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IUCLID 5 Guidance and support

Getting Started

Volume: 2
June 2007
IUCLID 5 has been developed by the European Commission in association with the OECD

LEG L !"#ICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information ! wealth of additional information on the European Union is available on the Internet It can be accessed through the Europa "erver #http$%%europa eu&

' European Communities( )**+ ,eproduction is authorised provided the source is ac-nowledged Printed in Italy

Getting Started with IUCLID 5

Getting started - Sample session for beginners


This Getting Started manual is an excerpt from the IUCLID 5 End User Manual, chapter C To re!ie" an# references to chapters other than chapter C, see the full manual

1. Introduction to sample session


The guidance gi!en in this Getting Started manual aims at assisting the no!ice IUCLID user to set up the application and use it immediatel# "ithout ha!ing to read the details pro!ided "ith the full !ersion of the IUCLID 5 End User Manual first The references to specific chapters of the full !ersion are intended as hints for "here to find more details This session is $ased on the follo"ing parts%

The First steps wizard which guides you through the different steps involved to setting up your application so that you can use it i chapter " Starting IUCLID 5! First steps wizard#

ediately! see

$ self%tutorial sa ple session which guides you through the ost co on features needed for handling a Su&stance dataset' which is the central core of infor ation in IUCLID# This session is su&divided into the following chapters!

( Creating a dataset for a Su&stance and assigning a )eference su&stance * Co pleting a Su&stance dataset

*#+ ,ntering-editing data in sections + to ( *#" ,ntering-editing data in sections * to +(

5 .rinting the Su&stance dataset / Creating a Dossier 0 ,1porting the Su&stance dataset 2 I porting the Su&stance dataset

Getting Started with IUCLID 5

3 4a5ing annotations

3#+ $nnotating raw data 3#" $nnotating a Dossier

+6 Logging out

$ nu &er of real e1a ples are presented in this hands%on session# These e1a ples were ta5en fro different pu&lished datasets' &ut are not necessarily related to the sa ple su&stances used# In this respect' all e1a ples should &e considered as fictitious#

Note
The hands%on e1a ples ay not &e relevant for your particular su& ission# 7onetheless' it can &e helpful to carry out these self%tutorial e1ercises to get ac8uainted with the IUCLID functionality in general#

2. Starting IUCLID 5: irst steps !i"ard


9hen you start IUCLID for the first ti e' after installing it on your co puter' a First steps wizard will co e up' which guides you through the different steps involved to setting up your application so that you can use it i ediately# If the IUCLID application and your user account have &een set up &y your ad inistrator' you can s5ip this chapter# $ny user%related settings can also &e ade using the features descri&ed in the IUCLID 5 ,nd User 4anual chapter D#+/ 4anage Users' )ole' .references etc#' although for so e of the SuperUser rights are re8uired :see the IUCLID 5 ,nd User 4anual chapter D#+/#"#+ Difference &etween SuperUser and ;SuperUser; attri&ute<#

Important
This wizard helps to define a user account' which is a prere8uisite to wor5 with the application# This is not possi&le when logging in with the SuperUser account that is provided as ad inistrator account &y default# =efore running this wizard' a5e sure that at least the Legal entity infor ation of your Co pany-organisation is stored on your co puter in

"

Getting Started with IUCLID 5

the for of a IUCLID e1port file :for entity<#

ore infor ation' see the IUCLID 5 ,nd User 4anual chapter D#3#"#+ Creating an ;official; Legal ended to have the following files stored on your .C

Following infor ation can also &e uploaded at a later stage' &ut it is strongly reco already when you run this wizard!

,C Inventory :for details' see the IUCLID 5 ,nd User 4anual chapter D#+" Inventory :>iew ,C Inventory related infor ation< Inventory of )eference su&stances :for details' see the IUCLID 5 ,nd User 4anual chapter D#++ )eference su&stance :Create and update )eference su&stance related infor ation<<

Note
If you want to launch the wizard co ands# anually' log in as ;SuperUser; and fro the File enu select the Administrative tools and Initialise

To set up your IUCLID application for the first ti e and create a user account suita&le for every day wor5 and to assure that the installation was perfor ed correctly' follow these steps! +# Start IUCLID &y clic5ing the respective icon on your des5top

"# 9hen starting the application for the first ti e' the only user availa&le is the ad inistrator' na ed ;SuperUser;# Log in as ad inistrator &y entering the following :case%sensitive?< na es!

Userna e! SuperUser .assword! root

Getting Started with IUCLID 5

(# The First steps wizard co es up with general infor ation in Step +# Clic5 the Next &utton

Getting Started with IUCLID 5

*# Step "! If you have not changed the default password of the SuperUser to a ore secure password' the traffic light in the wizard screen will &e yellow# Select the Change SuperUser password chec5&o1' type the old password ;root; and then type the new password# Clic5 the Next &utton#

Getting Started with IUCLID 5

5# Step (! Select the i port file for the Legal entity :see introductory re ar5s a&ove< and then clic5 the Next &utton# The Legal entity will &e i ported i ediately#

Important
7ote that you have to i port at least one Legal entity in order to succeed with this wizard# If you have no Legal entity in the IUCLID syste ' the traffic light in the wizard screen will &e red# The First steps wizard will &e auto atically launched when you log in IUCLID' until a Legal entity has &een successfully i ported#

Getting Started with IUCLID 5

/# Step *! Select the file for the ,C inventory :see introductory re ar5s a&ove<# The ,C Inventory will not &e i ported i ediately# The i port will start at the end of the First steps wizard# Depending on your achine speed and the size of the inventory' this i port ay ta5e so e ti e' i#e# up to half an hour#

Getting Started with IUCLID 5

0# Step 5! Select the file for the )eference su&stance inventory :see introductory re ar5s a&ove<# The )eference su&stance inventory will not &e i ported i ediately# The i port will start at the end of the first steps wizard together with the ,C Inventory i port# Depending on your achine speed and the size of the inventory' this &ul5 operation ay ta5e a very long ti e# The )eference su&stance inventory itself ay ta5e up to several hours for i port?

