re
100 0.0003 0.0008 0.0009 0.0021
n.
io
NOA 448112 0 0.0023 0.0061
1 0.0023 0.0023 lat
0.0060 0.0060
iso
2 0.0022 0.0023 0.0058 0.0060
4 0.0021 0.0022 0.0056 0.0058
in
7 0.0020 0.0022 0.0053 0.0057

d
14 0.0018 0.0020 0.0046 0.0053

ea
21 0.0015 0.0019 0.0040 0.0050

er
28 0.0013 0.0018 0.0035 0.0047

56 0.0008 0.0014 0.0021 0.0037
tb
100 0.0003 0.0010 0.0009 0.0027

no
ld
NOA 457464 0 0.0015 0.0041

ou
1 0.0014 0.0014 0.0040 0.0040

2 0.0014 0.0014 0.0040 0.0040
sh
4 0.0014 0.0014 0.0039 0.0040

d
7 0.0014 0.0014 0.0038 0.0039

an
14 0.0013 0.0014 0.0035 0.0038

ge
21 0.0012 0.0013 0.0033 0.0036

28 0.0011 0.0013 0.0030 0.0035
a
ck
56 0.0008 0.0011 0.0023 0.0031

pa
100 0.0005 0.0009 0.0014 0.0025

ta
NOA 457465 0 0.0014 0.0042

da
1 0.0014 0.0014 0.0041 0.0042

n
2 0.0014 0.0014 0.0041 0.0041

io
4 0.0014 0.0014 0.0041 0.0041

at
7 0.0014 0.0014 0.0040 0.0041

alu
14 0.0013 0.0014 0.0038 0.0040

21 0.0013 0.0014 0.0037 0.0039
ev
28 0.0012 0.0013 0.0035 0.0038

EC
56 0.0010 0.0012 0.0029 0.0035

100 0.0008 0.0011 0.0022 0.0031
n
fa
to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
55
cu
do
s
thi
of
glasshouse application of Vertimec 018 to tomatoes at 5 x 0.0216 kg as/ha per single treatment.
is
as
eb
Abamectin 0 0.0144 0.0154
th
1 0.0098 0.0120 0.0105 0.0128
2 0.0067 0.0100 0.0071 0.0108
on
4 0.0031 0.0073 0.0033 0.0079
d
7 0.0010 0.0050 0.0010 0.0053
e
nt
14 0.0001 0.0027 0.0001 0.0029
ra
21 0.0000 0.0018 0.0019
eg
28 0.0013 0.0014
56 0.0007 0.0007
tb
100 0.0004 0.0004
no
NOA 448111 0 0.0015 0.0062
t
us
1 0.0015 0.0015 0.0061 0.0061
m
2 0.0015 0.0015 0.0060 0.0061
4 0.0014 0.0015 0.0058 0.0060
n
tio
7 0.0014 0.0014 0.0055 0.0058
14 0.0012 0.0014 0.0050 0.0055
ra
21 0.0011 0.0013 0.0045 0.0053
st
28 0.0010 0.0012 0.0040 0.0050
gi
56 0.0006 0.0010 0.0026 0.0041
Re
100 0.0003 0.0008 0.0013 0.0032
n.
io
NOA 448112 0 0.0023 0.0089
1 0.0023 0.0023 lat
0.0088 0.0060
iso
2 0.0022 0.0023 0.0086 0.0060
4 0.0021 0.0022 0.0083 0.0058
in
7 0.0020 0.0022 0.0078 0.0057

d
14 0.0018 0.0020 0.0068 0.0053

ea
21 0.0015 0.0019 0.0060 0.0050

er
28 0.0013 0.0018 0.0052 0.0047

56 0.0008 0.0014 0.0030 0.0037
tb
100 0.0003 0.0010 0.0013 0.0027

no
ld
NOA 457464 0 0.0015 0.0063

ou
1 0.0014 0.0014 0.0062 0.0063

2 0.0014 0.0014 0.0062 0.0062
sh
4 0.0014 0.0014 0.0061 0.0062

d
7 0.0014 0.0014 0.0059 0.0061

an
14 0.0013 0.0014 0.0054 0.0059

ge
21 0.0012 0.0013 0.0051 0.0057

28 0.0011 0.0013 0.0047 0.0055
a
ck
56 0.0008 0.0011 0.0035 0.0048

pa
100 0.0005 0.0009 0.0022 0.0039

ta
NOA 457465 0 0.0014 0.0067

da
1 0.0014 0.0014 0.0066 0.0066

n
2 0.0014 0.0014 0.0066 0.0066

io
4 0.0014 0.0014 0.0065 0.0066

at
7 0.0014 0.0014 0.0064 0.0065

alu
14 0.0013 0.0014 0.0061 0.0064

21 0.0013 0.0014 0.0058 0.0062
ev
28 0.0012 0.0013 0.0056 0.0061

EC
56 0.0010 0.0012 0.0047 0.0056

100 0.0008 0.0011 0.0036 0.0050
n
fa
to
ar
Method 2
sp
The PECS of the metabolites was additionally calculated with Berkely-Madonna, using the formation
m
or
fractions and rate constants as obtained from the laboratory study fits as input.The average formation
tf
en
fractions were 0.23 and 0.30 for NOA 448111 and NOA 448112 (both from avermectin B1a), 0.58 for
m
NOA 457464 (from NOA 448111) and 0.85 for NOA 457465 (from NOA 448112), the geometric mean
cu
do
rate constants were 0.0153/d for NOA 448111, 0.0194/d for NOA 448112, 0.0105/d for NOA 457464
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
56
cu
s do
hi
and 0.0062/d for NOA 457465. Schematically drawn, the following simulation was performed (Figure
t
of
2.5.2-2):
is
as
eb
Figure 2.5.2-2. Modelled pathway for the calculation of PECS of metabolites.
th
Sink 0.47 avermectin B1a
on
e d
nt
0.30 0.23
ra
eg
Sink 0.42 NOA 448112 NOA 448111 0.15 Sink
tb
k = 0.0194/d k = 0.0153/d
no
0.58 0.85
t
us
m
NOA 457464 NOA 457465
n
k = 0.0105/d k = 0.0062/d
tio
ra
1 1
st
gi
Re
Sink Sink
n.
io
lat
In this way, the PECS of the metabolites depends on the combination of formation and decline and the
iso
maximum level is found only after a certain time period. Resulting PECS are given in Tables 2.5.2-10
in
for citrus, 2.5.2-11 and 2.5.2-12 for lettuce and 2.5.2-13 and 2.5.2-14 for tomatoes. Maximum concen-
d
ea
er
trations for metabolites are indicated in bold.

tb
no
ld
ou
sh
d
an
a ge
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
57
cu
s do
hi
t
of
is
as
application of Vertimec 018 to citrus at 3 x 0.0216 kg as/ha per single treatment as calculated with Berkely-Madonna.
eb
th
abamectin 0 0.00864 0.0093
on
1 0.0059 0.0072 0.0063 0.0077
d
2 0.0040 0.0060 0.0043 0.0065
e
4 0.0019 0.0044 0.0020 0.0047
nt
7 0.0006 0.0030 0.0006 0.0032
ra
14 0.0000 0.0016 0.0000 0.0017
eg
21 0.0011 0.0011
tb
28 0.0008 0.0009
no
56 0.0004 0.0004
100 0.0002 0.0002
t
us
NOA 448111 0 0.0000 0.0034
m
1 0.0010 0.0005 0.0044 0.0039
n
tio
2 0.0015 0.0008 0.0048 0.0042
4 0.0018 0.0012 0.0050 0.0045
ra
7 0.0018 0.0014 0.0049 0.0047
st
14 0.0016 0.0016 0.0044 0.0047
gi
21 0.0015 0.0016 0.0040 0.0045
Re
28 0.0013 0.0015 0.0036 0.0043
n.
56 0.0009 0.0013 0.0023 0.0036
io
100 0.0004 0.0010 0.0012 0.0028
lat
iso
NOA 448112 0 0.0000 0.0043
1 0.0013 0.0006 0.0055 0.0049
in
2 0.0019 0.0011 0.0061 0.0053

4 0.0023 0.0015 0.0063 0.0057
d
ea
7 0.0023 0.0018 0.0061 0.0059

er
14 0.0020 0.0020 0.0054 0.0058

21 0.0018 0.0019 0.0047 0.0055
tb
28 0.0015 0.0019 0.0041 0.0052

no
56 0.0009 0.0015 0.0024 0.0042

100 0.0004 0.0011 0.0010 0.0031
ld
ou
NOA 457464 0 0.0000 0.0005

sh
1 0.0000 0.0000 0.0005 0.0005

d
2 0.0000 0.0000 0.0006 0.0005

an
4 0.0001 0.0000 0.0007 0.0006

7 0.0001 0.0001 0.0009 0.0007
ge
14 0.0003 0.0001 0.0013 0.0009

a
ck
21 0.0004 0.0002 0.0015 0.0010

28 0.0005 0.0003 0.0018 0.0012
pa
56 0.0007 0.0005 0.0022 0.0016

ta
100 0.0007 0.0006 0.0020 0.0018

da
NOA 457465 0 0.0000 0.0000 0.0004

n
io
1 0.0000 0.0000 0.0005 0.0004

at
2 0.0000 0.0000 0.0005 0.0005

alu
4 0.0001 0.0000 0.0006 0.0005

7 0.0001 0.0001 0.0008 0.0006
ev
14 0.0003 0.0001 0.0012 0.0008

EC
21 0.0004 0.0002 0.0015 0.0008

28 0.0005 0.0003 0.0018 0.0012
n
56 0.0008 0.0005 0.0025 0.0017

fa
100 0.0009 0.0006 0.0027 0.0021

to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
58
cu
s do
hi
t
of
is
as
field application of Vertimec 018 to lettuce at 3 x 0.018 kg as/ha per single treatment as calculated with Berkely-Madonna.
eb
th
abamectin 0 0.0144 0.0154
on
1 0.0098 0.0120 0.0105 0.0128
d
2 0.0067 0.0100 0.0071 0.0108
e
4 0.0031 0.0073 0.0033 0.0079
nt
7 0.0010 0.0050 0.0010 0.0053
ra
14 0.0001 0.0027 0.0001 0.0029
eg
21 0.0000 0.0018 0.0000 0.0019
tb
28 0.0013 0.0014
no
56 0.0007 0.0007
100 0.0004 0.0004
t
us
NOA 448111 0 0.0000 0.0057
m
1 0.0016 0.0008 0.0073 0.0065
n
tio
2 0.0024 0.0014 0.0080 0.0070
4 0.0030 0.0020 0.0084 0.0076
ra
7 0.0030 0.0024 0.0082 0.0078
st
14 0.0027 0.0026 0.0074 0.0078
gi
21 0.0025 0.0026 0.0066 0.0075
Re
28 0.0022 0.0025 0.0060 0.0072
n.
56 0.0014 0.0022 0.0039 0.0060
io
100 0.0007 0.0017 0.0020 0.0046
lat
iso
NOA 448112 0 0.0000 0.0072
1 0.0021 0.0011 0.0092 0.0082
in
2 0.0032 0.0018 0.0101 0.0089

4 0.0038 0.0026 0.0106 0.0095
d
ea
7 0.0038 0.0030 0.0102 0.0098

er
14 0.0034 0.0033 0.0089 0.0097

21 0.0030 0.0032 0.0078 0.0092
tb
28 0.0026 0.0031 0.0068 0.0087

no
56 0.0015 0.0026 0.0040 0.0070

100 0.0006 0.0019 0.0017 0.0051
ld
ou
NOA 457464 0 0.0000 0.0008

sh
1 0.0000 0.0000 0.0008 0.0008

d
2 0.0000 0.0000 0.0009 0.0008

an
4 0.0001 0.0001 0.0012 0.0009

7 0.0002 0.0001 0.0015 0.0011
ge
14 0.0005 0.0002 0.0021 0.0014

a
ck
21 0.0007 0.0004 0.0026 0.0017

28 0.0009 0.0005 0.0029 0.0020
pa
56 0.0012 0.0008 0.0036 0.0027

ta
100 0.0011 0.0010 0.0033 0.0030

da
NOA 457465 0 0.0000 0.0007

n
io
1 0.0000 0.0000 0.0008 0.0007

at
2 0.0000 0.0000 0.0009 0.0008

alu
4 0.0001 0.0000 0.0011 0.0009

7 0.0002 0.0001 0.0014 0.0010
ev
14 0.0005 0.0002 0.0020 0.0014

EC
21 0.0007 0.0003 0.0025 0.0017

28 0.0009 0.0004 0.0030 0.0019
n
56 0.0013 0.0008 0.0041 0.0028

fa
100 0.0015 0.0011 0.0046 0.0035

to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
59
cu
s do
hi
t
of
is
as
glasshouse application of Vertimec 018 to lettuce at 4 x 0.009 kg as/ha per single treatment as calculated with Berkely-
eb
Madonna.
th
on
abamectin 0 0.0072 0.0077
d
1 0.0049 0.0060 0.0053 0.0064
e
2 0.0033 0.0050 0.0036 0.0054
nt
4 0.0015 0.0037 0.0017 0.0039
ra
7 0.0005 0.0025 0.0005 0.0027
eg
14 0.0000 0.0013 0.0000 0.0014
tb
21 0.0009 0.0010
no
28 0.0007 0.0007
56 0.0003 0.0004
t
us
100 0.0002 0.0002
m
NOA 448111 0 0.0000 0.0041
n
tio
1 0.0008 0.0004 0.0049 0.0045
2 0.0012 0.0007 0.0052 0.0047
ra
4 0.0015 0.0010 0.0054 0.0050
st
7 0.0015 0.0012 0.0052 0.0051
gi
14 0.0014 0.0013 0.0047 0.0050
Re
21 0.0012 0.0013 0.0042 0.0048
n.
28 0.0011 0.0013 0.0038 0.0046
io
56 0.0007 0.0011 0.0025 0.0038
100 0.0004 0.0008 lat
0.0013 0.0029
iso
NOA 448112 0 0.0000 0.0051

in
1 0.0011 0.0005 0.0061 0.0056

2 0.0016 0.0009 0.0065 0.0059
d
ea
4 0.0019 0.0013 0.0066 0.0062

er
7 0.0019 0.0015 0.0064 0.0063

14 0.0017 0.0016 0.0056 0.0061
tb
21 0.0015 0.0016 0.0049 0.0058

no
28 0.0013 0.0016 0.0043 0.0055

56 0.0007 0.0013 0.0025 0.0044
ld
ou
100 0.0003 0.0009 0.0011 0.0032

sh
NOA 457464 0 0.0000 0.0007

d
1 0.0000 0.0000 0.0008 0.0008

an
2 0.0000 0.0000 0.0008 0.0008

4 0.0001 0.0000 0.0010 0.0009
ge
7 0.0001 0.0001 0.0012 0.0009

a
ck
14 0.0003 0.0001 0.0015 0.0012

21 0.0004 0.0002 0.0018 0.0013
pa
28 0.0004 0.0002 0.0020 0.0015

ta
56 0.0006 0.0004 0.0024 0.0019

da
100 0.0006 0.0005 0.0022 0.0021

n
io
NOA 457465 0 0.0000 0.0007

at
1 0.0000 0.0000 0.0007 0.0007

alu
2 0.0000 0.0000 0.0008 0.0007

4 0.0001 0.0000 0.0009 0.0008
ev
7 0.0001 0.0000 0.0011 0.0009

EC
14 0.0002 0.0001 0.0015 0.0011

21 0.0003 0.0002 0.0018 0.0013
n
28 0.0004 0.0002 0.0021 0.0015

fa
56 0.0007 0.0004 0.0028 0.0020

to
100 0.0008 0.0005 0.0030 0.0024

ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
60
cu
do
s
thi
of
is
as
field application of Vertimec 018 to tomatoes at 3 x 0.0216 kg as/ha per single treatment as calculated with Berkely-Madonna..
eb
th
abamectin 0 0.0144 0.0154
on
1 0.0098 0.0120 0.0105 0.0128
2 0.0067 0.0100 0.0071 0.0108
d
e
4 0.0031 0.0073 0.0033 0.0079
nt
7 0.0010 0.0050 0.0010 0.0053
ra
14 0.0001 0.0027 0.0001 0.0029
eg
21 0.0000 0.0018 0.0000 0.0019
28 0.0013 0.0014
tb
56 0.0007 0.0007
no
100 0.0004 0.0004
t
us
NOA 448111 0 0.0000 0.0057
m
1 0.0016 0.0008 0.0073 0.0065
n
2 0.0024 0.0014 0.0080 0.0070
tio
4 0.0030 0.0020 0.0084 0.0076
ra
7 0.0030 0.0024 0.0082 0.0078
st
14 0.0027 0.0026 0.0074 0.0078
gi
21 0.0025 0.0026 0.0066 0.0075
Re
28 0.0022 0.0025 0.0060 0.0072
56 0.0014 0.0022 0.0039 0.0060
n.
100 0.0007 0.0017 0.0020 0.0046
io
lat
NOA 448112 0 0.0000 0.0072
iso
1 0.0021 0.0011 0.0092 0.0082

2 0.0032 0.0018 0.0101 0.0089
in
4 0.0038 0.0026 0.0106 0.0095

d
7 0.0038 0.0030 0.0102 0.0098

ea
14 0.0034 0.0033 0.0089 0.0097

er
21 0.0030 0.0032 0.0078 0.0092

tb
28 0.0026 0.0031 0.0068 0.0087

no
56 0.0015 0.0026 0.0040 0.0070

100 0.0006 0.0019 0.0017 0.0051
ld
ou
NOA 457464 0 0.0000 0.0008

sh
1 0.0000 0.0000 0.0008 0.0008

2 0.0000 0.0000 0.0009 0.0008
d
4 0.0001 0.0001 0.0012 0.0009

an
7 0.0002 0.0001 0.0015 0.0011

ge
14 0.0005 0.0002 0.0021 0.0014

a
21 0.0007 0.0004 0.0026 0.0017

ck
28 0.0009 0.0005 0.0029 0.0020

pa
56 0.0012 0.0008 0.0036 0.0027

100 0.0011 0.0010 0.0033 0.0030
ta
da
NOA 457465 0 0.0000 0.0007

n
1 0.0000 0.0000 0.0008 0.0007

io
2 0.0000 0.0000 0.0009 0.0008

at
4 0.0001 0.0000 0.0011 0.0009

alu
7 0.0002 0.0001 0.0014 0.0010

ev
14 0.0005 0.0002 0.0020 0.0014

21 0.0007 0.0003 0.0025 0.0017
EC
28 0.0009 0.0004 0.0030 0.0019

n
56 0.0013 0.0008 0.0041 0.0028

fa
100 0.0015 0.0011 0.0046 0.0035

to
ar
sp
m
or
tf
en
m
cu
do
is
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t.
en
m
61
cu
s do
hi
t
of
glasshouse application of Vertimec 018 to tomatoes at 5 x 0.0216 kg as/ha per single treatment as calculated with Berkely-
is
Madonna.
as
eb
th
abamectin 0 0.0144 0.0154
1 0.0098 0.0120 0.0105 0.0128
on
2 0.0067 0.0100 0.0071 0.0108
d
4 0.0031 0.0073 0.0033 0.0079
e
nt
7 0.0010 0.0050 0.0010 0.0053
ra
14 0.0001 0.0027 0.0001 0.0029
eg
21 0.0000 0.0018 0.0019
28 0.0013 0.0014
tb
56 0.0007 0.0007
no
100 0.0004 0.0004
t
us
NOA 448111 0 0.0000 0.0104
m
1 0.0016 0.0008 0.0119 0.0112
2 0.0024 0.0014 0.0126 0.0116
n
tio
4 0.0030 0.0020 0.0128 0.0121
7 0.0030 0.0024 0.0124 0.0123
ra
14 0.0027 0.0026 0.0112 0.0120
st
21 0.0025 0.0026 0.0100 0.0115
gi
28 0.0022 0.0025 0.0090 0.0110
Re
56 0.0014 0.0022 0.0059 0.0092
n.
100 0.0007 0.0017 0.0030 0.0070
io
NOA 448112 0 0.0000 lat
0.0128
iso
1 0.0021 0.0011 0.0147 0.0137
2 0.0032 0.0018 0.0155 0.0143
in
4 0.0038 0.0026 0.0157 0.0149

d
7 0.0038 0.0030 0.0150 0.0150

ea
14 0.0034 0.0033 0.0131 0.0145

er
21 0.0030 0.0032 0.0115 0.0138

28 0.0026 0.0031 0.0100 0.0130
tb
56 0.0015 0.0026 0.0058 0.0104

no
100 0.0006 0.0019 0.0025 0.0075

ld
ou
NOA 457464 0 0.0000 0.0023

1 0.0000 0.0000 0.0025 0.0024
sh
2 0.0000 0.0000 0.0026 0.0025

d
4 0.0001 0.0001 0.0029 0.0026

an
7 0.0002 0.0001 0.0033 0.0028

ge
14 0.0005 0.0002 0.0042 0.0033

21 0.0007 0.0004 0.0048 0.0037
a
ck
28 0.0009 0.0005 0.0053 0.0040

pa
56 0.0012 0.0008 0.0060 0.0049

100 0.0011 0.0010 0.0053 0.0053
ta
da
NOA 457465 0 0.0000 0.0022

n
1 0.0000 0.0000 0.0024 0.0023

io
2 0.0000 0.0000 0.0025 0.0024

at
4 0.0001 0.0000 0.0028 0.0025

alu
7 0.0002 0.0001 0.0032 0.0027

14 0.0005 0.0002 0.0041 0.0032
ev
21 0.0007 0.0003 0.0049 0.0037

EC
28 0.0009 0.0004 0.0056 0.0041

56 0.0013 0.0008 0.0071 0.0052
n
fa
100 0.0015 0.0011 0.0075 0.0062

to
ar
For the ease of comparison, the maximum PECS for the metabolites as determined by both methods is
sp
given in Table 2.5.2-15. The maximum PECS for abamectin, which is the same for both methods, is
m
or
given as well.
tf
en
m
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is
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t.
en
m
62
cu
sdo
hi
t
Table 2.5.2-15. Comparison of maximum actual PECS as determined by the standard method 1 and by fitting with Berkely-
of
Madonna (method 2).
is
Crop Compound Single application Multiple Applications
as
method 1 method 2 method 1 method 2
eb
Citrus abamectin 0.00864 0.00864 0.0093 0.0093
th
NOA 448111 0.0009 0.0018 0.0024 0.0050
on
NOA 448112 0.0014 0.0023 0.0037 0.0063
NOA 448464 0.0009 0.0007 0.0024 0.0026
d
NOA 448465 0.0009 0.0009 0.0025 0.0027
e
nt
ra
Lettuce, field abamectin 0.0144 0.0144 0.0154 0.0154
eg
NOA 448111 0.0015 0.0030 0.0041 0.0084
NOA 448112 0.0023 0.0038 0.0061 0.0106
tb
NOA 448464 0.0015 0.0012 0.0041 0.0036
no
NOA 448465 0.0014 0.0015 0.0042 0.0046
t
us
Lettuce, glasshouse abamectin 0.0072 0.0072 0.0077 0.0077
m
NOA 448111 0.0008 0.0015 0.0020 0.0054
NOA 448112 0.0012 0.0019 0.0030 0.0066
n
tio
NOA 448464 0.0007 0.0006 0.0020 0.0024
NOA 448465 0.0007 0.0008 0.0021 0.0030
ra
st
gi
Re
Tomatoes, field abamectin 0.0144 0.0144 0.0154 0.0154
NOA 448111 0.0015 0.0030 0.0041 0.0084
n.
NOA 448112 0.0023 0.0038 0.0061 0.0106
io
NOA 448464 0.0015 0.0012 0.0041 0.0036
NOA 448465 0.0014 0.0015 0.0042 lat0.0046
iso
in
Tomatoes, glasshouse abamectin 0.0144 0.0144 0.0154 0.0154

d
NOA 448111 0.0015 0.0030 0.0082 0.0128

ea
NOA 448112 0.0023 0.0038 0.0089 0.0157

er
NOA 448464 0.0015 0.0012 0.0063 0.0053

tb
NOA 448465 0.0014 0.0015 0.0067 0.0062

no
ld
From this comparison it can be seen that both methods yield similar results for NOA 457464 and NOA
ou
457465, whereas for NOA 448111 and NOA 448112 a difference of up to a factor of two is found.
sh
d
Since the Berkely-Madonna method is a more accurate representation of the processes occurring in
an
soil, the PECS as calculated using method 2 are used for further risk assessment.
ge
a
Compared to the results from fieldstudies it is clear that calculated PECs for the metabolites are worst
ck
pa
case values.
ta
da
n
io
at
2.5.3 Fate and behaviour in water

alu
ev
2.5.3.1 Rate of degradation

EC
n
Hydrolysis
fa
Hydrolysis of avermectin B1a was tested at different pH and temperatures. Both 14C- and 3H-
to
ar
avermectin B1a were hydrolytically stable at environmental relevant pH (4 - 7) and temperature (25 °C).
sp
Under basic conditions (pH 9), DT50,hydrolysis of avermectin B1a was 4.9, 9.9 and 213 days at 60, 50 and
m
or
25 °C, respectively. Main degradation products were 2-epi-avermectin B1a (24.6 and 25.4 % at 50 and
tf
en
60 °C), 1,18-hydrolysed avermectin B1a (17.5 % of AR at 60 °C) and an unnamed fraction D3 (15.6 %
m
cu
of AR at 60 °C)
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cu
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t
of
is
Photodegradation in water
as
eb
The photodegradation of avermectin B1a was determined in three studies, the first of which was con-
th
ducted under artificial sunlight. Under the conditions of this study, the DT50,photolysis for avermectin B1a
on
was estimated as 2 days, equivalent to 1.5 sunlight days at 30 - 50 °N. Two metabolites were identi-
e d
nt
fied: 8a-oxo-avermectin B1a (NOA 448111, maximum 5.6 % of AR) and the [8,9-Z]-isomer of avermec-
ra
eg
tin B1a (maximum 8.2 % of AR). DT50,photolysis for the latter compound was estimated as 7.6 days (5.8
tb
sunlight days at 30 - 50 °N). In the third study, a DT50,photolysis of 1.3 days was obtained after irradiation
no
with natural sunlight at Three Bridges, NJ, USA from September 26 to October 2, 1990. Samples re-
t
us
ceived about 8 hours sunlight each day. Quantum yield was determined to be 0.0347, 0.0316 and
m
n
0.0287 at 40 °N in summer, fall and winter, respectively. In the second study, also performed under
tio
ra
natural sunlight, concentrations of 3H-avermectin B1a after irradiation were different between replicate
st
gi
samples, indicating that conditions were not comparable. Besides, light intensity and temperature
Re
were not given and the study was consided not reliable for a quantitative assessment of photodegra-
n.
io
dation. Three metabolite peaks were found in this experiment, one was identified as the [8,9-Z]-isomer
lat
iso
of avermectin B1a. The other peaks were polar and moderately polar fractions. The moderately polar
in
fraction could not be identified, the polar fraction contained multiple components with an intact sugar
d
ea
moiety. It is likely that individual compounds in these fractions exceeded 10 % of AR.

er
tb
Ready biodegradability
no
From the results of a manometric respirometry test it is concluded that abamectin is not readily biode-
ld
ou
gradable.
sh
Degradation in water-sediment systems

d
an
Two laboratory water/sediment degradation studies were supplied, one of which was not accepted
ge
a
because of a failing mass balance for water and large differences between replicate samples. In the
ck
pa
other study, a sandy loam system (River Rhine) and a silty clay loam system (pond) were applied with
ta
14
C-avermectin B1a and incubated under aerobic or anaerobic conditions at 20 °C in the dark. Aver-
da
mectin B1a is the major compound in abamectin, the other minor component is avermectin B1b. Both
n
io
at
components differ only by having an ethylgroup (B1a) or a methylgroup (B1b) at the 26-C position. Be-
alu
cause the content of avermectin B1a in abamectin is ≥ 80 %, and given the small difference in struc-
ev
ture, the laboratory results obtained with avermectin B1a are considered representative for abamectin.
EC
n
The field dissipation studies (see below) have been carried out with the formulated product.
fa
to
ar
The following DT50-values were obtained for avermectin B1a after aerobic incubation in water/sediment
sp
systems under laboratory conditions:

m
or
• DT50,water 1.8 and 2.9 days (average 2.4 days; r2 0.945 - 0.953)
tf
en
• DT50,sediment 87 and 111 days (average 99 days; r2 0.942 - 0.987)

m
cu
• DT50,system 87 and 91 days (average 89 days; r2 0.965 - 0.991)

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64
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The decline of concentrations in the water phase was mainly determined by a rapid initial sorption, and
t
of
the DT50,water thus represents dissipation rather than degradation. The maximum level of avermectin
is
as
B1a found in sediment was 78.1 and 82.8 % of AR after 14 days. At the end of the study after 100
eb
days, levels of avermectin B1a had declined to 44.3 and 45.3 % of AR.
th
on
Bound residues increased to 20 - 23 % of AR at the end of the study after 100 days, mineralisation
e d
was low with a maximum of 3 % of AR after 100 days in the river system.
nt
ra
Metabolites in the water phase all accounted for < 1 % of AR. In sediment, the following metabolites
eg
were detected:
tb
no
• 8a-oxo-avermectin B1a (NOA 448111): maximum 1.9 % of AR in river system (day 70) and 2.8 %
t
us
of AR in pond system (day 100)
m
• 8a-hydroxy-avermectin B1a (NOA 448112): maximum 1.9 % of AR in river system (day 70) and 1.5
n
tio
% of AR in pond system (day 35 and 70)
ra
st
• 4"-oxo-avermectin B1a (NOA 426289): maximum 6.9 % of AR in river system (day 70) and 8.6 % of
gi
Re
AR in pond system (day 100)
n.
•
io
3"-demethyl-avermectin B1a (NOA 445495): maximum 2.0 % of AR in river system (day 70) and
lat
1.7 % of AR in pond system (day 70).
iso
in
d
In the anaerobic systems, dissipation from the water phase was similarly fast with DT50,water values of
ea
er
7.2 and 5.6 days (average 6.4 days), but degradation in the total system was much slower with < 50 %
tb
degradation at the end of the study after 100 days. Extrapolated DT50,system-values were 230 and 312
no
days (average 271 days). DT50,sediment-values could not be estimated because there were too few data
ld
ou
points with decline. Metabolites NOA 448111, NOA 448112 and NOA 426289 were all < 1 % of AR in
sh
water and sediment. Metabolite NOA 445495 was found in low levels in the water phase (0.4 - 1.6 %
d
an
of AR). This metabolite reached maximum levels of 11.8 and 7.2 % of AR in the river and pond sedi-
ge
a
ment, respectively, at the end of the study after 100 days.

ck
pa
Aquatic dissipation in the field

ta
da
Three studies were submitted in which the fate of abamectin was studied under semi-field conditions.
n
io
In the first study, abamectin was applied to outdoor water/sediment systems by spray treatment to
at
alu
simulate drift, and by addition of contaminated soil to simulate run-off. Because equilibrium between
ev
water, suspended particles and sediment was only reached after a few days, dissipation rates could
EC
not be calculated. Moreover, the study was considered not acceptable due to a failing mass balance.
n
fa
The other two studies were aquatic microcosm experiments, submitted under Annex point IIA, 8.2.9 on
to
aquatic ecotoxicology. Microcosms consisted of water/sediment systems with fyto- and zooplankton,
ar
sp
invertebrates and macrophytes. Abamectin was applied by spray treatment, the development of con-
m
centrations over time was followed in the highest treatment rates. After a single application of Vertimec
or
tf
018 EC at 17 µg as/L and at an average temperature of 21 °C, the DT50,water of abamectin was 9.6
en
m
days. Initial dissipation was mainly due to rapid sorption to sediment. A DT50 for sediment could not be
cu
calculated, but concentrations of abamectin dropped below the LOQ by day 13. The test concentration
do
is
of 17 µg as/L corresponds to 240 g as/ha, which is over 10 times the highest recommended single
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
65
cu
s do
hi
application rate of 21.6 g as/ha. This may have influenced the dissipation rate. In the other study, Ver-
t
of
timec 018 EC was applied three times at 17 g as/ha (3 x 1.22 µg as/L) with a 7-days interval, the
is
as
DT50,water after the last application was 5.2 days at an average temperature of 18 °C. Sediment was not
eb
analysed. Because the DT50,water is assumed to include dissipation by sorption, it is not considered ap-
th
on
propriate to apply a correction for temperature. In both studies, pH was relatively high with maximum
e d
levels of ca. 10. The hydrolysis experiments show that degradation of avermectin B1a and formation of
nt
ra
metabolites is enhanced under basic conditions, but only at elevated temperature (50 and 60 °C). It is
eg
thus not expected that the relatively high pH has affected the degradation rate or pattern.
tb
no
t
us
The laboratory studies show that dissipation of avermectin B1a from the total system is determined by
m
the degradation rate in sediment, which is relatively slow. In the field, sediment seems not to be a ma-
n
tio
jor sink for abamectin. It is possible that other degradation processes, such as photolysis, have influ-
ra
st
enced the concentration pattern in the field studies. Furthermore, sorption to other organic fractions,
gi
Re
including plant material, may have taken place, thereby lowering the analysed concentrations in the
n.
water phase.
io
lat
Formation of metabolites in environmentally relevant concentrations in the water phase is not consid-
iso
ered likely, except for the photolysis product [8,9-Z]-avermectin B1a. The laboratory water/sediment
in
d
studies were performed in the dark, and this metabolite was likely not present in these systems. The
ea
er
field samples have not been analysed for metabolites. It is therefore not possible to estimate the rele-
tb
vance of this compound under field conditions, although the photolysis experiment indicates a rela-
no
tively fast decay (DT50 ca. 6 days) and environmental concentrations may thus be low. Because the
ld
ou
ecotoxicological (field) studies are all performed under light, it can be assumed that potential effects of
sh
the isomer on aquatic organisms are covered by the studies with the parent compound.
d
an
Metabolite 4"-oxo-avermectin B1a (NOA 426289) was the only degradation product found in sediment
ge
in amounts > 5 % of AR.

a
ck
pa
The degradation route of avermectin B1a in aqueous environments is shown in Figure 2.5.3-1. Metabo-
ta
lised positions are indicated with block arrows, the pathways that are less relevant for normal envi-
da
ronmental conditions are indicated by dotted lines.

n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
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en
m
cu
do
is
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t.
en
m
66
cu
s do
hi
t
Figure 2.5.3-1. Degradation pathway of avermectin B1a in aqueous environments.
of
is
as
eb
O
O
1,18-hydrolysed avermectin B1a
th
O
O
O O
(DT 4)
on
O O O
O 14C
O O
2-Epi-avermectin B1a O
H
d
O O O
(DT1) O O
e
14 C 14 O
H C
nt
O O O H
O O O
OH
ra
O O
O
OH
O
eg
O
O DT3 OH
tb
O
OH H
H O
no
O
OH O
H
H O
t
us
OH
m
O
HO
HO 3''-demethyl-avermectin B1a
n
O 8,9-Z avermectin B1a O
O (NOA 445495)
tio
hydrolysis (pH 9) O O
O O (NOA 427011) HO
ra
H O H
O O O O O
O
avermectin B1a
st
O O
O O
H H
gi
H
H O O O H
O
Re
O O O
O
OH H H anaerobic water/sediment OH H
n.
H
O O
O
io
OH H O
H
OH photolysis photolysis water/sediment H
O water/sediment O
lat OH
iso
H O
HO
O OH
O
O 8a-oxo avermectin B1a 4"-oxo-avermectin B1a
HO
in
O
O O (NOA 448111) (NOA 426289)
O water/sediment O O
d
H O O
ea
O O O H
O O O
O H
er
H O O O O
H
H O
O O H H
tb
O O
OH H H
8a-hydroxy avermectin B1a O O OH H
no
O (NOA 448112) OH H
O
ld
H HO O
OH O H
ou
OH
H
OH
sh
d
bound residues minor degradates

an
CO 2
a ge
ck
pa
2.5.3.2 Impact of water treatment procedures

ta
da
No information is provided on the fate of abamectin in waste water plants.

n
io
at
alu
ev
2.5.3.3 Predicted environmental concentrations in surface water, groundwater and in sediment

(PECSW, PECGW, PECSED)
EC
n
Surface water (PECSW)

fa
to
The formulation Vertimec 018 EC (18 g as/L) is to be applied on citrus, lettuce and tomatoes, glass-
ar
sp
house and field applications are proposed for the latter two crops. The PECSW for abamectin have
m
been calculated according to FOCUS Surface Water, Step 2, using version 1.1 of the STEP 1 - 2 in
or
tf
FOCUS-program. Because trigger values for aquatic organisms were exceeded, additional calcula-
en
m
tions have been performed according to FOCUS Surface Water, Step 3, using SWASH 2.1 (9 April
cu
2003), with MACRO 4.3b, PRZM 3.21.b and TOXSWA 2.1.1.F1.

do
is
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:
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
67
cu
s do
hi
According to the guidance, the DT50,system should be used in case the DT50,water obtained in wa-
t
of
ter/sediment studies represents dissipation by sorption rather than degradation. No reliable DT50,system
is
as
could be obtained from the semi-field microcosm experiments, as sediment concentrations were only
eb
determined on two time points in one of the studies. Therefore, the average DT50,system of 89 days from
th
on
the aerobic water/sediment study was used, together with the average KOM of 3270 L/kg. Both values
e d
were obtained in studies with avermectin B1a, but are considered representative for abamectin. Vapour
nt
ra
pressure was set at 3.7 x 10-6 Pa and water solubility at 1.21 mg/L, both at 25 °C. Soil DT50 was set at
eg
1 day, based on the results of field studies (DT50 < 1 – 1.8 days at 13 – 17 °C).
tb
no
For the glasshouse applications, diffuse emission, mainly due to drainage and condensation, is re-
t
us
garded as the primary route of exposure to surface water. For Step 2 calculations, a total emission
m
value of 0.1 % of the application rate is used. Because the program does not offer the possibility to
n
tio
change the total fraction emitted, the correct emission was obtained by first choosing no drainage and
ra
st
run-off and setting the crop interception to 0, resulting in 100 % loading via drift, and then changing the
gi
Re
application rate so that the total loading to the water surface (in g/m2) was equal to 0.1 % of the appli-
n.
cation rate. A further refinement using Step 3 is not possible.
io
lat
No calculation is performed for metabolites, as formation in the water phase was < 1 %.
iso
in
d
Below the calculated PECSW are given for each of the proposed uses, Step 3-values for the field appli-
ea
er
cations and Step 2-values for the glasshouse uses. The highest initial PECSW for each combination of
tb
crop and water type in Step 3 are indicated in bold. These values will be used for the aquatic risk as-
no
sessment.
ld
ou
sh
Citrus
d
an
The maximum application rate for citrus is 3 x 21.6 g as/ha with a 7-days interval. Scenario's D6
ge
(ditch) and R4 (stream). The maximum PECSW, and time weighted average concentrations after one or
a
ck
three applications are given in Table 2.5.3-1.

pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
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en
m
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is
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t.
en
m
68
cu
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hi
t
Table 2.5.3-1. Actual and Time Weighted Average (TWA) Predicted Environmental Concentrations of abamectin in surface wa-
of
ter (PECSW, in µg/L) after application of Vertimec 018 EC to citrus at 3 x 21.6 g as/ha, FOCUS Step 3.
is
Scenario Days after Step 3 PECSW [µg/L]
as
maximum Single application Three applications
eb
concentration actual TWA actual TWA
th
D6, ditch 0 0.791 0.687
on
1 0.69 0.736 0.61 0.646
2 0.612 0.693 0.548 0.611
d
4 0.449 0.612 0.435 0.552
e
nt
7 0.227 0.492 0.253 0.462
ra
14 0.058 0.304 0.075 0.404
eg
21 0.026 0.216 0.036 0.352
28 0.014 0.167 0.021 0.311
tb
42 0.006 0.114 0.009 0.26
no
50 0.004 0.097 0.007 0.224
100 0.001 0.049 0.001 0.116
t
us
m
R4, stream 0 0.590 0.432
1 0 0.069 0 0.088
n
tio
2 0 0.034 0 0.044
ra
4 0 0.017 0 0.028
st
7 0 0.01 0.422 0.023
gi
14 0.008 0.006 0.422 0.015
Re
21 0 0.004 0 0.014
28 0 0.003 0 0.011
n.
42 0 0.002 0 0.007
io
50 0 0.002 0 0.006
100 0 0.001 0 0.003
lat
iso
in
d
Lettuce, field application

ea
er
The maximum application rate for field grown lettuce is 3 x 18 g as/ha with a 7-days interval. Sce-
tb
nario's D3 (ditch), D4 (pond and stream), D6 (ditch), R1 (pond and stream), R2 (stream), R3 (stream).
no
ld
For D3, R1, R2, R3 and R4, two crops per season are considered. Resulting PECSW are given in Table
ou
2.5.3-2.
sh
d
an
ge
a
ter (PECSW, in µg/L) after application of Vertimec 018 EC to lettuce at 3 x 18 g as/ha, FOCUS Step 3.
ck
Scenario Days after Step 3 PECSW [µg/L] Step 3 PECSW [µg/L]

pa
maximum first crop second crop

ta
concentration Single application Three applications Single application Three applications

da
actual TWA actual TWA actual TWA actual TWA

D3, ditch 0 0.114 --- 0.082 --- 0.114 --- 0.083 ---
n
io
1 0.045 0.085 0.036 0.062 0.074 0.095 0.054 0.069

at
2 0.004 0.052 0.004 0.039 0.021 0.071 0.017 0.052

alu
4 0 0.026 0 0.02 0.001 0.039 0.002 0.029

7 0 0.015 0 0.012 0 0.022 0.001 0.017
ev
14 0 0.008 0.082 0.011 0 0.011 0 0.017

EC
21 0 0.005 0 0.008 0 0.008 0.001 0.011

28 0 0.004 0 0.009 0 0.006 0 0.011
n
42 0 0.003 0 0.006 0 0.004 0 0.008

fa
50 0 0.002 0 0.005 0 0.003 0 0.006

to
100 0 0.001 0 0.002 0 0.002 0 0.003

ar
sp
D4, pond 0 0.004 --- 0.007

1 0.004 0.004 0.007 0.007
m
2 0.004 0.004 0.007 0.007

or
4 0.003 0.004 0.007 0.007

tf
7 0.003 0.003 0.006 0.007

en
14 0.002 0.003 0.005 0.006

m
21 0.002 0.003 0.005 0.006

cu
28 0.002 0.003 0.004 0.006

do
42 0.001 0.002 0.003 0.005

50 0.001 0.002 0.003 0.005
is
100 0.001 0.001 0.002 0.004

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Mon Feb 05 03:52:00 CET 2018

t.
en
m
69
cu
sdo
hi
t
of
is
as
eb
th
D4, stream 0 0.090 --- 0.066
on
1 0 0.006 0 0.006
2 0 0.003 0 0.003
ed
4 0 0.002 0 0.001
nt
7 0 0.001 0.062 0.001
ra
14 0 0 0 0.001
eg
21 0 0 0 0.001
tb
28 0 0 0 0
42 0 0 0 0
no
50 0 0 0 0
t
100 0 0 0 0
us
m
D6, ditch 0 0.115 --- 0.112
n
1 0.103 0.108 0.097 0.104
tio
2 0.092 0.103 0.086 0.098
ra
4 0.070 0.092 0.066 0.087
st
7 0.034 0.075 0 0.069
gi
14 0 0.044 0 0.058
Re
21 0 0.029 0 0.04
28 0 0.022 0 0.03
n.
42 0 0.015 0 0.02
io
50 0 0.012 0 0.017 lat
100 0 0.006 0 0.008
iso
R1, pond 0 0.004 --- 0.007 0.004 --- 0.006 ---

in
1 0.004 0.004 0.007 0.007 0.004 0.004 0.006 0.006

d
2 0.004 0.004 0.007 0.007 0.004 0.004 0.006 0.006

ea
4 0.003 0.004 0.007 0.007 0.003 0.004 0.006 0.006

er
7 0.003 0.003 0.006 0.007 0.003 0.003 0.005 0.006

tb
14 0.002 0.003 0.006 0.006 0.002 0.003 0.005 0.005

no
21 0.002 0.003 0.005 0.006 0.002 0.003 0.004 0.005

28 0.002 0.003 0.005 0.006 0.002 0.002 0.004 0.005
ld
42 0.001 0.002 0.004 0.006 0.001 0.002 0.003 0.005

ou
50 0.001 0.002 0.003 0.005 0.001 0.002 0.003 0.004

sh
100 0 0.001 0.002 0.004 0.001 0.001 0.002 0.004

d
an
R1, stream 0 0.075 --- 0.053 0.074 --- 0.054 0.011

1 0 0.014 0 0.011 0 0.012 0 0.006
ge
2 0 0.007 0 0.005 0 0.006 0 0.003

a
4 0 0.004 0 0.005 0 0.003 0 0.002

ck
7 0 0.002 0 0.003 0 0.002 0 0.001

pa
14 0 0.001 0 0.002 0 0.001 0 0.001

ta
21 0 0.001 0 0.002 0 0.001 0 0.001

da
28 0 0.001 0.001 0.001 0 0 0 0.001

42 0 0 0 0.001 0 0 0 0.001
n
50 0 0 0 0.001 0 0 0 0.001
io
100 0 0 0 0.001 0 0 0 0
at
alu
R2, stream 0 0.098 --- 0.080 0.100 --- 0.072 ---

ev
1 0 0.008 0 0.009 0 0.011 0 0.008

EC
2 0 0.004 0 0.005 0 0.006 0 0.004

4 0 0.002 0 0.003 0 0.003 0 0.002
n
7 0 0.001 0 0.003 0 0.002 0 0.001

fa
14 0 0.001 0 0.002 0 0.001 0 0.001

to
21 0 0 0 0.002 0 0.001 0 0.001

ar
28 0 0 0 0.002 0 0 0 0.001
sp
42 0 0 0 0.001 0 0 0 0.001
50 0 0 0 0.001 0 0 0 0.001
m
100 0 0 0 0 0 0 0 0
or
tf
en
R3, stream 0 0.106 --- 0.075 0.105 --- 0.075 ---

m
1 0 0.039 0 0.028 0 0.035 0 0.025

cu
2 0 0.020 0 0.014 0 0.017 0 0.013

do
4 0 0.010 0 0.007 0 0.009 0 0.006

7 0 0.006 0 0.007 0 0.005 0 0.004
is
14 0 0.003 0 0.005 0 0.003 0 0.004

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Mon Feb 05 03:52:00 CET 2018

t.
en
m
70
cu
sdo
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t
of
is
as
eb
21 0 0.002 0 0.004 0 0.002 0 0.002
28 0 0.001 0 0.003 0 0.001 0 0.003
th
42 0 0.001 0 0.002 0 0.001 0 0.002
on
50 0 0.001 0 0.002 0 0.001 0 0.002
100 0 0 0 0.001 0 0 0 0.001
ed
nt
R4, stream 0 0.074 --- 0.082 --- 0.074 --- 0.053
ra
1 0 0.010 0 0.055 0 0.012 0 0.011
eg
2 0 0.005 0 0.028 0 0.006 0 0.005
tb
4 0 0.002 0 0.018 0 0.003 0 0.003
7 0 0.001 0 0.011 0 0.002 0 0.003
no
14 0 0.001 0 0.01 0 0.001 0 0.002
t
21 0 0.001 0 0.007 0 0.001 0 0.002
us
28 0 0 0.003 0.005 0 0 0 0.002
m
42 0 0 0 0.004 0 0 0 0.001
n
50 0 0 0 0.003 0 0 0 0.001
tio
100 0 0 0 0.002 0 0 0 0.001
ra
st
gi
Re
Lettuce, glasshouse applications
n.
io
The maximum application rate for lettuce in glasshouses is 4 x 9 g as/ha with a 7-days interval. Crop
lat
specific input: No drainage, run-off or crop interception and application rate multiplied by [0.1/default
iso
drift %] to obtain the correct emission of 0.0009 mg/m2 per single application. No difference in emis-
in
d
sion between Northern- and Southern-Europe is assumed. Glasshouse crops may be grown the whole
ea
er
year round. However, in view of the time between the series of applications in relation to the low con-
tb
centrations observed in the water phase, a single crop per season is assumed in the PECSW calcula-
no
ld
tions. PECSW after one or four applications are given in Table 2.3.5-3.
ou
sh
ter (PECSW, in µg/L) after one or four glasshouse applications of Vertimec 018 EC to lettuce at 9 g as/ha, FOCUS Step 2.
d
an
Days after PECSW [µg/L]

maximum Single application Four applications
ge

a
ck
0 0.0030 --- 0.0043 ---

1 0.0012 0.0021 0.0025 0.0034
pa
2 0.0007 0.0016 0.002 0.0029

ta
4 0.0005 0.0011 0.0018 0.0024

da
7 0.0005 0.0008 0.0017 0.0021

14 0.0005 0.0006 0.0016 0.0019
n
io
21 0.0004 0.0006 0.0016 0.0018

at
28 0.0004 0.0005 0.0015 0.0017

alu
42 0.0004 0.0005 0.0013 0.0016

50 0.0003 0.0005 0.0012 0.0016
ev
100 0.0002 0.0004 0.0008 0.0013

EC
n
fa
to
Tomatoes, field applications

ar
The maximum application rate for field grown tomatoes is 3 x 21.6 g as/ha with a 7-days interval. Sce-
sp
m
nario's D6 (ditch), R2 (stream), R3 (stream) and R4 (stream). The maximum PECSW, and time
or
tf
weighted average concentrations after one or three applications are given in Table 2.5.3-4.
en
m
cu
do
is
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
71
cu
s do
hi
t
of
is
as
ter (PECSW, in µg/L) after field application of Vertimec 018 EC to tomatoes at 3 x 21.6 g as/ha, FOCUS Step 3.
eb
Scenario Days after Step 3 PECSW [µg/L]
th
on
D6, ditch 0 0.136 0.098
d
1 0.006 0.067 0.047 0.077
e
nt
2 0 0.034 0.006 0.05
ra
4 0 0.017 0.001 0.026
eg
7 0 0.01 0 0.015
14 0 0.005 0 0.011
tb
21 0 0.003 0 0.009
no
28 0 0.003 0 0.007
42 0 0.002 0 0.004
t
us
50 0 0.001 0 0.004
m
100 0 0.001 0 0.002
n
tio
R2, stream 0 0.119 0.087
1 0 0.011 0 0.008
ra
2 0 0.005 0 0.004
st
4 0 0.003 0 0.003
gi
7 0 0.002 0 0.003
Re
14 0 0.001 0 0.002
n.
21 0 0.001 0 0.001
io
28 0 0 0 0.001
42 0 0 0 lat
0.001
iso
50 0 0 0 0.001
100 0 0 0 0
in
d
R3, stream 0 0.127 0.093

ea
1 0.001 0.047 0 0.035

er
2 0 0.024 0 0.017
4 0 0.012 0 0.009
tb
7 0 0.007 0 0.005
no
14 0 0.004 0 0.003
ld
21 0 0.002 0 0.003
ou
28 0 0.002 0 0.003
42 0 0.001 0 0.003
sh
50 0 0.001 0 0.002
d
100 0 0.001 0 0.001

an
ge
R4, stream 0 0.090 0.068

1 0 0.018 0.001 0.049
a
ck
2 0 0.009 0 0.025
pa
4 0 0.004 0 0.016
7 0 0.003 0 0.009
ta
14 0 0.002 0 0.008
da
21 0 0.002 0 0.006
n
28 0 0.001 0 0.004
io
42 0 0.001 0 0.003
at
50 0 0.001 0 0.003
alu
100 0 0 0 0.001
ev
EC
n
Tomatoes, glasshouse applications

fa
to
The maximum application rate for tomatoes in glasshouses is 5 x 21.6 g as/ha with a 7-days interval.
ar
The application rate is multiplied by [0.1/default drift %] to obtain the correct emission of 0.0022 mg/m2
sp
m
per single application. PECSW after one or five applications are given in Table 2.5.3-5. No difference in
or
tf
emission between Northern- and Southern-Europe is assumed.

en
m
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
72
cu
s do
hi
t
of
is
as
ter (PECSW, in µg/L) after glasshouse applications of Vertimec 018 EC to tomatoes at 5 x 21.6 g as/ha, FOCUS Step 2.
eb
Days after PECSW [µg/L]
th
maximum Single application Five applications
on
0 0.0072 --- 0.0114 ---
d
1 0.0029 0.0051 0.0071 0.0092
e
nt
2 0.0017 0.0037 0.0058 0.0078
ra
4 0.0012 0.0025 0.0052 0.0066
eg
7 0.0011 0.0019 0.0051 0.0060
14 0.0011 0.0015 0.0048 0.0055
tb
21 0.0010 0.0014 0.0046 0.0052
no
28 0.0010 0.0013 0.0043 0.0050
42 0.0009 0.0011 0.0039 0.0047
t
us
50 0.0008 0.0011 0.0036 0.0046
m
100 0.0005 0.0009 0.0025 0.0038
n
tio
ra
Groundwater (PECGW)
st
gi
The PECGW is calculated with FOCUS PEARL 2.2.2 (release August 2003), applying the following ap-
Re
plication scheme (Table 2.5.3-6). Cabbage was used as a representative crop for lettuce.
n.
io
Table 2.5.3-6. Cropping and application scheme used for PEARL-simulations.lat
iso
Crop Application rate Time Scenario Emergence date Application dates
[g as/ha]
in
Cabbage 3 x 18.0 per crop March - November Chateaudun 20/4 4/5 11/5 18/5
d
(Lettuce) 31/7 14/8 21/8 28/8

ea
Hamburg 20/4 4/5 11/5 18/5

er
31/7 14/8 21/8 28/8

tb
Joikioinen 20/5 3/6 10/6 17/6

Kremsmünster 20/4 4/5 11/5 18/5
no
31/7 14/8 21/8 28/8

ld
Porto 28/2 14/3 21/3 28/3

ou
31/7 14/8 21/8 28/8

Sevilla
sh
1/3 15/3 22/3 29/3

15/6 29/6 6/7 13/7
d
Thiva 15/8 29/8 5/9 12/9

an
Tomatoes 3 x 21.6 April - July Chateaudun 10/5 24/5 31/5 7/6

ge
Piacenza 10/5 24/5 31/5 7/6

a
Porto 15/3 29/3 5/4 12/4

ck
Sevilla 15/4 29/4 6/5 13/5

pa
Thiva 10/4 24/4 1/5 8/5

Citrus 3 x 21.6 April - July Piacenza 7/4 14/4 21/4
ta
Porto 7/4 14/4 21/4

da
Sevilla 7/4 14/4 21/4

n
Thiva 7/4 14/4 21/4

io
at
alu
The average KOM of 3270 L/kg and the geometric mean laboratory DT50 of 28.4 days at 20 °C were
ev
used as input values. PECGW for the metabolites were calculated concurrently, applying the degrada-
EC
tion pathway, formation fractions and degradation rate constants as obtained in the Berkely-Madonna
n
fa
fits (Figure 2.5.3-1):

to
ar
sp
m
or
tf
en
m
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do
is
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:
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
73
cu
s do
hi
Figure 2.5.3-1. Modelled pathway for the calculation of PECS of metabolites.
t
of
is
avermectin B1a
as
eb
0.30 0.23
th
on
NOA 448112 NOA 448111
d
k = 0.0194/d k = 0.0153/d
e
nt
ra
0.58 0.85
eg
tb
NOA 457464 NOA 457465
no
k = 0.0105/d k = 0.0062/d
t
us
m
Resulting PECGW for abamectin and metabolites were < 0.001 µg/L for all crops and application
n
tio
schemes.
ra
st
gi
Re
Sediment (PECSED)
n.
The maximum predicted concentrations of abamectin in sediment (PECSED), are calculated with STEP
io
lat
1 - 2 IN FOCUS for glasshouse applications and according to Step 3 using the methods and input data
iso
as decribed above for surface water. Calculated PECSED are given in Tables 2.5.3-10 to 2.5.3-18. Note
in
d
that all concentrations are given in µg/kg dwt sediment. The highest initial PECSW for for each combi-
ea
er
nation of crop and water type in Step 3 are indicated in bold. These values will be used for risk as-
tb
sessment.
no
ld
ou
Citrus
sh
The PECSED as obtained with Step 2 and Step 3 are given in Tables 2.5.3-7 and 2.5.3-8
d
an
Table 2.5.3-7. Actual and Time Weighted Average (TWA) Predicted Environmental Concentrations of abamectin in sediment
ge
(PECSED, in µg/kg dwt) after application of Vertimec 018 EC to citrus at 3 x 21.6 g as/ha, FOCUS Step 2.
a
ck
Days after PECSED [µg/kg dwt]

pa

ta
0 7.56 --- 14.7 ---

da
1 7.50 7.53 14.6 14.7

n
2 7.45 7.50 14.5 14.6

io
4 7.33 7.45 14.3 14.5

at
7 7.16 7.36 13.9 14.3

alu
14 6.78 7.17 13.2 13.9

ev
21 6.42 6.98 12.5 13.6

28 6.08 6.80 11.8 13.2
EC
42 5.45 6.45 10.6 12.5

50 5.12 6.26 10.0 12.2
n
fa
100 3.47 5.25 6.75 10.2

to
ar
sp
m
or
tf
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
74
cu
sdo
hi
t
of
water (PECSED, in µg as/kg dwt) after application of Vertimec 018 EC to citrus at 3 x 21.6 g as/ha, FOCUS Step 3.
is
Scenario Days after Step 3 PECSED [µg/kg dwt]
as
eb
th
D6, ditch 0 1.682 --- 2.905 ---
on
1 1.667 1.680 2.886 2.903
2 1.629 1.676 2.837 2.898
d
4 1.521 1.659 2.687 2.879
e
nt
7 1.348 1.617 2.426 2.829
ra
14 1.038 1.483 1.928 2.655
eg
21 0.833 1.348 1.593 2.474
28 0.693 1.230 1.339 2.351
tb
42 0.515 1.045 0.989 2.098
no
50 0.442 0.963 0.849 1.963
100 0.189 0.646 0.363 1.423
t
us
m
R4, stream 0 0.050 --- 0.195 ---
1 0.045 0.048 0.184 0.192
n
tio
2 0.040 0.045 0.175 0.187
ra
4 0.032 0.041 0.159 0.178
st
7 0.024 0.038 0.142 0.168
gi
14 0.032 0.034 0.119 0.151
Re
21 0.034 0.032 0.103 0.139
28 0.028 0.031 0.092 0.130
n.
42 0.022 0.029 0.076 0.115
io
50 0.019 0.028 0.068 0.109
100 0.010 0.021 0.036
lat
0.082
iso
in
d

ea
er
The PECSED as obtained with Step 2 and Step 3 are given in Tables 2.5.3-9 and 2.5.3-10.
tb
no
ld
(PECSED, in µg/kg dwt) after field application of Vertimec 018 EC to lettuce at 3 x 18 g as/ha, FOCUS Step 2.
ou

maximum Northern-Europe Southern-Europe
sh

d

an
0 1.35 --- 2.50 --- 1.00 --- 2.09 ---

ge
1 1.34 1.34 2.48 2.49 0.993 0.995 2.09 2.09

a
2 1.33 1.34 2.46 2.48 0.987 0.992 2.08 2.09

ck
4 1.31 1.33 2.42 2.46 0.972 0.986 2.04 2.07

pa
7 1.28 1.31 2.36 2.43 0.950 0.975 2.00 2.05

14 1.21 1.28 2.24 2.37 0.900 0.950 1.89 2.00
ta
21 1.15 1.24 2.12 2.30 0.852 0.925 1.79 1.95

da
28 1.09 1.21 2.01 2.24 0.807 0.901 1.70 1.89

n
42 0.973 1.15 1.80 2.13 0.723 0.856 1.52 1.80

io
50 0.914 1.12 1.69 2.07 0.680 0.831 1.43 1.75

at
100 0.619 0.938 1.15 1.73 0.460 0.697 0.97 1.47

alu
ev
EC
(PECSED, in µg/kg dwt) after field application of Vertimec 018 EC to lettuce at 3 x 18 g as/ha, FOCUS Step 3.
n
fa
Scenario Days after Step 3 PECSED [µg/kg dwt] Step 3 PECSED [µg/kg dwt]
to

ar

sp
D3, ditch 0 0.076 --- 0.084 --- 0.107 --- 0.108 ---
m
1 0.074 0.076 0.079 0.083 0.102 0.107 0.105 0.107

or
2 0.072 0.075 0.073 0.081 0.094 0.105 0.102 0.107

tf
4 0.067 0.073 0.064 0.077 0.080 0.100 0.094 0.104

en
7 0.061 0.070 0.054 0.071 0.065 0.091 0.084 0.099

m
14 0.049 0.063 0.040 0.060 0.046 0.076 0.067 0.089

cu
21 0.041 0.058 0.033 0.057 0.070 0.074 0.055 0.081

28 0.035 0.053 0.028 0.055 0.051 0.071 0.046 0.074
do
42 0.027 0.046 0.022 0.049 0.035 0.065 0.035 0.063

is
50 0.023 0.043 0.019 0.047 0.030 0.061 0.030 0.058

Th
:
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
75
cu
sdo
hi
t
of
is
as
eb
100 0.012 0.030 0.010 0.033 0.017 0.043 0.018 0.041
th
D4, pond 0 0.036 --- 0.050 ---
on
1 0.036 0.036 0.050 0.050
2 0.036 0.036 0.050 0.050
e d
4 0.036 0.036 0.050 0.050
nt
7 0.035 0.036 0.050 0.050
ra
14 0.035 0.036 0.049 0.050
eg
21 0.034 0.036 0.048 0.050
tb
28 0.033 0.035 0.047 0.049
42 0.031 0.035 0.044 0.049
no
50 0.029 0.035 0.042 0.048
t
100 0.023 0.032 0.033 0.045
us
m
D4, stream 0 0.005 --- 0.006 ---
n
1 0.004 0.005 0.005 0.005
tio
2 0.004 0.004 0.005 0.005
ra
4 0.004 0.004 0.004 0.005
st
7 0.004 0.004 0.005 0.004
gi
14 0.003 0.004 0.003 0.004
Re
21 0.003 0.003 0.002 0.004
28 0.002 0.003 0.002 0.003
n.
42 0.002 0.003 0.001 0.003
io
50 0.002 0.003 0.001 0.003 lat
100 0.001 0.002 0.001 0.002
iso
D6, ditch 0 0.336 --- 0.343 ---

in
1 0.334 0.335 0.314 0.341

d
2 0.329 0.335 0.285 0.337

ea
4 0.311 0.333 0.204 0.326

er
7 0.272 0.327 0.141 0.306

tb
14 0.206 0.302 0.109 0.264

no
21 0.164 0.275 0.090 0.233

28 0.135 0.251 0.065 0.208
ld
42 0.099 0.213 0.056 0.171

ou
50 0.084 0.196 0.003 0.156

sh
100 0.046 0.132 0.002 0.102

d
an
R1, pond 0 0.036 --- 0.064 --- 0.034 --- 0.048 0.048
1 0.036 0.036 0.064 0.064 0.034 0.034 0.048 0.048
ge
2 0.036 0.036 0.064 0.064 0.034 0.034 0.048 0.048

a
4 0.036 0.036 0.063 0.064 0.034 0.034 0.048 0.048

ck
7 0.036 0.036 0.063 0.064 0.034 0.034 0.048 0.048

pa
14 0.035 0.036 0.062 0.063 0.033 0.034 0.048 0.048

ta
21 0.034 0.036 0.061 0.063 0.033 0.034 0.048 0.048

da
28 0.033 0.036 0.059 0.063 0.032 0.034 0.047 0.048

42 0.031 0.035 0.055 0.062 0.031 0.033 0.046 0.048
n
50 0.030 0.035 0.052 0.062 0.031 0.033 0.045 0.048

io
100 0.021 0.032 0.036 0.057 0.027 0.032 0.0439 0.046

at
alu
R1, stream 0 0.011 --- 0.141 --- 0.009 --- 0.012 ---
ev
1 0.011 0.011 0.139 0.140 0.008 0.009 0.011 0.011

EC
2 0.010 0.011 0.137 0.139 0.008 0.009 0.010 0.011

4 0.010 0.010 0.133 0.137 0.008 0.008 0.008 0.010
n
7 0.009 0.010 0.129 0.135 0.007 0.008 0.007 0.009

fa
14 0.008 0.009 0.126 0.131 0.006 0.007 0.005 0.008

to
21 0.008 0.008 0.117 0.130 0.005 0.006 0.004 0.007

ar
28 0.007 0.008 0.113 0.127 0.004 0.006 0.004 0.006

sp
42 0.006 0.007 0.122 0.123 0.003 0.005 0.003 0.006

50 0.004 0.006 0.118 0.124 0.003 0.005 0.003 0.006
m
100 0.002 0.004 0.077 0.112 0.002 0.003 0.002 0.005

or
tf
en
R2, stream 0 0.006 --- 2.155 --- 0.008 --- 0.010 ---
m
1 0.006 0.006 2.131 2.146 0.008 0.008 0.009 0.010

cu
2 0.005 0.006 2.127 2.140 0.008 0.008 0.008 0.009

do
4 0.005 0.005 2.083 2.128 0.007 0.008 0.007 0.009

7 0.005 0.005 2.025 2.116 0.006 0.007 0.006 0.008
is
14 0.004 0.005 1.927 2.085 0.005 0.007 0.004 0.007

Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
76
cu
sdo
hi
t
of
is
as
eb
21 0.004 0.005 1.826 2.039 0.004 0.006 0.003 0.006
28 0.003 0.004 1.737 1.992 0.004 0.005 0.003 0.006
th
42 0.003 0.004 1.577 1.901 0.003 0.005 0.002 0.005
on
50 0.002 0.004 1.496 1.852 0.002 0.004 0.002 0.004
100 0.001 0.003 1.037 1.582 0.001 0.003 0.001 0.003
e d
nt
R3, stream 0 0.030 --- 0.038 --- 0.026 --- 0.047 ---
ra
1 0.029 0.029 0.035 0.037 0.025 0.026 0.044 0.046
eg
2 0.028 0.029 0.032 0.036 0.024 0.025 0.042 0.045
tb
4 0.026 0.028 0.028 0.033 0.022 0.025 0.038 0.043
7 0.024 0.027 0.024 0.030 0.021 0.023 0.035 0.040
no
14 0.020 0.024 0.018 0.028 0.017 0.021 0.029 0.037
t
21 0.017 0.023 0.027 0.025 0.014 0.019 0.024 0.037
us
28 0.015 0.021 0.020 0.026 0.011 0.018 0.021 0.035
m
42 0.011 0.018 0.015 0.024 0.088 0.015 0.017 0.032
n
50 0.010 0.017 0.013 0.022 0.077 0.014 0.015 0.030
tio
100 0.006 0.012 0.007 0.017 0.003 0.009 0.008 0.022
ra
st
R4, stream 0 0.016 --- 0.261 --- 0.010 --- 0.175 ---
gi
1 0.016 0.016 0.252 0.258 0.010 0.010 0.172 0.174
Re
2 0.015 0.016 0.244 0.254 0.010 0.010 0.169 0.172
4 0.015 0.015 0.248 0.252 0.009 0.010 0.162 0.169
n.
7 0.015 0.015 0.231 0.247 0.009 0.009 0.155 0.165
io
14 0.014 0.015 0.206 0.233 lat 0.007 0.009 0.139 0.164
21 0.013 0.015 0.199 0.223 0.006 0.009 0.126 0.161
iso
28 0.012 0.014 0.198 0.216 0.006 0.008 0.115 0.159

42 0.011 0.014 0.174 0.206 0.004 0.007 0.097 0.151
in
50 0.010 0.013 0.162 0.200 0.004 0.007 0.089 0.146

d
100 0.007 0.011 0.104 0.167 0.002 0.005 0.054 0.116

ea
er
tb
no
Lettuce, glasshouse application

ld
The PECSED as obtained with Step 2 are given in Table 2.5.3-11.

ou
sh
d
(PECSED, in µg/kg dwt) after glasshouse application of Vertimec 018 EC to lettuce at 4 x 9 g as/ha, FOCUS Step 2.
an

ge
maximum Single application Four applications

a

ck
0 0.0183 --- 0.0667 ---

pa
1 0.0182 0.0182 0.0665 0.0666

ta
2 0.0181 0.0182 0.0661 0.0665

da
4 0.0178 0.0181 0.0651 0.0661

7 0.0174 0.0179 0.0636 0.0653
n
io
14 0.0165 0.0174 0.0603 0.0636

at
21 0.0156 0.017 0.0571 0.062

alu
28 0.0148 0.0165 0.054 0.0604

42 0.0133 0.0157 0.0484 0.0573
ev
50 0.0125 0.0152 0.0455 0.0556

EC
100 0.0084 0.0128 0.0308 0.0467

n
fa
to
Tomatoes, field application

ar
sp
The PECSED as obtained with Step 2 and Step 3 are given in Tables 2.5.3-12 and 2.5.3-13.
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
77
cu
s do
hi
t
of
is
as
(PECSED, in µg/kg dwt) after field application of Vertimec 018 EC to tomatoes at 3 x 21.6 g as/ha, FOCUS Step 2.
eb
th
on
0 1.87 --- 3.26 ---
d
1 1.85 1.86 3.23 3.24
e
nt
2 1.84 1.85 3.21 3.23
ra
4 1.81 1.84 3.16 3.21
eg
7 1.77 1.82 3.08 3.17
14 1.68 1.77 2.92 3.09
tb
21 1.59 1.72 2.77 3.00
no
28 1.50 1.68 2.62 2.93
42 1.35 1.59 2.35 2.78
t
us
50 1.27 1.55 2.21 2.70
m
100 0.858 1.30 1.50 2.26
n
tio
ra
Table 2.5.3-13. Actual and Time Weighted Average (TWA) Predicted Environmental Concentrations of abamectin in surface
st
water (PECSED, in µg/kg dwt) after field application of Vertimec 018 EC to tomatoes at 3 x 21.6 g as/ha, FOCUS Step 3.
gi
Scenario Days after Step 3 PECSED [µg/kg dwt]
Re
n.
io
D6, ditch 0 0.047 --- 0.082 --
1 0.043 0.046 0.076 lat
0.081
iso
2 0.038 0.044 0.070 0.079
4 0.031 0.040 0.059 0.074
in
7 0.024 0.035 0.047 0.067

d
14 0.016 0.028 0.049 0.056

ea
21 0.012 0.024 0.035 0.052

er
28 0.010 0.020 0.027 0.047

42 0.007 0.017 0.019 0.040
tb
50 0.006 0.015 0.017 0.037

no
100 0.003 0.010 0.007 0.025

ld
ou
R2, stream 0 0.247 --- 0.456 ---

1 0.243 0.245 0.450 0.454
sh
2 0.241 0.243 0.445 0.451

d
4 0.234 0.241 0.434 0.446

an
7 0.228 0.237 0.420 0.442

ge
14 0.213 0.229 0.394 0.428

21 0.200 0.222 0.371 0.415
a
ck
28 0.190 0.215 0.351 0.403

pa
42 0.170 0.204 0.316 0.381

50 0.160 0.198 0.298 0.370
ta
100 0.111 0.166 0.198 0.311

da
n
R3, stream 0 0.034 --- 0.048 ---

io
1 0.030 0.033 0.045 0.047

at
2 0.027 0.031 0.042 0.046

alu
4 0.022 0.028 0.037 0.043

7 0.017 0.025 0.032 0.040
ev
14 0.017 0.022 0.025 0.034

EC
21 0.014 0.020 0.021 0.033

28 0.012 0.018 0.019 0.031
n
fa
42 0.009 0.015 0.015 0.028

50 0.008 0.014 0.013 0.026
to
100 0.004 0.010 0.007 0.020

ar
sp
R4, stream 0 0.496 --- 1.665 ---

1 0.488 0.493 1.638 1.653
m
or
2 0.480 0.489 1.610 1.639

4 0.466 0.481 1.571 1.615
tf
7 0.448 0.471 1.509 1.583

en
14 0.421 0.453 1.458 1.542

m
21 0.395 0.438 1.370 1.499

cu
28 0.372 0.425 1.290 1.457

do
42 0.333 0.401 1.158 1.380

50 0.308 0.388 1.069 1.338
is
Th
100 0.179 0.315 0.622 1.088

:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
78
cu
s do
hi
t
of
is
as
Tomatoes, glasshouse application
eb
The PECSED as obtained with Step 2 are given in Table 2.5.3-14.
th
on
d
(PECSED, in µg/kg dwt) after glasshouse application of Vertimec 018 EC to tomatoes at 5 x 21.6 g as/ha, FOCUS Step 2.
e
nt
maximum Single application Five applications
ra
concentration actual
eg
TWA actual TWA
0 0.0431 --- 0.196 ---
tb
1 0.0430 0.0431 0.195 0.196
no
2 0.0428 0.0430 0.194 0.195
4 0.0421 0.0427 0.191 0.194
t
us
7 0.0412 0.0423 0.187 0.192
m
14 0.0390 0.0412 0.177 0.187
21 0.0369 0.0401 0.167 0.182
n
tio
28 0.0350 0.0391 0.159 0.177
42 0.0313 0.0371 0.142 0.168
ra
50 0.0295 0.0360 0.134 0.163
st
100 0.0200 0.0302 0.0905 0.137
gi
Re
n.
Metabolite 4"-oxo-avermectin B1a (NOA 426289) was found in the sediment phase of the aerobic wa-
io
lat
ter/sediment systems with a maximum level of 8.6 % of AR at the end of the study. In view of the rapid
iso
dissipation of abamectin to the sediment phase, it is likely that this metabolite results from degradation
in
of abamectin in the sediment phase, rather than from transfer to sediment after formation in water. In
d
ea
view of this, and because no DT50 and KOM are available for this compound, the maximum concentra-
er
tb
tion in sediment is calculated by multiplying the peak concentration of abamectin with the formation
no
percentage of 8.6 %. Parent and metabolite only differ by one H-atom at the 4"-C-position, and the
ld
ou
relative molar mass is thus equal to 1 after rounding off. Resulting peak concentrations in sediment
sh
are given in Table 2.5.3-15.

d
an
Table 2.5.3-15. Peak concentrations of 4"-oxo-avermectin B1a in sediment (PECSED, in µg/kg dwt) after application of Vertimec
ge
018 EC to citrus, lettuce and tomatoes.

a
ck
Crop Scenario Application Peak concentration Peak concentration

rate abamectin abamectin 4"-oxo-avermectin B1a
pa
[g as/ha] [µg/kg dwt] [µg/kg dwt]

ta
citrus D6 3 x 21.6 2.905 0.250

da
lettuce, field R2 3 x 18 2.155 0.185

lettuce, glasshouse Step 2 4x9 0.0667 0.0057
n
io
tomatoes, field R4 3 x 21.6 1.665 0.143

at
tomatoes, glasshouse Step 2 5 x 21.6 0.196 0.0169

alu
ev
EC
2.5.4 Fate and behaviour in air

n
fa
Concentrations of abamectin in air are expected to be low. Abamectin has vapour pressure of < 3.7
to
x·10-6 Pa, and a Henry’s law constant of ≤2.7 x 10-3 Pa·m3·mol-1, or in dimensionless form ≤1.13 x 10-6.
ar
sp
Based on this information it is considered that significant volatilisation of abamectin is unlikely to occur
m
from soil. The gas phase oxidation half-life for abamectin was estimated to be < 1 hour (24 hour day).
or
tf
Should abamectin volatilise, then the compound will degrade quickly.

en
m
cu
do
is
Th
:
NG
NI
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W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
79
cu
s do
hi
2.6 Effects on non-target species
t
of
is
as
2.6.1 Effects on terrestrial vertebrates
eb
th
2.6.1.1 Birds
on
d
Routes of exposure
e
nt
ra
eg
house and field applications are proposed for the latter two crops. The following exposure routes are
tb
considered:
no
t
• direct exposure via food: scenarios for orchard (citrus) and leafy crops (field grown lettuce and
us
m
tomatoes), for the acute, short-term and long-term time-scale
n
tio
• direct exposure via drinking of surface water (acute time-scale; field and glasshouse applications)
ra
st
• indirect exposure by consumption of earthworms containing residues of abamectin (long-term
gi
Re
time-scale; field applications)
n.
• indirect exposure by consumption of fish containing residues of abamectin (long-term time-scale;
io
lat
field and glasshouse applications)
iso
in
Acute and short-term dietary toxicity data

d
Acute oral toxicity studies were performed with bobwhite quails (Colinus virginianus) and mallard
ea
er
ducks (Anas platyrhynchos), resulting LD50's were > 2000 mg/kg bw for C. virginianus and 77 mg/kg
tb
bw for A. platyrhynchos. The latter value is considered indicative, as vomiting occurred and the actual
no
ld
ingested dose may have been lower. Vomiting is often observed in studies with the mallard, and it is
ou
thus not considered to be an artefact related to this specific experiment. But considering the fact that
sh
d
the TER for the medium herbivorous bird in tomatoes (scenario: leafy crops) would be < 10 at an LD50
an
value < 29 mg/kg bw and this could be achieved after vomiting 2/3 of the total dose administered, an
ge
a
acute risk can not be excluded.

ck
pa
In short-term dietary studies, LC50-values of 3102 and 883 mg/kg fd were obtained for C. virginianus
ta
and A. platyrhynchos. For A. platyrhynchos, almost all mortalities occurred on the first day and body
da
n
weight and food consumption could thus be estimated accurately. The LC50, expressed as daily dose
io
at
was 48.6 mg/kg.bw.d. Recalculation for C. virginianus was not possible, because mortality increased
alu
with time and there was an irregular pattern of consumption, either due to wastage or to avoidance. An
ev
EC
indicative LC50 of 560 mg/kg.bw.d was derived by interpolation.

n
From a reproduction study with A. platyrhynchos, a NOECof 12 mg/kg fd was obtained, corresponding
fa
to
to 1.33 and 1.49 mg/kg bw.d for males and females, respectively. The NOEC for C. virginianus was
ar
sp
≥ 20 mg/kg fd, corresponding to ≥ 2.0 mg/kg bw.d for males and females.
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
80
cu
s do
hi
Acute and short-term risk assessment
t
of
is
as
Exposure via food
eb
The acute risk assessment is based on the lowest LD50 of 77 mg/kg bw, which in view of the single
th
on
oral dose can be regarded as a daily dose in mg/kg bw.d. Estimated theoretical exposure (ETE) and
d
Toxicity Exposure Ratios (TER's) are given in Table B.9.1.4-1. Due to vomiting the actual LD50 may
e
nt
have been lower than 77 mg/kg bw. Considering the fact that the TER for the medium herbivorous bird
ra
eg
in tomatoes (scenario: leafy crops) would be < 10 at an LD50 value < 29 mg/kg bw and this could be
tb
achieved after vomiting 2/3 of the total dose administered, an acute risk can not be excluded.
no
t
us
Table 2.6.1-1. Acute risk for birds resulting from exposure to residues on food.
m
Crop Scenario Indicator Dose RUD FIR/bw MAF ETE TER
n
species [mg/kg at
tio
[kg as/ha] 1 kg as/ha] [g fd/g bw·d] [mg/kg bw·d]
ra
st
citrus orchard insectivorous bird 3 x 0.0216 52 1.04 - 1.2 66
gi
Re
lettuce leafy crops medium herbivorous bird 3 x 0.018 87 0.76 1.7 2.0 39
insectivorous bird 52 1.04 - 0.97 79
n.
io
tomatoes leafy crops medium herbivorous bird 3 x 0.0216 87 0.76
lat 1.7 2.4 32
iso
in
The short-term risk assessment is based on the lowest LC50 of 48.6 mg/kg bw.d. Estimated theoretical
d
ea
exposure (ETE) and Toxicity Exposure Ratios (TER's) are given in Table 2.6.1-2. All TER's are above
er
tb
the trigger of 10, a short-term risk is not expected.

no
Table 2.6.1-2. Short-term risk for birds resulting from exposure to residues on food.
ld

ou
species [mg/kg at
sh

d
an

ge
a
ck

pa
tomatoes leafy crops medium herbivorous bird 3 x 0.0216 40 0.76 2.0 1.3 37
ta

da
n
io
at
Exposure via water

alu
ev
The highest concentration in surface water as calculated with FOCUS Step 3, is 0.791 µg/L after sin-
EC
gle application to citrus. The acute risk assessment is performed for a small bird of 10 g, which has a
n
daily water intake of 2.7 mL. The ETE for this bird is 0.214 µg/kg bw.d. Based on the LD50 of 77 mg/kg
fa
to
bw, the TER is 3.6 x 105. Although the LD50 might have been lower than 77 mg/kg bw an acute risk is
ar
sp
not expected.
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
81
cu
do
s
thi
Long-term/reproductive risk
of
is
as
Exposure via food
eb
th
The long-term risk assessment is based on the lowest NOEC of 1.33 mg/kg bw.d. Estimated theoreti-
on
cal exposure (ETE) and Toxicity Exposure Ratios (TER's) are given in Table 2.6.1-3.
de
nt
Table 2.6.1-3. Long-term risk for birds resulting from exposure to residues on food.
ra
1
Crop Scenario Indicator Dose RUD FIR/bw MAF ftwa ETE TER
eg
species [mg/kg at
tb
no
citrus orchard insectivorous bird 3 x 0.0216 29 1.04 - - 0.65 2.0
t
us
lettuce leafy crops medium herbivorous bird 3 x 0.018 40 0.76 2.0 0.53 0.58 2.3
m
insectivorous bird 29 1.04 - - 0.54 2.5
n
tio
tomatoes leafy crops medium herbivorous bird 3 x 0.0216 40 0.76 2.0 0.53 0.70 1.9
ra
insectivorous bird 29 1.04 - - 0.65 2.0
st
1: based on DT50 10 days and 3 weeks averaging time.
gi
Re
The TER's are lower than the trigger of 5. For the herbivorous birds, the ETE can be refined using
n.
io
data on measured residues on leaves. From residue trials with lettuce with field application of 3 x 18 g
lat
iso
as/ha, a DT50 of < 3 days is obtained for dissipation of abamectin from leaves. In view of the fast dissi-
in
pation of avermectin B1a in soil, it is considered justified to use this lower DT50 instead of the default of
d
ea
10 days. According the Guidance Document, the averaging time should be set at the application inter-
er
val when using a refined DT50. With a DT50 of 3 days, a spray interval and averaging time of 7 days,
tb
no
the MAF is 1.24 and the ftwa is 0.50, resulting in an ETE of 0.34 and 0.41 mg/kg bw.d for lettuce and
ld
tomatoes, respectively. Corresponding TER's are 3.9 and 3.2, which is still lower than the trigger of 5.
ou
sh
No information is available with respect to decline of residues on insects.

d
an
There are reasons to assume that the TER's as calculated above are a worst case estimate. In the
ge
pilot reproduction study, effects were found at 64 mg/kg fd, whereas in the final study a dose level of
a
ck
12 mg/kg fd showed no effects. The 'true' NOEC is thus lower than 64 mg/kg fd, but might be higher
pa
than 12 mg/kg fd. Furthermore, the calculations on the conservative assumptions that bird spends its
ta
da
whole fouraging period in the treated field (PT = 1) and that the whole diet consists of treated food (PD
n
io
= 1). Both PD and PT may be lower than 1, because birds will feed over a larger area, not all food will
at
alu
be contaminated and the bird may use other food sources as well. As, however, no additional informa-
ev
tion is available, a risk cannot be excluded.

EC
n
Indirect exposure via contaminated worms or fish

fa
to
Worms
ar
sp
The concentration in worms is calculated according to the Guidance Document on risk assessment for
m
birds and mammals as

or
tf
PECworm = 21-days TWA-PECS x BCF, with

en
BCF = (0.84 + 0.01 KOW)/foc x KOC.

m
cu
Using log KOW 4.4, foc 0.02 and KOC 5638 L/kg, a BCF of 2.24 kgsoil/kgworm is obtained. The highest
do
TWA-PECS over 21 days is 0.0010 mg/kg, resulting from application on lettuce or tomatoes. The PEC-
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
82
cu
do
s
hi
is 0.00224 mg/kgworm. This value is converted to a daily dose by multiplying with 1.1, resulting in
t
worm
of
0.0025 mg/kg bw.d. With a NOEC of 1.33 mg/kg bw.d, the TER is 532. A risk from the consumption of
is
as
worms is not expected.
eb
Fish
th
on
The concentration in fish is calculated according to the Guidance Document on risk assessment for
ed
birds and mammals as:
nt
ra
PECfish = 21-days TWA-PECSW x BCF.
eg
The BCF is 69 L/kgfish and the highest TWA-PECSW over 21 days as calculated with FOCUS Step 3 is
tb
no
0.352 µg/L, resulting from multiple application on citrus (see Section B.8.6.1, Table B.8.6.1-6). The
t
us
PECfish is 0.024 mg/kgfish. This value is converted to a daily dose by multiplying with 0.21, resulting in
m
n
tio
fish is not expected.
ra
st
gi
Re
Risk refinement notifier
n.
The notifier has submitted a risk refinement regarding the acute and long-term risk for birds. Hereafter
io
lat
this risk refinement is presented (text in italics).
iso
in
d
Acute risk assessment:

ea
er
tb
The Rapporteur Member State (RMS) has proposed that the lowest acute LD50 value is 77 mg ai/kg
no
bw (correcting the 85 mg ai/kg bw figure for mallard given above for purity of the active ingredient).
ld
ou
Using this endpoint for the acute risk assessment generates TER values between 32 and 79 for insec-
sh
tivorous birds and for medium herbivorous birds in all crops, all of which are well above the relevant
d
an
trigger value of 10 (as shown in the DAR).

age
ck
The RMS has pointed out that the acute LD50 value for mallard of 77 mg ai/kg bw is in doubt due to
pa
ta
vomiting by the test birds and hence the TER for herbivorous bird in tomatoes may be less than the
da
trigger value of 10. The RMS therefore suggests that if the birds had vomited approximately 2/3 of the
n
io
total dose administered, then it is reasonable to assume an acute LD50 value equivalent to <29 mg
at
alu
ai/kg bw (the next lowest dose level). The following acute risk assessment (Table 2.6.1-4) has there-
ev
fore been carried out using a conservative acute LD50 value of 26 mg ai/kg bw, which represents
EC
2/3rds of the dose of 77 mg ai/kg bw.

n
fa
to
Table 2.6.1-4: Acute risk to birds resulting from exposure to abamectin residues on food based on worst-case acute LD50 of 26
ar
mg as/kg bw/day
sp
m
Crop Scenario Indicator species Dose RUD FIR/bw MAF ETE TER
or
(kg as/ha) (mg

tf
as/kg
en
bw/day)
m
cu

do
is

Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
83
cu
do
s
thi
of
(kg as/ha) (mg
is
as/kg
as
bw/day)
eb
tomatoes leafy crops medium herbivorous bird 3 x 0.0216 87 0.76 1.7 2.4 11
th
on
ed
nt
All of the acute TER values are above the trigger value of 10, even using a highly conservative LD50
ra
eg
value of 26 mg ai/kg bw, indicating acceptable acute risk to birds from all uses of abamectin. The
tb
lowest TER is for tomato but at the later growth stages when abamectin is applied, the foliage of toma-
no
toes is unlikely to be eaten by herbivorous birds. Therefore, it is more appropriate to consider acute
t
us
risk to birds from eating tomato fruit treated with abamectin.
m
n
tio
ra
Therefore, a risk assessment has been conducted below for a typical frugivore, starling (Sturnus vul-
st
gi
garis) feeding on tomato fruit. The standard residue value (RUD) for fruit, based on values proposed
Re
by Kenaga, 19733, was used in the risk assessment below. The FIR/bw for starling was calculated
n.
io
using the spreadsheet for this purpose on the PSD website lat
iso
(http://www.pesticides.gov.uk/applicant_advice.asp?id=713) according to the EU Guidance Document,

in
citing Crocker et al. (2002)4. The assumptions used are that the starling bodyweight is 78g, that it
d
ea
feeds entirely on tomatoes with an energetic content of 1.89 kJ/g wet weight (value for orchard topfruit,
er
the closest category) and an assimilation efficiency of 67%.

tb
no
ld
Table 2.6.1-5: Acute risk to frugiferous birds in tomato using Kenaga residue values on food, based on worst-case acute LD50 of
ou
26 mg ai/kg bw/day
sh
Crop Scenario Dose RUD (mg FIR/bw MAF ETE TER

d
as/kg fw)
an
(kg ai/ha) (mg as/kg

bw/day)
ge
a
ck
tomatoes starling
pa
3 x 0.0216 1.3 2.17 1.7 0.104 250

(Sturnus vulgaris)
ta
da
The acute TER for a starling feeding on tomato fruits that have been treated with abamectin is well
n
io
at
above the trigger value of 10, indicating an acceptable acute risk to birds for this scenario.
alu
ev
EC
n
fa
to
3 Kenaga EE (1973): Factors to be considered in the evaluation of toxicity of pesticides to birds in their environment. Environmental Quality
ar
sp
and Safety. Academic Press, New York, II: 166-181.