Note
If you do not wish to i port the co plete )eference su&stances inventory into your IUCLID syste ' individual )eference su&stances files are availa&le for download at the IUCLID we& site#

Getting Started with IUCLID 5

2# Step /! Create a new user account and assign a role to this user' which defines the user@s access rights to the data# It is necessary to create a new user as wor5ing with the SuperUser is not supported#

Select the Create user chec5&o1# Fill in all fields# The user needs a Login name for identification during login# The Full name is used for proper user identification# The Assigned role is needed to ad inistrate the access per issions :in a newly installed IUCLID 5 the roles ;$d inistrator;' ;Full access; and ;)ead%only; are provided &y default<#

,nter a Login name' as it should &e used for identification during login' and the Full name used for proper user identification#

Getting Started with IUCLID 5


Aptionally' clic5 Set password and define a password# Clic5 and highlight a role in the list of unassigned roles and assign it to the user &y clic5ing the )ight arrow# $ssigning a )ole is needed to ad inistrate the access per issions :in a newly installed IUCLID' the roles ;$d inistrator;' ;Full access; and ;)ead%only; are availa&le &y default<#

Tip
It is reco ended to create a User with the ;$d inistrator; )ole regardless of whether a stand alone or a distri&uted version of IUCLID is set up# Ance a User has &een created' the IUCLID $d inistrator :in case of a distri&uted version< can define different other User:s< and assign different )ole:s< to the :see the IUCLID 5 ,nd User 4anual chapter D#+/#+ .rinciples of ad inistration tools for user settings <#

$ssign a Legal entity :nor ally the Legal entity i ported in the third step of this wizard< &y clic5ing the green plus &utton and perfor ing a search for the desired Legal entity# In the Buery field Legal entity name' enter the na e of the desired Legal entity or an asteris5 :C< as wildcard and clic5 the Search &utton# In the Buery results list' clic5 the desired entry and then clic5 the Assign &utton# Aptionally' select default attach ent and i port-e1port directories# These settings can &e ade at a later stage as descri&ed in the IUCLID 5 ,nd User 4anual chapter D#+/#5 Feature ;User .references;! Dow to set User .references # Clic5 the Next &utton

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Getting Started with IUCLID 5

3# Step 0! If you have selected an ,C Inventory and-or )eference su&stances inventory file:s< during the wizard steps' you can now run the i ports# Clic5 the Execute imports &utton# 7ote again that these i ports ay ta5e up to several hours' depending on your achine speed and the a ount of data you are i porting# Then clic5 the Finish &utton# If you have launched any i ports' you will now have to wait until the i ports are co pleted# $fterwards' you should

++

Getting Started with IUCLID 5

log out and then log in again as a user for the newly defined account :re e &er! wor5ing as SuperUser is not supported<#

#. Creating a dataset for a Substance and assigning a $eference substance


The tutorial in this chapter shows how to create a Su&stance dataset and assign a )eference su&stance to it#

Introduction
In IUCLID' there are three i portant parts related to the identification of a Su&stance!

,C Inventory! This is the che icals identifiers catalogue which is centrally anaged and provided &y the ,uropean Co Che icals $gency# The IUCLID feature ,C Inventory allows &rowsing this catalogue' provided it was downloaded fro the IUCLID 5 ,nd User 4anual chapter D#+" Inventories :>iew Inventory related infor ation< #

ission - ,uropean the IUCLID we& site# See

)eference su&stance inventory! This is a local inventory anaged and upgraded &y the users on their IUCLID installations as appropriate# See the IUCLID 5 ,nd User 4anual chapter D#++#+ )eference su&stance inventory # +"

Getting Started with IUCLID 5

Note
$n inventory of ca# 06'666 )eference su&stances listed in the ,C inventory can &e downloaded fro i ported into your IUCLID syste #

the IUCLID we& site and

Su&stance dataset! This is the central core of infor ation in IUCLID# It contains all data related to a che ical su&stance li5e the che ical identity including the su&stance co position' infor ation on anufacture' use and e1posure' infor ation on the classification and la&elling' and all re8uired and availa&le endpoint study su aries# $ Su&stance dataset is the repository of data' which is used to create a Dossier for the su& ission su&stance# See the IUCLID 5 ,nd User 4anual chapter D#* Su&stance :Create and update su&stance related infor ation< #

9hen a Su&stance dataset is created for a given che ical su&stance' it is assigned to a )eference su&stance' which in turn is &ased on the ,C Inventory or' if not listed' newly defined# The difference &etween the :su& ission< su&stance after which a Su&stance dataset is na ed and the assigned )eference su&stance is &riefly e1plained &ased on the following e1a ples of :i< a ono%constituent su&stance and :ii< a ulti%constituent su&stance!

Diethyl pero1ydicar&onate!

)eference su&stance E Diethyl pero1ydicar&onate as listed in ,C inventory' with the following identifiers! ,C "(2%060%(' C$S +*///%02%5' C/D+6A/ Su& ission su&stance E e#g# Diethyl pero1ydicar&onate' i#e# na ed after the )eference su&stance as ain constituent' &ut includes isododecane as sta&ilizing agent and' hence' an additive together with i purities which need to &e specified in section 1.2 Composition# The typical concentration of diethyl pero1ydicar&onate in this su&stance is ""F with an upper li it of "0F#

4i1ture of +'*%di ethyl&enzene' +'"%di ethyl&enzene and +'(%di ethyl&enzene!

)eference su&stance E 4i1ture of +'*%di ethyl&enzene' +'"%di ethyl&enzene and +'(%di ethyl&enzene' with the following identifiers! ,C "+5%5(5%0' C$S +((6%"6%0' C2D+6 Su& ission su&stance E e#g# 4i1ture of +'*%di ethyl&enzene' +'"%di ethyl&enzene and +'(%di ethyl&enzene' i#e# na ed after )eference su&stance as ain constituents' &ut with identification of all these constituents' i#e# +'*%di ethyl&enzene :(6%*6F<' +'"%di ethyl&enzene :"5% (5F<' +'(%di ethyl&enzene :"6%(6F<' and i purities :water' 5%+"F<#

+(

Getting Started with IUCLID 5

Workflow
The creation of a Su&stance dataset and co pletion of sections + to ( includes the following wor5flow!

Launch the 7ew Su&stance feature and define the Su&stance na e and the Legal entity owner# $ssign a )eference su&stance to the Su&stance dataset# In case of a newly created )eference su&stance' switch to the corresponding record and assign the respective identity fro )eference su&stanceG co plete other identifier fields# Switch &ac5 to the Su&stance# Co plete sections +' " and ( as appropriate# the ,C inventory to that

Step-by-step guide
The following step%&y%step guide is illustrated &y screenshots &ased on fictitious sa ple data# +# Select the co and New Substance either fro the IUCLID Tas5 panel or the File enu on the 4enu &ar#

"# The Su&stance wizard co es up and guides you through following steps!

,nter the user%defined na e of the Su&stance and clic5 the Next &utton#

+*

Getting Started with IUCLID 5

(# Select the Legal entity fro the drop%down list and clic5 the Finish &utton# :7ote! Use the Legal entity defined for your co pany or' if not availa&le yet' any other availa&le Legal entity created at the IUCLID we& site :i#e# ;official; Legal entity' L,A<# If necessary' a new Legal entity can &e created later on and assigned to this dataset# See the IUCLID 5 ,nd User 4anual chapter D#3#" Feature ;Legal entity;! Dow to create a Legal entity <#

*# The newly created Su&stance dataset is displayed in the Data entry window and ta&s Query results and Section tree appear in the 7avigation window# In case of a s aller onitor' you ay clic5 the Minimize &utton on the 7avigation &ar :circled in the screenshot &elow< to enlarge the Data entry window#

+5

Getting Started with IUCLID 5

5# To assign a )eference su&stance' clic5 the &utton Add re erence &utton appearing Buery dialogue &o1' proceed as follows!

in field Reference substance :see the screenshot a&ove<# In the

Case +! Search for the desired )eference su&stance# For e1a ple enter ;ethanol; or ;ethC; in the search field EC name and clic5 the Search &utton or press the ,nter 5ey# Case "! If the su&stance is not found' clic5 the 7ew &utton and enter an appropriate na e' e#g# ;ethanol;# Then clic5 the Finish &utton# :7ote! The )eference su&stance can also &e defined later using the corresponding feature :see the IUCLID 5 ,nd User 4anual chapter D#++#( Feature ;)eference su&stance % 7ew;! Dow to create a )eference su&stance < and assigned to this dataset#<

+/

Getting Started with IUCLID 5

/# If a new )eference su&stance has &een created' an ,C inventory and-or other identifiers should &e defined as follows!

Switch to the )eference su&stance feature &y clic5ing the !oto &utton

to the very right#

+0

Getting Started with IUCLID 5

0# $n e pty )eference su&stance record appears#

2# To assign the corresponding ,C inventory identity' if availa&le' press the Add re erence &utton to the very right and in the Buery dialogue appearing' search for the su&stance and clic5 the Assign &utton# :7ote! If data entry is loc5ed' clic5 the Edit &utton on the tool&ar#<

+2

Getting Started with IUCLID 5

3# ,C nu &er' ,C na e' C$S nu &er' 4olecular for ula and Description :if any< are auto atically entered in the )eference su&stance record# Hou ay co plete any other fields :e#g# C$S na e' IU.$C na e' Synony s' S4IL,S notation< now or later#

=y clic5ing the "ac# &utton on the tool&ar' you can then navigate &ac5 to the Su&stance dataset# The identifier fields of the assigned )eference su&stance are displayed#

+3

Getting Started with IUCLID 5

+6# The newly created Su&stance dataset is now related to a )eference su&stance and you can close the dataset &y clic5ing the !o $ome continue co pleting the dataset as instructed in chapter * Co pleting a Su&stance dataset#

&utton or

Tip
$lthough the )eference su&stance can &e assigned to a Su&stance any ti e' it is highly reco ended to do this right when creating the Su&stance dataset &ecause of the following reason! $s shown in chapter *#" ,ntering-editing data in sections * to +(' each ti e you create a new ,ndpoint study record' the field Test material identity is auto atically filled with the identifiers of the )eference su&stance# If the )eference su&stance is assigned later' this field will not &e auto atically updated# Instead' the su&stance identifiers would have to &e entered anually in each record#

%. Completing a Substance dataset


The tutorial in this chapter shows how to co plete sections of a Su&stance dataset# Sa ple data and instructions are given for

,ntering-editing data in sections + to ( :chapter *#+< ,ntering-editing data in sections * to +( :chapter *#"<

"6

Getting Started with IUCLID 5

Introduction
$ IUCLID dataset is structured into +( screenshot! ain sections# 4any of these sections are further &ro5en down to su&sections as e1e plified in the following

There is a stri5ing difference as regards data entry &etween sections + % ( and sections * %+( as follows!

Sections + % (! Data are entered directly into the su&sections and all sections + to ( are physically created# Sections * %+(! Data can only &e entered into ,ndpoint study records or ,ndpoint su

anaged as one record# 7o further records can &e

ary records' which have to &e created &y the user#

This is illustrated on the user interface &y different sy &ols! any title of su&sections within sections + to ( are preceded &y a green or red leaf sy &ol ' while any record in sections * to +( is indicated &y a green &ullet # For ore infor ation see the IUCLID 5 ,nd User 4anual chapter D#*#/#+ Differences &etween sections 6 % ( and sections * % +( #

Note
Section 0 Related Information contains special infor ation on Te plates' Categories and 4i1tures and is not considered in this sa ple session for &eginners' which e1plains the features and functions that are ost co only used for editing a Su&stance dataset &ased on hands% on e1a ples#

"+

Getting Started with IUCLID 5

Workflow
To edit and co plete a Su&stance dataset the following wor5flow applies!

Apen the Su&stance dataset# ,1pand the section tree to display the su&sections# Custo ise the view ode' i#e# display the sections re8uired for a given regulatory progra e#

Co plete sections +' " and ( as appropriate# Co plete the ,ndpoint sections * to +( as far as re8uired#

4.1. Entering editing data in sections 1 to !


Introduction

IUCLID sections + to ( co prise general and non%endpoint infor ation# The following type of infor ation is addressed!

Section 1 General information! General infor ation on the su&stance includes its che ical identity as represented &y the associated )eference su&stance' its co position' its various &usiness relationships :identity of sponsors' suppliers or recipients and e &ers of a Ioint su& ission-consortiu <' identifiers assigned &y regulatory progra es :e#g# ),$CD registration nu &er< and other IT syste s :e#g# IUCLID * reference<' analytical infor ation and spectral data' and infor ation on product and process oriented research and develop ent :if applica&le<# For ore infor ation' see the IUCLID 5 ,nd User 4anual chapter ,#+ Section +! General Infor ation# Section 2 Classification and labelling! The classification and la&elling infor ation can &e added to this section according to the Glo&ally Dar onised Syste for Classification and La&elling :GDS< and -or according to the ,uropean Directives :/0-5*2-,,C for su&stances and +333-*5-,C for preparations< and a end ents and adoptions thereof# For ore infor ation' see the IUCLID 5 ,nd User 4anual chapter ,#" Section "! Classification and La&elling#

""

Getting Started with IUCLID 5

Section 3 Manufacture, use and exposure! Infor ation stored in this section includes the following! infor ation on the anufacturing ethods' esti ated 8uantities of production' i port and use' production-use sites' availa&ility in the supply chain' uses and e1posure scenarios' waste production' and che ical co pounds resulting fro the production or use of the su&stance# For ore infor ation' see the IUCLID 5 ,nd User 4anual chapter ,#( Section (! 4anufacture' Use and ,1posure #