m
or
tf
4
Crocker D, Hart A, Gurney J & McCoy C (2002) Methods for estimating daily food intake of wild birds and mammals. Central
en
Science Laboratory; Project PN0908. Final Report, July 2002. Available at: http://www.pesticides.gov.uk/approvals.asp?id=1183
m
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do
is
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:
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t.
en
m
84
cu
do
s
thi
of
Conclusion: All of the acute TER values are above the trigger value of 10, even using a conservative
is
as
LD50 value of 26 mg ai/kg bw derived assuming two-thirds of the dose was vomited, clearly indicating
eb
acceptable acute risk to birds from all uses of abamectin.
th
on
ed
Comments RMS
nt
ra
RMS can agree with the approach of the notifier to take a LD50-value of 26 mg as/kg bw/day for risk
eg
assessment. Also the RMS considers this value as a conservative value, certainly in comparison with
tb
no
the LD50 of Colinus virginianus, which is higher than 2000 mg/kg bw/day. It can be conluded that
t
us
there is an acceptable acute risk for birds.
m
n
tio
Long-term risk assessment:
ra
st
The RMS has requested a refined long-term risk assessment for birds, which is presented below. This
gi
Re
risk assessment is based on a Daily Dietary Dose NOEL of 1.49 mg as/kg bw/day (see Part A: Toxicity
n.
above), though reference is also made to the CTB proposed endpoint of 1.33 mg as/kg bw/day. The
io
lat
risk assessments below are based upon the conservative assumptions that the bird spends all of it’s
iso
foraging time in the treated field (PT = 1) and that the whole diet consists of treated food (PD = 1).
in
d
ea
er
Insectivorous birds
tb
An initial Tier 1 risk assessment for insectivorous birds is shown below in Table 2.6.1-6.
no
ld
ou
Table 2.6.1-6: Long-term risk to insectivorous birds resulting from exposure to abamectin residues on food based on long-term
sh
NOEL of 1.49 mg as/kg bw/day

d
an
ge
(kg as/ha) (mg

as/kg
a
ck
bw/day)
pa
citrus orchard insectivorous bird 3 x 0.0216 29 1.04 - 0.65 2.3

ta
lettuce leafy crops insectivorous bird 3 x 0.018 29 1.04 - 0.54 2.8

da
tomatoes leafy crops insectivorous bird 3 x 0.0216 29 1.04 - 0.65 2.3

n
io
at
alu
The initial TER values for long-term risk to insectivorous birds are below the trigger value of 5, indicat-
ev
ing the need for a refined risk assessment, which is presented below.
EC
n
The EC Guidance Document on Risk Assessment for Birds and Mammals on birds and mammals
fa
to
does not allow for the use of degradation of default insect residue values since it is considered that
ar
sp
m
or
tf
en
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do
is
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:
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en
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cu
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hi
insufficient is known about the time-course of residues on insects. Therefore, a field study has been
t
of
conducted to measure abamectin residues and abamectin residue decline on invertebrates and
is
as
ground vegetation in an apple orchard (Bakker, 20055). An apple orchard was used rather than a citrus
eb
grove since there was little or no ground vegetation in citrus groves surveyed and it was important for
th
on
the study to generate residue data for ground vegetation as well as for arthropods. Abamectin was
d
e
applied according to recommended field practice in apple orchards, and invertebrates and ground
nt
ra
vegetation were sampled for residue analysis. The invertebrates were divided into a number of
eg
groups according to type and collection method, and residues were measured for each group. Model
tb
no
Manager software6 was used to fit first order models that describe the dissipation of active substance
t
us
within an insect guild over time. These models take the form:
m
n
tio
Residue at time (t) = R(0) * exp(-rt)
ra
st
gi
Re
Where:
n.
t = time in days.
io
R(t) = Residue at a time t lat
iso
R(0) = the predicted residue at the time of application.
in
d
This model therefore gives an estimate of the initial residue level (even if a sample was not taken im-
ea
er
mediately after application) and an estimate of the DT50 of the compound within that insect guild
tb
(loge(0.5)/r). The invertebrates have also been grouped by location in the crop into foliar, aerial and
no
ld
ground dwellers, since these will represent food components of the diet of bird species with different
ou
foraging habits (see Table 2.6.1-7 below).

sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
5
Bakker F (2005). MK936 (abamectin): A field study to determine residues of a 18.0 g/L EC formulation (A8612A) in apple or-
or
chard invertebrates as potential food items for birds and small mammals.
tf
6
Chapman P, Dyson J, Dark RJ and Waller M (2000). Model Manager Functional Specification. Internal Syngenta report No.
en
TMJ4485A.
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is
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en
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cu
s do
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t
of
Table 2.6.1-7: Measured invertebrate residues for abamectin orchard application
is
as
Mean DT50
eb
Location Initial residue (mg
Invertebrate group DT50 (days) (days) by loca-
th
as/kg fw)
tion
on
Foliar beetles 0.052 3.023
d
Foliar 5.3
e
nt
Foliar others (mainly aphids) 0.084 7.630
ra
eg
Aerial Aerial others (mainly Cantharidae) 0.129 1.026 0.94
tb
Aerial Lepidoptera 0.050 0.857
no
Ground surface spiders 0.013 5.717
t
us
0.183
Ground dwellers Ground surface beetles 0.418 5.4
m
n
Ground surface others (mainly caterpil-
tio
lars) 0.010 9.988
ra
st
gi
Re
It can be assumed that the weights of particular invertebrate groups caught by a specific capture
n.
method depend upon their abundance in the environment. In the absence of specific knowledge of
io
lat
bird scenario species and their dietary preferences, it is reasonable to assume that the proportions of
iso
different invertebrate groups in the birds’ diet will reflect their relative abundance in the crop. There-
in
fore, the relative proportion by weight in the catch of the different groups within a location (and, there-
d
ea
fore, capture method) can be used as PD values to reflect the estimated relative proportions of differ-
er
tb
ent groups in the diet. Since there are likely to be differences in capture efficiency between different
no
methods, no attempt is made to compare relative invertebrate abundances between capture methods
ld
ou
(location). The resulting PD values are presented in Table 2.6.1-8 below.

sh
d
an
Table 2.6.1-8: Invertebrate proportions in catch for abamectin orchard study

ge
Location Invertebrate group Proportion in catch (PD)

a
ck
pa
Foliar Foliar beetles 0.24

ta
Foliar others (mainly aphids) 0.76

da
Aerial others (mainly Cantharidae) 0.068

n
Aerial
io
at
Aerial Lepidoptera 0.932

alu
Ground surface spiders 0.525

ev
Ground dwellers
Ground surface beetles 0.220
EC
Ground surface others (mainly caterpillars) 0.255

n
fa
to
ar
sp
Citrus.
m
Since citrus groves represent a structured habitat with the trees providing good cover for foliar-feeding
or
tf
birds as well as opportunities for ground and aerial feeding, it is assumed that there will be a range of
en
m
bird species present that will forage predominantly on either foliar, aerial or ground-dwelling inverte-
cu
brates. Therefore, a risk assessment is conducted for birds feeding purely on each of these inverte-
do
is
brate groups. There are also likely to be species that feed on invertebrates from more than one loca-
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:
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t.
en
m
87
cu
s do
hi
tion within the crop but the risk to these species will be covered by the risk assessments for each loca-
t
of
tion separately. Measured DT50 values (Table 2.6.1-7) for each group are applied to decay the resi-
is
as
due on that group.
eb
th
on
The risk assessment for insectivorous birds in citrus is presented in Tables 2.6.1-9, -10 and -11 below.
de
nt
ra
Table 2.6.1-9: Long-term risk to foliar-feeding insectivorous birds in citrus resulting from exposure to abamectin residues on
eg
invertebrates, based on long-term NOEL of 1.49 mg as/kg bw/day
tb
Crop Indicator spe- Dose Invertebrate Mean ini- MAF fTWA FIR/bw PD ETE TER
no
cies group tial resi-
(kg (mg
due (mg
t
as/ha) as/kg
us
as/kg fw)
bw/day)
m
n
Foliar feeding Foliar beetles 0.052 1.24 0.50 1.04 0.24 0.0080 -
tio
3x
citrus insectivorous
0.0216 Foliar others
ra
bird 0.084 1.81 0.74 1.04 0.76 0.0889 -
(mainly aphids)
st
gi
Total
0.0969 15
Re
ETE
n.
io
Table 2.6.1-10: Long-term risk to ground-feeding insectivorous birds in citrus resulting from exposure to abamectin residues on
lat
iso
in

(kg (mg
d
due (mg
ea
as/ha) as/kg
as/kg fw)
er
bw/day)
tb
Ground surface
0.013 1.61 0.674 1.04 0.525 0.0077 -
no
spiders
Ground feeding
ld
3x Ground surface
citrus insectivorous 0.183 1.00 0.087 1.04 0.220 0.0036 -
ou
0.0216 beetles
bird
sh
Ground surface
others (mainly 0.010 1.99 0.792 1.04 0.255 0.0042 -
d
an
caterpillars)
ge
Total
0.0154 97
ETE
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
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or
tf
en
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cu
do
is
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:
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en
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cu
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t
of
Table 2.6.1-11: Long-term risk to aerial-feeding insectivorous birds in citrus resulting from exposure to abamectin residues on
is
as
eb
th
(kg (mg
due (mg
on
as/ha) as/kg
as/kg fw) bw/day)
de
Aerial others
nt
Aerial feeding (mainly Canthari- 0.129 1.01 0.21 1.04 0.034 0.0010 -
ra
3x
citrus insectivorous dae)
eg
0.0216
bird
Aerial Lepidoptera 0.050 1.0 0.176 1.04 0.466 0.0043 -
tb
no
Total
0.0053 280
ETE
t
us
m
The TER values for insectivorous birds in citrus are all well above the long-term trigger value of 5.
n
tio
Similarly, if the NOEC of 1.33 mg/kg bw/day proposed by the CTB were used then all of the TER val-
ra
st
ues would still be well above the trigger value of 5. This indicates acceptable long-term risk to insec-
gi
Re
tivorous birds feeding in citrus treated with abamectin.
n.
io
lat
Tomato
iso
For risk assessment to insectivorous birds in tomatoes, standard residue per unit dose (RUD) values
in
d
are used for insects, as recommended in the EC Guidance Document on Risk Assessment for Birds
ea
er
and Mammals. A tomato crop is considered to be a less attractive feeding habitat for birds than a cit-
tb
rus grove and the simpler habitat structure is expected to support a lower diversity of species. The low
no
and relatively open crop structure is unlikely to be favoured by strictly foliar feeders in the long-term.
ld
ou
Therefore, for the purposes of this risk assessment, it is assumed that birds feeding in a tomato crop
sh
will feed in equal proportions on invertebrates from the foliage, ground and aerial compartments. Both
d
an
foliar-dwelling and aerial insects are considered to be mostly small insects and hence the RUD for
ge
a
small insects is used. Ground-dwelling invertebrates taken by birds tend to be larger beetles, spiders
ck
pa
etc. and hence the RUD for large insects is applied. The EC Guidance Document does not recom-
ta
mend a default DT50 to account for dissipation of residues on insects but in this case DT50 values
da
have been generated in the orchard residue trial described above (Table 10.1-6). The mean DT50
n
io
at
values for foliar (5.3 days), aerial (0.94 days) and ground-dwelling (5.4 days) invertebrates are used in
alu
this risk assessment. A ‘maximum moving-window approach’ has been used to generate a 21-day
ev
EC
time weighted average. The maximum moving-window approach selects the worst-case 21-day TWA
n
residue across the whole application period. This risk assessment is shown in Table 2.6.1-12 below.
fa
to
ar
sp
m
or
tf
en
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cu
do
is
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en
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t
of
Table 2.6.1-12: Long-term risk to insectivorous birds in tomato resulting from exposure to abamectin residues on invertebrates,
is
based on long-term NOEL of 1.49 mg as/kg bw/day
as
eb
Crop Indicator Dose Invertebrate RUD (mg MAF fTWA FIR/bw PD ETE TER
species group as/kg fw)
th
(kg (mg
on
as/ha) as/kg
bw/day)
de
Foliar dwellers Moving
nt
29 1.56 1.04 0.33 0.181 -
(small insects) window
ra
eg
insectivorous 3x Ground –dwellers Moving
tomato 5.1 1.57 1.04 0.33 0.032 -
bird 0.0216 (large insects) window
tb
Aerial insects Moving
no
29 1.01 1.04 0.33 0.040 -
(small insects) window
t
us
Total 0.253 5.9
m
n
tio
ra
The TER value for insectivorous birds in tomato is above the long-term trigger value of 5. Similarly, if
st
gi
the NOEC of 1.33 mg/kg bw/day proposed by the CTB were used then the TER value (5.3) would still
Re
n.
be above the trigger value of 5. This indicates acceptable long-term risk to insectivorous birds feeding
io
in tomato crops treated with abamectin. lat
iso
in
Lettuce
d
ea
For risk assessment to insectivorous birds in lettuce, standard residue per unit dose (RUD) values are
er
tb
used for insects, as recommended in the EC Guidance Document on Risk Assessment for Birds and
no
Mammals. Like tomato, the low and open crop structure of a lettuce field is highly unlikely to be fa-
ld
ou
voured by strictly foliar feeders in the long-term. Therefore, for the purposes of this risk assessment, it
sh
is assumed that birds feeding in a lettuce crop will feed in equal proportions on invertebrates from the
d
an
foliage, ground and aerial compartments. Both foliar-dwelling and aerial insects are considered to be
ge
mostly small insects and hence the RUD for small insects is used. Ground-dwelling invertebrates
a
ck
taken by birds tend to be larger beetles, spiders etc. and hence the RUD for large insects is applied.
pa
The EC Guidance Document on Risk Assessment for Birds and Mammals does not recommend a de-
ta
da
fault DT50 to account for dissipation of residues on insects but in this case DT50 values have been
n
io
generated in the orchard residue trial described above. The mean DT50 values for foliar (5.3 days),
at
alu
aerial (0.94 days) and ground-dwelling (5.4 days) invertebrates are used in this risk assessment. A
ev
‘maximum moving-window approach’ has been used to generate a 21-day time weighted average
EC
residue. The maximum moving-window approach selects the worst-case 21-day TWA residue across
n
fa
the whole application period. This risk assessment is shown in Table 2.6.1-13 below.
to
ar
sp
m
or
tf
en
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cu
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is
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:
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Table 2.6.1-13: Long-term risk to insectivorous birds in lettuce resulting from exposure to abamectin residues on invertebrates,
is
as
eb
Crop Indicator Dose Invertebrate group RUD (mg MAF fTWA FIR/bw PD ETE TER
species as/kg fw)
th
(kg (mg
on
as/ha) as/kg
bw/day)
de
Foliar dwellers
nt
29 1.56 0.655 1.04 0.33 0.220 -
(small insects)
ra
eg
insectivorous 3x Ground –dwellers
tomato 5.1 1.57 0.660 1.04 0.33 0.027 -
bird 0.018 (large insects)
tb
Aerial insects
no
29 1.01 0.042 1.04 0.33 0.034 -
(small insects)
t
us
Total 0.211 7.1
m
n
tio
The TER value for insectivorous birds in lettuce is above the long-term trigger value of 5. Similarly, if
ra
st
the NOEC of 1.33 mg/kg bw/day proposed by the CTB were used then the TER value (6.3) would still
gi
Re
be above the trigger value of 5. This indicates acceptable long-term risk to insectivorous birds feeding
n.
in lettuce crops treated with abamectin.
io
lat
iso
Conclusion: The TER values for long-term risk to birds feeding on insects in citrus, lettuce and tomato
in
are all above the trigger value of 5, indicating acceptable risk from the representative uses of abamec-
d
ea
tin considered in Syngenta’s EU submission.

er
tb
no
Comments RMS
ld
ou
Citrus
sh
The field study with regard to residues on food is summarised in Volume 3 (B.9.1.5). This study is
d
an
considered valid.
ge
The RMS considers the refinement of the risk as presented by the notifier as acceptable, except for
a
ck
the toxicity value which has been chosen by the notifier (1.49 mg/kg bw/day). The RMS is of the opin-
pa
ta
ion that this value should be 1.33 mg/kg bw/day. But also with this value the TER-values are higher
da
than the trigger value of 5, so there is an acceptable long-term risk for birds from the application in
n
io
citrus.
at
alu
ev
Tomato and lettuce

EC
A ‘maximum moving-window approach’ has been used by the notifier to generate a 21-day time
n
fa
weighted average. This is not according to the Guidance Document for Birds and Mammals and also it
to
ar
has not been made clear how this calculation has been performed. Therefore this approach is not ac-
sp
cepted by the RMS.

m
or
Instead of the ‘maximum moving-window approach’ the RMS is of the opinion that the approach as
tf
en
presented in the Guidance Document should be followed (twa-factor based on the interval-period be-
m
cu
tween two applications, in this case 7 days), as has been done also in the case of the citrus-
do
is
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application. The TER-values, calculated according to this method, are presented in tables 2.6.1-14
t
of
and 2.6.1-15. A NOEL-value of 1.33 mg/kg bw/day has been taken for calculating the TER-values.
is
as
eb
Table 2.6.1-14: Long-term risk to insectivorous birds in tomato resulting from exposure to abamectin residues on invertebrates,
th
on
d
Crop Indicator Dose Invertebrate RUD MAF fTWA FIR/bw PD ETE TER
e
species group (mg
nt
(kg (mg
as/kg
ra
as/ha) as/kg
fw)
eg
bw/day)
tb
Foliar dwellers
29 1.56 0.655 1.04 0.33 0.220 -
no
(small insects)
Ground –
t
us
insectivorous 3x
tomato dwellers (large 5.1 1.57 0.660 1.04 0.33 0.039 -
bird 0.0216
m
insects)
n
tio
Aerial insects
29 1.01 0.193 1.04 0.33 0.042 -
(small insects)
ra
st
Total 0.301 4.4
gi
Re
n.
io
Table 2.6.1-15: Long-term risk to insectivorous birds in lettuce resulting from exposure to abamectin residues on invertebrates,
lat
iso
Crop Indicator Dose Invertebrate RUD (mg MAF fTWA FIR/bw PD ETE TER
in
species group as/kg fw)

d
(kg (mg
ea
as/ha) as/kg
er
bw/day)
tb
Foliar dwellers
29 1.56 0.655 1.04 0.33 0.183 -
no
(small insects)
ld
insectivorous 3x Ground –dwellers

tomato 5.1 1.57 0.660 1.04 0.33 0.033 -
ou
bird 0.018 (large insects)

sh
Aerial insects
29 1.01 0.193 1.04 0.33 0.035 -
(small insects)
d
an
Total 0.251 5.3

age
ck
The TER-value for the use in tomato is below the trigger value of 5. However, the value is close to the
pa
ta
trigger and taking into account that the values for PD and PT are set to 1, which is very conservative,
da
the long term risk to birds from the use in tomato is considered acceptable.
n
io
The TER-value for the use in lettuce is above the trigger value of 5. Therefore the long-term risk to
at
alu
birds from the use in lettuce is considered acceptable.

ev
EC
Herbivorous birds
n
fa
to
ar
The appropriate scenarios to consider, as recommended in the EC Guidance Document on Risk As-
sp
sessment for Birds and Mammals, are medium herbivorous birds feeding in leafy crops, i.e. lettuce
m
or
and tomato. Herbivorous birds are not recommended as a relevant scenario to consider in orchards,
tf
en
and hence citrus.

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en
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cu
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Lettuce
t
of
An initial risk assessment assuming that a medium herbivorous bird feeds entirely on treated lettuce
is
as
leaves (i.e. PD and PT assumed to be 1) is shown below. A ‘maximum moving-window approach’ has
eb
been used to generate a 21-day time weighted average residue. The maximum moving-window ap-
th
on
proach selects the worst-case 21-day TWA residue across the whole application scenario. This risk
d
e
assessment is shown in Table 2.6.1-16 below.
nt
ra
eg
Table 2.6.1-16: Long-term risk to herbivorous birds in lettuce resulting from exposure to abamectin residues on food, based on
tb
long-term NOEL of 1.49 mg as/kg bw/day
no
Crop Scenario Indicator species Dose RUD FIR/bw 21-day TER
t
us
(kg as/ha) TWA ETE
m
(mg as/kg
n
bw/day)
tio
ra
lettuce leafy crops medium herbivorous bird 3 x 0.018 40 0.76 0.311 4.8
st
gi
Re
The long-term TER for a medium herbivorous bird is slightly below the trigger value of 5, indicating the
n.
need for further refinement of the risk assessment.
io
lat
iso
The initial risk assessment presented above uses a RUD of 40 mg/kg for leafy crops, which is equiva-
in
lent to a concentration of 0.018 x 40 = 0.72 mg abamectin/kg lettuce foliage. However, measured field
d
ea
residue data are available based on this GAP (3 x 0.018 kg abamectin/ha at 7 day intervals) for four
er
tb
trials conducted in lettuce in southern Europe (see Volume 3, B.7.6.5) which show that residues of
no
avermectin B1a on lettuce foliage range from 0.034 to 0.24 mg/kg on day 0, the day of the last applica-
ld
ou
tion and rapidly dissipate with a DT50 of less than 3 days. Therefore, a refined risk assessment has
sh
been conducted using the highest measured residue value of 0.24 mg/kg and a DT50 of 3 days (see
d
an
Table 2.6.1-17 below). Since the residue value used represents the cumulative residue from 3 appli-
ge
cations, it is appropriate to calculate a time-weighted average factor (fTWA) using an averaging period
a
ck
of 21 days.
pa
ta
da
Table 2.6.1-17: Refined long-term risk to herbivorous birds in lettuce using measured abamectin residues on food, based on
n
io
at
Crop Scenario Indicator species Dose Maximum FIR/bw fTWA 21-day TWA TER
alu
measured ETE
(kg as/ha)
initial residue
ev
(mg as/kg
(mg as/kg fw
bw/day)
EC
medium herbivorous
n
lettuce leafy crops 3 x 0.018 0.24 0.76 0.204 0.037 40

fa
bird
to
ar
The long-term TER for a medium herbivorous bird feeding on lettuce foliage is greater than the trigger
sp
value of 5, indicating acceptable long-term risk to birds in this scenario.

m
or
tf
en
Comments RMS
m
cu
The RMS has several comments on the risk refinement above presented by the notifier:
do
- The maximum moving-window approach’ is not accepted (see long-term risk to insectivorous birds);
is
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en
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cu
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- it is not clear if a MAF-value is included in table 2.6.1-16;
t
of
- in the risk assessment, in which the measured residue has been taken an averaging period of 21
is
as
days is used, because the cumulative residue from 3 applications has been measured. In the opinion
eb
of the RMS this is not the right approach. According to the Guidance Document the averaging period
th
on
must be the interval between two applications, in this case 7 days;
ed
- the long-term NOEL should be 1.33 mg/kg bw/day, in the opinion of the RMS.
nt
ra
The TER-value has been recalculated, taking these comments into account (see table 2.6.1-18).
eg
tb
no
Table 2.6.1-18: Refined long-term risk to herbivorous birds in lettuce using measured abamectin residues on food, based on
t
us
m
Crop Scenario Indicator species Dose Maximum FIR/bw fTWA 7-day TWA TER
measured ETE
n
(kg as/ha)
tio
initial residue (mg as/kg
ra
(mg as/kg fw
bw/day)
st
gi
medium herbivorous
Re
lettuce leafy crops 3 x 0.018 0.24 0.76 0.50 0.091 14.6
bird
n.
io
lat
The TER-value is now 14.6, still above the trigger-value of 5. Therefore the risk to herbivorous birds
iso
from the use in lettuce is acceptable.

in
d
ea
Tomato
er
tb
Considering herbivorous birds in a tomato crop, at the later growth stages when abamectin is applied
no
the foliage of tomatoes is unlikely to be eaten by herbivorous birds. However, it is possible that
ld
ou
frugivorous birds will feed on tomato fruit. Therefore, a risk assessment has been conducted below for
sh
a typical frugivore, starling (Sturnus vulgaris), feeding on tomato fruit. The FIR/bw for starling was
d
an
calculated using the spreadsheet for this purpose on the PSD website
ge

a
ck
citing Crocker et al. (2002)7. The assumptions used are that the starling bodyweight is 78g, that it
pa
ta
feeds entirely on tomatoes with an energetic content of 1.89 kJ/g wet weight (value for orchard topfruit,
da
the closest category) and an assimilation efficiency of 67%. This results in a FIR/bw value of 2.17.
n
io
The standard residue value (RUD) for fruit based on values proposed by Kenaga, 19738 is used in the
at
alu
risk assessment as below. The results of this risk assessment are presented in Table 2.6.1-19 below
ev
EC
n
fa
to
ar
7
sp
8 Kenaga EE (1973): Factors to be considered in the evaluation of toxicity of pesticides to birds in their environment. Environmental Quality and Safety. Aca-
m
or
demic Press, New York, II: 166-181.

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en
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t.
en
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94
cu
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s
thi
of
Table 2.6.1-19: Long-term risk to frugiverous birds in tomato using measured abamectin residues on food, based on long-term
is
as
eb
Crop Scenario Dose RUD (mg FIR/bw MAF fTWA ETE TER
as/kg fw)
th
(kg ai/ha) (mg as/kg
on
bw/day)
ed
tomatoes starling
nt
3 x 0.0216 1.3 2.17 1.24 0.5 0.038 39
ra
(Sturnus vulgaris)
eg
tb
The long-term TER for a starling feeding on tomato fruits that have been treated with abamectin is well
no
above the trigger value of 5, hence indicating acceptable long-term risk to birds for this scenario.
t
us
m
n
Conclusion: The TER values for long-term risk to birds feeding on vegetation or tomato fruit in lettuce
tio
ra
and tomato crops are all above the trigger value of 5, indicating acceptable risk from the representa-
st
gi
tive uses of abamectin considered in Syngenta’s EU submission.
Re
n.
io
Comments RMS: lat
iso
RMS can agree with the refined risk assessment for herbivorous birds regarding the use in tomatoes.
in
The TER is higher than 5, so the risk is considered acceptable.

d
ea
er
Overall conclusion: The acute risk as well as the long-term risk to birds from the applications
tb
no
of abamectine in citrus, lettuce and tomato is considered acceptable.

ld
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
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en
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t
2.6.1.2 Mammals
of
is
as
Routes of exposure
eb
th
house and field applications are proposed for the latter two crops. The following exposure routes are
on
d
considered:
e
nt
• direct exposure via food: scenarios for orchard (citrus) and leafy crops (field grown lettuce and
ra
eg
tomatoes), for the acute, short-term and long-term time-scale
tb
• direct exposure via drinking of surface water (acute time-scale; field and glasshouse applications)
t no
• indirect exposure by consumption of earthworms containing residues of abamectin (long-term
us
m
time-scale; field applications)
n
tio
• indirect exposure by consumption of fish containing residues of abamectin (long-term time-scale;
ra
st
field and glasshouse applications)
gi
Re
Toxicity data
n.
io
Acute oral LD50-values for males and females are 8.7 and 12.8 mg/kg bw after exposure via an oil ve-
lat
hicle, and 232 and 214 mg/kg bw after exposure via an aqueous vehicle. Because the product con-
iso
tains an oily emulsifier, the lower values are used for risk assessment. The NOAEL for reproduction is
in
d
0.12 mg/kg bw.d.

ea
er
Acute and short-term risk assessment

tb
no
ld
Exposure via food

ou
The acute risk assessment is based on the lowest LD50 of 8.7 mg/kg bw, which in view of the single
sh
d
oral dose can be regarded as a daily dose in mg/kg bw.d. Estimated theoretical exposure (ETE) and
an
Toxicity Exposure Ratios (TER's) are given in Table 2.6.1-20. For citrus and tomatoes, the TER is
ge
a
lower than the trigger of 10 and a risk is expected.

ck
pa
Table 2.6.1-20. Acute risk for mammals resulting from exposure to residues on food.
ta

da
species [mg/kg at
n

io
at
citrus orchard small herbivorous mammal 3 x 0.0216 85 1.39 1.7 4.3 2.0
alu
ev
lettuce leafy crops medium herbivorous mammal 3 x 0.018 87 0.28 1.7 0.75 11
EC
tomatoes leafy crops medium herbivorous mammal 3 x 0.0216 87 0.28 1.7 0.89 9.7
n
fa
to
From residue trials with lettuce with field application of 3 x 18 g as/ha, a DT50 of < 3 days is obtained
ar
for dissipation of abamectin from leaves. In view of the fast dissipation of avermectin B1a in soil, it is
sp
m
considered justified to assume that dissipation from citrus and tomato leaves is similarly fast. A refined
or
DT50 cannot be used directly to re-calculate the MAF, because special MAF's are used for the acute
tf
en
assessment in connection with the 90th percentile residue values: the acute MAF's are lower than
m
cu
MAF's for the short- or long-term situation (1.7 vs. 2.0 for 3 applications with a 7-days interval), be-
do
cause it is unlikely that the upper percentile is exceeded with each application. However, as the for-
is
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
96
cu
do
s
hi
mula thus gives a worst case MAF, it can be used in this case. Using the DT50 of 3 days, the MAF is
t
of
1.24, which for tomatoes would decrease the ETE to 0.65 and increase the TER to 13. It can be as-
is
as
sumed that there is no acute risk to be expected from the use on tomatoes. For citrus, however, even
eb
for a single application (MAF = 1) the TER of 3.4 does not meet the trigger and a risk is expected.
th
on
d
Exposure via water
e
nt
The highest concentration in surface water as calculated with FOCUS Step 3, is 0.791 µg/L after sin-
ra
eg
gle application to citrus. The acute risk assessment is performed for a small mammal of 10 g, which
tb
has a daily water intake of 1.6 mL. The ETE for this mammal is 0.119 µg/kg bw.d. Based on the LD50
no
of 8.7 mg/kg bw, the TER is 7.3 x 104. An acute risk from drinking contaminated water is not expected.
t
us
m
Long-term/reproductive risk
n
tio
ra
st
Exposure via food
gi
Re
The long-term risk assessment is based on the NOAEL of 0.12 mg/kg bw.d. Estimated theoretical ex-
n.
posure (ETE) and Toxicity Exposure Ratios (TER's) are given in Table 2.6.1-21.
io
lat
Table 2.6.1-21. Long-term risk for mammals resulting from exposure to residues on food.
iso
1
Crop Scenario Indicator Dose RUD FIR/bw MAF ftwa ETE TER
species [mg/kg at
in

d
ea
citrus orchard small herbivorous mammal 3 x 0.0216 46 1.39 2.0 0.53 1.46 0.08
er
tb
lettuce leafy crops medium herbivorous mammal 3 x 0.018 40 0.28 2.0 0.53 0.21 0.56
no
tomatoes leafy crops medium herbivorous mammal 3 x 0.0216 40 0.28 2.0 0.53 0.26 0.47
ld
1: based on DT50 10 days and 3 weeks averaging time.

ou
sh
d
The TER's are lower than the trigger of 5. The ETE can be refined using data on measured residues
an
on leaves. From residue trials with lettuce with field application of 3 x 18 g as/ha, a DT50 of < 3 days is
ge
a
obtained for dissipation of abamectin from leaves. In view of the fast dissipation of avermectin B1a in
ck
pa
soil, it is considered justified to use this lower DT50 instead of the default of 10 days. According to the
ta
Guidance Document, the averaging time should be set at the application interval when using a refined
da
n
DT50. With a DT50 of 3 days, a spray interval and averaging time of 7 days, the MAF is 1.24 and the ftwa
io
at
is 0.50, resulting in ETE's of 0.86, 0.12 and 0.15 mg/kg bw.d for citrus, lettuce and tomatoes, respec-
alu
tively. Corresponding TER's are 0.14, 1 and 0.8, which are still lower than the trigger of 5.
ev
EC
These calculations are based on the conservative assumptions that mammals spend their whole four-
n
aging period in the treated field (PT = 1) and that the whole diet consists of treated food (PD = 1). Both
fa
to
PD and PT may be lower than 1, because mammals will feed over a larger area, not all food will be
ar
contaminated and the animal may use other food sources as well. As, however, no additional informa-
sp
m
tion is available, a risk cannot be excluded.

or
tf
en
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cu
do
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en
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97
cu
s do
hi
Indirect exposure via contaminated worms or fish
t
of
Worms
is
as
eb
The concentration in worms is calculated according to the Guidance Document on risk assessment for
th
birds and mammals as
on
PECworm = 21-days TWA-PECS x BCF, with
d
e
BCF = (0.84 + 0.01 KOW)/foc x KOC.
nt
ra
Using log KOW 4.4, foc 0.02 and KOC 5638 L/kg, a BCF of 2.24 kgsoil/kgworm is obtained. The highest
eg
tb
TWA-PECS over 21 days is 0.0010 mg/kg, resulting from application on lettuce or tomatoes. The PEC-
no
worm is 0.00224 mg/kgworm. This value is converted to a daily dose by multiplying with 1.1, resulting in
t
us
m
n
worms is not expected.
tio
Fish
ra
st
gi
The concentration in fish is calculated according to the Guidance Document on risk assessment for
Re
birds and mammals as:
n.
io
PECfish = 21-days TWA-PECSW x BCF. lat
iso
The BCF is 69 L/kgfish and the highest TWA-PECSW over 21 days as calculated with FOCUS Step 3 is
in
0.352 µg/L, resulting from multiple application on citrus (see Section B.8.6.1, Table B.8.6.1-6). The
d
ea
PECfish is 0.024 mg/kgfish. This value is converted to a daily dose by multiplying with 0.21, resulting in
er
tb
no
fish is not expected.

ld
ou
Risk refinement
sh
d
The notifier has submitted a risk refinement regarding the acute and long-term risk for mammals.
an
ge
Hereafter this risk refinement is presented (in italics). The risk assessment is based upon the conser-
a
ck
vative assumptions that the mammal spends all of its foraging time in the treated field (PT = 1) and
pa
that the whole diet consists of treated food (PD = 1).

ta
da
n
Acute risk
io
at
alu
The acute risk assessment for mammals in citrus in the original submission was based upon a stan-
ev
dard RUD value of 85 to calculate exposure. However, since that submission an orchard field trial has
EC
been conducted to measure residues on invertebrates and ground vegetation (Bakker, 20059). The
n
fa
to
ar
sp
m
or
tf
9
Bakker F (2005). MK936 (abamectin): A field study to determine residues of a 18.0 g/L EC formulation (A8612A) in apple or-
en
chard invertebrates as potential food items for birds and small mammals.
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cu
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
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cu
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s
hi
measured initial residue and DT50 for vegetation derived from this trial are given below in Table 2.6.1-
t
of
22.
is
as
eb
Table 2.6.1-22: Measured vegetation residues for abamectin following orchard application
th
on
Insect group Initial residue (mg as/kg fw) DT50 (days)
d
Vegetation 0.266 1.7
e
nt
ra
eg
An acute risk assessment has been conducted below using the measured residue on vegetation
tb
(grass) and is shown in Table 2.6.1-23 below.
no
t
us
Table 2.6.1-23: Acute risk to mammals in citrus resulting from exposure to abamectin residues on food based on LD50 of 8.7 mg
m
as/kg bw/day
n
tio
Crop Scenario Indicator species Dose Initial FIR/bw MAF ETE TER
ra
residue
st
(kg (mg
(mg
gi
as/ha) as/kg
as/kg
Re
bw/day)
fw)
n.
citrus orchard small herbivorous mammal 3x 0.266 1.39 1.7 0.629 13.8
io
0.0216 lat
iso
The TER value for herbivorous mammals in citrus is above the acute trigger value of 10 indicating ac-
in
d
ceptable acute risk to herbivorous mammals feeding in citrus crops treated with abamectin.
ea
er
tb
However, small herbivorous mammals, like the field vole (Microtus agrestis), are unlikely to forage in
no
short grass in orchards because they prefer the cover and protection given by dense grassy habitats
ld
ou
in which they can conceal runways (Eldridge10, 1971). This is supported by a survey of small mam-
sh
mals that was carried out in 5 apple orchards in the vicinity of Tarrega, Spain (Bakker, 200511). Small
d
an
mammal trapping was carried out during late July/early August 2004. No voles were caught or re-
ge
corded. The most common rodent captured was Apodemus sylvaticus, wood mouse. Other species
a
ck
captured were Mus musculus, house mouse, Mus spretus, Algerian mouse and Crodicera russula,
pa
ta
white-toothed shrew.
da
Therefore, a more relevant scenario to consider in citrus is an insectivorous mammal feeding on large
n
io
insects, and a risk assessment for this scenario is shown below in Table 2.6.1-24.
at
alu
ev
EC
n
fa
to
ar
sp
m
or
10
Eldridge J (1971) Some observations on the dispersion of small mammals in hedgerows. J. Zool. 165: 530-534.
tf
11
Bakker F (2005) Contract report on occurrence of birds and mammals in apple orchards in Southern France and Spain. In
en
prep.
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:
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t.
en
m
99
cu
do
s
thi
of
Table 2.6.1-24: Acute risk to mammals in citrus resulting from exposure to abamectin residues on food based on LD50 of 8.7 mg
is
as/kg bw/day
as
eb
th
(kg (mg (mg
on
as/ha) as/kg as/kg
fw food bw/day)
ed
per kg
nt
applied)
ra
eg
citrus orchard insectivorous mammal 3x 5.1 0.63 1.7 0.118 74
0.0216
tb
no
The TER value for insectivorous mammals in citrus is well above the acute trigger value of 10 indicat-
t
us
m
ing acceptable acute risk to insectivorous mammals feeding in citrus crops treated with abamectin.
n
tio
Conclusion: The acute TER values for small herbivorous mammals feeding on grass and insec-
ra
tivorous mammals feeding on large insects in citrus are above the trigger value of 10, indicat-
st
gi
ing that use of abamectin in citrus poses no unacceptable acute risk to wild mammals.
Re
n.
io
Comments RMS: lat
iso
The RMS can agree with the risk refinement for small herbivorous mammals feeding on grass and
in
insectivorous mammals feeding on large insects in citrus, as presented by the notifier. The acute risk
d
ea
to mammals is considered acceptable.

er
tb
no
Long-term risk
ld
ou
Citrus
sh
d
an
As stated above, voles are unlikely to occur in managed orchards and hence it is more appropriate to
ge
consider the wood mouse (Apodemus sylvaticus) as a relevant species in citrus. The wood mouse is
a
ck
omnivorous so data from the literature has been used to define the diet of this species. A study by
pa
Pelz (198912) gave the average proportions of different food types in wood mouse diet on arable farm-
ta
da
land in all months of the year. Data from Pelz has been used to estimate the mixed diet of a typical
n
io
wood mouse for this risk assessment. The diet has been averaged across the months April to August
at
alu
to reflect the potential application window in citrus (Table 2.6.1-25).

ev
EC
n
fa
to
ar
sp
m
or
tf
12
Pelz HJ (1989) Ecological aspects of damage to sugar beet seeds by Apodemus sylvaticus. In Mammals as Pests (ed.
en
Putman RJ), 34-48 (Chapman and Hall, London).

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Mon Feb 05 03:52:00 CET 2018

t.
en
m
100
cu
s do
hi
t
of
Table 2.6.1-25: Proportions of different food types in wood mouse diet on arable farmland: mean diet for April to September
is
(calculated from data given in Pelz, 1989)
as
eb
(1)
Food % of diet wet weight
th
Vegetation 13
on
Cereal seeds 31
e d
nt
Dicot seeds 14
ra
eg
Insect larvae 27
tb
Earthworms 16
t no
us
(1)
Determined as % volume of stomach contents
m
n
The weights of different food types consumed by the wood mouse assuming the above mixed diet, are
tio
ra
calculated using the spreadsheet for this purpose on the UK PSD website
st
gi
Re
citing Crocker et al. (2002)13. The measured residue of 0.266 mg/kg and DT50 of 1.7 days (table 10.3-
n.
io
3) are used for vegetation and, as a worst-case, for seeds also, in the diet of the wood mouse. Since
lat
iso
cereal seeds will not be available within a citrus grove, it is assumed that alternative weed seeds will
in
be consumed instead and hence the proportion of cereal seeds is added to the weed seeds consump-
d
ea
tion. Measured invertebrate residue data are available from an orchard residue trial (Bakker, 200514)
er
and are given below in Table 2.6.1-26.

tb
no
ld
Table 2.6.1-26: Measured invertebrate residues for abamectin orchard application

ou
sh
Invertebrate group Initial residue (mg as/kg fw) DT50 (days)

d
Foliar beetles 0.052 3.023

an
Foliar others (mainly aphids) 0.084 7.630

ge
a
Aerial others (mainly Cantharidae) 0.129 1.026

ck
pa
Aerial Lepidoptera 0.050 0.857

ta
Ground surface spiders 0.013 5.717

da
0.183
n
io
Ground surface beetles 0.418

at
Ground surface others (mainly caterpillars) 0.010 9.988

alu
ev
EC
n
fa
to
ar
sp
m
13
or
tf
14
Bakker F (2005). MK936 (abamectin): A field study to determine residues of a 18.0 g/L EC formulation (A8612A) in apple
en
orchard invertebrates as potential food items for birds and small mammals.
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cu
do
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:
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NI
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
101
cu
do
s
hi
The closest food type to ‘insect larvae’ among the invertebrate residue field trial data is caterpillars,
t
of
represented by the ‘ground surface others’ category and therefore the initial measured residue of
is
as
0.010 mg as/kg fw and DT50 of 9.98 days for caterpillars are used to calculate exposure via this food
eb
type.
th
on
Table 2.6.1-27 below shows the calculated exposure for wood mice consuming a mixed diet in a citrus
d
e
crop treated with abamectin.
nt
ra
eg
Table 2.6.1-27: Estimate of long-term exposure of wood mice to abamectin following application to citrus
tb
Food % of diet Energetic Assimilation Wt (g) Initial MAF fTWA TWA residue for 3 ETE
no
fresh food (3)
wet content of efficiency measured apps mg as/ kg
t
consumed
us
weight (1) food residue mg as/25g wood bw/day (4)
m
KJ/g wet mouse/day
n
tio
wt
ra
st
Grasses & ce- 13 4.24 0.46 1.02 0.266 1.06 0.33 9.49E-05
gi
real shoots
Re
Weed seeds 45 18.63 0.83 3.52 0.266 1.06 0.33 0.000378
n.
io
lat
iso
Caterpillars 27 4.46 0.88 2.11 0.01 1.99 0.792 3.325E-10

in
d
ea
Earthworms 16 2.88 0.88 1.25 0.0046(2) 7.8775E-07

er
tb
no
Total 0.000423 0.0169

ld
(1)
Determined as % volume of stomach contents.
ou
(2)
Residues in earthworms have been estimated assuming that an earthworm contains 30% w/w soil (fresh weight), containing
sh
the peak predicted environmental concentration in soil (PECS) of 0.01544 mg as/kg soil. The maximum residue concentration in
d
an
earthworms is therefore considered to be 0.0046 mg as/kg bw (fresh weight). Field DT50 for abamectin of 2 days is used to
ge
calculate TWA residue.

a
ck
(3)
TWA residue = Wt of food consumed x initial measured residue x use rate of abamectin, 0.0216 kg ha x MAF x fTWA
pa
(5)
ETE is calculated as follows: ETE (mg as/kg bw/day) = total residue consumed by 25 g mouse (mg ai) x 1000/25
ta
da
The long-term risk assessment for wood mice feeding in citrus is shown in Table 2.6.1-28 below.
n
io
at
alu
Table 2.6.1-28: Long-term risk to wood mice in citrus resulting from exposure to abamectin residues on food based on long-term
ev

EC
Crop Scenario Indicator species Dose ETE TERLT

n
(kg as/ha) (mg as/kg

fa
bw/day)
to
ar
sp
citrus orchard wood mouse 3 x 0.0216 0.0169 7.1

m
or
The TERLT for wood mice is above the trigger value of 5, indicating acceptable risk to wild mammals
tf
en
following use of abamectin in citrus.