Note
Section 6 )elated infor ation is actually not a data entry section' &ut provides eans to relate other IUCLID ele ents to a dataset or indicates any related infor ation' i#e# Te plates' 4i1tures' Categories :see the IUCLID 5 ,nd User 4anual chapter =#*#"#+ General and non%endpoint infor ation <#
Step-b&-step guide

The following step%&y%step guide is illustrated &y screenshots &ased on fictitious sa ple data# +# Select the co and %pdate Substance fro the IUCLID Tas5 panel#

"# $ screen co es up with an e pty Data entry window on the right side and a Query results pane on the left :&elow the title &ar Navigation< showing all su&stances availa&le in your local IUCLID installation or the networ5 you are connected to# Dou&le%clic5 the desired Su&stance :left ouse &utton< to open the corresponding dataset# If there is a large nu &er of Su&stances listed' run a 8uery as descri&ed in the following the IUCLID 5 ,nd User 4anual chapter D#*#(#" Buerying for a Su&stance in the Buery results pane # :7ote! Hou can also open the dataset fro the conte1t enu that co es up on right%clic5ing the Su&stance#<

"(

Getting Started with IUCLID 5

(# 9hen the Su&stance dataset is opened' the 7avigation window provides' ne1t to the Query results ta&' a second ta&' i#e# the Section tree# Clic5 it to switch to the Section tree pane# Get ac8uainted with following features!

Expand section tree! Clic5 the &lus sy &ol in front of any section :e#g# 1 General Information< or the arrow ne1t to the Find pane circle in the screenshot &elow< and fro the drop%down list &o1 select Expand all #

:red

"*

Getting Started with IUCLID 5

'iew mode selector! Clic5 the &lac5 arrow ne1t to the view ode indicator :Iust &elow the Buery-Section tree ta&s< to open a drop%down list &o1 for selecting the view ode# =y default' the view ode ;Co plete; is set# Select another ode as appropriate' e#g# ;),$CD )egistration + % +6 tonnes' standard re8uire ents;# The section tree then changes in such a way that the &oo5 sy &ols in front of the sections re8uired for such a registration or su& ission are coloured red' while the sy &ol for all optional sections re ains green# So e sections' which do not apply :i#e# &iocides%related sections< are e1cluded#

"5

Getting Started with IUCLID 5

*# In IUCLID section 1.1 Identification' co plete the fields under headings Role in the supply chain' Type of substance' Trade name and Contact person' as illustrated in the screenshot a&ove#

"/

Getting Started with IUCLID 5

Tip
Throughout the IUCLID sections' flags dialogue &o1es are provided either related to specific parts :e#g# Trade names flag and Person flag in the screenshot a&ove< or to an entire record# These dialogue &o1es have always the sa e design and include &oth the Confidentiality flag and Regulatory purpose flags' which can &e used to filter out the flagged data in su&se8uent operations such as e1porting' printing or Dossier creation# For e1a ple' set flags ;C=I; :confidential &usiness infor ation< and ;,U! ),$CD; for Trade names flag#

"0

Getting Started with IUCLID 5

5# 7avigate to section !" Composition &y dou&le%clic5ing the respective section title in the Section tree pane :if necessary' clic5 the Maximise &utton on the 7avigation &ar or hover the ouse directly on the divider &etween the 7avigation and the Data entry window until the pointer changes to a dou&le%headed arrow# Then clic5 and drag the line to the left or right<#

"2

Getting Started with IUCLID 5

/# In section !" Composition' co plete the fields in the repeata&le &loc5' which allows to specify :needed for su&stances with e#g# different i purity profiles<!

ultiple co positions for the su&stance

Clic5 the $dd sy &ol

to e1pand the &loc5 Substance composition#

,nter the na e you wish to assign to this co position :or co position profile< and specify the typical degree of purity of the su&stance# Set the Confidentiality and-or )egulatory purpose flags related to the degree of purity if so re8uired :see the following screenshot<#

"3

Getting Started with IUCLID 5

0# Clic5 the Add sy &ol

to open the &loc5 Constituents#

Specify the constituent &y assigning the respective )eference su&stance' which is identical with that for the Su&stance in case of a ono% constituent :i#e# ethanol<# See step * :Case +< on assigning a )eference su&stance to the Su&stance in chapter ( Creating a dataset for a Su&stance and assigning a )eference su&stance# Co plete the fields Typical concentration and Concentration range in the Constituents &loc5# The field Remar#s can &e used for any relevant infor ation :e#g# for giving a &rief Iustification in case of deviation of the 26F rule for ulti%constituent su&stances<#

(6

Getting Started with IUCLID 5

2# Clic5 the Add sy &ol

to open the &loc5 $mpurities#

Specify the first i purity &y assigning the respective )eference su&stance :e#g# ethanol<# See steps * and 5 on assigning a )eference su&stance to the Su&stance# =e aware to clic5 the Edit &utton on the tool&ar if the )eference su&stance record is loc5ed# Fro the )eference su&stance record go &ac5 to the $mpurities &loc5' again clic5 the Edit &utton and co plete the fields#

(+

Getting Started with IUCLID 5

3# )epeatedly clic5 the Add sy &ol

for the &loc5s Constituents' $mpurities and-or Additi%es to record all su&stances as appropriate#

+6# Co plete any other su&sections of sections +' " and (# See guidance in the IUCLID 5 ,nd User 4anual chapter ,#+ Section +! General Infor ation ' ,#" Section "! Classification and La&elling and ,#( Section (! 4anufacture' Use and ,1posure' respectively#

4.". Entering editing data in sections 4 to 1!


Introduction

IUCLID sections * to ++ are also called ;,ndpoint sections;# In this conte1t' an endpoint is ("

eant as an infor ation re8uire ent or data point with regard to

Getting Started with IUCLID 5

the physico%che ical properties of the su&stance' environ ental fate and &ehaviour' ecoto1icological infor ation' to1icological infor ation and specific infor ation :e#g# residues in food and feedingstuffs< according to a given regulatory progra e' e#g# the standard infor ation re8uire ents set out in the ,U ),$CD $nne1es >I to JI# $ IUCLID ,ndpoint section provides the container for storing ;endpoint study; data' e#g# a study on vapour pressure to &e entered in section 4. !apour pressure or a study on repeated dose to1icity :oral< to &e entered in section ".#.1 Repeated dose toxicit$% oral# The ter ;study; has a rather generic eaning in that it refers to any e1peri ental study' &ut also to an esti ation or prediction ethod including :B<S$)' read%across' weight of evidence evaluation' data waiving or any other type of infor ation &eing relevant for a given infor ation re8uire ent# For ore infor ation see the IUCLID 5 ,nd User 4anual chapter =#*#"#" Su aries of study reports and other infor ation # The collection of endpoint%related infor ation in IUCLID is &ased on su arising descriptions of full study reports# These study su aries can &e very condensed or very detailed# Dowever' a study su ary should provide sufficient infor ation to a5e an assess ent of the relevance of the study# >ery detailed study su aries are also ter ed ;ro&ust study su aries;' if they address all relevant study ite s :see the IUCLID 5 ,nd User 4anual chapter =#*#"#"#(#+ Definition of 5ey studies' supporting studies' ro&ust study su aries <# In IUCLID' study su aries are anaged using ,ndpoint study records' which are te plates with predefined fields and freete1t pro pts intended to help the user su arise a study :see the IUCLID 5 ,nd User 4anual chapter D#*#0#+ 9hat is an ,ndpoint study recordK <# ,ach ,ndpoint study record of sections * to +6 is structured into the following ain parts!