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:
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
102
cu
s do
hi
An alternative mammalian scenario to consider in citrus is a wood mouse eating entirely insects, since
t
of
the greater abundance of insects in Southern Europe may mean that these represent a higher propor-
is
as
tion of the diet than indicated by the mixed diet used above. A shrew feeding on insects would also be
eb
a relevant scenario, and the presence of shrews in Spanish orchards has been confirmed in a trapping
th
on
survey described above (Bakker, 200515). Since the higher FIR/bw for shrew will make this a worst-
de
case insectivorous mammal, a risk assessment is conducted below (Table 2.6.1-29) for a shrew feed-
nt
ra
ing wholly on ground-dwelling invertebrates, which would also cover the scenario of a wood mouse
eg
feeding entirely on insects. Measured residues and DT50 values are used from the residue trial (see
tb
no
Table 2.6.1-26). On the assumption that the weights of particular invertebrate groups caught by a
t
us
specific capture method depends upon their abundance in the environment, then the relative propor-
m
tion by weight in the catch of the different groups within a type can be used as PD values to reflect the
n
tio
estimated relative proportions of different groups in the diet (see Table 2.6.1-7).
ra
st
gi
Re
Table 2.6.1-29: Long-term risk to insectivorous mammals in citrus resulting from exposure to abamectin residues on inverte-
brates, based on long-term NOEL of 0.12 mg as/kg bw/day
n.
io
Crop Indicator Dose Invertebrate Mean ini- MAF fTWA FIR/bw PD ETE TER
species group tial resi-
lat
(kg (mg
iso
due (mg
as/ha) as/kg
as/kg fw)
bw/day)
in
d
Ground surface
ea
0.013 1.61 0.674 0.63 0.525 0.004659 -

spiders
er
Ground surface
tb
insectivorous 3x 0.183 1.00 0.087 0.63 0.220 0.002207 -

citrus beetles
mammal 0.0216
no
Ground surface
ld
others (mainly 0.01 1.99 0.792 0.63 0.255 0.002522 -

ou
caterpillars)
sh
Total
0.009388 13
d
ETE
an
ge
a
The TERLT for shrew is above the trigger value of 5, indicating acceptable risk to wild mammals follow-
ck
pa
ing use of abamectin in citrus.

ta
da
Comments RMS
n
io
at
RMS can agree with the risk refinement with respect to the long-term risk to mammals from the use in
alu
citrus, so the risk is considered acceptable.

ev
EC
n
fa
to
ar
sp
m
or
tf
en
15
Bakker F (2005) Contract report on occurrence of birds and mammals in apple orchards in Southern France and Spain.
m
cu
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is
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t.
en
m
103
cu
s do
hi
Lettuce
t
of
When considering exposure of herbivorous mammals to residues of abamectin on lettuce foliage it is
is
as
relevant to consider data from residue trials. Four trials have been carried out on lettuce in Southern
eb
Europe (see Volume 3, B.7.6.5) in which lettuces were sprayed at weekly intervals with 3 applications
th
on
of 0.018 kg ai/ha abamectin. Residues of avermectin B1a on the whole plant range from 0.034 to 0.24
de
mg/kg on day 0, the day of the last application and rapidly dissipate with a DT50 of less than 3 days.
nt
ra
The highest measured residue value has therefore been used, together with a DT50 of 3 days in the
eg
risk assessment presented below in Table 2.6.1-30. Since the residue value used represents the cu-
tb
no
mulative residue from 3 applications, it is appropriate to calculate a time-weighted average factor (fTWA)
t
us
using an averaging period of 21 days, rather than the application interval of 7 days as is recom-
m
mended in the EC Guidance Document on Risk Assessment for Birds and Mammals for cases where
n
tio
the residue value represents a single application only and a MAF factor is also being applied.
ra
st
gi
Re
Table 2.6.1-30: Long-term risk to mammals in lettuce resulting from exposure to abamectin residues on food based on long-
term NOEL of 0.12 mg as/kg bw/day
n.
io
Crop Scenario Indicator species Dose Initial lat FIR/bw fTWA ETE TER
residue
iso
(kg (mg
(mg as/kg
as/ha) as/kg
fw)
in
bw/day)
d
ea
lettuce leafy crops medium herbivorous 3 x 0.018 0.24 0.28 0.205 0.0138 8.7
mammal
er
tb
no
The TERLT for medium herbivorous mammal is 8.7, above the long-term trigger value of 5.
ld
ou
sh
Comments RMS
d
an
In the risk assessment, in which the measured residue has been taken, an averaging period of 21
ge
days is used, because the cumulative residue from 3 applications has been measured. In the opinion
a
ck
of the RMS this is not the right approach. According to the Guidance Document the averaging period
pa
must be the interval between two applications, in this case 7 days. Taking this into account the ftwa-
ta
da
factor is 0.50. With this value the ETE-value is 0.0336 and the TER 3.6. This value is below the trig-
n
io
ger-value and a further refinement of the risk is necessary.

at
alu
ev
Tomato
EC
Since tomato foliage, at the later growth stages when abamectin is applied, is unlikely to be eaten by
n
fa
herbivorous mammals, it is not appropriate to consider risk to herbivores and instead a risk assess-
to
ment is conducted for an insectivorous mammal. Shrews are unlikely to be present in a tomato crop
ar
sp
since they prefer habitats like long grass that provide cover. The most appropriate mammalian sce-
m
nario to consider is therefore a woodmouse Apodemus sylvaticus. This is supported by Loman (1991)
or
tf
who found that shrews were absent from cropped land in Southern Sweden but woodmice were pre-
en
m
sent. The FIR/bw for woodmouse was calculated using the spreadsheet for this purpose on the PSD
cu
do
website (http://www.pesticides.gov.uk/applicant_advice.asp?id=713) according to the EU Guidance

is
Document, citing Crocker et al. (2002). The assumptions used are that the woodmouse bodyweight is
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t.
en
m
104
cu
sdo
hi
25g, that it feeds entirely on arthropods with an energetic content of 6.71 kJ/g wet weight and an as-
t
of
similation efficiency of 88%. This results in a FIR/bw value of 0.46.
is
as
eb
The RUD for large insects is used as recommended for mammals in the EC Guidance Document on
th
on
Risk Assessment for Birds and Mammals. Since the large insects fed on by wild mammals will pre-
ed
dominantly be ground-dwelling, it is appropriate to account for interception of spray by the tomato
nt
ra
crop. Therefore, the recommended FOCUS16 interception value of 50% for tomatoes at the leaf de-
eg
velopment stage (BBCH 10-19) was applied when calculating exposure of insects in the crop. Al-
tb
no
though the EC Guidance Document on Risk Assessment for Birds and Mammals does not allow for
t
us
the use of default MAF and fTWA factors for insects in the risk assessment, in this case measured resi-
m
due and decline data are available from an insect residue field trial (Bakker, 200517) described above
n
tio
in Section 10.1. Therefore, the mean DT50 from the insect residue trial of 5.4 days was used in the
ra
st
risk assessment. A ‘maximum moving-window approach’ has been used to generate a 21-day time
gi
Re
weighted average residue. The maximum moving-window approach selects the worst-case 21-day
n.
TWA residue across the whole application period. This risk assessment is shown in Table 2.6.1-31
io
lat
below.
iso
in
Table 2.6.1-31: Long-term risk to insectivorous mammals in tomato from exposure to abamectin residues on food, based on
d
ea

er
Crop Scenario Indicator species Dose RUD FIR/bw MAF fTWA Interception ETE TER
tb
factor
(kg (mg
no
as/ha) as/kg
ld
bw/day)
ou
tomato leafy insectivorous mam- 3x Moving

5.1 0.46 1.54 0.5 0.022 5.4
sh
crops mal 0.0216 window

d
an
ge
The TERLT for insectivorous mammals is greater than the trigger value of 5, indicating acceptable risk
a
ck
to insectivorous mammals feeding in tomatoes.

pa
ta
da
Comments RMS
n
A ‘maximum moving-window approach’ has been used by the notifier to generate a 21-day time
io
at
weighted average. This is not according to the Guidance Document for Birds and Mammals and also it
alu
ev
has not been made clear how this calculation has been performed. Therefore this approach is not ac-
EC
cepted by the RMS.

n
fa
to
ar
sp
m
16
FOCUS (2000) “FOCUS groundwater scenarios in the EU review of active substances”, Report of the FOCUS Groundwater
or
Scenarios Workgroup, EC Document Reference SANCO/321/2000 rev.2, 202pp.

tf
17
Bakker F (2005). MK936 (abamectin): A field study to determine residues of a 18.0 g/L EC formulation (A8612A) in apple
en
orchard invertebrates as potential food items for birds and small mammals.
m
cu
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is
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
105
cu
s do
hi
Instead of the ‘maximum moving-window approach’ the RMS is of the opinion that the approach as
t
of
presented in the Guidance Document should be followed (twa-factor based on the interval-period be-
is
as
tween two applications, in this case 7 days). The ftwa-factor is then 0.660 and the ETE-value 0.026.
eb
Based on this value the TER is 4.7, lower than the trigger value of 5. However, the value is close to
th
on
the trigger and taking into account that the values for PD and PT are set to 1, which is very conserva-
e d
tive, the long term risk to insectivorous mammals from the use in tomato is considered acceptable.
nt
ra
Conclusion: The long-term risk to mammals from the use of abamectine in citrus and tomato is
eg
considered acceptable. With regard to the risk from the use in lettuce the risk is not considered
tb
no
acceptable and further refinement of the risk is necessary.
t
us
m
n
tio
2.6.2 Effects on aquatic species
ra
st
gi
Acute toxicity data
Re
n.
abamectin
io
lat
Accepted data on the acute toxicity of abamectin are summarised in Table 2.6.2-1. In accordance with
iso
the Guidance Document on Aquatic Ecotoxicology18, the tests with algae are considered chronic,
in
these tests are summarised in the next section. In Table 2.6.2-1 it is indicated whether endpoints are
d
ea
based on nominal or actual concentrations, and in case of the latter, the recovery of the test com-
er
tb
pound as percentage of nominal concentrations is given. From the studies where test concentrations
no
were analytically verified, it appears that in most cases mean measured concentrations over the test
ld
ou
period are lower than 80 % of nominal. The decline in test concentrations may be either due to degra-
sh
dation by photolysis or to sorption of the test compound to test containers or organic debris. This indi-
d
an
cates that the results based on nominal concentrations may represent an underestimation of toxicity,
ge
and preferably actual concentrations should be used for risk assessment. An exception is Chaoborus
a
ck
sp., where the actual EC50 is higher than the nominal value.
pa
Daphnia pulex is the freshwater invertebrate species that is most sensitive to abamectin, but EC50-
ta
da
values for the different daphnid species are very similar. The large difference between the static LC50
n
io
of 0.21 µg/L for the saltwater species Mysidopsis bahia and the results of the flow-trough experiments
at
alu
(LC50 0.020 and 0.022 µg/L) may be due to the fact that the first value is based on nominal concentra-
ev
tions. From the fish species, Oncorhynchus mykiss is most sensitive to abamectin. Toxicity of abamec-
EC
tin to Cyprinus carpio is more than a factor of 10 lower compared to toxicity to Oncorhynchus mykiss.
n
fa
to
ar
sp
m
or
tf
en
18
Sanco/3268/2001 rev. 4 (final) 17-10-2002
m
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is
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t.
en
m
106
cu
sdo
hi
Table 2.6.2-1. The acute toxicity of abamectin to aquatic life.
t
of
Species Method Duration Criterion Value Remark Reference
is
[h] [µg/L]
as
invertebrates (freshwater)
eb
Daphnia magna static 48 EC50 0.34 nominal IIA 8.2.4/001
Daphnia magna static 48 EC50 0.37 actual; 58 - 67 % of nominal IIA 8.2.4/002
th
Daphnia magna static 48 EC50 0.26 actual; test with spiked soil IIA 8.2.4/003
on
Daphnia magna static 48 EC50 0.56 actual; 78 - 105 % of nominal; IIA 8.2.4/004
pond water
d
e
nt
Daphnia galeata static 48 EC50 0.55 nominal; pond water IIA 8.2.4/005
ra
Daphnia longispina static 48 EC50 0.38 actual; 50 - 111 % of nominal IIA 8.2.4/006
eg
Daphnia pulex static 48 EC50 0.12 actual; 50 - 111 % of nominal IIA 8.2.4/006
Daphnia pulex static 48 EC50 0.28 nominal IIA 8.2.4/007
tb
Simocephalus sp. static 48 EC50 0.30 actual; 66 - 105 % of nominal IIA 8.2.4/006
no
Diaphanosoma sp. static 48 EC50 0.53 nominal IIA 8.2.4/007
t
Thamnocephalus platyurus static 24 EC50 30 nominal IIA 8.2.4/008
us
Thamnocephalus platyurus static 24 EC50 2.8 actual; 55 - 67 % of nominal IIA 8.2.4/009
m
Brachionus calyciflorus static 24 EC50 4000 actual; 72 - 96 % of nominal IIA 8.2.4/009
n
Chaoborus sp. static 48 EC50 190 actual; 87 - 109 % of nominal IIA 8.2.4/010
tio
Chaoborus sp. static 48 EC50 41 nominal IIA 8.2.4/011
ra
Cloeon sp. static 48 EC50 2.9 nominal IIA 8.2.4/011
st
Gammarus sp. static 48 EC50 6.2 nominal IIA 8.2.4/012
gi
Gammarus sp. static 48 EC50 8.6 actual; 81 – 104 % of nominal IIA 8.2.4/013
Re
Lymnaea stagnalis static 48 LC50 55 actual; 63 - 88 % of nominal) IIA 8.2.4/014
n.
invertebrates (saltwater)
io
Mysidopsis bahia static 96 LC50 0.21 nominal
lat IIA 8.2.4/015
Mysidopsis bahia flow-through 96 LC50 0.022 actual; 91 - 116 % of nominal IIA 8.2.4/016
iso
Mysidopsis bahia flow-through 96 LC50 0.020 actual; 39 - 69 % of nominal IIA 8.2.4/017

Crassostrea viriginica static 48 LC50 430 nominal IIA 8.2.4/018
in
Penaeus duorarum static 96 LC50 1.6 nominal IIA 8.2.4/019

d
Callinectes sapidus static 96 LC50 153 nominal IIA 8.2.4/020

ea
er
fish (freshwater)
tb
Oncorhynchus mykiss static 96 LC50 3.6 nominal IIA 8.2.1/002

no
Cyprinus carpio flow-through 96 LC50 42 nominal IIA 8.2.1/003

Ictalurus punctatus static 96 LC50 24 nominal IIA 8.2.1/004
ld
ou
fish (saltwater)
sh
Cyprinodon variegatus semi-static 96 LC50 15 nominal IIA 8.2.1/005

d
an
ge
avermectin B1a
a
ck
A summary of accepted data for avermectin B1a is given in Table 2.6.2-2. The toxicity of avermectin
pa
B1a to Daphnia magna is similar to that of abamectin, the LC50 of avermectin B1a for fish is in the same
ta
da
order of magnitude as the value obtained with abamectin.

n
io
at
alu
Table 2.6.2-2. The acute toxicity of avermectin B1a to aquatic life.

ev

[h] [µg/L]
EC
invertebrates
n

fa
to
fish
Lepomis macrochirus flow-through 96 LC50 7.2 nominal IIA 8.2.1/006
ar
sp
m
formulated products
or
tf
Toxicity of the 18 g as/L EC formulations to Daphnia magna and Oncorhynchus mykiss (Table 2.6.2-3)
en
is comparable to that of abamectin when expressed on the basis of active substance.

m
cu
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is
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t.
en
m
107
cu
s do
hi
t
of
Table 2.6.2-3. The acute toxicity of 18 g as/L EC formulations (Vertimec 015 EC and Avermectin B1) to aquatic life.
is
Species Method Duration Criterion Value Value Remark Reference
as
[h] product
eb
[mg/L] [µg as/L]
th
invertebrates
Daphnia magna flow-through 48 EC50 0.029 0.59 actual; 78 - 123 % of nominal IIIA 10.2.1/001
on
d
fish
e
nt
Oncorhynchus mykiss flow-through 96 LC50 0.130 2.6 actual; IIA 8.2.1/009
ra
Oncorhynchus mykiss flow-through 96 LC50 0.130 2.3 nominal IIA 8.2.1/010
eg
tb
metabolites
no
t
For metabolites [8,9-Z]-avermectin B1a (NOA 427011), 8a-hydroxy-avermectin B1a (NOA 448112) and
us
m
4”-oxo-avermectin B1a (NOA 426289), studies with Daphnia magna and Oncorhynchus mykiss are
n
tio
available. An overview is given in Tables 2.6.2-4 to 2.6.2-6.
ra
st
Table 2.6.2-4. The acute toxicity of [8,9-Z]-avermectin B1a to aquatic life.
gi
Re
[h] [µg/L]
n.
invertebrates
io
Daphnia magna static 48 EC50 14 nominal IIA 8.2.4/024
Daphnia magna static 48 EC50 0.082 actual lat IIA 8.2.4/025
iso
fish
in
Oncorhynchus mykiss flow-through 96 LC50 5.1 actual; 74 - 82 % of nominal IIA 8.2.1/007

d
ea
er
Table 2.6.2-5. The acute toxicity of 8a-hydroxy-avermectin B1a to aquatic life.

tb

no
[h] [µg/L]
ld
invertebrates
ou
Daphnia magna static 48 EC50 26 nominal IIA 8.2.4/022

Daphnia magna static 48 EC50 1.6 actual; 78 - 123 % of nominal IIA 8.2.4/023
sh
d
fish
an
Oncorhynchus mykiss semi-static 96 LC50 520 actual IIA 8.2.1/008

ge
a
ck
Table 2.6.2-6. The acute toxicity of 4”-oxo-avermectin B1a to aquatic life.

pa

ta
[h] [µg/L]
da
invertebrates
n

io
at
alu
The large difference obtained for Daphnia magna in the two studies with [8,9-Z]-avermectin B1a and
ev
8a-hydroxy-avermectin B1a cannot be explained solely by a difference between nominal and actual
EC
concentrations. Both the low and high values were obtained by the same authors in the same year:
n
fa
the high EC50-values result from studies by Forbis, Georgie and Burgess in 1985, the low values were
to
ar
obtained by Peither in 2001. It is possible that there is a difference in sensitivity between the strains
sp
used in the respective studies.

m
or
tf
Chronic toxicity data

en
m
Accepted data on the chronic toxicity of abamectin, avermectin B1a, [8,9-Z]-avermectin B1a, 8a-
cu
hydroxy-avermectin B1a and Vertimec 018 EC are summarised in Table 2.6.2-7 to 2.6.2-11. No reliable
do
is
data on the toxicity of abamectin technical for algae are available. The test with the product, however,
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:
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
108
cu
do
s
hi
is considered to be sufficient for risk assessment. The saltwater species Mysidopsis bahia is most
t
of
sensitive to abamectin, the NOEC is a factor of almost 3 lower than the NOEC for D. magna. Toxicity
is
as
of abamectin and avermectin B1a to Daphnia magna is similar. Toxicity of [8,9-Z]-avermectin B1a, 8a-
eb
hydroxy-avermectin B1a and Vertimec 018 EC to algae is very low, compared to toxicity to other tested
th
on
species.
d
e
nt
Table 2.6.2-7. The chronic toxicity of abamectin to aquatic life.
ra
Species Method Duration Criterion Value Based on Reference
eg
[d] [µg/L]
invertebrates (freshwater)
tb
Daphnia magna flow-through 21 NOEC 0.010 nominal IIA 8.2.5/002
no
Chironomus riparius water-spiked 28 NOEC 0.081 nominal initial in water phase IIA 8.2.7/001
t
Chironomus riparius sediment-spiked 28 NOEC 3.3 µg/kg dwt nominal initial in sediment IIA 8.2.7/001
us
m
invertebrates (saltwater)
n
Mysidopsis bahia flow-through 28 NOEC 0.0035 actual; 70 - 116 % of nominal IIA 8.2.5/003
tio
ra
fish
st
Cyprinus carpio flow-through 28 NOEC 6.1 actual; 76 - 113 % of nominal IIA 8.2.2.1/001
gi
Oncorhynchus mykiss flow-through 72 NOECELS 0.52 actual; 96 - 120 % of nominal IIA 8.2.2.2/001
Re
n.
io
Table 2.6.2-8. The chronic toxicity of avermectin B1a to aquatic life.
Species Method Duration Criterion Value
lat
Remark Reference
iso
[d] [µg/L]
invertebrates
in
Daphnia magna flow-through 21 NOEC 0.030 actual; 109 - 143 % of nominal IIA 8.2.5/001
d
ea
er
Table 2.6.2-9. The chronic toxicity of Vertimec 018 EC to aquatic life.

tb
Species Method Duration Criterion Value value Based on Reference

no
product abamectin
ld
[h] [µg/L] [mg as/L]

ou
algae
sh
Pseudokirchneriella subcapitata static 72 ErC50 > 82 > 1.59 nominal IIIA 10.2.1/001
NOErC > 82 > 1.59
d
EbC50 > 82 > 1.59

an
NOEbC > 82 > 1.59

ge
a
ck
pa
Table 2.6.2-10. The chronic toxicity of [8,9-Z]- avermectin B1a to aquatic life.
ta
[h] [µg/L]
da
algae
n
Selenastrum capricornutum static 72 ErC50, EbC50 > 9.0 nominal IIA 8.2.6/003
io
> 9.0
at
alu
Table 2.6.2-11. The chronic toxicity of 8a-hydroxy-avermectin B1a to aquatic life.

ev

[h] [µg/L]
EC
algae
Selenastrum capricornutum static 72 ErC50 > 6.1 actual; 61% of nominal IIA 8.2.6/004
n
fa
EbC50 > 6.1 actual; 61% of nominal

to
ar
sp
Field data
m
or
Two field studies performed with Vertimec 018 EC in field microcosm studies were provided. In the
tf
en
first study, a single application of Vertimec 018 EC was performed and pond water was recirculated
m
cu
starting two weeks after application of the test substance. The water replacement rate in this study
do
is
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t.
en
m
109
cu
s do
hi
resulted in a water residence time of ca. 5 days. A No Observed Ecologically Adverse Effect Concen-
t
of
tration (NOEAEC) of 1.8 µg as/L (nominal) was obtained.
is
as
In the second field microcosm study, the aquatic community was exposed to abamectin via three ap-
eb
plications of Vertimec 018 EC with 7-days intervals between applications. No recirculation of system
th
on
water occurred. The NOEAEC was equivalent to a nominal concentration of 0.049 µg as/L.
d
e
nt
First tier risk assessment
ra
eg
Acute risk assessment
tb
no
For field applications, an initial assessment was carried out using the PECSW calculated with FOCUS
t
us
Surface Water, Step 2, and trigger values were exceeded in this case (results not shown). Therefore,
m
further assessment was performed using the Step 3 PECSW. For glasshouse applications, the Step 2
n
tio
values were used. The acute risk assessment is thus based on the highest initial PECSW after single or
ra
st
multiple applications, and the lowest available toxicity endpoint for Daphnia and fish. Although the
gi
Re
LC50 for the saltwater species Mysidopsis bahia is a factor of 5 to 6 more sensitive than D. pulex, the
n.
risk assessment is based on the EC50 for the latter species, as this is considered more representative
io
lat
for the areas of use. The resulting TER-values for abamectin are presented in Tables 2.6.2-12 to
iso
2.6.2-16. TER's that do not meet the trigger of 100 are indicated in bold.
in
d
ea
Citrus
er
tb
The highest initial PECSW of abamectin after a single application as calculated with Step 3 is 0.791
no
µg/L (D6). The highest initial PECSW after three applications is 0.687 µg/L (D6). TER's for single and
ld
ou
multiple applications are given in Table 2.6.2-12. The trigger of 100 is not met.
sh
d
Table 2.6.2-12. Acute toxicity-exposure ratios for use of abamectin on citrus after single or multiple application of 21.6 g as/ha.
an
L(E)50 Single application Three applications

ge
[µg as/L] (PECSW 0.791 µg/L) (PECSW 0.687 µg/L)

abamectin product abamectin product abamectin product
a
ck
D. pulex 0.12 0.15 0.17

pa
D. magna 0.59 0.75 0.86

O. mykiss 3.6 2.3 4.6 2.9 5.2 3.3
ta
da
n
io
at

alu
ev
EC
n
fa
to
Table 2.6.2-13. Acute toxicity-exposure ratios for field use of abamectin on lettuce after single or multiple field application of 18
ar
g as/ha.
sp

m

or

tf
D. pulex 0.12 1.0 1.1

en
D. magna 0.59 5.3 5.3

m
O. mykiss 3.6 2.3 31 21 32 21

cu
do
is
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en
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110
cu
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t
of
is
The highest initial PECSW of abamectin as calculated with Step 2 is 0.0030 µg/L, the highest initial
as
PECSW after three applications is 0.0043 µg/L. TER's for single and multiple applications are given in
eb
th
Table 2.6.2-14. The trigger of 100 is not met.
on
Table 2.6.2-14. Acute toxicity-exposure ratios for use of abamectin on lettuce after single or multiple application of 9 g as/ha in
ed
glasshouses.
nt
L(E)50 Single application Four applications
ra
eg
tb
D. pulex 0.12 0.59 40 197 28 137
no
D. magna 0.59 197 137
O. mykiss 3.6 2.3 1200 767 837 535
t
us
m
n
tio
ra
st
gi
Re
n.
io
lat
Table 2.6.2-15. Acute toxicity-exposure ratios for use of abamectin on tomatoes after single or multiple field application of 21.6 g
iso
as/ha
in

d

ea

er
D. pulex 0.12 0.88 1.2

tb
D. magna 0.59 4.3 23

O. mykiss 3.6 2.3 26 17 37 23
no
ld
ou

sh
d
The highest initial PECSW of abamectin as calculated with Step 2 is 0.0072 µg/L, the highest initial
an
PECSW after five applications is 0.0114 µg/L. TER's for single and multiple applications are given in
age
Table 2.6.2-16. The trigger of 100 is met for fish, but not for invertebrates.
ck
pa
Table 2.6.2-16. Acute toxicity-exposure ratios for use of abamectin on tomatoes after single or multiple application of 21.6 g
ta
as/ha in glasshouses.
da
L(E)50 Single application Four applications

n

io

at
D. pulex 0.12 0.59 17 82 11 52

alu
D. magna 0.59 82 52
ev
O. mykiss 3.6 2.3 500 319 250 202

EC
n
fa
Chronic risk assessment

to
For algae, the risk assessment is based on the highest initial PECSW after single or multiple application
ar
sp
as calculated with FOCUS Surface Water, Step 3 and the lowest toxicity endpoint EC50 > 1590 µg as/L
m
from a test with the product. According to the Guidance document, the chronic risk assessment for
or
tf
daphnids and fish should also initially be based on the maximum PECSW. In view of the expected
en
m
TER's however, this step is skipped, and the risk assessment is based on the highest TWA-PECSW
cu
and the lowest available toxicity endpoint for each taxonomic group, i.e. for daphnids the NOEC of
do
is
0.010 µg as/L for Daphnia pulex, and for fish the NOEC of 0.52 µg as/L for Oncorhynchus mykiss. The
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resulting TER-values for abamectin are presented in Tables 2.6.2-17 to 2.6.2-21. TER's that do not
t
of
meet the trigger of 10 are indicated in bold.
is
as
eb
Citrus
th
on
In Step 3, the highest (TWA-)PECSW of abamectin are obtained for scenario D6. The TER's for the
d
single and multiple applications are given in Table 2.6.2-17. The trigger of 10 is met for algae but not
e
nt
ra
for invertebrates and fish. For fish, the 50-days TWA-PECSW is used because no 72-days value is
eg
generated by TOXSWA. If the TWA-PECSW over 100 days are used (single: 0.049 µg/L; multiple 0.116
tb
no
µg/L), the acute TER is 10.6 for single applications and 4.5 for multiple applications. With a true 72-
t
us
days TWA-PECSW the trigger would thus not be met either.
m
n
Table 2.6.2-17. Chronic toxicity-exposure ratios for use of abamectin on citrus after single or multiple application of 21.6 g as/ha.
tio
EC50 or Single application Three applications
ra
Species NOEC (TWA-)PEC TER (TWA-)PEC TER
st
[µg as/L] [µg as/L] [µg as/L]
gi
1
P. subcapitata > 1590 0.791 (0 d) > 2010 0.687 (0 d) > 2314
Re
2
D. magna 0.010 0.216 (21 d) 0.05 0.352 (21 d) 0.03
3
O. mykiss 0.52 0.097 (50 d) 5.4 0.224 (50 d) 2.3
n.
io
1: EC50 3 days, test with product
2: NOEC 21 days lat
3: NOEC-ELS 72 days
iso
in

d
ea
In Step 3, the highest TWA-PECSW of abamectin are obtained for scenario D6. The TER's for the sin-
er
tb
gle and multiple application are given in Table B.9.2.8-18. For algae and fish, the trigger of 10 is met,
no
for invertebrates not.

ld
ou
Table 2.6.2-18. Chronic toxicity-exposure ratios for use of abamectin on lettuce after single or multiple field application of 18 g
sh
as/ha.
Species EC50 or Single application Three applications
d
an
NOEC (TWA-)PEC TER (TWA-)PEC TER

ge
P. subcapitata > 1590 0.115 (0 d) > 13826 0.112 (0 d) > 14196

a
ck
D. magna 0.010 0.029 (21 d) 0.35 0.011 (21 d) 0.90

O. mykiss 0.52 0.012 (50 d) 43 0.006 (50 d) 87
pa
ta
da
n

io
at
The TER's for single and multiple applications are given in Table 2.6.2-19. Both are based on TWA-
alu
ev
PECSW values as obtained from Step 2. The trigger of 10 is met for all groups after single application,
EC
but not for invertebrates after multiple applications.

n
fa
Table 2.6.2-19. Chronic toxicity-exposure ratios for use of abamectin on lettuce after glasshouse application of 4 x 9 g as/ha.
to
Species EC50 or Single application Four applications

ar

sp

5 5
P. subcapitata > 1590
m
0.0030 (0 d) > 5.3 x10 0.0043 (0 d) > 3.7 x10

or
D. magna 0.010 0.0006 (21 d) 17 0.0018 (21 d) 5.6

O. mykiss 0.52 0.0005 (50 d) 1040 0.0017 (50 d) 306
tf
en
m
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do
is
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t.
en
m
112
cu
do
s
hi
t
of
is
In Step 3, the highest TWA-PECSW of abamectin are obtained for scenario D6. The TER's for the sin-
as
gle and multiple applications are given in Table 2.6.2-20. For single applications, the trigger of 10 is
eb
th
met for algae, fish and plants, but not for invertebrates. For multiple applications, the trigger of 10 is
on
met for algae, but not for invertebrates and fish.
d
e
nt
Table 2.6.2-20. Chronic toxicity-exposure ratios for use of abamectin on tomatoes after single or multiple field application of 21.6
ra
g as/ha.
eg
Species EC50 or Single application Three applications
tb
no
P. subcapitata > 1590 0.136 (0 d) > 11691 0.098 (0 d) > 16224
t
us
D. magna 0.010 0.003 (21 d) 3.4 0.009 (21 d) 1.1
O. mykiss 0.52 0.001 (50 d) 520 0.004 (50 d) 130
m
n
tio
ra
st
gi
Re
The TER's for single and multiple applications are given in Table 2.6.2-21. Both are based on TWA-
n.
PECSW values as obtained from Step 2. The trigger of 10 is met for algae and fish, but not for inverte-
io
brates.
lat
iso
Table 2.6.2-21. Chronic toxicity-exposure ratios for use of abamectin on tomatoes after glasshouse application of 5 x 21.6 g
in
as/ha.
d
ea
Species EC50 or Single application Five applications

er
NOEC TWA-PEC TER TWA-PEC TER

tb
5 5
P. subcapitata > 1590 0.0072 (0 d) > 2.2 x10 0.0114 (0 d) > 1.4 x10
no
D. magna 0.010 0.0014 (21 d) 7.0 0.0052 (21 d) 1.9

ld
O. mykiss 0.52 0.0011 (50 d) 473 0.0046 (50 d) 113

ou
sh
Risks of metabolites
d
an
In aquatic photolysis studies, metabolite [8,9-Z]-avermectin B1a was formed in levels of 8.9 - 12 % of
ge
a
AR. This and other metabolites were not detected in substantial amounts in the water phase during
ck
pa
the aerobic water/sediment studies, which may be explained from the fact that these studies were per-
ta
formed in the dark. According to the results of the acute toxicity studies, this metabolite might be more
da
n
toxic to invertebrates as compared to the parent substance (EC50 0.082 µg/L for Daphnia magna), al-
io
at
though in another study with several photolysis products toxicity seemed less. For algae and fish, the
alu
parent is more toxic. Because [8,9-Z]-avermectin B1a was not found in the aerobic water/sediment
ev
EC
studies, calculation of the PECSW for this metabolite is not possible on the basis of the available infor-
n
mation. However, with a formation percentage of 12 % and the EC50 of 0.082 µg/L, the risk assess-
fa
to
ment for [8,9-Z]-avermectin B1a less critical than that for the parent compound, which is based on an
ar
EC50 of 0.12 µg/L. Furthermore, it is assumed that the potential effects of [8,9-Z]-avermectin B1a have
sp
m
been covered by the field microcosm experiments.

or
tf
Risk assessment for sediment-dwelling organisms

en
m
In water-sediment fate studies, avermectin B1a was present in the sediment in amounts > 10% of AR.
cu
Therefore, potential risk for sediment-dwelling invertebrates must be identified. The following toxicity
do
is
values are available (Table 2.6.2-22):

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Table 2.6.2-22. Toxicity of avermectin B1a to sediment dwelling organisms
t
of
Species Method Spiking Duration Criterion Value Based on Reference
is
[d]
as
Chironomus riparius static; water 28 NOECemergence 0.081 µg as/L nominal initial in IIA 8.2.7/001
eb
water/sediment water phase
Chironomus riparius static; sediment 28 NOEC 3.3 µg as/kg dwt nominal initial in IIA 8.2.7/001
th
water/sediment sediment phase
on
e d
In Table 2.6.2-23, the highest initial PECSW (Step 3; Step 2 for glasshouse crops) is given for each
nt
ra
crop and TER's are calculated. The TER's based on PECSED (Step 3; Step 2 for glasshouses) are
eg
given in Table 2.6.2-24. Values that do not meet the trigger of 10 are indicated in bold.
tb
no
Table 2.6.2-23. TER's for C. riparius based on concentrations in water phase.
t
us
Crop Waterbody highest Step 3 Scenario TER
PECSW
m
[µg as/L]
n
tio
citrus ditch 0.791 D6, 1 application 0.10
stream 0.590 R4, 1 application 0.14
ra
lettuce, field ditch 0.115 D6, 1 application 0.70
st
pond 0.007 D4, 3 applications 12
gi
st
R1, 3 applications (1 crop)
Re
st
stream 0.106 R3, 1 application (1 crop) 0.76
n.
lettuce, glasshouse ditch 0.0043 Step 2, 4 applications 19
io
tomatoes, field ditch 0.136 D6, 1 application 0.60
stream 0.127 R3, 1 application lat 0.64
iso
tomatoes, glasshouse ditch 0.0144 Step 2, 5 applications 5.6
in
d
ea
Table 2.6.2-24. TER's for C. riparius based on concentrations in sediment.

er
Crop Waterbody highest Step3 Scenario TER

PECSED
tb
[µg as/kg dwt]

no
citrus ditch 2.905 D6, 3 applications 1.1

stream 0.195 R4, 3 applications 17
ld
lettuce, field ditch 0.343 D6, 3 applications 9.6

ou
st
pond 0.064 R1, 3 applications (1 crop) 52
sh
st
stream 2.155 R2, 3 applications (1 crop) 1.5
d
lettuce, glasshouse ditch 0.0667 Step 2, 4 applications 49

an
tomatoes, field ditch 0.082 D6, 3 applications 40

stream 1.665 R4, 3 applications 2.0
ge
tomatoes, glasshouse ditch 0.196 Step 2, 5 applications 17

a
ck
pa
The risk assessment based on the PECSED is less critical as compared to that based on PECSW. Based
ta
da
on concentrations in the water phase, the trigger of 10 is only met for glasshouse application on let-
n
io
tuce and field application on lettuce adjacent to ponds.

at
alu
Assessment of bioconcentration potential

ev
In a bioaccumulation study with Lepomis macrochirus, a whole fish steady state BCF value of 69 L/kg
EC
wwt was found for abamectin. Therefore, no higher tier risk assessment has to be conducted and the
n
fa
compound is considered not to have potential to bioaccumulate. Although [8,9-Z]-avermectin B1a was
to
ar
found as relevant residue in water, the BCF is expected to be in the same range considering the fact
sp
that [8,9-Z]-avermectin B1a is an isomer of avermectin B1a. Therefore this metabolite is considered not
m
or
to have potential to bioaccumulate.

tf
en
m
Higher tier risk assessment

cu
do
Risk assessment on the basis of field studies

is
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en
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cu
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For those uses that do not meet the triggers in the acute and chronic assessment, a refined risk as-
t
of
sessment is performed using the results of the field microcosm studies. This refined risk assessment
is
as
applies only to aquatic and sediment dwelling invertebrates, but not to fish as these species were not
eb
included in the microcosm eperiments.
th
on
The risk assessment can be done either by comparing dosages or concentrations. A comparison of
e d
concentrations is considered more appropriate, as in this way differences in form and dimensions be-
nt
ra
tween the experimental units and the FOCUS waterbodies are corrected for.
eg
tb
no
The ditch and stream as modelled in Step 3 consider water residence times of 5 and 1 day, respec-
t
us
tively. The water replacement rate in the first mesocosm study was ca. 5.9 days, which is thus compa-
m
rable to the model ditch and worst-case as compared to the model stream. The No Observed Ecologi-
n
tio
cally Adverse Effect Concentration (NOEAEC) from the first study was equivalent to a nominal single
ra
st
application of 1.8 µg as/L. For the estimation of the Ecologically Acceptable Concentration (EAC), a
gi
Re
safety factor of 3 is applied, and the EAC is considered as 0.6 µg as/L. This EAC is used to refine the
n.
risk assessment for those scenarios with (slowly) streaming waterbodies, where the highest PECSW is
io
lat
found after a single application (D6, R4, R3). From the second study, a NOEAEC is obtained of 0.049
iso
µg as/L was obtained. For the estimation of the EAC a safety factor of 3 is used, and the EAC is set at
in
d
0.016 µg as/L. This EAC is used to refine the risk assessment for the pond scenarios (D4, R1), and is
ea
er
also used for the glasshouse applications, where the highest PECSW is found after multiple applica-
tb
tions. It is recognised that an assessment based on TWA concentrations would be most appropriate
no
for the refinement of the chronic risk assessment. A reliable TWA-EAC, however, could not be calcu-
ld
ou
lated due to the shortage of analytical data and it is assumed that the potential chronic risks are cov-
sh
ered by the assessment on the basis of peak concentrations.

d
an
In Table 2.6.2-25, the highest actual concentrations per crop are given for streaming and stagnant wa-
ge
terbodies. The TER based on EAC and PECSW is calculated, if this value is < 1, a risk is expected.
a
ck
pa
ta
da
Table 2.6.2-25. Comparison of PECSW and EAC for citrus, lettuce and tomatoes.
Crop Waterbody highest Scenario EAC used TER
n
io
PECSW EAC/PECSW
at
[µg as/L] [µg as/L]

alu
citrus ditch 0.791 D6, 1 application 0.6 0.75

stream 0.590 R4, 1 application 0.6 1.0
ev
lettuce, field ditch 0.115 D6, 1 application 0.6 5.2

EC
pond 0.007 D4, 3 applications 0.016 2.3

st
R1, 3 applications (1 crop)
n
st
stream 0.106 R3, 1 application (1 crop) 0.6 5.7
fa
lettuce, glasshouse ditch 0.0043 Step 2, 4 applications 0.016 3.7

to
tomatoes, field ditch 0.136 D6, 1 application 0.6 4.4

ar
stream 0.127 R3, 1 application 0.6 4.7

sp
tomatoes, glasshouse ditch 0.0144 Step 2, 5 applications 0.016 1.1

m
or
From this table it can be concluded that a safe use with respect to aquatic invertebrates is demon-
tf
en
strated for all scenarios, except for citrus with emission to ditches.For this application, a mitigation dis-
m
cu
tance of at least 6 m should be applied for concentration to drop below the EAC of 0.6 µg as/L.
do
is
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en
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cu
s do
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For fish, an adequate risk assessment should be performed for those uses where in the first tier as-
t
of
sessment an acute and/or chronic risk was identified, i.e. citrus and field applications to lettuce and
is
as
tomatoes. For the glasshouse uses, no risk for fish is expected.
eb
th
on
Higher tier risk assessment fish
ed
The notifier has submitted the following higher tier risk assessment for fish (in italics):
nt
ra
eg
Refined risk assessments are conducted below for acute risk to fish from field applications to citrus,
tb
no
lettuce and tomato and for chronic risk from field applications to citrus.
t
us
m
Acute toxicity to fish
n
tio
Two additional studies have been conducted with abamectin technical since the original Annex I sub-
ra
st
mission in order to further address potential issues in this area. These were an acute toxicity test with
gi
Re
an additional freshwater fish species, Pimephales promelas, and a modified exposure study with rain-
n.
bow trout that simulated the dissipation of abamectin in water.
io
lat
iso
The results of fish acute toxicity studies with abamectin technical are summarised in Table 2.6.2-26.
in
d
ea
er
Table 2.6.2-26: Abamectin Acute Toxicity to Fish

tb
Test sub- Species Test 96h-LC50 LOEC NOEC Reference

no
stance conditions [µg/L] [µg/L] [µg/L]

ld
Abamectin tech. Lepomis macrochirus static 9.6 9.7 5.8 LeBlanc & Wilson,
ou
(Bluegill sunfish) 1981

sh
Oncorhynchus mykiss static 3.6 1.3 0.78 LeBlanc & Sousa,

d
(Rainbow trout) 1981

an
Cyprinus carpio flow-through 42 32 18 Douglas & Pell,

ge
(Carp) 1985
a
ck
Ictalurus punctatus static system 24 18 10 McAllister et al,

1985
pa
(Channel catfish)
ta
Cyprinodon variegatus semi-static system 15 13 7.8 Ward G.S., 1985

da
(Sheepshead minnow)
n
io
Pimephales promelas flow-through 17 12 5.6 Bätscher R, 2003

at
(Fathead minnow)
alu
Oncorhynchus mykiss flow-through, 10.1 6.8 3.1 Peither A, 2003

ev
(Rainbow trout) modified exposure

EC
n
fa
to
Acute risk assessment for fish

ar
TER values generated from the initial acute risk assessment in citrus using the highest initial FOCUS
sp
m
Step 3 PEC values (for D6 ditch) are presented in Table 2.6.2-27 below.
or
tf
en
m
cu
do
is
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
116
cu
s do
hi
t
of
Table 2.6.2-27: Acute toxicity-exposure ratios for fish from use of abamectin on citrus after single or multiple field applications
is
using FOCUS Step 3 PEC values
as
eb
Species LC50 TER from a single application TER from three applications
th
[µg as/L] PECSW 0.791 µg as/L PECSW 0.687 µg as/L
on
Abamectin Product Abamectin Product Abamectin Product
d
e
nt
O. mykiss 3.6 2.3 4.6 4.0 5.2 3.3
ra
eg
tb
The TER values are all well below the trigger value of 100. Therefore, a further risk assessment is
no
presented below using the highest initial FOCUS Step 4 PEC (D6 ditch) values with a 6m buffer in cit-
t
us
rus.
m
n
tio
ra
st
gi
Re
n.
io
O. mykiss 3.6 2.3 8.4 lat
5.3 11 6.8
iso
in
TER values generated from the initial acute risk assessment for field use in lettuce using the highest
d
ea
initial FOCUS Step 3 PEC values (D6 ditch) are presented in Table 2.6.2-29 below.
er
tb
no
Table 2.6.2-29: Acute toxicity-exposure ratios for fish from use of abamectin on lettuce after single or multiple field applications
ld
ou
sh

d
an

ge
a
O. mykiss 3.6 2.3 31 20 32 21

ck
pa
ta
TER values generated from the initial acute risk assessment for field use in tomato using the highest
da
initial FOCUS Step 3 PEC values (D6 ditch) are presented in Table 2.6.2-30 below.
n
io
at
alu
Table 2.6.2-30: Acute toxicity-exposure ratios for fish from use of abamectin on tomato after single or multiple field applications
ev

EC
n

fa

to
ar
sp
O. mykiss 3.6 2.3 26 17 37 23

m
or
The initial acute TER values for uses in citrus and field applications in lettuce and tomato are all less
tf
en
than the trigger value of 100, indicating the need for a refined acute risk assessment.
m
cu
do
is
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t.
en
m
117
cu
s do
hi
Refinement of acute risk to fish
t
of
The initial risk characterisation presented above will potentially overestimate risk. All of the fish stud-
is
as
ies considered in the risk assessment so far were conducted under conditions of continuous exposure,
eb
whereas under environmental conditions, abamectin dissipates readily from water with a DT50 = 4.9
th
on
days. In order to evaluate toxicity under environmentally relevant conditions, an acute toxicity study
de
with rainbow trout has been conducted with a modified exposure pattern to mimic the dissipation of
nt
ra
abamectin in a natural aquatic system calculated from the DT50 of 4.9 days, which is summarised
eg
above. Following the recommendations of HARAP19 the 96- hour LC50 to rainbow trout in the modi-
tb
no
fied exposure study of 10.1 µg/l can be compared to the FOCUS PEC values to calculate TER values
t
us
and these are shown in Tables 2.6.2-31, -32 and -33 below.
m
n
tio
ra
st
gi
Re
n.
io
O. mykiss 10.1 23 30
lat
iso
in

d
ea
er

tb
no
O. mykiss 10.1 88 90
ld
ou
sh
d
an
ge

a
ck
O. mykiss 10.1 74 103

pa
ta
da
The TER value for three applications in tomato is above the trigger value of 100 but the TER values
n
io
for the remaining uses are still below the trigger value of 100, indicating the need for further refine-
at
alu
ment.
ev
EC
The effects level (LC50) for the most sensitive fish tested is still at least 23 times above the worst-case
n
fa
PECs (Table 2.6.2-31). It is therefore appropriate to investigate the likelihood of effects at these
to
ar
sp
m
or
tf
en
19
Guidance Document on Higher-tier Aquatic Risk Assessment of Pesticides (HARAP), SETAC-Europe (Campbell et al, 1999)
m
cu
do
is
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t.
en
m
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cu
s do
hi
worst-case PECs. The toxicity data for fish (Table 2.6.2-26) indicates differences in LC50 values.
t
of
However, the toxicity is restricted to a narrow range of about one order of magnitude over the six fish
is
as
species tested, with 96 h EC50 values ranging from 3.6 – 42 µg/l. Thus, there is little difference in
eb
th
inter-species sensitivity and in this situation, smaller safety factors would be protective. According to
on
the European Guidance document on Aquatic Ecotoxicology20 and HARAP21, if sufficient species of
e d
similar sensitivity have been tested (five species is considered sufficient for fish), then the ecologically
nt
ra
acceptable concentration for fish can be reduced to a value 10 times lower than the lowest fish 96 h
eg
LC50 (application of a TER trigger value of 10). Therefore, a lowest acute TER of 23 (single applica-
tb
no
tion in citrus) represents acceptable risk.
t
us
Confidence in this low risk conclusion can be obtained from using the acute toxicity data to develop a
m
Species Sensitivity Distribution (SSD). In this, the toxicity data (expressed as a cumulative ranked
n
tio
probability) for LC50 values were plotted against effect concentrations (log transformed). The logit
ra
st
model used assumes a log-normal distribution (R2 = 0.816) and based on the predicted distribution
gi
Re
0.0861 % (<1 in 10,000) of fish species would have LC50 values below the worst-case PEC of
n.
0.430µg/L. Considering that there are only around 200 different freshwater fish species in Europe, this
io
lat
assessment implies that it is unlikely that any species of fish would be affected following exposure to
iso
an initial concentration of 0.430 ug/L in the aquatic environment. SSD methods commonly use the 5th
in
d
or the 10th percentile toxicity values as the level that gives adequate protection and so abamectin
ea
er
clearly presents low acute risk to fish.

tb
no
Conclusions: The lowest TERA for fish based on worst-case exposure is 23. This is below the Annex
ld
ou
VI trigger of 100, however additional data has demonstrated that interspecies sensitivity is low and
sh
that the TER of 23 represents a low risk. This has been confirmed from fitting the toxicity data into a
d
an
species sensitivity distribution that showed only 0.0861 % (<1 in 10,000) of fish species would have
ge
a
LC50 values below the worst-case PEC of 0.430µg/L.