$d inistrative data Data source 4aterial and ethods

)esults and discussion Averall re ar5s' attach ents $pplicant@s su ary and conclusions

Under these headings certain data entry fields are su&su ed which are co on to all ,ndpoint study records' in addition to endpoint%specific data entry fields# =ecause any fields are only relevant for ro&ust study su aries' a syste of detail levels has &een i ple ented in IUCLID# This allows displaying

((

Getting Started with IUCLID 5

either only the &asic fields or all fields :see the IUCLID 5 ,nd User 4anual chapter D#*#0#/ Switching &etween display type ;&asic fields; :detail level +< and ;all fields; :detail level "<<# $l ost all IUCLID ,ndpoint study records are odelled on the so%called A,CD har onised te plates' which are standard for ats for reporting endpoint study su aries related to any type of a che ical :e#g# pesticides' &iocides' industrial che icals< :see the IUCLID 5 ,nd User 4anual chapter D#*#0#+ 9hat is an ,ndpoint study recordK <# IUCLID does not prescri&e how detailed the study su aries should &e recorded# The fields provided should &e considered as a a1i u degree of detail# Alder study reports or literature sources often do not provide the details for which any fields pro pt for on a ro&ust study su ary level# An the other hand' ore recently conducted studies and any new studies can &e su arised in a very detailed anner# )efer to the relevant guidance for the respective che ical progra e on how detailed studies need to &e su arised# In the case of e1isting IUCLID * datasets prepared in the conte1t of the A,CD Digh .roduction >olu e Che icals .rogra e' ,U )is5 $ssess ent or for other purposes' which will &e used for ,U ),$CD' a prag atic approach ay have to &e considered to avoid unnecessary additional wor5 for adIusting these datasets to the new for at in IUCLID 5#

Note
Sections 11 Guidance on safe use' 12 &iterature searc' and 13 (ssessment Reports are not used for recording endpoint study su are also related to endpoint infor ation#
Step-b&-step guide

aries' &ut

The following step%&y%step guides are illustrated &y screenshots &ased on fictitious sa ple data#
Creating an 'ndpoint stud& record

+# Apen the Su&stance dataset as instructed in *#+ ,ntering-editing data in sections + to (# "# >erify if the view (<# ode ;),$CD )egistration + % +6 tonnes' standard re8uire ents; is selected :see chapter *#+ ,ntering-editing data in sections + to

(# Clic5 the .lus sy &ol in front of section 4 )'$sical and c'emical properties to display all su&su ed su&sections# (*

Getting Started with IUCLID 5

*# )ight%clic5 section 4.2 Melting point*free+ing point and fro

the

enu displayed' clic5 the New Endpoint study record co

and#

5# $ new record appears indicated &y a green &ullet # $ default record na e is generated and displayed &oth in the section tree pane and the record title&ar# This record na e consists of the section title followed &y a dot and a consecutive nu &er' e#g# ;4elting point-freezing point#66+;' as shown in the following screenshot#

(5

Getting Started with IUCLID 5

(/

Getting Started with IUCLID 5

$enaming an 'ndpoint stud& record

+# Select the record in the section tree pane and either press the F" 5ey or right%clic5 the record and fro co and# "# ,dit the record na e as appropriate and then clic5 AL#

the

enu displayed' clic5 the (ename

Tip
It can &e useful to add additional infor ation or even replace the default record na e &y infor ation that gives an overview of the value of that record on the fly# ,1a ple! ;Do el :+320<-5ey#66+; :indicates the $uthor and Hear and that the record contains a 5ey study<# For ore infor ation see the IUCLID 5 ,nd User 4anual chapter D#*#0#( )ena ing an ,ndpoint Study )ecord #
'ntering (andboo) data for section %.2 *elting point+free"ing point

This use case includes the entry of :li ited< hand&oo5 data# It is assu ed that the data are fro a trusted source and can therefore &e used as 5ey study# :7ote! )efer to the relevant guidance docu ent for the regulatory progra e as to whether hand&oo5 data are accepted to cover endpoints for physico% che ical properties#< +# The newly created record in section 4.2 Melting point*free+ing point should &e open and displayed in the Data entry window# If not' dou&le%clic5 the record in the Section tree#

Tip
$ny newly created record will auto atically &e in the ,dit the tool&ar# ode# 9hen you re%open a record' you need to clic5 the Edit &utton on

"# .art ;$d inistrative Data;! co plete the appropriate fields as shown in the following screenshot!

(0

Getting Started with IUCLID 5

(# .art ;Data Source;! In field &loc5 Reference' clic5 the Add &utton and in the dialogue opened' select the )eference type and enter the &i&liographic reference infor ation as shown in the following screenshot# Ather fields in this part are not applica&le#

(2

Getting Started with IUCLID 5

*# .art ;4aterials and

ethods;! The only field that can &e co pleted in this e1a ple is the field &LP compliance#

(3

Getting Started with IUCLID 5

5# .art ;)esults and discussions;! In field &loc5 'elting ( free)ing point' clic5 the Add &utton and in the dialogue opened' enter the freezing point in degree Centigrade# If re8uired' repeat this procedure and enter the corresponding value in 5elvin#

/# If you continue creating another ,ndpoint study record' a dialogue will as5 you to save the

odified data# Confir

&y clic5ing the Save &utton#

*6

Getting Started with IUCLID 5

Important
If you discontinue wor5ing with IUCLID for a longer ti e :i#e# ore than two hours<' it is reco ended to clic5 the Save &utton on the tool&ar to a5e sure that the data entered are saved# Atherwise a session ti eout ight occur causing IUCLID to stall# The data could then not &e saved any ore#
'ntering t(e basic data of a stud& in section ,.1.1 S(ort-term to-icit& to fis(

This use case includes the entry of the &asic data of a study in an ,ndpoint study record# It is assu ed that only li ited infor ation is availa&le fro a pu&lication and and e1ecutive su ary of a study report# =ut the study report itself is not availa&le yet# This use case is intended to de onstrate the Detail level switch' how to use &asic fields only' launching the online help' handle a co prehensive drop%down list' use a Freete1t te plate and the Undo function# +# Create a new ,ndpoint study record in section .1.1 ,'ort-term toxicit$ to fis'# "# )ena e the record to ;Dorgerloh :+33"<; (# Clic5 the Detail level &utton &elow the record title &ar and fro the enu displayed' select ;&asic fields;#

Note
$s descri&ed in the IUCLID 5 ,nd User 4anual chapter D#*#0#+ 9hat is an ,ndpoint study recordK ' IUCLID allows displaying either *+

Getting Started with IUCLID 5

the &asic fields only or all fields' i#e# including additional fields' which are nor ally only relevant for ro&ust study su field la&els of any additional fields are set in &lue colour' while the la&el of all &asic fields is &lac5#

aries# The

*# .art ;$d inistrative Data;! In field Study result type' select ;e1peri ental study;# In field Study period' enter ;+33+; as assu ingly indicated in the pu&lication# Ather fields are left e pty for the ti e &eing#

5# .art ;Data Source;!

In field &loc5 Reference' enter the two references shown in the screenshot!

Launch the conte1t%sensitive online help fro

within any field via the F+ 5ey or &y clic5ing the $elp &utton

on the tool&ar#

Custo ise the size of the Delp window as appropriate :If you need to loo5 up online help for fields fre8uently' it can &e useful to position &oth the Delp window and the IUCLID screen in such a way that &oth windows are visi&le without having to switch &ac5 and forth# Dowever' the conte1t%sensitive help for each field has to &e e1plicitly evo5ed &y pressing the F+ 5ey or clic5ing the $elp &utton *"

Getting Started with IUCLID 5

#<

,nter the &i&liographic data as appropriate# ;data pu&lished;#

In field *ata access' select the ite

/# .art ;4aterials and

ethods;!

,nter the guideline given in the data source! Select ;according to; in the field +ualifier# Select ;other guideline; in the field &uideline' &ecause the guideline used is not listed in the pic5list' and enter ;DI7 (2*+" L+5; in the associated te1t field#

*(

Getting Started with IUCLID 5

Indicate that this guideline is e8uivalent to A,CD Guideline "6(! )epeat this procedure' &ut select the appropriate ite s fro shown in the screenshot &elow# Select ;yes; in the field &LP compliance#

the pic5lists as

0# .art ;Test

aterials;!

Fields related to the identity of the test aterial are filled auto atically &ased on the )eference su&stance assigned to the Su&stance dataset :see chapter ( Creating a dataset for a Su&stance and assigning a )eference su&stance<# Hou can add any additional identifiers#

Note
If the study was conducted with another than the su& ission su&stance :i#e# as identified &y the )eference su&stance< and used as read%across' you would have to update these fields accordingly#

Field *etails on test material! Clic5 the puzzle%li5e icon &elow the field la&el# In the Freete1t te plates dialogue &o1 that opens' edit the Freete1t te plate provided in such a way that only the ite ;% $nalytical purity!; is 5ept' while all other ite s are deleted# Specify as shown in the screenshot &elow# **

Getting Started with IUCLID 5

Co plete the fields Analytical monitoring :;yes;< and ,ehicle :;no;<#

2# .arts ;Test organis s;' ;Study design; and ;Test conditions;! ,nter the &asic data as shown in the screenshot &elow#

Tip
In case of very co prehensive pic5lists provided in a drop%down co &o &o1' you can find the desired ite the following ethods!

8uic5ly &y using either of

Clic5 the drop%down arrow and in the pic5list that opens' clic5 into the Find pane and enter an ade8uate part of the ite # For e1a ple' ; y; will i ediately find any ite that contains this string' e#g# ;Ancorhynchus y5iss;# Hou need not use *5

Getting Started with IUCLID 5

wildcards :C< and such on the%fly 8ueries are not case%sensitive#

Must start typing the ite of your choice in the list field# The autofill function of IUCLID will display the first entry in the list starting with the letter:s< you enter# For e1a ple' typing ;A; or ;o; will e1tend to ;Ancorhynchus gor&uscha;# 9hen you then clic5 the drop%down arrow' the first entry in the list starting with that-these letter:s< will &e displayed directly and you can find the desired ite :e#g# ;Ancorhynchus y5iss;< right away#

3# .art ;)esults and discussions;! In the field &loc5 Effect concentrations' clic5 the Add &utton and in the dialogue opened' enter the LC56 value and the para eters shown in the following screenshot!

*/

Getting Started with IUCLID 5

+6# .art ;Averall re ar5s' attach ents;! 7othing to add for this sa ple study# ++# .art ;$pplicant@s su te1t field# ary and conclusion;! In field ,alidity criteria fulfilled' select ;yes; and add a &rief e1planation in the related

Tip
In print%outs' the supple entary te1t field related to the list field is not separated &y any deli iter# This ight cause confusing te1t co &inations# It is therefore reco ended to include any supple entary te1t in parentheses to get it set aside fro the list ite # This is not re8uired if the pic5list ite end with a colon as for ;other!;#

*0

Getting Started with IUCLID 5

+"# Test the Undo function! Delete the entry in field ,alidity criteria fulfilled &y selecting the &lan5 ite # Then clic5 the %ndo &utton on the tool&ar# The previous pic5list ite will &e re%entered' &ut not the related te1t field#

Note
Using the Undo co and' the ost recent edit operations can &e undone in de onstrated with the e1a ple a&ove#
Cop&ing an 'ndpoint stud& record

ost cases# There are a few e1ceptions to this rule as

Use case! To de onstrate the Copy function it is assu ed that the ,ndpoint study record prepared in the sa ple a&ove shall &e e1panded to a ro&ust study su ary' while the first draft record shall &e stored# .roceed as follows! +# )ight%clic5 the record ;Dorgerloh :+33"<; in the section tree pane and fro the enu displayed' clic5 the )opy co and#

*2

Getting Started with IUCLID 5

"# The clip&oard

anager is opened and the copied record is displayed# &utton# The record will then appear in the section tree

(# Select and highlight the copied record in the clip&oard and clic5 the &aste selected items under the sa e na e as the orginal one#

*# )ena e one record to ;Dorgerloh :+33"<-draft :&asic data<; and the other one to ;Dorgerloh :+33"<-5ey;#