ck
pa
ta
Reaction RMS
da
n
The new fish studies are summarised in Volume 3 (STUDY IIA 8.2.1/007 and 008). The toxicity values
io
at
from these studies differ somewhat from the values mentioned by the notifier, because a correction
alu
has been made for the impurity of the a.s. After correction the LC50-values are 14.7 µg/L (NOEC-
ev
EC
value 4.8 µg/L) for Pimephales promelas and 8.7 µg/L for Oncorhynchus mykiss (modified exposure
n
test) (NOEC-value 2.7 µg/L).

fa
to
ar
sp
m
or
tf
en
m
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t.
en
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119
cu
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The notifier is of the opinion that the safety factor can be reduced from 100 to 10, because it has been
t
of
shown that the toxicity is restricted to a narrow range of about one order of magnitude over the six fish
is
as
species tested. The RMS does not fully agree with this approach because of the following reasons:
eb
- it is stated in HARAP that the uncertainty factors that are applied to the lowest toxicity values could
th
on
be lowered up to an order of magnitude. So, not a reduction factor of 10 is automatically applied in all
ed
cases.
nt
ra
- the final risk assessment (with a lowest TER of 23) is based on the modified exposure test, which is
eg
done only for one fish species. Normally a factor of 100 is applied to the result of such a test.
tb
no
So the notifier has mixed up two approaches which cannot be accepted as such.
t
us
Moreover, the notifier has taken a value of 10.1 µg/L as the LC50-value of the modified exposure test.
m
However, there must be corrected for the impurity of the a.s. After this correction the LC50-value is 8.7
n
tio
µg/L. With this value the lowest TER is 20.
ra
st
From the fish data also a HC5 can be calculated, based on the NOEC data from the acute studies.
gi
Re
The toxicity value of the study with Lepomis macrochirus is not taken into account, because the study
n.
was considered not acceptable by the RMS. The HC5-value, based on the NOEC-values of the other
io
lat
acute studies with fish is 0.66 µg/L. Because there are multiple applications it has to be demonstrated
iso
that the toxicity from a sensitive species after a single application is representative for the toxicity after
in
d
multiple application. In this case Oncorhynchus mykiss is the most sensitive species. The NOEC from
ea
er
the acute study is 0.78 µg/L. There is a long-term toxicity study for this species available; a 72 days
tb
flow-through study with a NOEC-value of 0.52 µg/L. Although the exposure is very worst-case com-
no
pared with the 3 applications and an interval of 7 days in practice the NOEC is just a little bit lower
ld
ou
than the NOEC-value from the acute study. Hence, it is concluded that the toxicity after a single appli-
sh
cation is representative for the toxicity after multiple applications. For this reason the RMS is of the
d
an
opinion that the HC5-value of 0.66 µg/L without an additional safety factor can be used for risk as-
ge
sessment.
a
ck
pa
ta
When the calculated HC5-value is compared with the FOCUS PEC values the following TER-values
da
for the different uses can be calculated (see table 2.6.2-34, -35 and –36):
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
20
Guidance Document on Aquatic Ecotoxicology, working document, SANCO/3268/2001, 17th October 2002.
tf
21
Campbell P.J. et al.; Guidance Document on Higher-tier Aquatic Risk Assessment for Pesticides (HARAP), From the SETAC-
en
Europe/OECD/EC Workshop, held at Lacanau Océan, France, 19-22 April 1998, Publisher: SETAC-Europe, August 1999.
m
cu
do
is
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t.
en
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120
cu
s do
hi
t
of
is
using FOCUS Step 4 PEC values and a HC5-value
as
eb
Species HC5 TER from a single application TER from three applications
th
(µg as/L) PECSW 0.430 µg as/L PECSW 0.336 µg as/L
on
fish 0.66 1.5 2.0
d
e
nt
ra
eg
tb
no
t
us
fish 0.66 5.7 5.9
m
n
tio
ra
st
gi
Re
n.
io
fish 0.66 4.9 lat 6.7
iso
in
All TER-values are higher than 1, so the risk to fish from the applications in citrus, lettuce and tomato
d
ea
is considered acceptable.
er
tb
no
Chronic toxicity to fish

ld
The results of fish chronic toxicity studies with abamectin technical are summarised in Table 2.6.2-37.
ou
sh
d
an
Table 2.6.2-37: Abamectin chronic toxicity to fish

ge
Species Test NOEC Reference

a
conditions [µg/L]
ck
pa
Oncorhynchus mykiss 72-d chronic, flow-through 0.52 McAllister, 1986

(Rainbow trout)
ta
da
Cyprinus carpio 28-d growth, flow-through 6.1 Rufli, 2000

(Carp)
n
io
at
alu
Chronic risk assessment for fish

ev
An initial chronic risk assessment to fish in citrus using the highest initial Step 3 PEC values (D6 ditch)
EC
and the lowest chronic fish endpoint is shown below in Table 2.6.2-38.
n
fa
to
Table 2.6.2-38: Chronic toxicity-exposure ratios for fish from use of abamectin on citrus after single or multiple field applications
ar

sp
m
Species NOEC TER from a single application TER from three applications
or

tf
en
O. mykiss 0.52 5.4 2.3

m
cu
do
The TER values are below the trigger value of 10 for chronic risk to fish, indicating the need for re-
is
finement of the risk assessment. In order to refine the risk assessment, FOCUS Step 4 PEC values
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en
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121
cu
sdo
hi
have been generated with a 6m buffer zone from the edge of the citrus field to the nearest water-body,
t
of
in order to reduce exposure of water bodies via drift. A chronic risk assessment to fish in citrus is con-
is
as
ducted below for both species of fish for which chronic endpoints are available, trout, Oncorhynchus
eb
mykiss and carp, Cyprinus carpio. Since the trout study was conducted over 72 days, the 50-day
th
on
TWA PECSW is used in the risk assessment as the closest available averaging time, whilst for carp,
ed
where the study was of 28 days duration, the 28-day TWA PECSW is used. Table 2.6.2-39 below
nt
ra
shows the chronic risk assessment to fish for single applications of abamectin.
eg
tb
no
Table 2.6.2-39: Chronic toxicity-exposure ratios for fish from use of abamectin on citrus after a single field application using
FOCUS Step 4 PEC values (6m buffer)
t
us
m
Species FOCUS scenario NOEC PECSW TER
n
tio
ra
D6 ditch 50d TWA = 0.034 15
st
O. mykiss 0.52
gi
R4 stream 50d TWA = 0.001 520
Re
D6 ditch 28d TWA = 0.060 700
n.
C.carpio 42
io
R4 stream 28d TWA = 0.002
lat 21 000
iso
in
d
ea
Table 2.6.2-40 below shows the chronic risk assessment to fish for multiple applications of abamectin.
er
tb
Table 2.6.2-40: Chronic toxicity-exposure ratios for fish from use of abamectin on citrus after multiple field applications using
no
FOCUS Step 4 PEC values (6m buffer)

ld
Species FOCUS scenario NOEC PECSW TER

ou
sh

d
D6 ditch 50d TWA = 0.077 6.8

an
O. mykiss 0.52
ge
R4 stream 50d TWA = 0.003 170

a
ck
D6 ditch 28d TWA = 0.122 340

pa
C.carpio 42
R4 stream 28d TWA = 0.005 8 400
ta
da
n
io
The TER values for all of the scenarios shown in Tables 2.6.2-39 and –40 are above the trigger value
at
alu
of 10 except for the TER for trout, Oncorhynchus mykiss with the PECSW for the D6 ditch scenario.
ev
However, in practice trout are highly unlikely to occur in a ditch as they naturally inhabit running waters
EC
such as streams. It is more appropriate to consider carp, Cyprinus carpio, as a relevant species with
n
fa
the D6 scenario and using the carp NOEC in this scenario generates a TER value of 170, well above
to
the trigger value of 10. Therefore, it is considered that use of abamectin in citrus poses acceptable
ar
sp
chronic risk to fish, provided that a buffer zone of 6m from the edge of the crop to the edge of any wa-
m
or
ter bodies is left unsprayed.

tf
en
m
Conclusion: An assessment of chronic risk to fish from abamectin use in citrus using long-term end-
cu
do
points for carp and trout and FOCUS Step 4 PECSW values based on a 6m buffer, has generated TER
is
values that are above the trigger value of 10 for both fish species, both single and multiple applications
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and for both ditch and stream scenarios, except for trout in a D6 ditch scenario where the TER was
t
of
6.8. However, since trout are highly unlikely to occur in ditches, it is considered more appropriate to
is
as
use the carp endpoint for this scenario, which gives a TER of 170. Therefore, it is considered that
eb
proposed uses of abamectin in citrus pose acceptable chronic risk to fish, provided that a buffer zone
th
on
of 6m from the edge of the crop to the edge of any water bodies is left unsprayed.
e d
nt
ra
Reaction RMS:
eg
- The notifier has used PECtwa-values for the chronic risk assessment, like also the RMS has done in
tb
no
the first risk assessment, on which the notifier has given a reaction. However, the actual state of the
t
us
art of the chronic risk assessment is that PECtwa-values are only used when there are strong indica-
m
tions that the effects are not caused by the exposure in the beginning of the test. In a lot of cases this
n
tio
is difficult to show. Also in this case there is no supporting information available with regard to this is-
ra
st
sue. Therefore the opinion of the RMS is nowthat in this case PIEC-values must be used for the
gi
Re
chronic risk assessment. - RMS does not accept the proposal of the notifier to replace rainbow trout by
n.
carp as the relevant species, because rainbow trout must be seen as an indicator species. There may
io
lat
be representative species as sensistive or more sensitive than rainbow trout.
iso
Using the PIEC-values from FOCUS Step 3 in the case of field applications and FOCUS Step 2 in the
in
d
case of glasshouse uses the chronic TER-values are as presented in table 2.6.2-41.
ea
er
tb
Table 2.6.2-41: Chronic toxicity-exposure ratios for fish from use of abamectin using FOCUS Step 3 (field applications) and 2
no
(glasshouse uses) PIEC values

ld
Species NOEC crop PIECsw TER

ou
sh
[µg as/L] (ug/L)

d
an
citrus 0.791 0.66

ge
Lettuce (field) 0.115 4.5

a
ck
Lettuce (glass- 121

pa
O. mykiss 0.52 0.0043

house)
ta
Tomato (field) 0.136 3.8

da
Tomato (glass- 46
n
0.0114
io
house)
at
alu
From this table it can be concluded that only the glasshouses uses have TER-values higher than the
ev
trigger-value of 10. The TER-values of the other uses are lower than the trigger value of 10.
EC
n
fa
to
ar
Refined chronic risk assessment for fish

sp
From the available data it is clear that the acute NOEC-value from a static acute test with rainbow trout
m
or
(0.78 µg/L) and the chronic NOEC-value from a flow-through chronic study with the same species
tf
en
(0.52 µg/L) don’t differ much from each other. Therefore it is very worst-case to take the lowest chronic
m
cu
NOEC-value together with the PIEC-value and a safety factor of 10. Another approach is to take the
do
HC5-value, based on the acute NOEC-values, and to put a safety factor on this value which takes ac-
is
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en
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123
cu
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count for the difference between the acute NOEC and the chronic NOEC-value. In that case all the
t
of
available data for fish are taken into account and also the difference between acute and chronic is
is
as
taken into account.
eb
For two fish species acute and chronic toxicity values are available:
th
on
- Oncorhynchus mykiss: acute 96 h NOEC = 0.78 µg/L and 72 days chronic NOEC = 0.52 µg/L;
e d
- Cyrpinus carpio: acute 96 h NOEC = 18 µg/L and 28 days chronic NOEC = 6.1 µg/L.
nt
ra
Based on these data it is proposed to take a factor of 3 to take account for the difference between the
eg
acute NOEC-values and the chronic NOEC-values. The HC5-value based on the acute NOEC-values
tb
no
is 0.66 µg/L; dividing this value by a factor of 3 yields a chronic HC5-value of 0.22 µg/L. No safety fac-
t
us
tor is considered necessary.
m
Another approach for calculating a chronic HC5 is to take the median acute HC5, based on acute
n
tio
LC50-values, together with a safety factor of 10. The median acute HC5 is 2.998 µg/L, so the chronic
ra
st
HC5 will be 0.30 µg/L. This result indicates that the original HC5-value of 0.22 µg/L is protective
gi
Re
enough.
n.
Based on the chronic HC5-value of 0.22 µg/L the following TER-values can be calculated (see table
io
lat
2.6.2-42).
iso
in
d
Table 2.6.2-42: Chronic toxicity-exposure ratios for fish from use of abamectin using FOCUS Step 3 (field applications) and 2
ea
(glasshouse uses) PIEC values and a chronic HC5-value

er
Species Chronic HC5 crop PIECsw TER

tb
no
[µg as/L] (ug/L)

ld
citrus 0.28
ou
0.791
sh

d
an
Lettuce (glass- 51
O. mykiss 0.22 0.0043
house)
ge
Tomato (field) 1.6

a
0.136
ck
pa
Tomato (glass- 19
0.0114
house)
ta
da
n
The TER-values for all uses are above 1, except for the use in citrus. For this use risk mitigation
io
at
measures, e.g. bufferzones, are necessary.

alu
ev
EC
2.6.3 Effects on bees and other arthropod species

n
fa
to
2.6.3.1 Bees
ar
sp
Toxicity data
m
or
From an acute toxicity study, a contact LD50 of 0.0022 µg/bee was obtained. No reliable oral LD50
tf
en
could be estimated.
m
cu
In a cage test where bees were exposed to 0.5 to 1 hour aged residues on leaves, full mortality was
do
observed at concentrations in the spray liquid of 0.0015 g as/L and higher. Mortality decreased with
is
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ageing time. A linear relationship was found between the concentration in the spray liquid and the time
t
of
needed to reduce mortality to 50 %. The minimum ageing time was estimated as 2 hours at 0.0015 g
is
as
as/L, 3.8 - 3.9 hours at 0.0030 g as/L, 15 hours at 0.006 g as/L, 19 hours at 0.0075 g as/L, 37 hours at
eb
0.012 g as/L and 41 hours at 0.015 g as/L. These time intervals apply to dry and warm weather condi-
th
on
tions, 24 - 27 °C. The minimum ageing time is a linear function of the concentration in the spray liquid
e d
and is given by: [Minimum ageing time] = [3188 x Concentration] - 4.4 (r2 0.986). Based on this rela-
nt
ra
tionship, a waiting time of 43 hours is necessary for residues on tomatoes to decline to levels causing
eg
< 50 % mortality. Control corrected mortality after 72 hours was 4.9 % at 0.015 g as/L.
tb
no
A glasshouse test was performed to determine the residual toxicity of abamectin 0.18 EC on tomato
t
us
plants that were sprayed at 14.6 g and 11.8 g as/ha. Bumblebees were exposed to 6 to 48 hours aged
m
residues. No significant effect on mortality and on pollination was found at both treatment levels. How-
n
tio
ever, there was a trend for the highest mortality to occur in the 6 and 12 hour interval treatments. The
ra
st
use of full size hives could result in significant differences in bee mortality. Exposure to residues within
gi
Re
6 - 48 hours after spraying could thus lead to a significant effect on bumblebee survival.
n.
io
Risk assessment lat
iso
The risk assessment is performed for the use of Vertimec 018 EC on citrus and tomatoes, since expo-
in
sure of bees on lettuce is not to be expected. The maximum single application rate is 21.6 g as/ha,
d
ea
with one to three applications for citrus and field grown tomatoes, and one to five applications for to-
er
matoes in glasshouses, all with a 7-days spraying interval.

tb
no
The risk assessment for bees is based on a single application at the maximum rate of 21.6 g as/ha,
ld
and the contact LD50 of 0.0022 µg/bee for Apis mellifera. The hazard quotient is calculated as
ou
dose/LD50, with dose in g as/ha and LD50 in µg as/bee and amounts to 9818 for contact exposure. This
sh
d
is above the Annex VI trigger of 50, indicating possible high risk.

an
ge
a
Field use
ck
pa
The maximum proposed concentration of spray liquid to be used is 0.0135 g as/L in citrus, and
ta
0.018 g as/L in tomatoes. From the relationship between the concentration in the spray liquid and the
da
n
minimum ageing time needed for residues to decline to levels which cause < 50 % mortality, it can be
io
at
calculated that the minimum waiting time under the proposed conditions of use is 39 hours for citrus
alu
and 43 hours for tomatoes. These time periods apply to single applications under dry and warm
ev
EC
weather conditions, and may be longer for multiple applications at lower temperature or under unfa-
n
vourable light conditions. Because under field conditions it is not possible to prevent bees from enter-
fa
to
ing the treated area, a risk for bees cannot be excluded and the following restrictions should be put on
ar
the label: “Dangerous to bees.To protect bees and other pollinating insects do not apply to crop plants
sp
m
when in flower.Do not use where bees are actively foraging. Do not apply when flowering weeds are
or
tf
present.”
en
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s
hi
Glasshouse use
t
of
is
Based on the laboratory test, where control corrected mortality after 72 hours was still 4.9 %, a waiting
as
time of at least 96 hours is considered necessary. This is confirmed by the glasshouse study, where
eb
th
effects on bees after exposure to residues of 6 - 48 hours could not be excluded.
on
d
e
Reaction notifier
nt
ra
eg
tb
Selectivity of abamectin to non-target arthropods in practice
no
t
us
Abamectin is rapidly broken down in the presence of UV light, degrading oxidatively and photo-
m
n
oxidatively. Surface residues on inert substrates and on foliage are rapidly degraded, with half-lives
tio
typically of less than one day (Bull et al, 199422 and Crouch et al, 199123). The post-application effi-
ra
st
cacy of abamectin can be attributed to translaminar movement of relatively small, but insecticidally or
gi
Re
acaricidally significant quantities (Babu, 198824). Rapid loss of surface residues potentially confers a
n.
io
high degree of selectivity to non-target arthropods. This enables abamectin to be successfully com-
lat
bined with innundative releases of predatory and parasitic arthropods under IPM crop management
iso
schemes.
in
d
ea
er
Further data on bees

tb
Under UK glasshouse conditions abamectin (Dynamec 1.8EC) treatment of flowering tomato plants at
no
ld
9mg ai/L caused no significant increase in bumble bee (Bombus terrestris) mortality or effects on polli-
ou
nation compared to the untreated when bees were introduced into treated houses at intervals from 6
sh
d
hours after application. Trends in the data suggested that 24 hours should be left between application
an
and introduction of hives 25. Biocontrol organism suppliers recommend that hives are removed prior to
age
application and replaced after a 24-hour withholding period 26.

ck
pa
Conclusion: The persistence of harmful effects of foliar surface residues of abamectin on glasshouse
ta
crops is dependent on arthropod species, crop and light intensity. Therefore, Syngenta considers
da
n
io
at
alu
ev
EC
n
22
Bull D L, Ivie G W, MacConnell J G, Gruber, V F, Ku C C, Arison, B H, Stevenson, J M and VandenHeuval, W J A (1984) Fate
fa
of Avermectin B1a in soil and plants. J. Agric. Food Chem. 32 (1) p94-102.
to
23
Crouch L S, Feely W F, Arison B H, VandenHeuvel W J A, Colwell L F, Stearns R A, Kline W F and Wislocki P G (1991)
ar
Photodegradation of avermectin B1a thin films on glass J. Agric. Food Chem. 39 (7) p1310-1319.
24
sp
Babu J R (1988) Avermectins: Biological and pesticidal Activities. In Culter H G Ed (1988) Biologically Active Natural Products
Potential Use in Agriculture. Pub ACS.
m
25
Buxton J H (1996) Testing the safety of Dynamec (abamectin 1.8EC) to foraging bumble bees on tomatoes in glasshouses,
or
including observations on the pollination of tomatoes when Dynamec was applied to a flowering crop. Syngenta Report 074-96-
tf
0005.
en
26
Biobest website http:// 207.5.71.37/biobest/en/neven/result.
m
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en
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that recommendations on re-introduction periods are most appropriately determined at the Member
t
of
State level on the basis of considerations of crops, species, region and season.
is
as
eb
Reaction RMS
th
on
RMS can agree with the opinion of the notifier that recommendations on re-introduction periods should
e d
be determined at the Member State level on the basis of considerations of crops, species, region and
nt
ra
season.
eg
tb
no
t
2.6.3.2 Other arthropod species
us
m
Toxicity data
n
tio
The submitted tests include worst case laboratory tests on inert substrates and extended laboratory
ra
st
tests substrates. Laboratory tests were performed to meet the requirements of the EPPO/CoE and
gi
Re
SETAC/ESCORT127, i.e. ‘old way’ of testing with a trigger value of 30 % for inert substrates. The ex-
n.
tended laboratory tests were all summarised according to the recommendations of the
io
lat
SETAC/ESCORT2 workshop leading to lethal and sublethal endpoints with a trigger value of 50 %.
iso
in
Predatory mites
d
ea
er
Laboratory tests
tb
Data on Typhlodromus pyri are available. Three tests on natural substrate were performed. Applica-
no
tion rates tested ranged from 0.088 to 22.4 g as/ha. An effect of > 50 % on reproduction was found
ld
ou
when exposed to fresh residue at application rates of 0.199 g as/ha and higher. When exposed to 1
sh
day old residue at an application rate of 4.33 g as/ha, the effect on reproduction was > 50 %. When
d
an
exposed to 6 day old residue at the same application rate, the effect on reproduction was < 50 %. Ex-
ge
posure to 6 day old residue at an application rate of 22.4 g as/ha resulted in an effect on reproduction
a
ck
> 50 %. Exposure to 15 day old residue at the same application rate resulted in < 50 % effect on sur-
pa
ta
vival and reproduction.

da
n
io
Field tests
at
alu
The effect of Vertimec 0.18 EC on Typhlodromus pyri was determined under field conditions at an ap-
ev
plication rate of 14.7 g as/ha, application 1x and 2x. The results of this study indicate no risk for Ty-
EC
phlodromus pyri at the application rates tested in vine. The results can not be used for the risk as-
n
fa
to
ar
sp
m
or
tf
en
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127
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sessment since the application rate is lower than the maximum application rate used on citrus and
t
of
tomato (21.7 g as/ha) and on lettuce (18 g as/ha), the number of applications is lower and the study
is
as
was performed on vine. Another field study was conducted in which the effect of abamectin plus a
eb
paraffin oil on (predatory) mites was determined. Only one application was performed. Multiple appli-
th
on
cations are not taken into account and might result in a different prey:predator ratio. The results of this
d
e
study are considered not to be useful for the risk assessment.
nt
ra
eg
Parasitoids
tb
no
Data on Aphidius rhopalosiphi and on Aphidius colemani are available. For Aphidius rhopalosiphi
t
us
three tests on natural substrate were performed. Application rates tested ranged from 0.023 to 22.4 g
m
as/ha. An effect of > 50 % on reproduction was found was after exposure to fresh residue at applica-
n
tio
tion rates of 0.143 g as/ha and higher. Effects of > 50 % on survival was found after exposure to fresh
ra
st
residue at application rates of 0.895 g as/ha and higher. When exposed to 6 day old residue at an ap-
gi
Re
plication rate of 4.32 g as/ha, the effect on reproduction was > 50 % (52 %). In a semi-field study with
n.
Aphidius colemani the application rate could not be determined accurately and therefore a minimum
io
lat
and maximum application rate was reported. At both application rates (ranges 0.20 - 0.73 and 2.48 -
iso
9.11 g as/ha) effects on survival and activity were > 50 % when exposed to fresh residue. When ex-
in
posed to residues of 3 and 7 days effects on reproduction and activity were < 50 %.
d
ea
er
Foliage dwelling predators

tb
no
Data on Orius laevigatus are available. Two tests on natural substrate were performed. In the first test
ld
ou
the application rates ranged from 1.2 to 58.4 g as/ha. An effect of > 50 % on survival was found at 1.2
sh
g as/ha. In the second test Orius laevigatus was exposed to fresh and aged residue (2 and 7 days) at
d
an
application rates of 2.7 and 13.5 g as/ha, with and without paraffin oil. An effect on survival > 50 %
ge
was found after exposure to fresh residue at an application rate of 13.5 g as/ha with and without paraf-
a
ck
fin oil. When exposed to residues of 2 and 7 days old the effect on survival was < 50 %.
pa
ta
da
Ground dwelling predators

n
io
Data on Poecilus cupreus are available. One test on inert substrate at application rates ranging from
at
alu
1.2 to 58 g as/ha. The effect on survival and food consumption was < 30 %. The second test was per-
ev
formed on natural soil at application rates ranging of 5.8 and 29.2 g as/ha (with and without adjuvant).
EC
The applications were performed twice. The effect on reproduction and survival was < 50 %.
n
fa
to
ar
sp
m
or
27
Barrett, K.L. et al. (eds.), 1994. Guidance document on regulatory testing procedures for pesticides and non-target arthro-
tf
pods. From the ESCORT workshop (European Standard Characteristics of beneficials regulatory testing), March 28 – 30, 1994,
en
Wageningen, The Netherlands. SETAC Europe.

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128
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t hi
of
A summary of all accepted tests is given in Tables 2.6.3-1 to -5.
is
as
eb
Table 2.6.3-1. Laboratory studies; Summary of the toxicity with A-8612 A on non-target arthropods; data meeting requirements
of EPPO/CoE and SETAC/ESCORT1.
th
Species Substrate Application Effects Parameter Risk Reference
on
1
and rate Classification
d
duration [g as/ha] [%]
e
nt
ra
Poecilus cupreus sand, 14 d 1.2 0 survival low IIA 8.3.2.1/001
eg
0 food consumption low
tb
5.8 0 survival low IIA 8.3.2.1/001
no
29 0 survival low IIA 8.3.2.1/001
t
us
58 0 survival low IIA 8.3.2.1/001
m
n
tio
1: Trigger value of 30 % for laboratory studies
ra
st
Table 2.6.3-2. Extended laboratory studies; summary of the toxicity studies with A-8612 A on predatory mites
gi
Species Substrate and duration Application Age of Effects Parameter Trigger Reference
Re
rate residue
n.
[g as/ha] [d] [%] [%]
io
Predatory mites
Typhlodromus pyri spraying on leaves, 14 d 1.17 lat
88.2 survival 50 IIA 8.3.2.1/009
iso
100 reproduction
5.84 97.9 survival 50 IIA 8.3.2.1/009
in
29.2 100 survival 50 IIA 8.3.2.1/009

d
58.4 100 survival 50 IIA 8.3.2.1/009

ea
Typhlodromus pyri spraying on leaves, 7 + 7 d 0.088 4 survival 50 IIA 8.3.2.1/010

er
27 reproduction
tb
0.133 13 survival 50 IIA 8.3.2.1/010

34 reproduction
no
0.199 11 survival 50 IIA 8.3.2.1/010

ld
52 reproduction
ou
0.298 24 survival 50 IIA 8.3.2.1/010

72 reproduction
sh
0.448 59 survival 50 IIA 8.3.2.1/010

d
Typhlodromus pyri spraying on plants, ageing 4.33 0 100 survival 50 IIA 8.3.2.1/011
an
outdoor, exposure in lab to 4.33 1 15 survival 50 IIA 8.3.2.1/011

ge
leaves, 7 + 7 d 56.5 reproduction

4.33 6 0 survival 50 IIA 8.3.2.1/011
a
ck
10.8 reproduction
pa
22.4 0 100 survival 50 IIA 8.3.2.1/011

22.4 1 100 survival 50 IIA 8.3.2.1/011
ta
22.4 6 12 survival 50 IIA 8.3.2.1/011

da
78.4 reproduction
n
22.4 15 0 survival 50 IIA 8.3.2.1/011

io
-6.7 reproduction
at
alu
ev
Table 2.6.3-3. Extended laboratory studies; summary of the toxicity studies with A-8612 A on aphid parasitoids.
EC
rate residue
n
[g as/ha] [d] [%]

fa
Aphid parasitoids
to
Aphidius rhopalosiphi spraying on plants, exposure 0.58 93.3 survival 50 IIA 8.3.2.1/005
ar
on plants indoor 2 +11 d 5.84 100 survival 50 IIA 8.3.2.1/005

sp
29.2 100 survival 50 IIA 8.3.2.1/005

58.4 100 survival 50 IIA 8.3.2.1/005
m
or
Aphidius colemani semi-field, spraying on plants 0.20-0.73 67 activity 50 IIA 8.3.2.1/006

outdoor, exposure on plants 62 reproduction
tf
outdoor, 3 + 12 d 2.48-9.11 77 activity 50 IIA 8.3.2.1/006

en
80 reproduction
m
0.20-0.73 13 activity 50 IIA 8.3.2.1/006

cu
2x 39 reproduction
do
2.48-9.11 86 activity 50 IIA 8.3.2.1/006

2x 54 reproduction
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129
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t hi
of
rate residue
is
[g as/ha] [d] [%]
as
0.20-0.73 34 activity 50 IIA 8.3.2.1/006
eb
4x 0 reproduction
2.48-9.11 84 activity 50 IIA 8.3.2.1/006
th
4x 26 reproduction
on
0.20-0.73 3 -9 activity 50 IIA 8.3.2.1/006
4x 29 reproduction
de
2.48-9.11 3 32 activity 50 IIA 8.3.2.1/006
nt
4x -34 reproduction
ra
0.20-0.73 7 -40 activity 50 IIA 8.3.2.1/006
eg
4x 6 reproduction
2.48-9.11 7 3 activity 50 IIA 8.3.2.1/006
tb
4x -11 reproduction
no
Aphidius rhopalosiphi spraying on plants, exposure 0.023 0 survival 50 IIA 8.3.2.1/007
t
on plants indoor, 2 + 12 d 0.057 0 survival 50 IIA 8.3.2.1/007
us
7 reproduction
m
0.143 3 survival 50 IIA 8.3.2.1/007
n
67 reproduction
tio
0.358 40 survival 50 IIA 8.3.2.1/007
ra
94 reproduction
st
0.895 80 survival 50 IIA 8.3.2.1/007
gi
2.238 97 survival 50 IIA 8.3.2.1/007
Re
Aphidius rhopalosiphi spraying on plants, ageing 4.32 0 95 survival 50 IIA 8.3.2.1/008
outdoor, exposure to leaves 22.4 0 100 survival 50 IIA 8.3.2.1/008
n.
indoor, 13-14 d 4.32 1 25 survival 50 IIA 8.3.2.1/008
io
lat 67 reproduction
22.4 1 80 survival 50 IIA 8.3.2.1/008
iso
4.32 6 3 survival 50 IIA 8.3.2.1/008

52 reproduction
in
22.4 6 15 survival 50 IIA 8.3.2.1/008

d
57 reproduction
ea
4.32 16 3 survival 50 IIA 8.3.2.1/008

er
-9 reproduction
tb
22.4 16 11 survival 50 IIA 8.3.2.1/008

no
-8 reproduction
ld
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
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or
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en
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t hi
Table 2.6.3-4. Extended laboratory studies; summary of the toxicity studies with A-8612 A on polyphagous predators
of
is
rate residue
as
[g as/ha] [d] [%]
eb
Polyphagous predators
th
Orius laevigatus spraying on plants, exposure 1.2 63.2 survival 50 IIA 8.3.2.1/003
on plants, 10 +10 d -8.3 reproduction
on
5.8 90.8 survival 50 IIA 8.3.2.1/003
d
29.2 97.7 survival 50 IIA 8.3.2.1/003
e
nt
58.4 100 survival 50 IIA 8.3.2.1/003
ra
Orius laevigatus semi-field, spraying on plants, 2.7 49.2 survival 50 IIA 8.3.2.1/004
eg
exposure on plants outdoor, 2.7 2 16.9 survival 50 IIA 8.3.2.1/004
15 +20 d 2.7 7 13.2 survival 50 IIA 8.3.2.1/004
tb
13.5 58.7 survival 50 IIA 8.3.2.1/004
no
13.5 2 45.8 survival 50 IIA 8.3.2.1/004
13.5 7 26.5 survival 50 IIA 8.3.2.1/004
t
us
2.7 38.1 survival 50 IIA 8.3.2.1/004
m
+ paraffin oil
2.7 2 8.5 survival 50 IIA 8.3.2.1/004
n
tio
+ paraffin oil
2.7 7 8.8 survival 50 IIA 8.3.2.1/004
ra
+ paraffin oil
st
13.5 63.5 survival 50 IIA 8.3.2.1/004
gi
+ paraffin oil
Re
13.5 2 49.2 survival 50 IIA 8.3.2.1/004
n.
+ paraffin oil
io
13.5 7 35.3 survival 50 IIA 8.3.2.1/004
+ paraffin oil lat
iso
paraffin oil 7.9 survival 50 IIA 8.3.2.1/004
paraffin oil 2 -13.6 survival 50 IIA 8.3.2.1/004
in
paraffin oil 7 16.2 survival 50 IIA 8.3.2.1/004

d
ea
er
Table 2.6.3-5. Extended laboratory studies; summary of the toxicity studies with A-8612 A on ground dwelling predators.
tb
Species Substrate Application Age of Effects Parameter Trigger Reference

no
and rate residue

duration [g as/ha] [d] [%]
ld
ou

1
Poecilus cupreus natural soil, 14 d 2 x 5.8 -3.4 survival 50 IIA 8.3.2.1/002
sh
0 food consumption
d
2
natural soil, 14 d 2 x 5.8 3.3 survival 50 IIA 8.3.2.1/002
an
6.1 food consumption

3
ge
natural soil, 14 d 2 x 5.8 -3.4 survival 50 IIA 8.3.2.1/002

-2.8 food consumption
a
ck
1
pa
0 food consumption
2
natural soil, 14 d 2 x 29.2) 0 survival 50 IIA 8.3.2.1/002
ta
0 food consumption
da
3
-5.6 food consumption
n
io
1
natural soil, 14 d 2 x 5.8 0 survival 50 IIA 8.3.2.1/002
at
+ adjuvant -3.0 food consumption

alu
2
+ adjuvant 15.2 food consumption
ev
3
EC

1
n
fa

2
to

ar
3
sp

st
m
1: beetles were introduced 3 days before 1 application, beetles and soil received two treatments, fly pupae one
or
nd
2: beetles were introduced immediately after 2 application, fly pupae received one treatment
nd
tf
3: beetles were introduced 14 days after the 2 application, fly pupae not treated
en
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t
Risk assessment
of
is
as
First tier assessment
eb
th
Non-target arthropods are likely to be exposed to abamectin when applied as Vertimec 0.18 EC on the
on
outdoor crops citrus, lettuce and tomatoes, and on the indoor crops lettuce and tomatoes. According
d
e
nt
to the recommendations of SETAC/ESCORT2 the Hazard Quotient approach can be divided in the
ra
determination of the in-field and off-field Hazard Quotient (HQ). In-field exposure is calculated as [Ap-
eg
tb
plication rate·MAF], where MAF is the Multiple Application Factor. The in-field HQ is the quotient of
no
exposure and LR50. The off-field exposure is calculated as [Application rate·MAF·Fdrift]/Fvegetation distribu-
t
us
tion]. The off-field HQ is given as [exposure/LR50]·10, the factor of 10 is intended to cover various
m
n
sources of uncertainty. In case the DT50 on leaves is not known, ESCORT2 gives a default-MAF that is
tio
ra
calculated for a ratio between T1/2 and spray interval of 2.3. The default MAF is 2.3, 2.7 and 3.0 for
st
three, four and five applications, respectively.
gi
Re
Since Vertimec 018EC was anticipated to have effects with glass plate studies, this level of testing
n.
io
was not carried out and more realistic extended laboratory studies were initially conducted, followed
lat
by semi-field studies where necessary to refine the risk assessment. The initial HQ risk assessment
iso
step recommended by ESCORT 2 is therefore omitted. The risk assessment presented is conducted
in
d
according to ESCORT 2 guidance for use with higher tier test data by using a trigger value of 50 %
ea
er
effect on lethal or sublethal endpoints in extended laboratory or semi-field tests with all available spe-
tb
cies and compared with the calculated exposure rate.

no
ld
ou
In-field and off-field exposure

sh
d
Calculated exposure for the respective uses is given in Table 2.6.3-6 and -7.
an
ge
Table 2.6.3-6. In-field exposure for citrus, lettuce, and tomatoes outdoor and lettuce and tomatoes indoor.
a
Crop Max. single number of MAF Exposure

ck
dose [g as/ha] applications in-field

pa
[g as/ha]
ta
citrus 21.6 3 2.3 49.7

da
lettuce, field 18 3 2.3 41.4

lettuce glasshouse 9 4 2.7 24.3
n
tomatoes, field 21.6 3 2.3 49.7

io
tomatoes glasshouse 21.6

at
5 3.0 63.6
alu
ev
Table 2.6.3-7. Off-field exposure for citrus, lettuce, and tomatoes.

EC
2 2
Crop Max. single number of MAF Vegetation Drift Exposure off-field Exposure off-field
n
dose applications distribution [%] without vegetation distribu- with vegetation distribu-
fa
factor tion factor tion factor

to
[g as/ha] [g as/ha] [g as/ha]

1
ar
citrus 21.6 3 2.3 10 15.73 39.0 3.9

lettuce, field 18 3 2.3 10 2.01 4.2 0.42
sp
tomatoes, field 21.6 3 2.3 10 2.01 5.0 0.50

m
1: drift value for late application to fruit crops used in accordance with FOCUS Surface water
or
2: off-field exposure value includes correction factor of 5 to be used in case of extended laboratory tests
tf
en
m
The vegetation distribution factor is included in the calculation of the exposure rate only when a 2-
cu
dimensional system (e.g. leaves or leaf discs) is treated but not when whole plants are treated.
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Effects at predicted exposure rates
t
of
More than 50 % effects were found for Aphidius rhopalosiphi, Typhlodromus pyri, Aphidius colemani
is
as
and Orius laevigatus at rates lower than the calculated exposure rates in-field and off-field for all three
eb
crops (indoor and outdoor), when no ageing of residus is included. This assessment indicates a poten-
th
on
tial risk both in-field and off-field to several non-target arthropods and further refinement of the risk
d
e
assessment is necessary.
nt
ra
eg
Refined assessment
tb
no
Exposure refinement
t
us
For the refined risk assessment the MAF is based on a DT50 value of 3 days (see risk assessment
m
birds). Refined calculated in-field and off-field exposure is given in Table 2.6.3-8 and 2.6.3-9.
n
tio
ra
Table 2.6.3-8. In-field exposure for citrus, lettuce, and tomatoes outdoor and lettuce and tomatoes indoor.
st
1
Crop Max. single Number MAF Exposure
gi
dose of in-field
Re
[g as/ha] applications [g as/ha]
citrus 21.6 3 1.24 26.8
n.
lettuce field 18 3 1.24 22.3
io
lettuce glasshouse 9 4 1.25 11.3 lat
tomatoes field 21.6 3 1.24 26.8
iso
tomatoes glasshouse 21.6 5 1.25 27.0

1: MAF based on DT50 of 3 days and spray interval 7 days
in
d
ea
Table 2.6.3-9. Off-field exposure for citrus, lettuce, and tomatoes.

er
1 2 3 3
Crop Maximum sin- Number MAF Vegetation Drift Exposure off-field Exposure off-field
tb
gle of distribution without vegetation distri- with vegetation distri-

no
dose applications factor bution factor bution factor

[g as/ha] [%] [g as/ha] [g as/ha]
ld
2
citrus 21.6 3 1.24 10 15.73 21.1 2.11
ou
lettuce field 18 3 1.24 10 2.01 2.24 0.22

sh
tomatoes field 21.6 3 1.24 10 2.01 2.69 0.27

1: MAF based on DT50 of 3 days and spray interval 7 days
d
an
2: drift value for late application to fruit crops used in accordance with FOCUS Surface water
3: off-field exposure value includes correction factor of 5 to be used in case of extended laboratory tests
ge
a
ck
The calculated exposure levels are still higher than the 50 % effect-rates for A. rhopalosiphi, T. pyri, A.
pa
colemani and O. laevigatus when fresh residues are considered.

ta
da
n
io
Effect of ageing
at
alu
Studies performed on Typhlodromus pyri with aged residue indicate that, at an application rate of 22.4
ev
g as/ha, the effect on reproduction is > 50 % with 6-day old residue and < 50 % with 15-day old resi-
EC
due. Studies performed on Aphidius rhopalosiphi with aged residue indicate that the effect on repro-
n
fa
duction is > 50 % with 6-day old residue and is < 50 % with 16-day old residue at an application rate of
to
ar
22.4 g as/ha. An effect of > 50 % on survival on Orius laevigatus after exposure to fresh residue at an
sp
application rate of 13.5 g as/ha was reduced to < 50 % after 2 days of ageing.
m
or
tf
en
In-field risk after ageing

m
Since the calculated in-field exposure rates (for indoor and outdoor crops) are in the same range or
cu
do
lower than the highest application rate used in the studies with 16 days aged residue (effect < 50 %), it
is
is safe to assume that effects on reproduction/survival of the tested non-target arthropods after expo-
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133
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sure to 16-day old residue of abamectin will be < 50%. Given the biology of the tested species, recolo-
t
of
nisation is expected to occur in all crops, also in lettuce (2 crops per year) outdoor. For indoor crops
is
as
non-target arthropods should be introduced not sooner than 16 days after the last application.
eb
th
on
Off-field risk after ageing
e d
The effect on reproduction of Aphidius rhopalosiphi, after exposure to 6-day old residue at an applica-
nt
ra
tion rate of 4.32 g as/ha, was 52 %. After exposure to 16-day old residue no effect was found on re-
eg
production. For Typhlodromus pyri exposure to 1-day old residue at an application rate of 4.33 g as/ha
tb
no
was 56.5 %, exposure to 6-day old residue reduced the effect on reproduction to 10.8 %. Given the
t
us
results of the studies < 50 % effect is to be expected after exposure to 6-day old residue to the off-field
m
exposure rates of all crops.
n
tio
ra
Overall conclusion
st
gi
Although the use of abamectin at the proposed application rates is expected to cause sincere effects
Re
on the populations of the non-target arthropod species tested (except for Poecilus cupreus) recoloni-
n.
io
sation is expected to occur in all crops. Regarding indoor crops non-target arthropods should be intro-
lat
iso
duced not sooner than 16 days after the last application.
in
d
ea
Reaction notifier
er
The Draft Assessment Report states that non-target arthropods should not be re-introduced to indoor
tb
no
crops sooner than 16 days after treatment with abamectin. This was based upon aged-residue stud-
ld
ies with Typhlodromus pyri (Waterman, 2003) and Aphidius rhopalosiphi (Fussell, 2003), which
ou
showed effects upon reproduction from a rate of 22.4 g as/ha abamectin after 6 days but no effects
sh
d
after 15 and 16 days respectively for each species. However, no timings between 6 and 15 days were
an
tested so it is possible that a re-introduction timing of between 6 and 16 days would be acceptable.
ge
a
ck
Further evidence is presented below to make a case for a more flexible re-introduction period.
pa
ta
da
Effects of abamectin upon beneficial arthropods in the glasshouse

n
A number of relevant studies on the duration of effects of abamectin on beneficial organisms in glass-
io
at
houses are available in the literature. These have been reviewed and findings are summarised below.
alu
ev
EC
n
fa
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sp
m
or
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thi
of
Parasitoids.
is
as
Laboratory studies conducted by Shipp et al (199928) demonstrated harmful effects against Encarsia
eb
formosa, Aphidoletes aphidimyza, Aphidius colmani and Dacnusa sibirica for up to 28 days on labora-
th
on
tory-aged plants treated with abamectin at 5.4mg ai/L. However, when the test was conducted in the
d
e
glasshouse using cucumber plants, mortality of Encarsia declined to less than 10% after 6 days. Simi-
nt
ra
lar results were obtained with Aphidius colemani. Under glasshouse conditions, Dacnusa mortality
eg
declined to less than 10% after only 4 days. Aphidoletes appeared more sensitive, with 50 and 20%
tb
no
mortality remaining at 6 and 22 DAT respectively.
t
us
Zchori-fein et al (199429) conducted pragmatic trials using combined treatments of Avid 0.15 EC at
m
11.2mg abamectin ai/L and E. formosa for the control of greenhouse whitefly on poinsettia. Adults
n
tio
caged onto leaves within 2 hours of application were all killed, but after 24 hours ageing no mortality
ra
st
was observed amongst adults similarly exposed. However, on plants infested with whitefly scales,
gi
Re
moderate levels of mortality were obtained through secondary exposure due to adult females feeding
n.
on the contaminated whitefly larvae. Subsequent small-scale glasshouse trials demonstrated that de-
io
lat
spite potential harmful effects, the percentage of parasitism of whitefly by E. formosa was not signifi-
iso
cantly different amongst plants treated with and without abamectin. Furthermore, the combined treat-
in
d
ment of abamectin and parasitoid significantly decreased the whitefly population on poinsettia com-
ea
er
pared to the use of abamectin alone. The combined biological and chemical treatment required fewer
tb
chemical applications than when abamectin was used alone. This study allowed factors such as insect
no
behaviour to moderate exposure and used end points that are pertinent to the glasshouse grower.
ld
ou
Suppliers of biological control agents suggest reintroduction is possible 5-7 days after treatment with
sh
abamectin for E. formosa, Aphidioletes aphidimyza and Aphidius colemani 30.