*3

Getting Started with IUCLID 5

.rdering 'ndpoint stud& records

Use case! )eorder records in the section tree to position the record designated as ;5ey study; first :useful in case of .roceed as follows! +# )ight%clic5 the section title .1.1 ,'ort-term toxicit$ to fis' and fro the

any records per ,ndpoint section<# and#

enu displayed' clic5 the *rder records co

"# In the dialogue &o1' highlight the record designated as ;5ey study;' clic5 the Move up arrow to position it first and then clic5 *+# (# The 5ey study then appears as first record#

56

Getting Started with IUCLID 5

/uic)l& finding specific 'ndpoint stud& records in t(e section tree

Use case! ,specially if a section contains a large nu &er of ,ndpoint study records' the 8uery - filter records# To 8uery and find a record +# Clic5 into the Find or Filter pane &elow the title &ar of the section tree pane#

ethod should &e used to 8uic5ly filter for specific

"# ,nter an ade8uate part of the record na e and all records containing this search string in their na es will &e filtered out and displayed i ediately# For e1a ple' ;Dor; :without 8uotation ar5s< will select records starting with this string# ;DorC5ey; will find the record ;Dorgerloh :+33"<-5ey;#

Tip
Use wildcards :C< for any characters preceding or following a search string#
'ntering additional data for a robust stud& summar& in section ,.1.1 S(ort-term to-icit& to fis(

Use case! It is assu ed that the full study report is now availa&le and can &e used to prepare a ro&ust study su ary# This use case is intended to de onstrate the Detail level ;all fields;' the 7avigation lin5s to the ain parts of an ,ndpoint study record' the use of co prehensive Freete1t te plates' sorting of ite s in repeata&le &loc5s of fields' using a rich te1t field and uploading a predefined ta&le' and other edit functions# 5+

Getting Started with IUCLID 5

+# Find the record ;Dorgerloh :+33"<-5ey; in the section tree and dou&le%clic5 it to open it# "# Clic5 the Edit &utton on the tool&ar to allow editing of the record# the enu displayed' select ;all fields;#

(# Clic5 the ,etail level &utton &elow the record title &ar and fro

*# .art ;$d inistrative Data;! Co plete the field Purpose flag' select the chec5&o1 for ;ro&ust study su ary; and specify the study period in the corresponding field as shown in the following screenshot# :7ote! Fields Reliability and Rationale for reliability will &e co pleted later' when the study has &een evaluated and the ro&ust study su ary is co pleted#<

5# .art ;Test

aterials;!

$dd additional infor ation in field *etails on test material# Clic5 the Freete1t te plate icon &elow the field la&el# In the Freete1t te plates dialogue &o1 that opens' edit the Freete1t te plate provided in such a way that only the needed ite s are 5ept' while all other ite s are deleted# Specify as shown in the screenshot &elow# 5"

Getting Started with IUCLID 5

Field Confidential details on test material! Select the ite ;% Lot-&atch 7o#!; fro the Freete1t te plate and add data as shown in the screenshot &elow# :7ote! $ny infor ation that can &e clai ed confidential :e#g# co position' i purities' lot-&atch no#< should &e included in this field' &ecause this will allow to filter out such data fro any print%out or e1port file#< Field *etails on properties of test surrogate or analogue material! Leave this field e pty' &ecause it is only relevant in case of read%across fro another su&stance' e#g# an analogue or surrogate#

/# .art ;Test organis s;' field *etails on test organisms! Select and edit the Freete1t te plate as shown in the following screenshot#

Tip
Clic5 the %n old button on the upper right of the field to e1pand the field or the Fold button to ini ise the display area#

5(

Getting Started with IUCLID 5

0# .art ;Test conditions;! Co plete the fields -ardness' Test temperature' p-' *issol%ed o.ygen' and /ominal and measured concentrations as shown in the following screenshot#

5*

Getting Started with IUCLID 5

2# .art ;Test conditions; :cont@d<' field *etails on test conditions! Select and edit the Freete1t te plate as shown in the following screenshot#

55

Getting Started with IUCLID 5

3# Field Any other information on materials and methods incl! tables! Upload a predefined or other availa&le ta&le into this rich te1t field as follows!

Clic5 the *pen ile &utton Fro

on the tool&ar of the rich te1t editor#

the *pen dialogue &o1 displayed' select the file you wish to upload into the field' and then clic5 the *pen &utton#

,dit the ta&le as appropriate#

5/

Getting Started with IUCLID 5

+6# .art ;)esults and discussions;! $dd additional effect concentration data in the field &loc5 Effect concentrations and details in the field *etails on results as shown in the following screenshot!

50

Getting Started with IUCLID 5

++# .art ;$d inistrative Data;! The fields Reliability and Rationale for reliability still need to &e co pleted &ased on the inherent 8uality of the test report or pu&lication and hence' the ade8uacy of data# .roceed as follows!

Clic5 the lin5 ;$d inistrative data; in the navigation &ar Iust &elow the title &ar to Iu p directly to that part#

Tip
Using the lin5s on the navigation &ar is particularly helpful in case of very co prehensive ,ndpoint study records or if you prefer to start editing or viewing with a particular part' e#g# ;)esults and discussion;#

Co plete the fields Reliability and Rationale for reliability as shown in the following screenshot# Clic5 the lin5 ;$pplicant@s su ary and conclusions; to Iu p to that part and proceed#

52

Getting Started with IUCLID 5

+"# .art ;$pplicant@s su

ary and conclusion;!

53

Getting Started with IUCLID 5

/6

Getting Started with IUCLID 5

5. 0rinting t(e Substance dataset


The tutorial in this chapter shows how to print

an ,ndpoint study record with &asic fields only an ,ndpoint study record with all fields the co plete Su&stance dataset

Step-by-step guide
To print the sa ple ,ndpoint study record ;Dorgerloh :+33"<-5ey; with &asic fields only +# )ight%clic5 this record in the section tree or select the &rint co and fro the File enu#

"# The .rint assistant co es up and guides you through several steps of a self%e1planatory .rint dialogue! >erify or change the default properties' for which the record shall &e printed# In Step 5' select the detail level ;=asic level;# Specify output path' file na e and other print options' and clic5 the Finish &utton# (# Apen the ht l file fro for viewing it# aterial infor ation;#

To print this record with all fields' follow the sa e procedure' e1cept for selecting detail level ;$ll fields % including confidential test To print the co plete dataset

+# Dou&le%clic5 any record in sections 6 to (# 4a5e sure one of the su&sections is displayed in the data entry window' e#g# section 1.1 Identification# "# Select the &rint co and fro the File enu#

(# The .rint assistant co es up and guides you through several steps of a self%e1planatory .rint dialogue! >erify or change the default properties' for which the records shall &e printed' specify output path' file na e and other print options' and clic5 the Finish &utton#

/+

Getting Started with IUCLID 5

The following screenshot show part of the print%out of the sa ple ,ndpoint study record!