d
an
ge
Mites
a
ck
pa
Vertimek applied to pepper foliage at the recommended Belgian rate of 10mg ai/L was moderately
ta
harmful to Amblyseius californicus after treated plants were assayed after 5 and 10 days aging in a
da
greenhouse. By 30 days aging, all signs of toxicity had dissipated. A lower rate of 5ppm only gave a
n
io
at
alu
ev
EC
n
fa
to
ar
sp
28
Shipp J L, Wang K, Ferguson G (1999) Residual toxicity of avermectin b1 and pyridaben to eight commercially produced
m
beneficial arthropod species used for control of greenhouse pests. Biological Control 17 p125-131.
or
29
Zchori-fein E, Roush R T and Sanderson J P (1994) Potential for integration of biological and chemical control of glasshouse
tf
whitefly using Encarsia formosa and abamectin. Environmental Entomology 25 (3) p1277-1282.
en
30
Biobest website http:// 207.5.71.37/biobest/en/neven/result.
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toxic effect for 5 days, and was recommended by the authors for use in IPM programmes 31. Commer-
t
of
cial suppliers of P. persimilis and A. cucumeris suggest re-introduction periods of 5-7 days 32.
is
as
Trials conducted in UK glasshouses by Syngenta Bioline demonstrated the importance of considering
eb
more appropriate end-points than mortality alone. Assessment at 5 and 12 DAT of populations of in-
th
on
troduced Phytoseiulus persimilis in bays treated with Dynamec 18EC at 4.5mg ai/L generally showed
de
slightly lower numbers of predatory mites in treated compared with untreated bays. However, the dif-
nt
ra
ferential toxicity of abamectin to the predatory and pest mite Tetranychus urticae and its dissipation
eg
from the foliar surface resulted in vastly superior predator to pest ratios in treated plots in addition to
tb
no
excellent control of the pest 33.
t
us
m
Conclusion: The majority of available and pertinent data support a shorter re-introduction period than
n
tio
16 days. This is recognised by commercial suppliers of biocontrol organisms.
ra
st
gi
Re
The persistence of harmful effects of foliar surface residues of abamectin on glasshouse crops is de-
n.
pendent on arthropod species, crop and light intensity. Therefore, Syngenta considers that recom-
io
lat
mendations on re-introduction periods are most appropriately determined at the Member State level
iso
on the basis of considerations of crops, species, region and season.

in
d
ea
er
Reaction RMS
tb
RMS can agree with the opinion of the notifier that recommendations on re-introduction periods should
no
be determined at the Member State level on the basis of considerations of crops, species, region and
ld
ou
season.
sh
d
an
ge
2.6.4 Effects on earthworms and other soil non-target macro-organisms

a
ck
pa
Earthworms
ta
da
Summary of toxicity data

n
io
Acute earthworm studies have been performed with abamectin, Vertimec 0.18 EC and metabolites
at
alu
[8,9-Z]-avermectin B1a (NOA 427011) and 8a-hydroxy-avermectin B1a (NOA 448112). A sub-lethal test
ev
EC
n
fa
to
ar
sp
m
31
Van de Veire M, Cornelis W and Tirry L (2001) Development of a laboratory test method to determine the duration of pesti-
or
cide-effects on predatory mites. Pesticides and Beneficial Organisms IOBC/wprs Bulletin Vol 24 (4) p61-66.
tf
32
Biobest website http:// 207.5.71.37/biobest/en/neven/result
en
33
GreatRex R (2004) personal communication cf. trials UK 04 005, 006, 007.
m
cu
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was performed with Vertimec 0.18 EC. The results of the studies are summarised in Table 2.6.4-1 and
t
of
2.6.4-2.
is
as
eb
th
Table 2.6.4-1. Summary of earthworm toxicity studies with (formulations of) abamectin
on
Test substance Species Soil type OM T Duration Criterion Value Value
product
e d
[%] [°C] [d] [mg/kg] [mg as/kg]
nt
abamectin Eisenia fetida artificial 10 25 28 14-d LC50 33
ra
abamectin Eisenia fetida artificial 10 25 28 14-d LC50 > 55
eg
Vertimec 0.18 EC Eisenia fetida artificial 10 20 14 LC50 > 1000 > 20
tb
Vertimec 0.18 EC Eisenia fetida artificial 10 20 56 NOEC ≥ 35 ≥ 0.72
tno
us
Table 2.6.4-2. Summary of earthworm toxicity studies with metabolites of abamectin
m
Test substance Species Soil type OM T Duration Criterion Value
n
tio
[%] [°C] [d] [mg/kg]
ra
NOA 427011 Eisenia fetida artificial 10 20 14 LC50 50
st
NOA 448112 Eisenia fetida artificial 10 20 14 LC50 321
gi
Re
n.
The two studies with abamectin were 28-day studies that were not performed according to OECD 207
io
lat
or equivalent guidelines. The mortality figures after 14 days have been used to estimate the LC50. Ac-
iso
tual concentrations were measued in the second study with abamectin. The results indicate that deg-
in
radation in artificial soil is slower than in natural soil with 62 - 72 % of nominal present after 28 days at
d
ea
25 °C. The toxicity of abamectin in the second study was less than expected on the basis of the first
er
tb
study where an LC50 of 33 mg/kg was found, and the LC50 of the [8,9-Z]-isomer of 50 mg/kg. Degrada-
no
tion and a delay in burrowing time may have caused differences in actual exposure between studies.
ld
ou
Abamectin caused a delay in burrowing time at levels of 23 mg/kg (nominal) and higher, a similar ef-
sh
fect was observed for the [8,9-Z]-isomer, where burrowing was delayed at 12 mg/kg and higher. The
d
an
acute study with Vertimec 0.18 EC was performed at lower concentrations of abamectin than the stud-
ge
ies with the active substance. It is therefore not possible to draw conclusions about a difference in tox-
a
ck
icity resulting from the formulation.

pa
ta
da
n
Risk assessment
io
at
Abamectin
alu
The acute risk assessment for earthworms is based on the highest initial PECS of 0.0145 mg/kg result-
ev
EC
ing from field and galsshouse application to lettuce or tomatoes (see Section B.8.3). With the lowest
n
LC50 of 33 mg/kg, the TER is 2276. This is higher than the trigger of 10 and an acute risk is not ex-
fa
to
pected.
ar
In view of the DT50 of 1 day and the maximum number of applications being five, an assessment of the
sp
m
sublethal risk is not considered necessary. Furthermore, when using the NOEC of ≥ 0.72 mg/kg and
or
the highest initial PECS, the TER is 50, indicating that the risk for earthworms is low.
tf
en
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t
of
Metabolites
is
as
For NOA 427011, no PECS was calculated as this metabolite was not identified in the soil biodegrada-
eb
tion studies. If, however, as a worst case the maximum initial PECS of abamectin is used for risk as-
th
on
sessment, the LC50 of 50 mg/kg leads to a TER of 3448, indicating a low risk for earthworms.
e d
The highest initial PECS of NOA 448112 is 0.0157 mg/kg, resulting from glasshouse application to to-
nt
ra
matoes (see Section B.8.3, Table B.8.3-5; calculated with Berkely-Madonna). Using the LC50 of 321
eg
mg/kg, the resulting TER is over 20000, indicating a low risk.
tb
no
For the other metabolites, NOA 448111, NOA 457464 and NOA 457465, no toxicity data are available.
t
us
In view of the LC50 for NOA 448112, it can be assumed that toxicity of these metabolites will also not
m
be higher than that of the parent. With PECS for these compound being lower than the PECS of NOA
n
tio
448112, a risk is not expected and further information is not considered necessary.
ra
st
gi
Other soil non-target macro-organisms
Re
n.
No information is supplied on the effects of abamectin on other soil macro-organisms. Further informa-
io
tion is not considered necessary. lat
iso
in
d
ea
er
2.6.5 Effects on soil micro-organisms

tb
no
Summary of toxicity data

ld
The effects of abamectin and metabolites 8a-hydroxy-avermectin B1a (NOA 448112) and [8,9-Z]-
ou
sh
avermectin B1a (NOA 427011) on soil micro-organisms have been studied in soil respiration and nitrifi-
d
cation tests. Abamectin had < 25 % effect on respiration and nitrification after 28 days at concentra-
an
ge
tions of 0.069 and 0.347 mg/kg, corresponding to 52 and 261 g as/ha assuming soil bulk density of
a
ck
1500 kg/m3 and 5 cm soil depth.

pa
Metabolite NOA 448112 was tested at 0.26 and 0.66 mg/kg. These test concentrations represent four
ta
da
and 10 times the expected concentration assuming a single application rate of abamectin of 300 g
n
io
as/ha and a metabolite formation rate of 15 %. This assumed application rate of 300 g as/ha is > 10
at
alu
times the proposed maximum single application rate of 21.6 g, and test concentrations are thus far
ev
above the expected concentrations in soil. Despite the high concentrations, < 25 % effect on respira-
EC
tion was observed, and < 25 % effect on nitrification was found at the 0.26 mg/kg. At 0.66 mg/kg, > 25
n
fa
% effect on nitrification was observed after 6 and 14 days, but effect was < 25 % after 28 days.
to
Metabolite NOA 427011 was also tested at high concentrations of 0.16 and 0.40 mg/kg. The effect on
ar
sp
respiration was < 25 % at both levels. The effect on nitrification was > 25 % after 6 and 14 days, but
m
< 25 % after 28 days.

or
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en
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t
of
is
Risk assessment
as
eb
Abamectin
th
The highest initial PECS of abamectin is 0.0145 mg/kg resulting from field application to lettuce or to-
on
matoes (see Section B.8.3). Less than 25 % effect was found at concentrations up to 0.347 mg/kg,
e d
nt
and an effect on soil microorganisms is not expected at the proposed use rates.
ra
eg
tb
Metabolites
no
For NOA 427011, no PECS was calculated as this metabolite was not identified in the soil biodegrada-
t
us
tion studies. If, however, as a worst case the maximum initial PECS of abamectin is used for risk as-
m
n
sessment, a low risk for microorganisms is expected since < 25 % effect was found at concentrations
tio
ra
up to 0.40 mg/kg.
st
gi
The highest initial PECS of NOA 448112 is 0.0157 mg/kg, resulting from glasshouse application to to-
Re
matoes (see Section B.8.3, Table B.8.3-5; calculated with Berkely-Madonna). A low risk for microor-
n.
io
ganisms is expected, as < 25 % effect was found at 0.66 mg/kg. lat
iso
For the other metabolites, NOA 448111, NOA 457464 and NOA 457465, no toxicity data are available.
in
In view of the results for NOA 448112, it can be assumed that toxicity of these metabolites will also not
d
ea
be higher than that of the parent. With PECS for these compound being lower than the PECS of NOA
er
448112, a risk is not expected and further information is not considered necessary.
tb
no
ld
ou
2.6.6 Effects on other non-target organisms (flora and fauna)

sh
The effect of Vertimec 0.18 on emergence and vegetative vigour of six plant species (maize, wild oat,
d
an
onion, sugar beet, oilseed rape and soybean) was determined at application rates of 78 to 2500 g
ge
a
product/ha. The highest dose is equivalent to two times the proposed maximum single application rate
ck
pa
of 21.6 g as/ha. No effect on emergence was observed for any of the tested species. Vegetative vig-
ta
our was not affected either except in soybean (Glycine max), where slight effects were observed at
da
1250 and 2500 g product/ha. According to Guidance Document on Terrestrial Ecotoxicicology, non-
n
io
at
target plants are "non-crop plants located outside the treated area." The tested plants are all crop spe-
alu
cies, but because tested species comprise monocotyledons and dicotyledons of different families, and
ev
slight effects were observed in only one species, further information is not considered necessary. A
EC
n
risk for non-target plants is not expected at the proposed maximum field application rate of 3 x 21.6 g
fa
to
as/ha.
ar
sp
m
or
2.6.7 Effects on biological methods of sewage treatment

tf
en
Emission of abamectin to sewage treatment plants may occur following the proposed use of Vertimec
m
0.18 EC in glasshouses. Based on the results of the activated sludge respiration test, with EC20, EC50
cu
do
and EC80 > 100 mg/L, no effect on biological methods of sewage treatment are expected.
is
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is
as
eb
th
on
e d
nt
ra
eg
tb
no
t
us
m
n
tio
ra
st
gi
Re
APPENDIX 1
n.
io
lat
iso
in
d
ea
er
tb
no
ld
ou
ABAMECTIN
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
PART 1: Standard terms and abbreviations

ev
EC
PART 2: Organisations and publications

n
fa
PART 3: Preparation (formulation) types and codes

to
ar
sp
m
or
tf
en
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140
cu
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t
of
Part 1 Standard terms and abbreviations
is
as
A ampere
eb
ACh acetylcholine
th
AChE acetylcholinesterase
on
ADI acceptable daily intake
ADP adenosine diphosphate
e d
AE acid equivalent
nt
AFID alkali flame-ionisation detector or detection
ra
eg
A/G albumin/globulin ratio
ai active ingredient
tb
ALD50 approximate median lethal dose, 50%
no
ALT alanine aminotransferase (SGPT)
t
us
AOEL acceptable operator exposure level
m
AMD automatic multiple development
n
ANOVA analysis of variance
tio
AP alkaline phosphatase
ra
approx approximate
st
gi
ARC anticipated residue contribution
Re
ARfD acute reference dose
n.
as active substance
io
AST aspartate aminotransferase (SGOT) lat
ASV air saturation value
iso
ATP adenosine triphosphate

in
d
BCF bioconcentration factor

ea
bfa body fluid assay

er
BOD biological oxygen demand

tb
bp boiling point
no
BSAF biota-sediment accumulation factor

ld
BSE bovine spongiform encephalopathie

ou
BSP bromosulfophthalein
sh
Bt bacillus thuringiensis
d
Bti bacillus thuringiensis israelensis

an
Btk bacillus thuringiensis kurstaki

ge
Btt bacillus thuringiensis tenebrionis

a
ck
BUN blood urea nitrogen

pa
bw body weight
ta
centi- (x 10-2)
da
c
°C degree Celsius (centigrade)
n
io
CA controlled atmosphere
at
CAD computer aided design

alu
CADDY computer aided dossier and data supply (an electronic dossier interchange and archiv-
ev
ing format)
EC
cd candela
n
CDA controlled drop(let) application

fa
cDNA complementary DNA

to
CEC cation exchange capacity

ar
cf confer, compare to
sp
CFU colony forming units

m
ChE cholinesterase
or
CI confidence interval
tf
en
CL confidence limits
m
cm centimetre
cu
CNS central nervous system

do
COD chemical oxygen demand

is
CPK creatinine phosphatase

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cv coefficient of variation
t
of
Cv ceiling value
is
CXL Codex Maximum Residue Limit (Codex MRL)
as
eb
d day
th
DES diethylstilboestrol
on
DFR dislodgeable foliar residue
d
DMSO dimethylsulfoxide
e
nt
DNA deoxyribonucleic Acid
ra
dna designated national authority
eg
DO dissolved oxygen
tb
DOC dissolved organic carbon
no
dpi days post inoculation
t
DRES dietary risk evaluation system
us
DT50 period required for 50 percent dissipation (define method of estimation)
m
DT90 period required for 90 percent dissipation (define method of estimation)
n
tio
dw dry weight
ra
DWQG drinking water quality guidelines
st
gi
ε decadic molar extinction coefficient
Re
EC50 median effective concentration
n.
ECD electron capture detector
io
ECU European currency unit lat
iso
ED50 median effective dose
EDI estimated daily intake
in
ELISA enzyme linked immunosorbent assay

d
ea
e-mail electronic mail

er
EMDI estimated maximum daily intake

tb
EPMA electron probe micro analysis

no
ERC environmentally relevant concentration

ERL extraneous residue limit
ld
ou
sh
F field
F0 parental generation
d
an
F1 filial generation, first

ge
F2 filial generation, second

a
FIA fluorescence immunoassay

ck
FID flame ionisation detector

pa
FOB functional observation battery

ta
fp freezing point
da
FPD flame photometric detector

n
FPLC fast protein liquid chromatography

io
at
alu
g gram
ev
G glasshouse
GAP good agricultural practice
EC
GC gas chromatography
n
fa
GC-EC gas chromatography with electron capture detector

to
GC-FID gas chromatography with flame ionisation detector

GC-MS gas chromatography-mass spectrometry
ar
sp
GC-MSD gas chromatography with mass-selective detection

GEP good experimental practice
m
or
GFP good field practice

tf
GGT gamma glutamyl transferase

en
GI gastro-intestinal
m
GIT gastro-intestinal tract

cu
GL guideline level
do
GLC gas liquid chromatography

is
GLP good laboratory practice

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GM geometric mean
t
of
GMO genetically modified organism
is
GMM genetically modified micro-organism
as
GPC gel-permeation chromatography
eb
GPPP good plant protection practice
th
GPS global positioning system
on
GSH glutathion
d
GV granulosevirus
e
nt
ra
h hour(s)
eg
H Henry’s Law constant (calculated as a unitless value) (see also K)
tb
ha hectare
no
Hb haemoglobin
t
HCG human chorionic gonadotropin
us
Hct haematocrit
m
HDT highest dose tested
n
tio
hL hectolitre
ra
HEED high-energy electron diffraction
st
HID helium ionisation detector
gi
HPAEC high performance anion exchange chromatography
Re
HPLC high pressure liquid chromatography or high performance liquid chromatography
n.
HPLC-MS high pressure liquid chromatography - mass spectrometry
io
HPPLC high pressure planar liquid chromatography lat
iso
HPTLC high performance thin layer chromatography
HRGC high resolution gas chromatography
in
HS Shannon-Weaver index
d
ea
Ht haematocrit
er
tb
I indoor
no
I50 inhibitory dose, 50%

IC50 median immobilisation concentration or median inhibitory concentration
ld
ICM integrated crop management

ou
ID ionisation detector
sh
IEDI international estimated daily intake

d
an
IGR insect growth regulator

im intramuscular
ge
inh inhalation
a
ck
ip intraperitoneal
pa
IPM integrated pest management

ta
IR infrared
da
ISBN international standard book number

n
ISSN international standard serial number

io
at
iv intravenous
alu
IVF in vitro fertilisation

ev
k kilo
EC
K Kelvin or Henry’s Law constant (in atmospheres per cubic meter per mole, see also H)
n
Kads adsorption constant

fa
Kdes apparent desorption coefficient

to
Koc organic carbon adsorption coefficient

ar
sp
Kom organic matter adsorption coefficient

kg kilogram
m
or
tf
L litre
en
LAN local area network

m
LASER light amplification by stimulated emission of radiation

cu
LBC loosely bound capacity

do
LC liquid chromatography
is
LC-MS liquid chromatography- mass spectrometry

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LC50 lethal concentration, median
t
of
LCA life cycle analysis
is
LCLo lethal concentration low
as
LC-MS-MS liquid chromatography with tandem mass spectrometry
eb
LD50 lethal dose, median; dosis letalis media
th
LDLo lethal dose low
on
LDH lactate dehydrogenase
d
LOAEC lowest observable adverse effect concentration
e
nt
LOAEL lowest observable adverse effect level
ra
LOD limit of detection
eg
LOEC lowest observable effect concentration
tb
LOEL lowest observable effect level
no
LOQ limit of quantification (determination)
t
LPLC low pressure liquid chromatography
us
LSC liquid scintillation counting or counter
m
LSD least squared denominator multiple range test
n
tio
LSS liquid scintillation spectrometry
ra
LT lethal threshold
st
gi
m metre
Re
M molar
n.
µm micrometer (micron)
io
MC moisture content lat
iso
MCH mean corpuscular haemoglobin
MCHC mean corpuscular haemoglobin concentration
in
MCV mean corpuscular volume

d
ea
MDL method detection limit

er
MFO mixed function oxidase

tb
µg microgram
no
mg milligram
MHC moisture holding capacity
ld
min minute(s)
ou
mL millilitre
sh
MLT median lethal time

d
an
MLD minimum lethal dose

mm millimetre
ge
mo month(s)
a
ck
mol Mole(s)
pa
MOS margin of safety

ta
mp melting point
da
MRE maximum residue expected

n
MRL maximum residue level or limit

io
at
mRNA messenger ribonucleic acid

alu
MS mass spectrometry
ev
MSDS material safety data sheet

MTD maximum tolerated dose
EC
n
n normal (defining isomeric configuration) or number of observations

fa
NAEL no adverse effect level

to
nd not detected
ar
sp
NEDI national estimated daily intake

NEL no effect level
m
or
NERL no effect residue level

tf
ng nanogram
en
nm nanometer
m
NMR nuclear magnetic resonance

cu
no number
do
NOAEC no observed adverse effect concentration

is
NOAEL no observed adverse effect level

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NOEC no observed effect concentration
t
of
NOED no observed effect dose
is
NOEL no observed effect level
as
NOIS notice of intent to suspend
eb
NPD nitrogen-phosphorus detector or detection
th
NPV nuclear polyhedrosis virus
on
NR not reported
d
NTE neurotoxic target esterase
e
nt
ra
OC organic carbon content
eg
OCR optical character recognition
tb
ODP ozone-depleting potential
no
ODS ozone-depleting substances
t
OM organic matter content
us
op organophosphorous pesticide
m
n
tio
Pa Pascal
ra
PAD pulsed amperometric detection
st
2-PAM 2-pralidoxime
gi
pc paper chromatography
Re
PC personal computer
n.
PCV haematocrit (packed corpuscular volume)
io
PEC predicted environmental concentration lat
iso
PECA predicted environmental concentration in air
PECS predicted environmental concentration in soil
in
PECSW predicted environmental concentration in surface water

d
ea
PECGW predicted environmental concentration in ground water

er
PED plasma-emissions-detector
tb
pH pH-value
no
PHED pesticide handler’s exposure data

PHI pre-harvest interval
ld
PIC prior informed consent

ou
pic phage inhibitory capacity

sh
PIXE proton induced X-ray emission

d
an
pKa negative logarithm (to the base 10) of the dissociation constant)
PNEC predicted no effect concentration
ge
po by mouth
a
ck
POW partition coefficient between n-octanol and water

pa
POP persistent organic pollutants

ta
ppb parts per billion (10-9)

da
PPE personal protective equipment

n
ppm parts per million (10-6)

io
at
ppp plant protection product

alu
ppq parts per quadrillion (10-24)

parts per trillion (10-12)
ev
ppt
PSP phenolsulfophthalein
EC
PrT prothrombin time

n
PRL practical residue limit

fa
PT prothrombin time
to
PTDI provisional tolerable daily intake

ar
sp
PTT partial thromboplastin time

m
or
QSAR quantitative structure-activity relationship

tf
en
r correlation coefficient
m
r2 coefficient of determination
cu
RBC red blood cell

do
REI restricted entry interval

is
Rf retardation factor
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en
m
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cu
s do
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RfD reference dose
t
of
RH relative humidity
is
RL50 median residual lifetime
as
RNA ribonucleic acid
eb
RP reversed phase
th
rpm rotations per minute
on
rRNA ribosomal ribonucleic acid
d
RRT relative retention time
e
nt
RSD relative standard deviation
ra
eg
s second
tb
SAC strong adsorption capacity
no
SAP serum alkaline phosphatase
t
SAR structure/activity relationship
us
SBLC shallow bed liquid chromatography
m
sc subcutaneous
n
tio
sce sister chromatid exchange
ra
SD standard deviation
st
se standard error
gi
SEM standard error of the mean
Re
SEP standard evaluation procedure
n.
SF safety factor
io
SFC supercritical fluid chromatography lat
iso
SFE supercritical fluid extraction
SIMS secondary ion mass spectroscopy
in
SOP standard operating procedures

d
ea
sp species (only after a generic name)

er
SPE solid phase extraction

tb
SPF specific pathogen free

no
spp subspecies
sq square
ld
SSD sulphur specific detector

ou
SSMS spark source mass spectrometry

sh
STEL short-term exposure limit

d
an
STMR supervised trials median residue

ge
t tonne (metric ton)

a
ck
t½ half-life (define method of estimation)

pa
T3 tri-iodothyroxine
ta
T4 thyroxin
da
TADI temporary acceptable daily intake

n
TBC tightly bound capacity

io
at
TCD thermal conductivity detector

alu
TCLo toxic concentration, low

ev
TID thermionic detector, alkali flame detector

TDLo toxic dose low
EC
TDR time domain reflectrometry

n
TER toxicity exposure ration

fa
TERI toxicity exposure ration for initial exposure

to
TERST toxicity exposure ration following repeated exposure

ar
sp
TERLT toxicity exposure ration following chronic exposure

tert tertiary (in a chemical name)
m
or
TEP typical end-use product

tf
TGGE temperature gradient gel electrophoresis

en
TIFF tag image file format

m
TLC thin layer chromatography

cu
Tlm median tolerance limit

do
TLV threshold limit value

is
TMDI theoretical maximum daily intake

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en
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TMRC theoretical maximum residue contribution
t
of
TMRL temporary maximum residue limit
is
TOC total organic carbon
as
Tremcard Transport emergency card
eb
tRNA transfer ribonucleic acid
th
TSH thyroid stimulating hormone (thyrotropin)
on
TWA time weighted average
e d
nt
UDS unscheduled DNA synthesis
ra
UF uncertainty factor (safety factor)
eg
ULV ultra low volume
tb
UV ultraviolet
no
t
v/v volume ratio (volume per volume)
us
m
WBC white blood cell
n
tio
wk week
ra
wt weight
st
w/v weight per volume
gi
ww wet weight
Re
w/w weight per weight
n.
io
XRFA X-ray fluorescence analysis lat
iso
yr year
in
d
ea
< less than

er
= less than or equal to

tb
> greater than

no
= greater than or equal to

ld
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
cu
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Part 2 Organisations and Publications
t
of
is
as
ACPA American Crop Protection Association
eb
ASTM American Society for Testing and Materials
th
BA Biological Abstracts (Philadelphia)
on
BART Beneficial Arthropod Registration Testing Group
e d
nt
CA Chemical Abstracts
ra
eg
CAB Centre for Agriculture and Biosciences International
CAC Codex Alimentarius Commission
tb
CAS Chemical Abstracts Service
no
CCFAC Codex Committee on Food Additives and Contaminants
t
us
CCGP Codex Committee on General Principles
m
CCPR Codex Committee on Pesticide Residues
n
CCRVDF Codex Committee on Residues of Veterinary Drugs in Food
tio
CE Council of Europe
ra
CIPAC Collaborative International Pesticides Analytical Council Ltd
st
gi
COREPER Comite des Representants Permanents
Re
n.
EC European Commission
io
ECB European Chemical Bureau lat
ECCA European Crop Care Association
iso
ECDIN Environmental Chemicals Data and Information Network of the European Communi-
in
ties
d
ECDIS European Environmental Chemicals Data and Information System

ea
ECE Economic Commission for Europe

er
ECETOC European Chemical Industry Ecology and Toxicology Centre

tb
ECLO Emergency Centre for Locust Operations

no
ECMWF European Centre for Medium Range Weather Forecasting

ld
ECPA European Crop Protection Association

ou
EDEXIM European Database on Export and Import of Dangerous Chemicals

sh
EHC (number) Environmental Health Criteria (number)

d
EINECS European Inventory of Existing Commercial Chemical Substances

an
ELINCS European List of New Chemical Substances

ge
EMIC Environmental Mutagens Information Centre

a
ck
EPA Environmental Protection Agency

pa
EPO European Patent Office

EPPO European and Mediterranean Plant Protection Organization
ta
da
ESCORT European Standard Characteristics of Beneficials Regulatory Testing

EU European Union
n
io
EUPHIDS European Pesticide Hazard Information and Decision Support System

at
EUROPOEM European Predictive Operator Exposure Model

alu
ev
FAO Food and Agriculture Organization of the UN

EC
FOCUS Forum for the Co-ordination of Pesticide Fate Models and their Use
FRAC Fungicide Resistance Action Committee
n
fa
to
GATT General Agreement on Tariffs and Trade

ar
GAW Global Atmosphere Watch

sp
GIFAP Groupement International des Associations Nationales de Fabricants de Produits

m
Agrochimiques (now known as GCPF)

or
GCOS Global Climate Observing System

tf
GCPF Global Crop Protection Federation (formerly known as GIFAP)

en
GEDD Global Environmental Data Directory

m
cu
GEMS Global Environmental Monitoring System

do
GIEWS Global Information and Early Warning System for Food and Agriculture
GRIN Germplasm Resources Information Network
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t
of
HRAC Herbicide Resistance Action Committee
is
as
IARC International Agency for Research on Cancer
eb
IATS International Academy of Toxicological Science
th
IBT Industrial Bio-Test Laboratories
on
ICBB International Commission of Bee Botany
d
ICBP International Council for Bird Preservation
e
nt
ICES International Council for the Exploration of the Seas
ra
ICPBR International Commission for Plant-Bee Relationships
eg
ILO International Labour Organization
tb
IMO International Maritime Organisation
no
IOBC International Organisation for Biological Control of Noxious Animals and Plants
t
IPCS International Programme on Chemical Safety
us
IRAC Insecticide Resistance Action Committee
m
IRC International Rice Commission
n
tio
ISCO International Soil Conservation Organization
ra
ISO International Organization for Standardization
st
IUPAC International Union of Pure and Applied Chemistry
gi
Re
JECFA FAO/WHO Joint Expert Committee on Food Additives
n.
JFCMP Joint FAO/WHO Food and Animal Feed Contamination Monitoring Programme
io
JMP Joint Meeting on Pesticides (WHO/FAO) lat
iso
JMPR Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the En-
vironment and the WHO Expert Group on Pesticide Residues (Joint Meeting on Pesti-
in
cide Residues)
d
ea
er
NATO North Atlantic Treaty Organisation

tb
NAFTA North American Free Trade Agreement

no
NCI National Cancer Institute (USA)

NCTR National Centre for Toxicological Research (USA)
ld
NGO non-governmental organisation

ou
NTP National Toxicology Programme (USA)

sh
d
an
OECD Organisation for Economic Co-operation and Development

OLIS On-line Information Service of OECD
ge
a
ck
PAN Pesticide Action Network

pa
ta
RNN Re-registration Notification Network

da
RTECS Registry of Toxic Effects of Chemical Substances (USA)

n
io
at
SCPH Standing Committee on Plant Health

alu
SETAC Society of Environmental Toxicology and Chemistry

ev
SI Systeme International d'Unites

SITC Standard International Trade Classification
EC
n
TOXLINE Toxicology Information On-line

fa
to
UN United Nations
ar
sp
UNEP United Nations Environment Programme

m
or
WCDP World Climate Data Programme

tf
WCP World Climate Programme

en
WCRP World Climate Research Programme

m
WFP World Food Programme

cu
WHO World Health Organization

do
WTO World Trade Organization

is
WWF World Wildlife Fund

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Part 3 Preparation (formulation) types and codes
t
of
is
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eb
Code Description Definition
th
AB Grain bait Special forms of bait.
on
e d
AE Aerosol dispenser A container-held preparation which is dispersed gener-
nt
ra
ally by a propellant as fine droplets/particles upon actua-
eg
tion of a valve.
tb
no
AL Other liquids to be applied Self defining.
t
us
undiluted
m
n
tio
BB Block blits Special forms of bait.
ra
st
BR Briquette Solid block designed for controlled release of active in-
gi
Re
gredient into water.
n.
io
CB Bait concentrate A solid or liquid intended for dilution before use as a bait.
lat
iso
CG Encapsulated granule A granule with a protective or release controlling coating.

in
d
CS Capsule suspension A stable suspension of capsules in a fluid normally in-

ea
er
tended for dilution with water before use.

tb
no
DC Dispersible concentrate A liquid homogeneous preparation to be applied as a

ld
solid dispersion after dilution in water.

ou
sh
DP Dustable powder A free-flowing powder suitable for dusting.

d
an
DS Powder for dry seed treat- A powder for application in the dry state directly to seed.
ge
a
ment
ck
pa
EC Emulsifiable concentrate A liquid, homogenous preparation to be applied as an

ta
da
emulsion after dilution in water.

n
io
ED Electrochargeable liquid Special liquid preparation for electrostatic (electrody-

at
alu
namic)spraying
ev
EC
EO Emulsion. water in oil A fluid. heterogeneous preparation consisting of a dis-

n
persion of fine globules of pesticide in water in a continu-

fa
to
ous organic liquid phase.

ar
sp
ES Emulsion for seed treatment A stable emulsion for application to the seed either di-
m
rectly or after dilution.

or
tf
en
EW Emulsion. Oil in water A fluid, heterogeneous preparation consisting of a dis-

m
persion of fine globules of pesticide in an organic liquid in

cu
do
a continuous water phase.

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FD Smoke tin Special form of smoke generator.
eb
FG Fine granule A granule in the particle size range from 300 to 2500 :.
th
on
FK Smoke candle A smoke generator in the form of a candle.
e d
nt
FP Smoke cartridge Special form of smoke generator.
ra
eg
FR Smoke rodlet Special form of smoke generator.
tb
no
FS Flowable concentrate for A stable suspension for application to the seed either
t
us
seed treatment directly or seed treatment after dilution.
m
n
tio
FT Smoke tablet Special form of smoke generator.
ra
st
FU Smoke generator A combustible preparation generally solid, which upon
gi
Re
ignition releases the active substances in the form of a
n.
smoke.
io
lat
iso
FW Smoke pellet Special form of smoke generator.

in
GA Gas A gas packed in pressure bottle or pressure tank.

d
ea
er
GB Granular bait Special forms of bait.

tb
no
GE Gas generating product A preparation which generates a gas by chemical reac-

ld
tion.
ou
sh
GG Macrogranule A granule in the particle size range from 2000 to 6000 :.

d
an
GP Flo-dust Very fine dustable powder for pneumatic application in

ge
a
glasshouses.
ck
pa
GR Hot fogging concentrate A free-flowing solid preparation of a defined granule size

ta
da
range ready for use.

n
io
GS Cold fogging concentrate Very viscous preparation based on oil or fat.

at
alu
ev
HN Hot fogging concentrate A preparation suitable for application by fogging equip-

EC
ment either directly or after dilution.

n
fa
KN Cold fogging concentrate A preparation suitable for application by cold fogging

to
equipment, either directly or after dilution.

ar
sp
LA Lacquer A solvent based film-forming preparation.

m
or
tf
LS Solution for seed treatment A solution for application to the seed either directly or
en
after dilution.
m
cu
do
MG Microgranule A granule in the particle ske range from 100 to 600

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OF Oil miscible flowable (=oil A stable suspension of concentrate fluid intended for di-
eb
active substances in a misci- lution in an organic liquid before use.
th
ble suspension)
on
e d
OL Oil miscible liquid A liquid, homogenous preparation to be applied as a ho-
nt
ra
mogenous liquid after dilution in an organic liquid.
eg
tb
OP Oil dispersible powder A powder preparation to be applied as a suspension after
no
dispersion in an organic liquid.
t
us
m
PA Paste A water based film forming preparation.
n
tio
PB Plate bait Special forms of bait.
ra
st
gi
PC Gel or paste concentrate A solid preparation to be applied as a gel or a paste after
Re
dilution with water.
n.
io
PR Plant rodlet lat
A small rodlet, usually a few centimetres in length and a
iso
few millimetres in diameter containing active substance.

in
d
PS Seed coated with a pesticide Self defining.

ea
er
RB Bait (ready for use) A preparation designed to attract and be eaten by the
tb
no
target species.
ld
ou
SB Scrap bait Special forms of bait.

sh
SC Suspension (= flowable con- A stable suspension of active substance(s) in a fluid in-

d
an
centrate) tended for dilution with water before use

ge
a
ck
SE Suspo-emulsion A fluid. heterogeneous preparation consisting of a stable

pa
dispersion of active substance(s) in the form of solid par-

ta
da
ticles.
n
io
SG Water soluble granules A preparation consisting of granules to be applied as a

at
alu
true solution of active substance after dissolution in water

ev
but many contain insoluble inert ingredients.

EC
n
SL Soluble concentrate A liquid homogenous preparation to be applied as a true

fa
to
solution of active substance after dissolution in water but

ar
many contain insoluble inert ingredients.

sp
m
SO Spreading oil A preparation designed to form a surface layer on appli-

or
tf
cation to water.
en
m
cu
do
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SP Water soluble powder A powder preparation to be applied as a true solution of
eb
the active substance after solution in water but which
th
may contain insoluble inert ingredients.
on
e d
SS Water soluble powder for A powder to be dissolved in water before application to
nt
ra
seed treatment the seed.
eg
tb
SU Ultra low volume (ULV) sus- A suspension ready for use through ULV equipment.
no
pension
t
us
m
TB Tablet Solid preparation in the form of small flat plates for disso-
n
tio
lution in water.
ra
st
TP tracking powder A rodenticidal contact preparation in powder form.
gi
Re
UL Ultra low volume (ULV) liquid A homogenous liquid ready for use through ULV equip-
n.
io
ment. lat
iso
VP Vapour releasing product A preparation containing one or more volatile ingredients,

in
the vapours of which are released into the air. Evapora-

d
ea
tion rate normally is controlled by using suitable prepara-

er
tb
tions and/or dispensers.

no
WG Water dispersible A preparation granule consisting of granules to be ap-

ld
ou
plied after disintegration and dispersion in water.

sh
d
WP Wettable powder A powder preparation to be applied as a suspension after

an
ge
dispersion in water.
a
ck
WS Water dispersible powder for A powder to be dispersed at high concentration in water

pa
slurry seed treatment before application as a slurry to the seed.

ta
da
XX Others
n
io
at
alu
ev
EC
n
fa
to
ar
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or
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153
tb
er
ea
d
in APPENDIX 2
ABAMECTIN
iso
lat
io
n.
Re
gi
st
ra
tio
n
m
us
t no
tb
SPECIFIC TERMS AND ABBREVIATIONS

eg
ra
nt
ed
on
th
eb
as
is
of
t hi
s do
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m
en
t.
t.
en
m
154
cu
s do
hi
a absolute organ weight
t
of
AAP Algal Assay Procedure medium
is
as
aerob aerobic test conditions
eb
a-GT alpha-glutamyl-transferase
th
on
ALAT alanine aminotransferase
e d
ALP alkaline phosphatase
nt
ra
amu atomic mass units
eg
anaer anaerobic test conditions
tb
no
AR applied radioactivity
t
us
ASAT aspartate aminotransferase
m
ASTM American Society for Testing and Materials
n
tio
ra
st
B bacteria
gi
Re
biodeg biodegradation
n.
io
lat
Chr. ab. chromosome aberrations
iso
CMC carboxymethylcellulose
in
d
CoE Council of Europe

ea
er
crit. criterion
tb
no
d decreased, but not statistically significantly

ld
ou
dc statistically significantly decreased

sh
DFI Daily Food Intake

d
an
DMF dimethylformamide
ge
DO Dissolved Oxygen
a
ck
pa
dr dose-related
ta
DWI Daily Water Intake

da
n
io
at
E total effect of mortality and fecundity/parasitic capacity, used in arthropod toxicity

alu
tests
ev
E. coli Escherichia coli

EC
equal used when the values given by the notifier are expressed in mg/kg bw/day.
n
fa
equivalent used when values given by the notifier are only expressed in mg/kg food, not in mg/kg
to
ar
bw/day, as species-dependent factor is used to translate these data to mg/kg bw/day.

sp
ETE Estimated Theoretical Exposure

m
or
tf
en
GCP good clinical practice

m
cu
GIDH glutamic-acid dehydrogenase

do
GOT glutamic-oxalacetic transaminase

is
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GPT glutamic-pyruvic transaminase
t
of
is
as
HDL high density lipoproteins
eb
HPRT hypoxanthine- guanine phosphoribosyl transferase
th
on
e d
i increased, but not statistically significantly
nt
ra
ic statistically significantly increased
eg
tb
no
MC moisture content in soil (v/v)
t
us
Mc mammalian cells
m
MWHC maximum water holding capacity (soils)
n
tio
ra
st
n/a not applicable
gi
Re
n.d. not detected
n.
n.r. not reported
io
lat
ns not significant
iso
in
d
o.m. organic matter

ea
er
tb
PEC Predicted Environmental Concentration

no
PEG polyethylene glycol

ld
ou
pF moisture tension (soil) in [log cmwater column]

sh
PIEC Predicted Initial Environmental Concentration

d
an
pointmut. pointmutations
ge
a
ck
pa
r relative organ weight

ta
r.a. radioactivity
da
res. result
n
io
at
Ri Reliability Index, referring to the intrinsic reliability of a test with respect to the
alu
quality of the study

ev
EC
S. typh. Salmonella typhimurium

n
fa
SPE Solid Phase Extraction

to
ar
Sub. Substance
sp
m
or
T temperature
tf
en
TWA time weighted average

m
cu
TWAEC time weighted average environmental concentration

do
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wat/sed water/sediment systeem
t
of
w/w weight per weight
is
as
eb
- negative
th
on
+ positive
e d
nt
ra
-act. without activation
eg
+act. with activation
tb
no
t
us
%v/v the percentage expressed by volume
m
%w/w the percentage expressed by weight
n
tio
ra
st
gi
Re
n.
io
lat
iso
in
d
ea
er
tb
no
ld
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
cu
do
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Mon Feb 05 03:52:00 CET 2018

EC
ev
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at
io
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age
an
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157
tb
er
ea
d
in
APPENDIX 3
ABAMECTIN
iso
lat
io
n.
LIST OF END-POINTS
Re
gi
st
ra
tio
n
m
us
t no
tb
eg
ra
nt
ed
on
th
eb
as
is
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158
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t
of
Chapter 2.1 Identity, Physical and Chemical Properties, Details of Uses, Further Information
is
as
Active substance (ISO Common Name) abamectin (consisting of a mixture of 80% butyl
eb
(B1a) and 20% isopropyl (B1b) isomers)
th
Function (e.g. fungicide) insecticide, acaricide
on
e d
nt
ra
Rapporteur Member State The Netherlands
eg
tb
no
Identity (Annex IIA, point 1)
t
us
Chemical name (IUPAC) Avermectin B1a
m
(10E,14E,16E,22Z)-
n
(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-6'-
tio
[(S)-sec-butyl]-21,24-dihydroxy-5',11,13,22-
ra
tetramethyl-2-oxo-3,7,19-
st
trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-
gi
Re
10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-
pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-
n.
io
methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-
lat
arabino-hexopyranoside
iso
in
Avermectin B1b
d
(10E,14E,16E,22Z)-
ea
(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-
er
21,24-dihydroxy-6'-isopropyl-5',11,13,22-
tb
tetramethyl-2-oxo-3,7,19-
no
trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-
ld
10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-
ou
pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-
sh
methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-
d
an
arabino-hexopyranoside
ge
Chemical name (CA) abamectin: avermectin B1

a
ck
avermectin B1a:
pa
5-O-demethyl-avermectin A1a
ta
da
avermectin B1b:
5-O-demethyl-25-de(1- methylpropyl)-25-(1-
n
io
methylethyl)-avermectin A1a
at
alu
CIPAC No 495 (abamectin)

ev
CAS No 71751-41-2 (abamectin)

EC
65195-55-3 (avermectin B1a)

n
fa
65195-56-4 (avermectin B1b)

to
ar
EEC No (EINECS or ELINCS) 265-610-3 (avermectin B1a)

sp
265-611-9 (avermectin B1b)

m
or
FAO Specification (including year of publica- not applicable

tf
tion)
en
m
Minimum purity of the active substance as Technical active substance contains:

cu
manufactured (g/kg)
do
Min. 850 g/kg abamectin (sum of avermectin B1a

and avermectin B1b)
is
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159
cu
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t
Min. 800 g/kg avermectin B1a
of
Max. 200 g/kg avermectin B1b.
is
as
Identity of relevant impurities (of toxicological, Based on environmental and (eco)toxicological in-
eb
environmental and/or other significance) in the formation, there are no relevant impurities
th
active substance as manufactured (g/kg)
on
Molecular formula C48H72O14 (avermectin B1a)
e d
C47H70O14 (avermectin B1b)
nt
ra
Molecular mass 873.1 (avermectin B1a)
eg
tb
859.1 (avermectin B1b)
no
Structural formula
t
us
m
n
tio
ra
st
gi
Re
n.
io
lat
iso
in
d
ea
er
tb
no
Physical-chemical properties (Annex IIA, point 2)

ld
ou
Melting point (state purity) 161.8-169.4 ºC (chemical purity 96.7%)

sh
Boiling point (state purity) Not determined, due to thermal decomposition dur-
d
an
ing melting of abamectin.

ge
Temperature of decomposition thermal decomposition during melting of abamectin.

a
ck
Appearance (state purity) white powder (chemical purity 96.7%)

pa
ta
Relative density (state purity) 1.18 (chemical purity 96.7%)

da
Surface tension 52.4 mN/m

n
io
< 3.7 * 10-6 Pa (at 25 ºC)

at
Vapour pressure (in Pa, state temperature)

alu
Henry’s law constant (Pa m3 mol-1) ≤ 2.7 * 10-3 Pa m3 mol-1

ev
EC
Solubility in water (g/L or mg/L, state pH and 1.21 ± 0.15 mg/L; pH 7.57 (25 ºC)
temperature)
n
fa
Solubility in organic solvents (in g/L or mg/L, acetone(25 ºC): 72 g/L

to
state temperature)
ar
dichloromethane (25 ºC): 470 g/L

sp
ethyl acetate (25 ºC): 160 g/L

m
or
hexane (25 ºC): 0.110 g/L

tf
en
methanol (25 ºC): 13 g/L

m
cu
octanol (25 ºC): 83 g/L

do
toluene (25 ºC): 23 g/L

is
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160
cu
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t
Partition coefficient (log POW, state pH and 4.4 ± 0.3; pH 7.2 ±0 .1 (in aqueous phase), 20 ºC
of
temperature)
is
as
Hydrolytic stability (DT50, state pH and tem- avermectin B1a:
eb
perature)
pH 4, 5 and 7, 20 ºC: no hydrolysis
th
on
pH 9, 20 ºC: DT50 380 d
e d
Dissociation constant no dissociation in the pH-range from 1 to 12
nt
ra
UV / VIS absorption (max.) (if absorption >290 no absorption maximum observed between 280 and
eg
nm state ε at wavelength) 750 nm
tb
no
Photostability (DT50, aqueous, sunlight, state avermectin B1a:
pH)
t
us
DT50: 2 d (1.5 sunlight days at 30-50 ºN, pH 7)
m
Quantum yield of direct phototransformation in 0.0347 (summer)
n
tio
water at Σ >290 nm
ra
Flammability not highly flammable
st
gi
Re
Explosive properties not thermally, shock or friction sensitive
n.
io
lat
iso
Classification and proposed labelling (Annex IIA, point 10)

in
with regard to physical and chemical data No classification is proposed

d
ea
er
tb
no
ld
ou
sh
d
an
ge
a
ck
pa
ta
da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
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do
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s do
thi
of
sis
List of representative uses evaluated (abamectin)* e ba
th
on
Crop and/ Member Product F Pests or d
tePHI Remarks:
or State name G Group of
Application rate per treatmentgr
an (days)
Formulation Application
situation or or pests e
o tb
Country I controlled
tn
us
m
Type Conc. method growth number interval kg as/hL ionwater kg as/ha
t
of as kind stage & min between t ra L/ha
s
(a) (b) (c)
(d-f) (i) (f-h) season max applications e
min
gi max min max
(l) (m)
(j) (k) (min) on

.R min max
i
o lat
is
in
Citrus EU Vertimec F Phyllocnistis EC 18 g/L 1 -a3d 7 0.00072– 1500- 0.0216 10
citrella r e 0.00135 3000
018 EC e
Panonychus
citri o tb
n
Tetranychus ld
urticae ou
Lettuce EU Vertimec F Liriomyza EC 18 g/L sh 1-3 7 0.0018 1000 0.018 7
d
018 EC
sp.
e an
Lettuce EU Vertimec G Liriomyza EC k agg/L
18 1-4 7 0.0009 1000 0.009 14
sp. c
018 EC pa
ta
Tomatoes EU Vertimec F Tetranychusda EC 18 g/L 1-3 7 0.0009 – 1200- 0.0216 3
urticae on 0.0018 2500
018 EC i
at
Liriomyza
u
a l
sp.
Tomatoes EU Vertimec G ev Tetranychus EC 18 g/L 1-5 7 0.0009 – 1200- 0.0216 3
018 EC EC urticae 0.0018 2500
f an Liriomyza
sp.
r to
a
Remarks: * sp
r m Uses for which risk assessment could not been concluded due to lack of essential (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between
fo data are marked grey the plants - type of equipment used must be indicated
e nt(a) For crops, the EU and Codex classifications (both) should be used; where relevant, (i) g/kg or g/l
the use situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants,
um
d oc (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on
is
: Th
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Mon
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en
162
s do
thi
of
s is
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds season at time of application ba
e under practical
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) th
The minimum and maximum number of application possible
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 conditions of use must be provided
o n
(f) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (l) PHI - minimum pre-harvest interval
e d
(g) All abbreviations used must be explained (m) t
Remarks may include: Extent of use/economic
n importance/restrictions
ra
eg
otb
tn
us
m
n
tio
is tra
g
Re
n.
io
lat
iso
in
ead
er
tb
no
d
oul
sh
and
ge
cka
pa
ta
da
n
tio
al ua
ev
EC
n
fa
rto
s pa
o rm
tf
en
um
doc
is
: Th
I NG
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AR
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Mon
t.
en
m
163
cu
s do
hi
t
of
Chapter 2.2 – Methods of Analysis
is
as
Analytical methods for the active substance (Annex IIA, point 4.1)
eb
Technical as (principle of method) avermectin B1a, avermectin B1b:
th
HPLC-UV at 254 nm
on
d
Impurities in technical as (principle of method) HPLC-UV at 254 nm
e
nt
GC-FID
ra
eg
Plant protection product (principle of method) avermectin B1a, avermectin B1b:
tb
HPLC-UV at 254 nm
no
t
us
Analytical methods for residues (Annex IIA, point 4.2)
m
n
tio
Food/feed of plant origin (principle of method HPLC-MS/MS method REM 198.02 with separate
and LOQ for methods for monitoring purposes) quantification of avermectin B1a, avermectin B1a
ra
st
8,9-Z isomer, and avermectin B1b.
gi
Re
LOQ 0.002 mg/kg for tomato, orange and cotton
seed.
n.
io
LOQ 0.01 mg/kg for green hops.
lat
iso
in
Food/feed of animal origin (principle of method No methods required. However a method was
d
and LOQ for methods for monitoring purposes) submitted (see also body fluids and tissues)
ea
er
tb
no
Soil (principle of method and LOQ) HPLC-MS/MS after extraction with acetoni-
trile/water and clean-up on HLB SPE columns.
ld
ou
Method validated on two soils.

sh
LOQ 0.5 µg/kg for individual compounds µg/kg

d
(avermectin B1a, avermectin B1b, [8,9-Z]-

an
avermectin B1a , 8a-oxo-avermectin B1a, 8a-

ge
hydroxy-avermectin B1a, 4,8a-dihydroxy-avermectin

a
ck
B1a and 4-hydroxy-8a-oxo-avermectin B1a)

pa
ta
da
Water (principle of method and LOQ) Determination by LC-MS/MS after dilution with ace-
n
tonitrile and clean-up on HLB SPE columns.

io
Method validated on river water, ground water and

at
drinking water.
alu
ev
LOQ for individual compounds 0.05 µg/L (avermec-

EC
tin B1a, avermectin B1b, [8,9-Z]-avermectin B1a,

4"-oxo-avermectin B1a, 3"-demethyl-avermectin
n
fa
B1a)
to
ar
sp
Air (principle of method and LOQ) Determination by HPLC-UV (243 nm) after extrac-
m
tion with methanol. Method validated at spiking lev-

or
els 0.1 and 10 µg/m3.

tf
en
LOQ for individual compounds 0.1 µg/m3 (avermec-

m
tin B1a, avermectin B1b)

cu
do
is
Body fluids and tissues (principle of method A method in (whole) blood is still required because
Th
:
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Mon Feb 05 03:52:00 CET 2018

t.
en
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164
cu
s do
hi
t
and LOQ) abamectin is classified as very toxic.
of
HPLC-MS/MS method REM 198.02 with separate
is
as
quantification of avermectin B1a, avermectin B1a
eb
8,9-Z isomer, and avermectin B1b.
th
LOQ 0.002 mg/kg for meat
on
e d
nt
ra
Chapter 2.3 – Impact on Human and Animal Health
eg
tb
Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)
no
Rate and extent of absorption: Max. concentration in blood within 4-8 h after ad-
t
us
ministration. Approximately 86% of oral dose is ab-
m
sorbed
n
tio
Distribution: Distributed throughout all major organs and tissues
ra
Potential for accumulation: No potential for accumulation upon repeated oral
st
gi
administration
Re
Rate and extent of excretion: Rapidly eliminated, almost exclusively via non-
n.
biliary excretion with the faeces
io
lat
Metabolism in animals Major pathways for biotransformation include de-
iso
methylation, hydroxylation, cleavage of the olean-

in
drosyl raing and oxidation reactions

d
ea
Toxicologically significant compounds (ani- Parent and 8,9-Z isomer of avermectin B1a (photo-
er
mals, plants and environment) degradation product)

tb
no
ld
Acute toxicity (Annex IIA, point 5.2)

ou
Rat LD50 oral oil vehicle: 8.7 mg/kg bw (m), 12.8 mg/kg bw (f)
sh
d
aqueous vehicle: 232 mg/kg bw (m), 214 mg/kg bw

an
(f)
ge
a
Rat LD50 dermal > 330mg/kg bw; (rabbit, > 2000 mg/kg bw)
ck
pa
Rat LC50 inhalation >0.051 mg/L (m), >0.034 mg/L and <0.051 mg/L (f)
ta
Skin irritation Not irritating

da
n
Eye irritation Not irritating

io
at
Skin sensitisation (test method used and re- Non-sensitizing (GPMT)

alu
sult)
ev
EC
Short-term toxicity (Annex IIA, point 5.3)

n
fa
to
Target / critical effect Tremors,ataxia and mydriasis (dog)

ar
Lowest relevant oral NOAEL / NOEL 0.25 mg/kg bw/day (18 and 53 week dog)
sp
m
Lowest relevant dermal NOAEL / NOEL No data

or
tf
Lowest relevant inhalation NOAEL / NOEL No data

en
m
cu
Genotoxicity (Annex IIA, point 5.4) No genotoxic potential

do
is
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s do
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t
Long-term toxicity and carcinogenicity (Annex IIA, point 5.5)
of
is
Target/critical effect Rat: increased mortality (m), tremors
as
Mouse: increased mortality (m), extramedullary
eb
hematopoiesis in the spleen (m), reduced bw gain
th
Lowest relevant NOAEL / NOEL 1.5 mg/kg bw/day (104 weeks, rat)
on
d
Carcinogenicity No carcinogenic potential
e
nt
ra
eg
Reproductive toxicity (Annex IIA, point 5.6)
tb
no
Reproduction target / critical effect Decreased bw gain during lactation (P), increased
mating time, decreased number of males and fe-
t
us
males mating, increased duration of cohabitation,
m
increased pup mortality, retarded pup growth, total
n
litter loss, decreased lactation index, retinal anom-
tio
aly
ra
st
Lowest relevant reproductive NOAEL / NOEL 0.12 mg/kg bw/day
gi
Re
Developmental target / critical effect Cleft palate, decreased fetal weight (rat, in the ab-
n.
sence of maternal toxicity) (abamectin)
io
lat
Cleft palate, omphalocele, clubbed fore-feet and
iso
delayed ossification (rabbit, at maternally toxic

dose) (abamectin)
in
Exencephaly, cleft palate, delayed ossification (CF-

d
ea
1 mouse) (8,9-Z isomer)

er
Lowest relevant developmental NOAEL / 0.8 mg/kg bw/day (rat, abamectin); 0.015 mg/kg
tb
NOEL bw/day (CF-1 mouse, 8,9-Z isomer)

no
ld
ou
Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)

sh
d
No study performed. No histopathological changes

an
in central or peripheral nervous systems, and

ge
abamectin does not belong to a class of chemistry

a
known to induce delayed neurotoxicity.

ck
pa
ta
da
Other toxicological studies (Annex IIA, point 5.8)

n
• Toxicity of the 8,9-Z isomer of avermectin B1a

io
at
is comparable to abamectin.
alu
• P-glycoprotein deficient animals (CF-1 mouse,

ev
neonatal rat) are more sensitive to abamectin

EC
n
fa
Medical data (Annex IIA, point 5.9)

to
No adverse health effects from manufacturing

ar
sp
Humans show low susceptibility to abamectin

m
or
Severely poisoned patients showed an uneventful

tf
recovery from typical symptoms of avermectin toxic-

en
ity
m
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t
Summary (Annex IIA, point 5.10) Value Study Safety factor
of
is
ADI 0.0012 mg/kg 2-generation 100
as
bw/day study with rats
eb
(abamectin)
th
10
teratogenicity
on
studies with CF-
e d
1 mice (8,9-Z
nt
isomer)
ra
eg
AOEL 0.0012 mg/kg 2-generation 100
tb
bw/day (0.084 study with rats
no
mg a.s./day) (abamectin)
t
10
us
teratogenicity
m
study with CF-1
n
mice (8,9-Z
tio
isomer)
ra
st
ARfD (acute reference dose) 0.005 mg/kg 18 week study 100
gi
bw/day dog (abamectin)
Re
n.
io
0.0015 mg/kg lat teratogenicity
10
iso
bw/day study CF-1

mouse (8,9-Z
in
isomer)
d
ea
er
tb
Dermal absorption (Annex IIIA, point 7.3)

no
<1% of applied dose (monkey)

ld
ou
sh
Acceptable exposure scenarios (including method of calculation)

d
an
Operator Acceptable for proposed uses, except for manual

ge
upward spraying on tomatoes in greenhouses.

a
However, this application is acceptable if PPE is

ck
pa
used (DE and UK models).

ta
Workers Acceptable for proposed uses (DFR and Dutch

da
models)
n
io
Bystanders Acceptable for proposed uses (EUROPOEM II 2002

at
model)
alu
ev
EC

n
with regard to toxicological data Symbol : T+

fa
to
Risk phrase : R26, R28, R60/R62, R61/R63

ar
sp
Safety phrase : S36/S37, S38, S45, S53

m
or
tf
en
m
cu
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167
cu
s do
hi
Chapter 2.4 – Residues
t
of
is
as
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
eb
th
Plant groups covered fruit (citrus, tomato)
on
leafy crops (celery)
e d
pulses/oilseeds (cotton)
nt
ra
Rotational crops leafy crop (lettuce)
eg
tb
roots and tubers (carrot, turnip)
no
cereal (sorghum)
t
us
Plant residue definition for monitoring Sum of avermectin B1a, avermectin B1a 8,9-Z iso-
m
mer, and avermectin B1b, expressed as avermectin
n
tio
B1a
ra
Plant residue definition for risk assessment Sum of avermectin B1a, avermectin B1a 8,9-Z iso-
st
gi
mer, and avermectin B1b, expressed as avermectin
Re
B1a
n.
Conversion factor (monitoring to risk assess- not applicable
io
ment) lat
iso
in
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
d
ea
Animals covered Lactating goat

er
tb
Animal residue definition for monitoring Not necessary

no
Animal residue definition for risk assessment Not necessary

ld
ou
Conversion factor (monitoring to risk assess- Not applicable

sh
ment)
d
an
Metabolism in rat and ruminant similar (yes/no) Not applicable

ge
Fat soluble residue: (yes/no) Not applicable

a
ck
pa
ta
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
da
low levels of residues present, which constitute no

n
io
consumer
at
alu
ev
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)
EC
commodities with high water content 3 years

n
fa
commodities with high water and high acid data required

to
content
ar
sp
m
or
tf
en
m
cu
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is
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cu
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s
thi
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
of
is
Intakes by livestock ≥ 0.1 mg/kg diet/day: Ruminant: Poultry: Pig:
as
no no no
eb
Muscle Not applicable
th
on
Liver Not applicable
d
e
Kidney Not applicable
nt
ra
Fat Not applicable
eg
tb
Milk Not applicable
no
Eggs Not applicable
t
us
m
n
Summary of critical residues data (Annex IIA, point 6.3, Annex IIIA, point 8.2)
tio
ra
Crop Northern or Trials results relevant to the critical GAP Rec- MRL STMR (b)
st
Mediterra- (a) (mg/kg) ommen- (mg/kg) (mg/kg)
gi
nean Re- dation
Re
gion /comme
n.
nts
io
lat
Citrus Southern orange: 3x <0.002, 4x 0.007 (provisional) 0.01 0.006
iso
EU
mandarin: 2x <0.002, 2x 0.006, 0.007 (provi- (provi-
in
(provisional) sional) sional)

d
ea
To- Northern 2x <0.002, 2x 0.008, 0.011, 0.012, 0.014, 0.05 0.0115

er
mato EU (glass- 0.016, 0.017, and 0.022

tb
house)
no
ld
Let- Northern 0.022 and 0.10 not possi- not pos-

ou
tuce EU (glass- ble sible

sh
house) (c)
d
an
Southern 0.007, 0.010 and 0.013 not possi- not pos-

EU (field) ble sible
ge
a
(a) Numbers of trials in which particular residue levels were reported e.g. 3 x <0.01, 1 x 0.01, 6 x 0.02, 1 x 0.04, 1 x 0.08, 2 x 0.1,
ck
2 x 0.15, 1 x 0.17
pa
(b) Supervised Trials Median Residue i.e. the median residue level estimated on the basis of supervised trials relating to the criti-
cal GAP
ta
da
(c) critical GAP on lettuce is in greenhouses application in Northern Europe, since the decrease of abamectine occurs through
photolytic breakdown and is lowest in greenhouses/Northern zones.
n
io
at
Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
alu
ev
ADI 0.0012 mg/kg bw/day

EC
TMDI (% ADI) 20% (EU); 6.2% (NL general); 9.1% (NL children)
n
fa
IEDI (% ADI) Not applicable

to
Factors included in IEDI Not applicable

ar
sp
ARfD 0.002 mg/kg bw

m
or
Acute exposure (% ARfD) ≤30% (NL general); ≤63% (NL children); ≤21% (UK
tf
adults); ≤77% (UK toddlers)

en
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t
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
of
is
Crop/processed crop Number of stud- Transfer factor % Transference *
as
ies
eb
Not required
th
on
* Calculated based on distribution in the different portions, parts, or products as determined through
d
balance studies
e
nt
ra
eg
Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
tb
no
Citrus 0.01 mg/kg (provisional)
t
us
Tomato 0.05 mg/kg
m
Lettuce Not possible
n
tio
ra
st
gi
Re
Chapter 2.5 – Fate and Behaviour in the Environment
n.
io
lat
iso
Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

in
Mineralisation after 100 days 12.4 % of AR (91 d)

d
ea
Non-extractable residues after 100 days 39.1 % of AR (91 d)

er
tb
Relevant metabolites - name and/or code, % of 8a-hydroxy-avermectin B1a (NOA 448112): 15.7 %
no
applied (range and maximum) of AR

ld
8a-oxo-avermectin B1a (NOA 448111):10.3 % of AR

ou
sh
4,8a-dihydroxy-avermectin B1a (NOA 457464):9.9 %

d
of AR
an
8a-oxo-4-hydroxy-avermectin B1a (NOA 457465):

ge
9.9 % of AR
a
ck
unknown metabolite U8 > 5 % of AR on > 2 con-

pa
secutive time points

ta
da
n
io
Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

at
alu
Anaerobic degradation DT50, lab (20°C, anaerobic): No reliable anaerobic

ev
study supplied. Information from partly aero-

EC
bic/anaerobic experiments indicate that additional

degradation under anaerobic conditions is negligi-
n
fa
ble as compared to preceding aerobic degradation

to
ar
sp
m
or
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en
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t
Soil photolysis mineralisation: 7.6 % after 28 d
of
bound residues: 25.9 % after 28 d
is
as
DT50,photolysis: 12.9 d at 12 h L:D, 24.5 °C, corre-
eb
sponding with 21.7 d at 30 - 50 °N
th
metabolites:
on
8a-oxo-avermectin B1a (NOA 448111): 5.7 % of AR
ed
8a-hydroxy-avermectin B1a (NOA 448112): 4.0 % of
nt
AR
ra
eg
[8,9-Z]-avermectin B1a (NOA 427011) is supposed
tb
to be formed under light
no
t
us
m
n
Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)
tio
ra
Method of calculation laboratory: first order kinetics for avermectin B1a,
st
simultaneous fit of formation and decline for me-
gi
Re
tabolites with Berkely-Madonna
n.
Laboratory studies (range or median, with n DT50, lab (20°C, aerobic):
io
value, with r2 value) lat
avermectin B1a:
iso
mean 28.7 d (range 11.2 - 65.7 d; n = 8; r2 0.9471 -

0.9970)
in
d
NOA 448111:
ea
mean 45.3 d (range 40.5 - 50.6 d; n = 4; r2 0.86 -

er
0.94)
tb
no
NOA 448112:
mean 35.8 d (range 26.8 - 75.4 d; n = 4; r2 0.93 -
ld
ou
0.98)
sh
NOA 457464:
d
mean 65.9 d (range 48.5 - 99.0 d; n = 3; r2 0.97 -

an
0.99)
ge
a
NOA 464457:
ck
mean 112 d (range 59.8 - 173 d; n = 3; r2 0.97 -

pa
0.98)
ta
da
DT90, lab (20°C, aerobic): calculated as DT50 x 3.3

n
io
avermectin B1a: 95.3 d

at
alu
NOA 448111: 150 d

ev
NOA 448112: 119 d

EC
NOA 457464: 219 d

n
fa
NOA 464457: 372 d

to
ar
DT50, lab (10°C, aerobic):

sp
avermectin B1a:
m
50.6 d, calculated with Arrheniuns equation from

or
tf
DT50 at 8.6, 20 and 30 °C

en
m
cu
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is
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Mon Feb 05 03:52:00 CET 2018

t.
en
m
171
cu
s do
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t
DT50, lab (20°C, anaerobic): No reliable anaerobic
of
study supplied. Information from partly aero-
is
as
bic/anaerobic experiments indicate that additional
eb
degradation under anaerobic conditions is negligi-
ble as compared to preceding aerobic degradation
th
on
degradation in the saturated zone: no information
d
available
e
nt
Field studies (state location, range or median DT50, field:
ra
eg
with n value)
avermectin B1a:
tb
Vouvry, CH: 1.8 d (grass cover after application
no
on bare soil, average temperature 16 °C)
t
Bavaria, D: < 1 d (grass cover after application
us
on bare soil, average temperature 17 °C)
m
n
avermectin B1a + [8,9-Z]-avermectin B1a:
tio
Bavaria, D: < 1 d (bare soil, average temperature
ra
17 °C)
st
gi
Alsace, F: < 1 d (bare soil, average temperature
Re
17 °C)
n.
Po Valley, I: < 1 d (bare soil, average temperature
io
13 °C) lat
Champagne, F: < 1 d (bare soil, average tempera-
iso
ture 13 °C)
in
DT90, field: < 1 d

d
ea
Soil accumulation and plateau concentration accumulation not expected in view of DT50,field
er
tb
no
Soil adsorption/desorption (Annex IIA, point 7.1.2)

ld
ou
KF / KOC KOC:
sh
avermectin B1a:
d
an
mean 5638 L/kg (range 1495 - 7893 L/kg; 1/n 0.789

- 1.01;
ge
7 soils)
a
ck
pa
NOA 448111:
ta
da
- 0.835;
3 soils)
n
io
at
NOA 448112:
alu

ev
- 0.961;
3 soils)
EC
n
NOA 457464:
fa

to
- 0.944;
ar
3 soils)
sp
NOA 464457:
m
or

tf
- 1.01;
en
3 soils)
m
cu
KD KF:
do
avermectin B1a:
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
172
cu
s do
hi
t
mean 129 L/kg (range 18.2 - 334 L/kg; 7 soils)
of
NOA 448111:
is
as
mean 81.7 L/kg (range 38.3 - 128 L/kg; 3 soils)
eb
NOA 448112:
th
mean 41.1 L/kg (range 15.9 - 78.9 L/kg; 3 soils)
on
NOA 457464:
e d
mean 35.4 L/kg (range 16.9 - 61.3 L/kg; 3 soils)
nt
ra
NOA 464457:
eg
mean 82.3 L/kg (range 32.7 - 148 L/kg; 3 soils)
tb
no
pH dependance (yes / no) (if yes type of de- no
pendence) Some indication that sorption of metabolites is de-
t
us
pendent on clay content, number of soils (3) too
m
small for definitive conclusion
n
tio
ra
st
Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
gi
Re
Column leaching no reliable information supplied
n.
Aged residues leaching Guideline: BBA IV, 4-2; OECD draft
io
lat
Precipitation: 200 mm
iso
Time period: 2 d
Radioactivity in leachate 0.5 - 0.9 % of radioactivity
in
applied after ageing, maximum of avermectin B1a

d
ea
0.2 % of aged residue, metabolites < 0.1 %.

er
Total extractable radioactivity in soil column 85.1 -

tb
92.9 % of aged residue, 44.8 - 36.6 % of aged resi-

no
due present as avermectin B1a in top 4 cm.

Metabolites in 0 - 4 cm: NOA 448111 8.0 %, NOA
ld
448112 14.0 - 14.2 %, NOA 457464 2.8 - 3.4 % and

ou
NOA 457465 1.6 - 2.3 % of aged residue, < 1 % in

sh
deeper layers.
d
an
Lysimeter/ field leaching studies not submitted, not considered necessary

ge
a
ck
pa
PEC (soil) (Annex IIIA, point 9.1.3)

ta
parent
da
n
Method of calculation DT50: 1.8 d (worst case DT50,field)

io
first-order kinetics
at
alu
Application rate citrus: 3 x 21.6 g as/ha, interception 70 %

ev
lettuce (field): 3 x 18 g as/ha, interception 40 %

EC
lettuce (glass): 4 x 9 g as/ha, interception 40 %

tomatoes (field): 3 x 21.6 g as/ha, intercep-
n
fa
tion 50 %
to
tomatoes (glass): 5 x 21.6 g as/ha, intercep-

ar
tion 50 %
sp
spray interval 7 days

m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
173
cu
s do
hi
t
of
is
PECS Single applica- Single application Multiple applica- Multiple application
as
(mg/kg) tion tion
eb
time weighted av- time weighted aver-
citrus
th
actual erage actual age
on
initial 0 0.00864 0.0093
ed
nt
short term 1 0.0043 0.0062 0.0044 0.0063
ra
eg
2 0.0022 0.0047 0.0022 0.0047
tb
4 0.0005 0.0029 0.0005 0.0029
no
long term 7 0.0001 0.0018 0.0001 0.0018
t
us
m
14 0.0000 0.0009 0.0000 0.0009
n
tio
21 0.0006 0.0006
ra
28 0.0004 0.0004
st
gi
56 0.0002 0.0002
Re
n.
100 0.0001 0.0001
io
lat
iso
PECS (mg/kg) Single applica- Single application Multiple applica- Multiple application
in
tion tion
lettuce (field)
d

ea
tomatoes (field
er
and glass-
tb
house)1
no
initial 0 0.0144 0.0154

ld
ou
short term 1 0.0072 0.0104 0.0073 0.0105

sh
2 0.0036 0.0078 0.0036 0.0079

d
an
4 0.0009 0.0049 0.0009 0.0049

ge
a
long term 7 0.0001 0.0029 0.0001 0.0030

ck
pa
14 0.0000 0.0015 0.0000 0.0015

ta
da
21 0.0010 0.0010
n
28 0.0007 0.0007
io
at
56 0.0004 0.0004
alu
ev
100 0.0002 0.0002

EC
1: Product of application rate and interception fraction is same for lettuce and tomatoes; because of
n
low DT50, number of applications does not change PECS.

fa
to
ar
sp
tion tion
m
lettuce (glass-
or

house)
tf

en
initial 0 0.0072 0.0077

m
cu
short term 1 0.0036 0.0052 0.0036 0.0052

do
is
2 0.0018 0.0039 0.0018 0.0039

Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
174
cu
s do
hi
t
of
tion tion
is
lettuce (glass-
as
house)
eb
th
4 0.0005 0.0024 0.0005 0.0025
on
long term 7 0.0001 0.0015 0.0001 0.0015
ed
nt
14 0.0000 0.0007 0.0000 0.0007
ra
eg
21 0.0005 0.0005
tb
28 0.0004 0.0004
no
56 0.0002 0.0002
t
us
m
100 0.0001 0.0001
n
tio
ra
st
gi
Metabolite NOA 448111 (8a-oxo-avermectin
Re
B1a)
n.
io
Method of calculation simultaneous formation and decline, fitted with
lat
Berkely-Madonna
iso
formation fraction 0.23 (from parent)

in
degradation rate constant k 0.0153/d based on

d
laboratory data
ea
er
highest PECS obtained for

tb
field applications: lettuce and tomatoes

no
glasshouse applications: tomatoes

ld
ou
sh
d
tion tion
an
field: lettuce and

tomatoes
ge

a
ck
initial 0 0.0000 0.0057

pa
short term 1 0.0016 0.0008 0.0073 0.0065

ta
da
2 0.0024 0.0014 0.0080 0.0070

n
io
4 0.0030 0.0020 0.0084 0.0076

at
alu
long term 7 0.0030 0.0024 0.0082 0.0078

ev
14 0.0027 0.0026 0.0074 0.0078

EC
21 0.0025 0.0026 0.0066 0.0075

n
fa
28 0.0022 0.0025 0.0060 0.0072

to
ar
56 0.0014 0.0022 0.0039 0.0060

sp
m
100 0.0007 0.0017 0.0020 0.0046

or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
175
cu
s do
hi
t
of
is
as
tion tion
eb
glasshouse: to-
matoes
th
on
initial 0 0.0000 0.0104
ed
nt
short term 1 0.0016 0.0008 0.0119 0.0112
ra
eg
2 0.0024 0.0014 0.0126 0.0116
tb
4 0.0030 0.0020 0.0128 0.0121
no
long term 7 0.0030 0.0024 0.0124 0.0123
t
us
m
14 0.0027 0.0026 0.0112 0.0120
n
tio
21 0.0025 0.0026 0.0100 0.0115
ra
28 0.0022 0.0025 0.0090 0.0110
st
gi
56 0.0014 0.0022 0.0059 0.0092
Re
n.
100 0.0007 0.0017 0.0030 0.0070
io
lat
iso
Metabolite NOA 448112 (8a-hydroxy-

in
avermectin B1a)
d
ea

er
Berkely-Madonna
tb

no

ld
laboratory data
ou

sh

d
an

ge
a
ck
pa
tion tion
field: lettuce and
ta

da
tomatoes
n
io
initial 0 0.0000 0.0072

at
alu
short term 1 0.0021 0.0011 0.0092 0.0082

ev
2 0.0032 0.0018 0.0101 0.0089

EC
4 0.0038 0.0026 0.0106 0.0095

n
fa
long term 7 0.0030 0.0102

to
0.0038 0.0098
ar
14 0.0034 0.0033 0.0089 0.0097

sp
m
21 0.0030 0.0032 0.0078 0.0092

or
tf
28 0.0026 0.0031 0.0068 0.0087

en
56 0.0015 0.0026 0.0040 0.0070

m
cu
100 0.0006 0.0019 0.0017 0.0051

do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
176
cu
s do
hi
t
of
tion tion
is
glasshouse: to-
as
matoes
eb
th
initial 0 0.0000 0.0128
on
short term 1 0.0021 0.0011 0.0147 0.0137
ed
nt
2 0.0032 0.0018 0.0155 0.0143
ra
eg
4 0.0038 0.0026 0.0157 0.0149
tb
long term 7 0.0038 0.0030 0.0150 0.0150
no
14 0.0034 0.0033 0.0131 0.0145
t
us
m
21 0.0030 0.0032 0.0115 0.0138
n
tio
28 0.0026 0.0031 0.0100 0.0130
ra
56 0.0015 0.0026 0.0058 0.0104
st
gi
Re
100 0.0006 0.0019 0.0025 0.0075
n.
io
Metabolite NOA 457464 (4,8-a-dihydroxy-avermectin B1a) lat
iso

in
Berkely-Madonna
d
formation fraction 0.58 (from NOA 448112)

ea

er
laboratory data
tb
no

ld

ou

sh
d
an
ge
tion tion
a
field: lettuce and

ck

tomatoes
pa

ta
initial 0 0.0000 0.0008

da
n
short term 1 0.0000 0.0000 0.0008 0.0008

io
at
2 0.0000 0.0000 0.0009 0.0008

alu
ev
4 0.0001 0.0001 0.0012 0.0009

EC
long term 7 0.0002 0.0001 0.0015 0.0011

n
fa
14 0.0005 0.0002 0.0021 0.0014

to
21 0.0007 0.0004 0.0026 0.0017

ar
sp
28 0.0009 0.0005 0.0029 0.0020

m
or
56 0.0012 0.0008 0.0036 0.0027

tf
100 0.0011 0.0010 0.0033 0.0030

en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
177
cu
s do
hi
t
of
tion tion
is
glasshouse: to-
as
matoes
eb
th
initial 0 0.0000 0.0023
on
short term 1 0.0000 0.0000 0.0025 0.0024
ed
nt
2 0.0000 0.0000 0.0026 0.0025
ra
eg
4 0.0001 0.0001 0.0029 0.0026
tb
long term 7 0.0002 0.0001 0.0033 0.0028
no
14 0.0005 0.0002 0.0042 0.0033
t
us
m
21 0.0007 0.0004 0.0048 0.0037
n
tio
28 0.0009 0.0005 0.0053 0.0040
ra
56 0.0008 0.0049
st
0.0012 0.0060
gi
Re
100 0.0011 0.0010 0.0053 0.0053
n.
io
Metabolite NOA 457465 (8a-oxo-4a-hydroxy-avermectin B1a) lat
iso

in
Berkely-Madonna
d

ea

er
laboratory data
tb
no

ld

ou

sh
d
an
ge
tion tion
a
field: lettuce and

ck

tomatoes
pa

ta
initial 0 0.0000 0.0007

da
n
short term 1 0.0000 0.0000 0.0008 0.0007

io
at
2 0.0000 0.0000 0.0009 0.0008

alu
ev
4 0.0001 0.0000 0.0011 0.0009

EC
long term 7 0.0002 0.0001 0.0014 0.0010

n
fa
14 0.0005 0.0002 0.0020 0.0014

to
21 0.0007 0.0003 0.0025 0.0017

ar
sp
28 0.0009 0.0004 0.0030 0.0019

m
or
56 0.0013 0.0008 0.0041 0.0028

tf
100 0.0015 0.0011 0.0046 0.0035

en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
178
cu
s do
hi
t
of
tion tion
is
glasshouse: to-
as
matoes
eb
th
initial 0 0.0000 0.0022
on
short term 1 0.0000 0.0000 0.0024 0.0023
ed
nt
2 0.0000 0.0000 0.0025 0.0024
ra
eg
4 0.0001 0.0000 0.0028 0.0025
tb
long term 7 0.0002 0.0001 0.0032 0.0027
no
14 0.0005 0.0002 0.0041 0.0032
t
us
m
21 0.0007 0.0003 0.0049 0.0037
n
tio
28 0.0009 0.0004 0.0056 0.0041
ra
56 0.0013 0.0008 0.0071 0.0052
st
gi
Re
100 0.0015 0.0011 0.0075 0.0062
n.
io
Route and rate of degradation in water (Annex IIA, point 7.2.1) lat
iso
Hydrolysis of active substance and relevant avermectin B1a:

in
metabolites (DT50, state pH and temperature) No hydrolysis at pH 4 -7, 25 °C

d
pH 9, 60 °C: 4.9 d
ea
pH 9, 50 °C: 9.9 d
er
pH 9, 25 °C: 213 d (extrapolated)

tb
pH 9, 20 °C: 380 d (calculated with Arrhenius

no
equation)
ld
ou
metabolites:
sh
2-epi-avermectin B1a: 25 % of AR at 50 and 60 °C

d
1,18 hydrolysed avermectin B1a: 17.5 % of AR at 60

an
°C
ge
unknown: 15.6 % of AR at 60 °C
a
ck
Photolytic degradation of active substance and avermectin B1a:

pa
relevant metabolites Xenon: 2 d, equivalent to 1.5 sunlight days at 30 -

ta
50 °N
da
natural sunlight: 1.3 d

n
io
metabolites:
at
NOA 448111: 5.6 % of AR

alu
[8,9-Z]-avermectin B1a: 8.2 % of AR, DT50,photo 5.8

ev
sunlight days at 30 - 50 °N
EC
Readily biodegradable (yes/no) avermectin B1a is not readily biodegradable

n
fa
Degradation in water/sediment (range or me- DT50, water:

to
dian, with n value, with r2 value, state tempera-

ar
avermectin B1a:
ture)
sp
mean 2.4 d (20 °C; range 1.8 - 2.9 d; n = 2, first-

order, r2 0.945 - 0.953).
m
or
Decline of concentrations in water column deter-

tf
mined by rapid initial sorption. Value represents

en
dissipation rather than degradation.

m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
179
cu
s do
hi
t
DT90, water:
of
is
calculation from DT50 not applicable as DT50 is de-
as
termined by sorption
eb
DT50, whole system:
th
on
avermectin B1a:
d
mean 89 d (20 °C; range 87 - 91 d; n = 2, first-
e
order, r2 0.965 - 0.991)
nt
ra
eg
DT90, whole system: calculated as 3.3 x DT50,system
tb
avermectin B1a:
no
mean 294 d
t
us
Mineralisation max. 0.1 - 3 % of AR (study end 100 d; n = 2)
m
Non-extractable residues max. 20 - 23 % of AR (study end 100 d; n = 2)
n
tio
ra
Distribution in water / sediment systems (active avermectin B1a:
st
substance) sediment: max. 78.1 - 82.8 % of AR after 14 d, 44.3
gi
- 45.3 % of AR at study end after 100 d
Re
DT50,sediment: mean 99 d (87 - 111 d; n = 2, first-
n.
order, r2 0.942 - 0.987)
io
lat
Distribution in water / sediment systems (me- water: metabolites < 1 % of AR
iso
tabolites)
sediment:
in
NOA 448111 max. 1.9-2.8 % of AR (70 - 100 d)

d
NOA 448112: max. 1.5-1.9 % of AR (35/70 - 70 d)

ea
er
NOA 426289 (4"-oxo-avermectin B1a): max. 6.9 -

tb
8.6 % of AR (70 - 100 d)

NOA 445495 (3"-demethyl-avermectin B1a): max.
no
1.7 - 2.0 % of AR (day 70)

ld
ou
PEC (surface water) (Annex IIIA, point 9.2.3)

sh
parent
d
an
Method of calculation field applications:

ge
FOCUS Surface Water - Step 3

a
ck
SWASH 2.1 (9 April 2003), with MACRO 4.3b,

pa
PRZM 3.21.b and TOXSWA 2.1.1.F1.

ta
glasshouse applications:
da
FOCUS Surface Water - Step 2 with modifications

n
(no drainage and run-off, no crop interception, ap-

io
at
plication rate changed so that total loading to water

alu
surface (in g/m2) is equal to 0.1 % of the application

ev
rate)
EC
input:
n
DT50 for degradation in water: 89 d (DT50,system at 20

fa
°C)
to
DT50 for degradation in soil: 1 d (DT50,field)

ar
sorption: KOM 3270 L/kg

sp
m
Application rate citrus: 3 x 21.6 g as/ha

or
lettuce (field): 3 x 18 g as/ha

tf
lettuce (glass): 4 x 9 g as/ha

en
tomatoes (field): 3 x 21.6 g as/ha

m
tomatoes (glass): 5 x 21.6 g as/ha

cu
do
spray interval 7 days

is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
180
cu
do
s
thi
Main routes of entry drift, drainage and run-off
of
is
as
eb
Highest PECSW for each combination of crop and type of waterbody
th
citrus
on
PECSW (µg/L) Single applica- Single application Multiple applica- Multiple application
d
e
tion tion
nt
ditch, D6
time weighted aver- time weighted average
ra
eg
actual age actual
tb
initial 0 0.791 - 0.687
no
short- 1 0.69 0.736 0.61 0.646
t
us
term
m
0.548 0.611
n
2 0.612 0.693
tio
0.435 0.552
ra
4 0.449 0.612
st
0.253 0.462
gi
long 7 0.227 0.492
Re
term
n.
14 0.058 0.304 0.075 0.404
io
lat
0.036 0.352
21 0.026 0.216
iso
28 0.014 0.167 0.021 0.311

in
d
42 0.006 0.114 0.009 0.26

ea
er
50 0.004 0.097 0.007 0.224

tb
0.001 0.116
no
10 0.001 0.049
0
ld
ou
sh
d
an
tion tion
stream, R4
ge

a
actual age actual

ck
pa
initial 0 0.590 - 0.432 -

ta
short- 1 0 0.069 0 0.088

da
term
n
io
2 0 0.034 0 0.044
at
alu
4 0 0.017 0 0.028
ev
long 7 0 0.01 0.422 0.023

EC
term
n
fa
14 0.008 0.006 0.422 0.015

to
ar
21 0 0.004 0 0.014
sp
28 0 0.003 0 0.011
m
or
42 0 0.002 0 0.007
tf
en
50 0 0.002 0 0.006
m
cu
10 0 0.001 0 0.003
do
0
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
181
cu
do
s
hi
lettuce, field application
t
of
is
as
tion tion
ditch, D6
eb
th
actual age actual
on
initial 0 0.115 - 0.112
d
e
short- 1 0.103 0.108 0.097 0.104
nt
ra
term
eg
2 0.092 0.103 0.086 0.098
tb
no
4 0.070 0.092 0.066 0.087
t
us
long 7 0.034 0.075 0 0.069
m
term
n
tio
14 0 0.044 0 0.058
ra
st
21 0 0.029 0 0.04
gi
Re
28 0 0.022 0 0.03
n.
42 0 0.015 0 0.02
io
lat
50 0 0.012 0 0.017
iso
10 0 0.006 0 0.008
in
0
d
ea
er
tb
no
st tion tion
pond, R1, 1
ld
crop
ou
actual age actual

sh
initial 0 0.004 - 0.007 -

d
an
short- 1 0.004 0.004 0.007 0.007

ge
term
a
ck
2 0.004 0.004 0.007 0.007

pa
4 0.003 0.004 0.007 0.007

ta
da
long 7 0.003 0.003 0.006 0.007

n
term
io
at
alu
14 0.002 0.003 0.006 0.006

ev
21 0.002 0.003 0.005 0.006

EC
28 0.002 0.003 0.005 0.006

n
fa
42 0.001 0.002 0.004 0.006

to
50 0.001 0.002 0.003 0.005

ar
sp
10 0 0.001 0.002 0.004

m
0
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
182
cu
sdo
hi
t
of
tion tion
is
stream, R3,
as
1st crop
eb
actual age actual
th
initial 0 0.106 - 0.075
on
short- 1 0 0.039 0 0.028
de
term
nt
ra
2 0 0.020 0 0.014
eg
tb
4 0 0.010 0 0.007
no
long 7 0 0.006 0 0.007
t
us
term
m
14 0 0.003 0 0.005
n
tio
21 0 0.002 0 0.004
ra
st
28 0 0.001 0 0.003
gi
Re
42 0 0.001 0 0.002
n.
50 0 0.001 0 0.002
io
lat
10 0 0 0 0.001
iso
0
in
d
ea
lettuce, glasshouse application

er
tb
no
tion tion
Step 2
ld

ou
actual age actual

sh
initial 0 0.0030 - 0.0043 -

d
an
short- 1 0.0012 0.0021 0.0025 0.0034

ge
term
a
ck
2 0.0007 0.0016 0.002 0.0029

pa
ta
4 0.0005 0.0011 0.0018 0.0024

da
long 7 0.0005 0.0008 0.0017 0.0021

n
io
term
at
alu
14 0.0005 0.0006 0.0016 0.0019

ev
21 0.0004 0.0006 0.0016 0.0018

EC
28 0.0004 0.0005 0.0015 0.0017

n
fa
42 0.0004 0.0005 0.0013 0.0016

to
ar
50 0.0003 0.0005 0.0012 0.0016

sp
10 0.0002 0.0004 0.0008 0.0013

m
or
0
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
183
cu
do
s
hi
tomatoes, field application
t
of
is
as
tion tion
ditch, D6
eb
th
actual age actual
on
initial 0 0.136 - 0.098 -
d
e
short- 1 0.006 0.067 0.047 0.077
nt
ra
term
eg
2 0 0.034 0.006 0.05
tb
no
4 0 0.017 0.001 0.026
t
us
long 7 0 0.01 0 0.015
m
term
n
tio
14 0 0.005 0 0.011
ra
st
21 0 0.003 0 0.009
gi
Re
28 0 0.003 0 0.007
n.
42 0 0.002 0 0.004
io
lat
50 0 0.001 0 0.004
iso
10 0 0.001 0 0.002
in
0
d
ea
er
tb
no
tion tion
stream, R3
ld
ou
actual age actual

sh
initial 0 0.127 - 0.093 -

d
an
short- 1 0.001 0.047 0 0.035

ge
term
a
ck
2 0 0.024 0 0.017
pa
4 0 0.012 0 0.009
ta
da
long 7 0 0.007 0 0.005

n
term
io
at
alu
14 0 0.004 0 0.003
ev
21 0 0.002 0 0.003
EC
28 0 0.002 0 0.003
n
fa
42 0 0.001 0 0.003
to
50 0 0.001 0 0.002
ar
sp
10 0 0.001 0 0.001
m
0
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
184
cu
sdo
hi
tomatoes, glasshouse application
t
of
is
as
tion tion
Step 2
eb
th
actual age actual
on
initial 0 0.0072 - 0.0114 -
de
short- 1 0.0029 0.0051 0.0071 0.0092
nt
ra
term
eg
2 0.0017 0.0037 0.0058 0.0078
tb
no
4 0.0012 0.0025 0.0052 0.0066
t
us
long 7 0.0011 0.0019 0.0051 0.0060
m
term
n
tio
14 0.0011 0.0015 0.0048 0.0055
ra
st
21 0.0010 0.0014 0.0046 0.0052
gi
Re
28 0.0010 0.0013 0.0043 0.0050
n.
42 0.0009 0.0011 0.0039 0.0047
io
lat
50 0.0008 0.0011 0.0036 0.0046
iso
10 0.0005 0.0009 0.0025 0.0038

in
0
d
ea
er
tb
PEC (sediment)
no
Parent
ld
ou
Method of calculation according to FOCUS Step 2; version 1.1 of STEP 1

sh
-2 IN FOCUS
d
an
Application rate field applications:

FOCUS Surface Water - Step 3
ge
SWASH 2.1 (9 April 2003), with MACRO 4.3b,

a
ck
PRZM 3.21.b and TOXSWA 2.1.1.F1.

pa
glasshouse applications:
ta
FOCUS Surface Water - Step 2 with modifications

da
(no drainage and run-off, no crop interception, ap-

n
io
plication rate changed so that total loading to water

at
surface (in g/m2) is equal to 0.1 % of the application

alu
rate)
ev
input:
EC
DT50 for degradation in water: 89 d (DT50,system at 20

n
°C)
fa
DT50 for degradation in soil: 1 d (DT50,field)

to
sorption: KOM 3270 L/kg

ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
185
cu
do
s
thi
of
is
Highest PECSED for each combination of crop and type of waterbody
as
eb
citrus
th
PECSED Single applica- Single application Multiple applica- Multiple application
on
(µg/kg dwt) tion tion
d
e
ditch, D6
nt
actual age actual
ra
eg
initial 0 1.682 - 2.905 -
tb
short- 1 1.667 1.680 2.886 2.903
no
term
t
us
2 1.629 1.676 2.837 2.898
m
4 1.521 1.659 2.687 2.879
n
tio
long 7 1.348 1.617 2.426
ra
2.829
st
term
gi
Re
14 1.038 1.483 1.928 2.655
n.
21 0.833 1.348 1.593 2.474
io
lat
28 0.693 1.230 1.339 2.351
iso
42 0.515 1.045 0.989 2.098

in
d
50 0.442 0.963 0.849 1.963

ea
er
10 0.189 0.646 0.363 1.423

tb
0
no
ld
ou

sh

d

an
stream, R4
actual age actual
ge
a
initial 0 0.050 - 0.195 -

ck
pa
short- 1 0.045 0.048 0.184 0.192

term
ta
da
2 0.040 0.045 0.175 0.187

n
io
4 0.032 0.041 0.159 0.178

at
alu
long 7 0.024 0.038 0.142 0.168

ev
term
EC
14 0.032 0.034 0.119 0.151

n
fa
21 0.034 0.032 0.103 0.139

to
ar
28 0.028 0.031 0.092 0.130

sp
42 0.022 0.029 0.076 0.115

m
or
50 0.019 0.028 0.068 0.109

tf
en
10 0.010 0.021 0.036 0.082

m
0
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
186
cu
do
s
hi
lettuce, field application
t
of
is
as
eb
ditch, D6
th
actual age actual
on
initial 0 0.336 - 0.343 -
d
e
short- 1 0.334 0.335 0.314 0.341
nt
ra
term
eg
2 0.329 0.335 0.285 0.337
tb
no
4 0.311 0.333 0.204 0.326
t
us
long 7 0.272 0.327 0.141 0.306
m
term
n
tio
14 0.206 0.302 0.109 0.264
ra
st
21 0.164 0.275 0.090 0.233
gi
Re
28 0.135 0.251 0.065 0.208
n.
42 0.099 0.213 0.056 0.171
io
lat
50 0.084 0.196 0.003 0.156
iso
10 0.046 0.132 0.002 0.102

in
0
d
ea
er
tb

no

ld
pond, R1, 1st

ou
actual age actual

crop
sh
d
initial 0 0.036 - 0.064 -

an
short- 1 0.036 0.036 0.064 0.064

ge
term
a
ck
pa
2 0.036 0.036 0.064 0.064

ta
4 0.036 0.036 0.063 0.064

da
long 7 0.036 0.036 0.063 0.064

n
io
term
at
alu
14 0.035 0.036 0.062 0.063

ev
21 0.034 0.036 0.061 0.063

EC
28 0.033 0.036 0.059 0.063

n
fa
42 0.031 0.035 0.055 0.062

to
ar
50 0.030 0.035 0.052 0.062

sp
m
10 0.021 0.032 0.036 0.057

or
0
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
187
cu
sdo
hi
t
of
is
as
stream, R2,
eb
actual age actual
1st crop
th
initial 0 0.006 - 2.155 -
on
d
short- 1 0.006 0.006 2.131 2.146
e
nt
term
ra
eg
2 0.005 0.006 2.127 2.140
tb
4 0.005 0.005 2.083 2.128
no
long 7 0.005 0.005 2.025 2.116
t
us
term
m
n
14 0.004 0.005 1.927 2.085
tio
ra
21 0.004 0.005 1.826 2.039
st
gi
28 0.003 0.004 1.737 1.992
Re
42 0.003 0.004 1.577 1.901
n.
io
50 0.002 0.004 1.496
lat 1.852
iso
10 0.001 0.003 1.037 1.582

0
in
d
ea
er
lettuce, glasshouse application

tb
no

ld

ou
Step 2
actual age actual
sh
d
initial 0 0.0183 - 0.0667 -

an
ge
short- 1 0.0182 0.0182 0.0665 0.0666

a
term
ck
pa
2 0.0181 0.0182 0.0661 0.0665

ta
4 0.0178 0.0181 0.0651 0.0661

da
n
long 7 0.0174 0.0179 0.0636 0.0653

io
term
at
alu
14 0.0165 0.0174 0.0603 0.0636

ev
21 0.0156 0.017 0.0571 0.062

EC
n
28 0.0148 0.0165 0.054 0.0604

fa
to
42 0.0133 0.0157 0.0484 0.0573

ar
50 0.0125 0.0152 0.0455 0.0556

sp
m
10 0.0084 0.0128 0.0308 0.0467

or
0
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
188
cu
do
s
hi
tomatoes, field application
t
of
is
as
eb
ditch, D6
th
actual age actual
on
initial 0 0.047 - 0.082 -
d
e
short- 1 0.043 0.046 0.076 0.081
nt
ra
term
eg
2 0.038 0.044 0.070 0.079
tb
no
4 0.031 0.040 0.059 0.074
t
us
long 7 0.024 0.035 0.047 0.067
m
term
n
tio
14 0.016 0.028 0.049 0.056
ra
st
21 0.012 0.024 0.035 0.052
gi
Re
28 0.010 0.020 0.027 0.047
n.
42 0.007 0.017 0.019 0.040
io
lat
50 0.006 0.015 0.017 0.037
iso
10 0.003 0.010 0.007 0.025

in
0
d
ea
er
tb

no

ld
stream, R4
ou
actual age actual

sh
initial 0 0.496 - 1.665 -

d
an
short- 1 0.488 0.493 1.638 1.653

ge
term
a
ck
2 0.480 0.489 1.610 1.639

pa
4 0.466 0.481 1.571 1.615

ta
da
long 7 0.448 0.471 1.509 1.583

n
term
io
at
alu
14 0.421 0.453 1.458 1.542

ev
21 0.395 0.438 1.370 1.499

EC
28 0.372 0.425 1.290 1.457

n
fa
42 0.333 0.401 1.158 1.380

to
50 0.308 0.388 1.069 1.338

ar
sp
10 0.179 0.315 0.622 1.088

m
0
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
189
cu
do
s
hi
tomatoes, glasshouse application
t
of
is
as
eb
Step 2
th
actual age actual
on
initial 0 0.0431 - 0.196 -
d
e
short- 1 0.0430 0.0431 0.195 0.196
nt
ra
term
eg
2 0.0428 0.0430 0.194 0.195
tb
no
4 0.0421 0.0427 0.191 0.194
t
us
long 7 0.0412 0.0423 0.187 0.192
m
term
n
tio
14 0.0390 0.0412 0.177 0.187
ra
st
21 0.0369 0.0401 0.167 0.182
gi
Re
28 0.0350 0.0391 0.159 0.177
n.
42 0.0313 0.0371 0.142 0.168
io
lat
50 0.0295 0.0360 0.134 0.163
iso
10 0.0200 0.0302 0.0905 0.137

in
0
d
ea
er
tb
metabolite NOA 426289 (4"-oxo-avermectin

no
B1a)
ld
Method of calculation Highest peak concentration of avermectin B1a in

ou
sediment multiplied by maximum formation per-

sh
centage 8.6 %
d
an
ge
PECSED (µg/kg dwt) Multiple applica-

a
ck
tions
crop and scenario
pa
actual
ta
da
citrus, D6 0.250
n
io
lettuce, field, R2 0.185

at
alu
lettuce, glasshouse, 0.0057

ev
Step 2
EC
tomatoes, field, R4 0.143

n
fa
tomatoes, glasshouse, 0.0169

to
Step 2
ar
sp
m
PEC (groundwater) (Annex IIIA, point 9.2.1)

or
tf
Method of calculation and type of study (e.g. Model used: PEARL version 2.2.2
en
modelling, monitoring, lysimeter )

Scenarios:
m
cu
citrus: Piacenza, Porto, Sevilla, Thiva, crop citrus

do
lettuce: Chateaudun, Hamburg, Joikoinen, Krems-

münster, Porto, Sevilla, Thiva, crop cabbage
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
190
cu
s do
hi
t
tomatoes: Chateaudun, Piacenza, Porto, Sevilla,
of
Thiva, crop tomatoes
is
as
avermectin B1a:
eb
mean DT50,lab 28.7 d (pF2, 20 °C)
th
mean KOM: 3270 L/kg, 1/n= 0.9
on
NOA 448111:
d
e
nt
mean klab 0.0153/d (pF2, 20 °C)
ra
mean KOM: 2115 L/kg, 1/n= 0.9
eg
NOA 448112:
tb
no
mean klab 0.0194/d (pF2, 20 °C)
t
us
mean KOM: 1127 L/kg, 1/n= 0.9
m
NOA 457464:
n
tio
ra
mean klab 0.0105/d (pF2, 20 °C)
st
mean KOM: 1019 L/kg, 1/n= 0.9
gi
Re
NOA 457465:
n.
io
mean klab 0.0062/d (pF2, 20 °C)
lat
mean KOM: 1898 L/kg, 1/n= 0.9
iso
Application rate citrus: 3 x 21.6 g as/ha

in
lettuce (field): 3 x 18 g as/ha

d
ea
tomatoes (field): 3 x 21.6 g as/ha

er
tb
no
PECGW (µg/L)
ld
Maximum concentration all scenarios: < 0.001 µg/L (avermectin B1a, aver-
ou
mectin B1b and metabolites)

sh
d
Average annual concentration all scenarios: < 0.001 µg/L

an
ge
a
ck
Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
pa
Direct photolysis in air no information supplied

ta
da
Quantum yield of direct phototransformation no information supplied

n
io
Photochemical oxidative degradation in air DT50,air < 1 h estimated by Atkinson method (24
at
hours)
alu
ev
Volatilisation from plant surfaces: no information supplied

EC
from soil: no information supplied

n
fa
to
PECA (air)
ar
sp
Method of calculation Based on vapour pressure of < 3.7 x 10-6 Pa,

Henry's law constant of ≤ 2.7 x 10-3 Pa/m3.mol (1.13
m
or
x 10-6 dimensionless), volatilisation is unlikely.

tf
Should abamectin volatilise, quick degradation will

en
occur.
m
cu
do
PECA
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
191
cu
s do
hi
t
Maximum concentration Negligible
of
is
as
eb
Definition of the Residue (Annex IIA, point 7.3)
th
Relevant to the environment soil:
on
avermectin B1a and avermectin B1b, [8,9-Z]- , aver-
d
mectin B1b (NOA 421704), avermectin B1a (NOA
e
nt
427011), 8a-oxo-avermectin B1a (NOA 448111), 8a-
ra
hydroxy-avermectin B1a (NOA 448112), 4,8a-
eg
dihydroxy-avermectin B1a (NOA 457464), 4-
tb
hydroxy-8a-oxo-avermectin B1a (NOA 457465).
no
Surface water:
t
us
avermectin B1a and avermectin B1b, [8,9-Z]-
m
avermectin B1a (NOA 427011)
n
tio
sediment:
ra
avermectin B1a and avermectin B1b, and 4"-oxo-
st
avermectin B1a (NOA 426289)
gi
Re
groundwater:
n.
avermectin B1a and avermectin B1b,
io
air: lat
iso
avermectin B1a and avermectin B1b,
in
d
ea
Monitoring data, if available (Annex IIA, point 7.4)

er
Soil (indicate location and type of study) No information supplied

tb
no
Surface water (indicate location and type of No information supplied

ld
study)
ou
Ground water (indicate location and type of No information supplied

sh
study)
d
an
Air (indicate location and type of study) No information supplied

ge
a
ck
pa

ta
with regard to fate and behaviour data Potential for R53

da
n
io
at
alu
ev
EC
n
fa
to
ar
sp
m
or
tf
en
m
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
192
cu
s do
hi
Chapter 2.6 – Effects on Non-target Species
t
of
is
as
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
eb
th
Acute toxicity to mammals LD50 8.7 mg/kg bw
on
Long-term toxicity to mammals NOEC 0.12 mg/kg bw.d (rat)
e d
nt
Acute toxicity to birds LD50 ≤ 77 mg/kg bw (Anas platyrhynchos)
ra
eg
Dietary toxicity to birds LC50 48.6 mg/kg bw.d (A. platyrhynchos)
tb
Reproductive toxicity to birds NOEC 1.33 mg/kg bw.d (A. platyrhynchos, males)
no
t
us
m
Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
n
tio
Application Crop Category step in the risk Time- TER Annex VI
ra
rate (e.g. insectivorous assessment scale trigger
st
(kg as/ha) bird)
gi
Re
3 x 0.0216 citrus (orchard small herbivorous first step acute 2.0 10
n.
scenario) mammal
io
lat
refinement acute 13.8 10
iso
first step long- 0.08 5

in
term
d
ea
refinement long- 7.1 5

er
term
tb
insectivorous mam- first step acute 74 10

no
mal
ld
ou
refinement long- 13 5
sh
term
d
an
insectivorous bird first step acute 66 10

ge
first step short- 75 10

a
ck
term
pa

ta
term
da
n

io
term
at
alu
3 x 0.018 lettuce (field; medium herbivorous first step acute 11 10

ev
leafy crops mammal

EC
scenario)
n

fa
term
to
ar

sp
term
m
or
medium herbivorous first step acute 39 10

tf
bird
en
m

cu
term
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
193
cu
s do
hi
t
of
term
is
as
eb
term
th
on
d
e
nt
term
ra
eg
tb
term
no
t
us
term
m
3 x 0.0216 tomatoes (field; medium herbivorous first step acute 9.7 10
n
tio
leafy crops mammal
ra
scenario)
st
gi
refinement acute accept
Re
able1
n.
io
lat
iso
term
in
refinement long- accept

d
term able1
ea
er
tb
insectivorous mam- refinement long- 4.72 5

no
mal term
ld
medium herbivorous first step acute 32 10

ou
bird
sh
d

an
term
ge

a
ck
term
pa
refinement long- 39 5
ta
da
term
n

io
at
alu

term
ev
EC

term
n
fa

to
term
ar
sp
all crops Exposure via small mammal first step acute 73000 10
m
drinking of sur-
or
face water3
tf
en
small bird first step acute 25200 10

m
0
cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
194
cu
do
s
thi
all crops Exposure via worm-eating mammal first step long- 48 5
of
eating of term
is
worms4
as
eb
worm-eating bird first step long- 532 5
th
term
on
all crops Exposure via fish-eating mammal first step long- 24 5
ed
eating of fish5 term
nt
ra
fish-eating bird first step long- 333 5
eg
term
tb
1: it is assumed that tomato foliage, at the later growth stages when abamectin is applied, is unlikely to be eaten by herbivorous
no
mammals
t
2: after weight of evidence approach risk is acceptable
us
3: based on highest PECSW (FOCUS Step 2, citrus) and 10 g bird with DWI 2.7 mL/d
m
4: based on highest 21-days TWA-PECS (lettuce, tomatoes) and BCF2.24 kg/kg (estimated)
n
5: based on highest 21- days TWA-PECSW (FOCUS Step 2, citrus) and BCF 69 L/kg
tio
ra
st
gi
Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Re
Annex IIIA, point 10.2)
n.
Group Test substance Time-scale Endpoint Toxicity
io
lat
(µg as/L)
iso
Laboratory tests
in
d
Daphnia pulex abamectin acute EC50 0.12

ea
er
Daphnia magna Vertimec 018 EC acute EC50 0.59

tb
Daphnia magna [8,9-Z]-avermectin B1a acute EC50 0.082

no
ld
Daphnia magna 8a-hydroxy- acute EC50 1.6

ou
avermectin B1a
sh
Daphnia magna 4”-oxo-avermectin B1a acute EC50 0.28

d
an
Daphnia magna abamectin chronic NOEC 0.010

ge
a
Oncorhynchus mykiss abamectin acute LC50 3.6

ck
pa
Oncorhynchus mykiss abamectin acute LC50 8.7

ta
(modified
da
exposure
n
test)
io
at
Oncorhynchus mykiss Vertimec 018 EC acute LC50 2.3

alu
ev
Oncorhynchus mykiss [8,9-Z]-avermectin B1a acute LC50 5.1

EC
Oncorhynchus mykiss 8a-hydroxy- acute LC50 520

n
avermectin B1a
fa
to
Oncorhynchus mykiss abamectin chronic NOEC 0.52

ar
Pseudokirchneriella sub- Vertimec 018 EC chronic ErC50 > 1590

sp
capitata
m
or
Pseudokirchneriella sub- [8,9-Z]-avermectin B1a chronic ErC50 > 9000

tf
capitata
en
m
Pseudokirchneriella sub- 8a-hydroxy- chronic ErC50 > 6100

cu
capitata avermectin B1a

do
is
Microcosm or mesocosm tests

Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
195
cu
s do
hi
t
No Observed Ecologically Adverse Effect Concentration (NOEAEC):
of
1.8 µg as/L, nominal concentration after single application, recirculation
is
0.049 µg as/L, nominal concentration after three applications, no recirculation
as
eb
th
on
Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2): first
e d
tier risk assessment
nt
ra
Application Crop Organism Time- PECSW1 TER Annex VI
eg
rate scale Trigger
tb
(µg
no
(kg as/ha) as/L)
t
us
abamectin
m
3 x 0.0216 citrus D. pulex acute 0.791 0.15 100
n
tio
O. mykiss acute 0.791 4.6 100
ra
st
D. magna chronic 0.352 0.03 10
gi
Re
O. mykiss chronic 0.224 2.3 10
n.
io
3 x 0.018 lettuce, field D. pulex acute 0.115 1.0 100
lat
O. mykiss acute 0.115 31 100
iso
in

d
ea
O. mykiss chronic 0.012 43 10

er
4 x 0.009 lettuce, glass- D. pulex acute 0.0043 28 100

tb
house
no

ld
ou

sh
d

an
3 x 0.0216 tomatoes, field D. pulex acute 0.136 0.88 100

ge
a
ck

pa

ta
da

n
io
5 x 0.0216 tomatoes, glass- D. pulex acute 0.0144 11 100

at
house
alu

ev
EC

n
fa

to
Vertimec 018
ar
EC
sp
m
3 x 0.0216 citrus D. magna acute 0.791 1.3 100

or
tf
O. mykiss acute 0.791 4.0 100

en
P. subcapi- chronic 0.791 > 2010 10

m
cu
tata
do
3 x 0.018 lettuce, field D. magna acute 0.115 5.3 100

is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
196
cu
s do
hi
t
of
is
as
tata
eb
4 x 0.009 lettuce, glass- acute 0.0043 137 100
th
D. magna
house
on
d
e
nt
5
ra
P. subcapi- chronic 0.0043 > 3.7 x 10 10
eg
tata
tb
3 x 0.0216 tomatoes, field D. magna acute 0.136 4.3 100
no
t
us
m
n
tata
tio
ra
5 x 0.0216 tomatoes, glass- D. pulex acute 0.0144 52 100
st
house
gi
Re
n.
5
P. subcapi- chronic 0.0144 > 1.4 x 10 10
io
tata lat
iso
1: PECSW is highest actual PECSW (acute daphnids, fish and algae) or TWA-PECSW (chronic daphnids, fish) after single or multi-
ple applications, selected from the different Step 3-scenarios for each crop. For glasshouse applications, Step 2-values are
in
used.
d
ea
er
Toxicity/exposure ratios based on the EAC-value (mesocosm without fish)

tb
Crop Water- highest Scenario EAC used TER Annex

no
body PECSW EAC/PEC VI trig-

ld
[µg [µg as/L] SW ger

ou
as/L]
sh
citrus ditch 0.791 D6, 1 application 0.6 0.75 1

d
an
ditch 0.430 D6, 1 application, 6m 0.6 1.4 1

ge
bufferzone
a
ck
stream 0.590 R4, 1 application 0.6 1.0 1

pa
lettuce, field ditch 0.115 D6, 1 application 0.6 5.2 1

ta
da
pond 0.007 D4, 3 applications 0.016 2.3 1

n
io
st
R1, 3 applications (1
at
crop)
alu
ev
stream 0.106 R3, 1 application (1st 0.6 5.7 1

EC
crop)
n
lettuce, glass- ditch 0.0043 Step 2, 4 applications 0.016 3.7 1

fa
house
to
ar
tomatoes, field ditch 0.136 D6, 1 application 0.6 4.4 1

sp

m
or
tomatoes, glass- ditch 0.0144 Step 2, 5 applications 0.016 1.1 1

tf
house
en
m
cu
do
is
Toxicity/exposure ratios for fish, based on the LC50-value of the modified exposure test
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
197
cu
s do
hi
Crop Water- highest Scenario LC50 TER Annex
t
of
is
[µg [µg as/L] ger
as
SW
as/L]
eb
citrus ditch 0.791 D6, 1 application 10.1 11 100
th
on
ditch 0.430 D6, 1 application, 6m 10.1 20 100
d
bufferzone
e
nt
stream 0.590 R4, 1 application 10.1 15 100
ra
eg
lettuce, field ditch 0.115 D6, 1 application 10.1 76 100
tb
pond 0.007 D4, 3 applications 10.1 1243 100
no
st
t
us
crop)
m
n
stream 0.106 R3, 1 application (1st 10.1 74 100
tio
crop)
ra
st
lettuce, glass- ditch 0.0043 Step 2, 4 applications 10.1 2023 100
gi
Re
house
n.
tomatoes, field ditch 0.136 D6, 1 application 10.1 64 100
io
stream 0.127 R3, 1 application
lat
10.1 69 100
iso
tomatoes, glass- ditch 0.0144 Step 2, 5 applications 10.1 604 100

in
house
d
ea
er
Acute toxicity/exposure ratios for fish, based on the HC5-value

tb
no
Crop Water- highest Scenario LC50 TER Annex

ld

ou
[µg [µg as/L] SW ger

sh
as/L]
d
citrus ditch 0.791 D6, 1 application 0.66 0.8 1

an
ge
ditch 0.430 D6, 1 application, 6m 0.66 1.5 1

a
bufferzone
ck
pa

ta
lettuce, field ditch 0.115 D6, 1 application 0.66 5.7 1

da
n
pond 0.007 D4, 3 applications 0.66 94 1

io
at
st
alu
crop)
ev
stream 0.106 R3, 1 application (1st 0.66 6.2 1

EC
crop)
n
fa
lettuce, glass- ditch 0.0043 Step 2, 4 applications 0.66 153 1

to
house
ar
sp
tomatoes, field ditch 0.136 D6, 1 application 0.66 4.9 1

m

or
tf
tomatoes, glass- ditch 0.0144 Step 2, 5 applications 0.66 46 1

en
house
m
cu
do
Chronic toxicity-exposure ratios for fish . using FOCUS Step 3 (field applications) and 2 (glass-
is
house uses) PIECvalues

Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
198
cu
sdo
hi
t
Species NOEC crop PIECsw TER
of
[µg as/L] (ug/L)
is
as
eb
citrus 0.791 0.66
th
on
Lettuce (glass- 121
d
O. my- 0.0043
e
0.52 house)
nt
kiss
ra
Tomato (field) 0.136 3.8
eg
Tomato (glass- 46
tb
0.0114
house)
no
t
us
Chronic toxicity-exposure ratios for fish from use of abamectin using FOCUS Step 3 (field ap-
m
plications) and 2 (glasshouse uses) PIEC values and a chronic HC5-value
n
tio
Species chronic HC5 crop PIECsw TER
ra
st
[µg as/L] (ug/L)
gi
Re
citrus 0.28
n.
0.791
io
Lettuce (field) lat
0.115 1.9
iso
O. my- Lettuce (glass- 51

0.22 0.0043
house)
in
kiss
Tomato (field) 1.6
d
0.136
ea
Tomato (glass- 19
er
0.0114
house)
tb
no
ld
ou
sh
Bioconcentration
d
an
Bioconcentration factor (BCF) 69 L/kg wwt, based on total radioactivity

ge
a
Annex VI Trigger for the bioconcentration fac- 100

ck
tor
pa
ta
Clearance time CT50: not determined

da
CT90: not determined

n
io
at
Level of residues (%) in organisms after the 14 0.32 µg/kg wwt

alu
day depuration phase

ev
EC
Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
n
fa
Acute oral toxicity no reliable information available

to
ar
Acute contact toxicity abamectin:

sp
0.0022 µg/bee
m
or
tf
Hazard quotients for honey bees (Annex IIIA, point 10.4)

en
m
Application rate Crop Route Hazard quotient Annex VI Trigger

cu
do
(kg as/ha)
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
199
cu
do
s
thi
Laboratory tests
of
is
0.0216 citrus, tomatoes contact 9818 50
as
eb
Field or semi-field tests
th
Residual toxicity to honeybees
on
Acute toxicity residues of abamectin on citrus and alfalfa leaves to honeybees. Leaves sprayed at
d
0.0015 - 0.015 g as/L in California during summer, ageing for 0.5 - 72 hours, average temperature 24
e
nt
- 27 °C. Mortality caused by 0.5 - 1 hour aged residues was 92 - 100 % at all concentrations, mortality
ra
decreased with increasing ageing time. The time needed to reduce mortality to 50 % was dependent
eg
of concentration and increased from 2.1 hours at 0.0015 g as/L to 41.3 hours at 0.015 g as/L. Mini-
tb
mum ageing time to reduce residual toxicity to < LD50 is estimated to be 39 hours for citrus and 43
no
hours for tomatoes after single spray at proposed concentration (0.0135 and 0.018 g as/L). Neces-
t
sary waiting time to non-toxic residues 96 hours.
us
m
Semi-field study with bumblebees
n
Glasshouse test to determine the residual toxicity of Dynamec 1.8 EC (abamectin 18 g as/L) to bum-
tio
blebees. Mini-hives introduced 6 to 48 hours after spraying tomato plants at 14.6 and 11.8 g as/ha.
ra
No significant effect on survival and pollination at both treatment levels, but trend for highest mortality
st
gi
to occur in the 6 and 12 hour aged treatments. Use of full size hives could result in significant differ-
Re
ences in bee mortality. Exposure to residues within 6 - 12 hours after spraying could thus lead to a
n.
significant effect on bumblebee survival.
io
lat
iso
Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)
in
Species Stage Test Dose Aged Endpoint Ef- Annex VI

d
ea
fect1 Trigger
Substance (g as/ha) (d)
er
(%)
tb
no
Laboratory tests
ld
Poecilus cupreus adults Vertimec 018 1.2 - survival 0 30

ou
EC food consump- 0
sh
tion
d
an
5.8 - survival 0 30
ge
food consump- 0
a
ck
tion
pa
29 - survival 0 30
ta
food consump- 0
da
tion
n
io
58 - survival 0 30
at
alu
food consump- 0
tion
ev
2 x 5.8 survival -3.4 50

EC
Poecilus cupreus adults Vertimec 018

EC food consump- 0
n
fa
tion
to
2 x 5.8 survival 3.3 50

ar
food consump- 6.1

sp
tion
m
2 x 5.8 survival -3.4 50

or
food consump- -2.8

tf
tion
en
2 x 29.2 survival 10.3 50

m
food consump- 0
cu
tion
do
2 x 29.2 survival 0 50
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
200
cu
do
s
thi
food consump- 0
of
tion
is
2 x 29.2 survival -3.4 50
as
food consump- -5.6
eb
tion
th
on
+ adju- food consump- -3.0
d
vant tion
e
nt
ra
+ adju- food consump- 15.2
eg
vant tion
tb
2 x 5.8 survival -3.4 50
no
t
us
vant tion
m
2 x 29.2 survival 6.9 50
n
tio
vant tion
ra
st
gi
+ adju- food consump- -6.1
Re
vant tion
n.
io
+ adju- lat food consump- -2.8
vant tion
iso
1: negative values indicate increase relative to control

in
d
ea

er
fect1 Trigger
tb
(%)
no
ld
Laboratory tests (cont.)

ou
Typhlodromus proto- Vertimec 018 1.17 - survival 88.2 50

sh
pyri nym- EC reproduction 100

d
an
phs
ge
5.84 - survival 97.9 50

a
ck
29.2 - survival 100 50

pa
58.4 - survival 100 50

ta
da
0.088 - survival 4 50
n
io
reproduction 27
at
alu
Typhlodromus proto- Vertimec 018 0.133 - survival 13 50

pyri nym- EC reproduction 34
ev
phs
EC
0.199 - survival 11 50
n
fa
reproduction 52
to
0.298 - survival 24 50
ar
sp
reproduction 72
m
0.448 - survival 59 50
or
tf
Typhlodromus proto- Vertimec 018 4.33 - survival 100 50

en
pyri nym- EC
m
phs
cu
do
4.33 1 survival 15 50
is
reproduction 56.5
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
201
cu
do
s
thi
4.33 6 survival 0 50
of
reproduction 10.8
is
as
22.4 0 survival 100 50
eb
22.4 1 survival 100
th
50
on
22.4 6 survival 12 50
d
reproduction 78.4
e
nt
ra
22.4 15 survival 0 50
eg
reproduction -6.7
tb
no
t
us
fect1 Trigger
m
n
(%)
tio
ra
Laboratory tests (cont.)
st
gi
Aphidius rhopa- adult Vertimec 018 0.58 survival 93.3 50
Re
losiphi EC
n.
io
5.84 survival 100 50
lat
iso
in

d
ea
Aphidius rhopa- adult Vertimec 018 0.023 survival 0 50

er
losiphi EC
tb
0.057 survival 0 50
no
reproduction 7
ld
ou
0.143 survival 3 50
sh
reproduction 67
d
an
reproduction 94
ge
a
ck
pa
ta
da
Aphidius rhopa- adult Vertimec 018 4.32 survival 95 50

n
losiphi EC
io
at

alu
4.32 1 survival 25 50
ev
reproduction 67
EC
22.4 1 survival 80 50
n
fa
4.32 6 survival 3 50
to
reproduction 52
ar
sp
22.4 6 survival 15 50
m
reproduction 57
or
tf
4.32 16 survival 3 50
en
reproduction -9
m
cu
22.4 16 survival 11 50
do
reproduction -8
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
202
cu
s do
hi
t
Orius laevigatus 1.2 survival 63.2 50
of
reproduction -8.3
is
5.8 survival 90.8
as
50
eb
29.2 survival 97.7 50
th
58.4 survival 100
on
50
d
e
nt
ra
eg
Species Stage Test Dose Aged Endpoint Ef- Annex
fect1 VI
tb
Trigger
no
(%)
t
us
Semi-field tests
m
Aphidius colema- adult Vertimec 018 0.20-0.73 activity 67 50
n
tio
ni EC reproduc- 62
ra
tion
st
gi
2.48-9.11 activity 77 50
Re
reproduc- 80
n.
tion
io
0.20-0.73
lat activity 13 50
iso
2x reproduc- 39
tion
in
d
ea
2.48-9.11 activity 86 50
er
2x reproduc- 54
tb
tion
no
0.20-0.73 activity 34 50
ld
4x reproduc- 0
ou
tion
sh
2.48-9.11 activity 84 50
d
an
4x reproduc- 26
ge
tion
a
ck
0.20-0.73 activity -9 50
pa
4x reproduc- 29
ta
tion
da
2.48-9.11 activity 32 50
n
io
4x reproduc- -34
at
tion
alu
0.20-0.73 activity -40 50

ev
4x reproduc- 6
EC
tion
n
fa
2.48-9.11 activity 3 50
to
4x reproduc- -11
ar
tion
sp
Orius laevigatus nymp Vertimec 018 2.7 survival 49.2 50

m
or
hs EC
tf
2
en
2.7 survival 16.9 50

m
2.7 7 survival 13.2 50

cu
do
13.5 survival 58.7 50

is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
203
cu
s do
hi
t
13.5 2 survival 45.8 50
of
is
13.5 7 survival 26.5 50
as
eb
2.7 survival 38.1 50
+ paraffin
th
oil
on
d
2.7 2 survival 8.5 50
e
nt
+ paraffin
ra
oil
eg
7
tb
2.7 survival 8.8 50
+ paraffin
no
oil
t
us
m
13.5 survival 63.5 50
n
+ paraffin
tio
oil
ra
2
st
13.5 survival 49.2 50
gi
+ paraffin
Re
oil
n.
7
io
13.5 survival 35.3 50
lat
+ paraffin
iso
oil
in
paraffin oil survival 7.9

d
ea
paraffin oil 2 survival -13.6

er
tb
paraffin oil 7 survival 16.2

no

ld
ou
sh
Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)
d
Acute toxicity abamectin:

an
LC50 33 mg/kg (10 % OM)

ge
equivalent to 16.5 mg/kg at default OM content of 5

a
ck
% for agricultural soil

pa
NOA 427011 ([8,9-Z]-avermectin B1a):

ta
LC50 50 mg/kg (10 % OM)

da
equivalent to 25 mg/kg at default OM content of 5 %

n
io
for agricultural soil

at
alu
NOA 448112 (8a-hydroxy-avermectin B1a):

LC50 321 mg/kg (10 % OM)
ev
equivalent to 161 mg/kg at default OM content of 5

EC
% for agricultural soil

n
fa
Reproductive toxicity Vertimec 0.18 EC:

to
NOEC ≥ 0.72 mg as/kg (10 % OM, 56 d)

ar
equivalent to ≥ 0.36 mg/kg at default OM content of

sp
5 % for agricultural soil

m
or
tf
Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)

en
m
Application rate Crop Time-scale TER Annex VI Trigger

cu
do
(kg as/ha)
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
204
cu
do
s
thi
3 x 0.0216 citrus acute, 14 d 1897 10
of
is
1
3 x 0.018 lettuce (field) acute, 14 d 1138 10
as
eb
3 x 0.009 lettuce (glasshouse) acute, 14 d 2260 10
th
3 x 0.0216 tomatoes (field) acute, 14 d 11381 10
on
1
5 x 0.0216 tomatoes (glasshouse) acute, 14 d 1138 10
d
e
nt
3 x 0.018 lettuce (field) long-term, 56 d ≥ 252 5
ra
3 x 0.0216 tomatoes (field)
eg
5 x 0.0216 tomatoes (glasshouse)1
tb
1: at given application rates, highest PECS is the same for these crops due to different crop interception; because of low DT50,
no
number of applications does not change PECS
t
2: based on highest initial PECS
us
m
n
Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)
tio
ra
Nitrogen mineralisation abamectin:
st
< 25 % effect after 28 days at 0.347 mg/kg (equiva-
gi
Re
lent to 216 g as/ha at 5 cm depth assuming soil bulk
density 1500 kg/m3)
n.
io
lat
< 25 % effect after 28 days at 0.40 mg/kg
iso

in

d
ea
er
Carbon mineralisation abamectin:

tb
< 25 % effect after 28 days at 0.347 mg/kg (equiva-

lent to 216 g as/ha at 5 cm depth assuming soil bulk
no
density 1500 kg/m3)

ld
ou

sh

d
an

ge
a
ck
pa
Effects on other non-target organisms (flora and fauna) (Annex IIA, point 8.6)
ta
da
herbicide profiling test Vertimec 0.18 EC:

n
io
seedling emergence:
at
no effect on maize, wild oat, onion, sugar beet, oil-

alu
seed rape and soybean at 50.6 g as/ha

ev
vegetative vigour:
EC
no effect on of maize, wild oat, onion, sugar beet

n
and oilseed rape at 50.6 g as/ha

fa
slight effect on vegetative vigour of soybean at 25.3

to
and 50.6 g as/ha (rating 8.5 and 8 out of 9)

ar
sp
m

or
tf
with regard to ecotoxicological data Risk phrase : R50/53

en
m
Safety phrase : S60, S61

cu
do
is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

W
AR
NI
NG
: Th
is
do
cu
m
en
tf
or
m
sp
ar
to
fa
n
Mon Feb 05 03:52:00 CET 2018

EC
ev
alu
at
io
n
da
ta
pa
ck
age
an
d
sh
ou
ld
no
205
tb
er
ea
d
in
LEVEL 3
iso
Abamectin
lat
io
n.
Re
PROPOSAL FOR THE DECISION

gi
st
ra
tio
n
m
us
t no
tb
eg
ra
nt
ed
on
th
eb
as
is
of
t hi
s do
cu
m
en
t.
t.
en
m
206
cu
s do
hi
t
of
3 Proposed decision with respect to the application for inclusion of the active
is
as
substance in Annex I
eb
th
on
3.1 Background to the proposed decision
d
Abamectin, also know as avermectin B1, is a mixture of avermectin B1a (5-O-demethyl-avermectin A1a;
e
nt
ra
min. 80%) and avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-avermectin
eg
A1a; max. 20%).
tb
Abamectin is a broad spectrum acaricide with insecticidal action, acting via contact and stomach ac-
no
t
tion. It stimulates the release of γ-aminobutryric acid, which acts as an inhibitory neurotransmitter. This
us
m
leads to paralysis and death of affected insects and mites.
n
tio
ra
st
An Acceptable Daily Intake (ADI) of 0.0012 mg/kg bw/day can be established for both abamectin and
gi
Re
its 8,9-Z isomer. A systemic AOEL of 0.0012 mg/kg bw/day, equal to 0.084 mg/worker/day can be set
n.
for both abamectin and its 8,9-Z isomer. For abamectin an ARfD of 0.005 mg/kg bw/day can be estab-
io
lat
lished, whereas for the 8,9-Z-isomer of abamectin an ARfD of 0.0015 mg/kg bw/day can be estab-
iso
lished.
in
d
ea
The EU representative uses of abamectin selected for this submission are citrus, tomatoes (field and
er
tb
glasshouse uses) and lettuce (field and glasshouse uses).

no
It is not likely that the use of abamectine, consistent with good plant protection practice, will have any
ld
ou
harmful effects on human health. Not are residues to be expected in livestock feed or animal products.
sh
However, due to gaps in the available information it is impossible to make definite MRL proposals.
d
an
Therefore, further data are required to make a complete assessment.

ge
a
ck
The available data indicate that application according to good agricultural practice will not lead to un-
pa
ta
acceptable residues in soil. Residues can be determined at an acceptable level by conventional ana-
da
lytical methods. Leaching to groundwater is not expected.

n
io
On the basis of the available information long-term effects for mammals concerning the application of
at
alu
abamectin in lettuce cannot be excluded. Further refinement of this risk is necessary.

ev
Residues in water, resulting from spray drift, drainage and/or run-off are expected to cause initial ef-
EC
fects on the aquatic ecosystem, but recovery is expected to occur within a relatively short period of
n
fa
time (eight weeks). For fish a separate risk assessment has been made, because they were not pre-
to
ar
sent in the submitted mesocosm study. Based on this risk assessment additional mitigation measures
sp
are necessary for the use in citrus, to reduce the risk. The use of abamectin is likely to have an impact
m
or
on bees, residual effects are expected to occur until 48 hours after spraying. Recommendations on re-
tf
en
introduction periods should be determined at the Member State level on the basis of considerations of
m
crops, species, region and season. As a waiting period is not applicable to field uses, an initial effect
cu
do
cannot be excluded. Although the use of abamectin at the proposed application rates is expected to
is
Th
cause sincere effects on the populations of the non-target arthropod species tested (except for
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

Mon Feb 05 03:52:00 CET 2018
W
AR
NI
NG
: Th
is
do
cu
m
en
tf
or
m
sp
ar
to
fa
n
Mon Feb 05 03:52:00 CET 2018

EC
ev
alu
at
io
n
da
ta
pa
ck
age
an
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in
iso
lat
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gi
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us
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AR
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: Th
is
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Mon Feb 05 03:52:00 CET 2018

EC
ev
alu
at
io
n
da
ta
pa
ck
age
an
d
sh
ou
ld
no
209
tb
er
ea
d
in
LEVEL 4
iso
Abamectin
lat
io
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Re
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DEMAND FOR FURTHER INFORMATION

tio
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210
cu
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of
4 Further information to permit a decision to be made, or to support a review of the
is
as
conditions and restrictions associated with the proposed inclusion in Annex I
eb
th
on
4.1 Identity of the active substance
d
Sufficient information is submitted. No further questions.
e
nt
ra
eg
4.2 Physical and chemical properties of the active substance
tb
no
• Solubility in organic solvents (technical active substance): the notifier to explain the difference
t
us
found in solubility of abamectin in toluene compared to the value stated in the e-Pesticide manual
m
(350 g/l).
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tio
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st
4.3 Data on application and further information
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Re
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4.4 Classification, packaging and labelling
iso

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tb
• Method 91-1 is sufficiently validated. However, for raisins a sufficient number of recoveries for all
no
three analytes are required. With regard to the use as method for supervised residue and storage
ld
ou
stability trials: until additional data are supplied and considered sufficient, results, generated with
sh
this method, are provisional.

d
an
• Method 1009 Rev.1 is at the moment insufficiently described and insufficiently validated. A de-
ge
a
scription, a sufficient number of recoveries for avermectin B1a in orange peel, grapefruit peel and
ck
pa
lemon peel at two concentration levels is required. With regard to the use as method for storage
ta
stability trial by Cobin (1987): until additional data are supplied and considered sufficient, this
da
n
method generates only provisional results.

io
at
• Method 10001 Rev.1 is at the moment insufficiently validated. Additional recovery data for at least
alu
2 concentration levels per analyte with a sufficient number of recoveries within the recovery limits
ev
EC
to cover the appropriate measurement range, and information on matrix interference (raw data on
n
control samples) are required. With regard to the use as method for storage stability trials: until
fa
to
additional data are supplied and considered sufficient, this method generates only provisional re-
ar
sults.
sp
m
• Method 8001 is at the moment insufficiently validated. Additional recovery data for at least 2 con-
or
tf
centration levels per analyte with a sufficient number of recoveries within the recovery limits to
en
cover the appropriate measurement range are required. With regard to the use as method for
m
cu
storage stability trials: until additional data are supplied and considered sufficient, this method
do
generates only provisional results.

is
Th
:
NG
NI
AR
W
Mon Feb 05 03:52:00 CET 2018

t.
en
m
211
cu
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•
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A method in (whole) blood is required because abamectin is classified as very toxic.
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4.6 Toxicology and metabolism
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th
on
e d
4.7 Residue data
nt
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• Storage stability data on avermectin B1a, avermectin B1a 8,9-Z isomer and avermectin B1b are
eg
tb
required for commodities with a combination of high water and high acid content, e.g. citrus, for a
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period of at least 11 months.
t
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• Six more residue trials on lettuce according to the glasshouse application in Northern Europe are
m
n
required.
tio
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st
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4.8 Environmental fate and behaviour
Re
n.
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lat
iso
4.9 Ecotoxicology
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• A further refinement of the risk for mammals regarding the use of abamectin in lettuce should be
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performed.
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Th
:
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Mon Feb 05 03:52:00 CET 2018

Abamectin DAR 01 Vol 1 Public

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Draft Assessment Report (DAR)

Initial risk assessment provided by the rapporteur Member State

Mon Feb 05 03:52:00 CET 2018

Rapporteur Member State: The Netherlands

of the possible inclusion of abamectin in Annex I of Council Directive 91/414/EEC

Mon Feb 05 03:52:00 CET 2018

2.3 Impact on human and animal health 18

2.5 Fate and behaviour in the environment 43

2.6 Effects on non-target species 79

Appendix 1 Part 1: Standard terms and abbreviations 140

Part 2: Organisations and Publications 147

Part 3: Preparation (formulation) types and codes 149

Appendix 2 Specific terms and abbreviations 153

Appendix 3 Endpoints 157

Level 3 Proposal for the decision 205

3.1 Background to the proposed decision 206

3.2 Proposed decision 207

3.3 Rationale for the proposed decision 207

Level 4 Demand for further information 209

Mon Feb 05 03:52:00 CET 2018

STATEMENT OF THE SUBJECT MATTER AND PURPOSE OF THE MONOGRAPH

Mon Feb 05 03:52:00 CET 2018

Avermectin B1b 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-avermectin A1a

1.3.4 Manufacturer's development code number (Annex IIA 1.5)

Avermectin B1a NOA 422601

Avermectin B1b NOA 421704

1.3.5 CAS, EEC and CIPAC numbers (Annex IIA 1.6)

CAS number: 71751-41-2 abamectin

65195-55-3 avermectin B1a

65195-56-4 avermectin B1b

CIPAC number: 495 abamectin

EINECS number: 265-610-3 avermectin B1a

265-611-9 avermectin B1b

Mon Feb 05 03:52:00 CET 2018

Mon Feb 05 03:52:00 CET 2018

Mon Feb 05 03:52:00 CET 2018

packed in a high density polyethylene container.

2.1.3 Details of uses and further information

action, by stimulation of γ-aminobutryric acid release, which acts as an inhibitory neurotransmitter.

2.1.4 Classification and labelling

Physical chemical properties

Based on the result no classification or labelling is proposed.

Mon Feb 05 03:52:00 CET 2018

that in the highest dose group less females had litters.

Indications of danger : category 2/category 3

Safety phrases : S36/S37: Wear suitable protective clothing and gloves.

S38: In case of insufficient ventilation, wear suitable respiratory equipment.

S53: Avoid exposure – obtain special instructions before use.

Mon Feb 05 03:52:00 CET 2018

Indications of danger : harmful

Risk phrase : R22 “harmful if swallowed”

Justification for the proposal: LD50 in rat is 300 mg/kg bw

Indications of danger : harmful

Risk phrase : R20 “harmful by inhalation”

Justification for the proposal: LC 50 in rat is 3.1 mg/L/4h

Indications of danger : irritant

Risk phrase : R36 “irritating to eyes”

Indications of danger : irritant

Risk phrase : R43 “may cause sensitization by skin contact”

Justification for the proposal: positive in GPMT test

Indications of danger : category 2/ category 3

Mon Feb 05 03:52:00 CET 2018

the aquatic environment (R53).