/"

Getting Started with IUCLID 5

/(

Getting Started with IUCLID 5

The co plete print%out is shown in the IUCLID 5 ,nd User 4anual chapter D#*#0#+( .rinting ,ndpoint study records#

,. Creating a Dossier
The tutorial in this chapter shows how to create a Dossier' which is very si ilar to the creation of a print%out#

Introduction
$ Dossier is a write%protected copy of the raw data stored in a Su&stance dataset# $n Awnership protection option can &e set' which prevents ,ndpoint study - su ary records provided with a Dossier fro &eing copied# This can &e relevant if a Dossier is ade availa&le to another party' &ut the su& itter does not want to allow copying ,ndpoint records# For further details' see the IUCLID 5 ,nd User 4anual chapter D#2 Dossier :create Dossier and &rowse Dossier data< #

Step-by-step guide
To create a Dossier for a Su&stance datset' follow these steps! +# Go Do e to the Tas5 panel if you are not already there# ' clic5 %pdate# the enu displayed' clic5 the )reate dossier

"# Under Substance

(# In the Query results pane' right%clic5 the desired Su&stance :i#e# the sa ple dataset< and fro co and#

*# The Create dossier assistant co es up and guides you through a several steps dialogue! >erify or change the default properties :i#e# for which the records shall &e included in the dossier<' specify specific dossier infor ation' and clic5 the Finish &utton# 5# The Dossier created appears in a new ta& of the 7avigation window' called Co ponents# ,ach co ponent of a Dossier is listed' i#e#!

The Dossier itself!

/*

Getting Started with IUCLID 5

The Dossier title includes the Dossier te plate type' the na e of the Su&stance - )eference su&stance' the C$S 7o#' Legal entity' date and the user%defined na e# The Dossier infor ation entered during the process of Dossier creation is displayed :read%only< in the Data entry window# Hou can directly navigate to the Dossier su&Iect# See the screenshot &elow# The Dossier%related Infor ation window#

The source Su&stance dataset# The )eference su&stance referred to in the Su&stance# The Legal entity the Su&stance is assigned to#

The following screenshot shows an e1a ple of Dossier co ponents and Dossier infor ation!

/5

Getting Started with IUCLID 5

//

Getting Started with IUCLID 5

1. '-porting t(e Substance dataset


The tutorial in this chapter shows how to e1port a co plete Su&stance dataset or individual records#

Step-by-step guide
To e1port the co plete Su&stance dataset +# Clic5 the Buery results pane if it is not already active or select the co "# Select the Su&stance dataset to &e e1ported!

and %pdate Substance fro

the IUCLID Tas5 panel#

,ither right%clic5 it and fro

the

enu displayed' clic5 the Export co and fro the File enu#

and#

Ar clic5 it and then select the Export co

(# The ,1port assistant co es up and guides you through a several steps ,1port dialogue! >erify or change the default properties' for which the records shall &e e1ported' specify output path' file na e and other options' and clic5 the Finish &utton# To e1port individual record:s< of a Su&stance dataset +# )ight%clic5 the record na e in the section tree and fro the enu displayed' clic5 the Export co and##

"# The ,1port assistant co es up and guides you through a several steps ,1port dialogue! >erify or change the default properties' for which the records shall &e e1ported' specify output path' file na e and other options' and clic5 the Finish &utton# For ore infor ation' see the IUCLID 5 ,nd User 4anual chapter D#*#0#+* ,1porting ,ndpoint study records #

2. Importing t(e Substance dataset


The tutorial in this chapter shows how to i port a co plete Su&stance dataset or individual records#

/0

Getting Started with IUCLID 5

.rere8uisite is that you have a IUCLID e1port file stored on your co puter' e#g# as created in the preceding e1ercise :see chapter C#0 ,1porting the Su&stance dataset<# If you i port an already e1isting Su&stance dataset' any identical records will &e auto atically deselected &y default# To test the i port of a Su&stance dataset that is not yet availa&le on your IUCLID installation' you ay delete the Su&stance dataset after e1porting it :right%clic5 it in the Buery results pane and select the ,elete co and<#

Step-by-step guide
To i port a IUCLID e1port file of a Su&stance dataset +# Go Do e to the Tas5 panel if you are not already there# ' clic5 Import#

"# Under Import

(# The I port assistant co es up and guides you through a several steps I port dialogue! Select the input path and file na eG verify or change the default properties' for which the records shall &e i ported' select-deselect all or individual records to &e i ported' and clic5 the Finish &utton# For ore infor ation' see the IUCLID 5 ,nd User 4anual chapter D#+* I port :i port data fro other IUCLID 5 syste s< #

3. *a)ing annotations
The tutorial in this chapter shows how to a5e annotations on records on the raw data level and on records provided with a Dossier#

Introduction
The $nnotations feature is pri arily designed for the use &y regulatory authorities' e#g# the ,uropean Che icals $gency or Co petent $uthorities of the 4e &er States' when evaluating the data su& itted &y the applicant# Dowever' it ay also &e used &y the Legal entity co piling a Su&stance dataset' for e1a ple' in the conte1t of the internal review process# /2

Getting Started with IUCLID 5

The $nnotations feature can &e found on the $nnotations ta& of the Infor ation window' which is provided Iust &elow the Data entry window' as shown in the following screenshot!

/3

Getting Started with IUCLID 5

06

Getting Started with IUCLID 5

Tip
Hou can ini ise - a1i ise the Infor ation window &y clic5ing the respective Minimise of the title &ar of this window# $n annotation record consists of the following three ta&s!

or Maximise

&utton in the upper right corner

Data! Constitutes the actual annotation entry screen# Infor ation! Contains general technical infor ation!

)ecord ID! Displays the UUID :%niversal %ni8ue I,entifier< assigned to the annotation record# Lin5ed record ID! Displays the UUID assigned to the record the annotation record refer to# Lin5ed record type! Displays the type of the lin5ed record# Lin5ed record date! Displays the date of the lin5ed record# odification history of the current annotation docu ent#

4odification! Shows the

$nnotations can &e created for any IUCLID ele ent# $s a general rule' the $nnotations ta& provided in the Infor ation window is related to the very record displayed in the a&ove Data entry window# This can &e the Dossier' an ,ndpoint study or su ary record of any Su&stance contained in the Dossier' the Legal entity or the Legal entity site' etc# For ore infor ation' see the IUCLID 5 ,nd User 4anual chapter D#*#3 Dow to use the Infor ation window #

#.1. $nnotating raw data


$lthough sections 6 to ( of a Su&stance dataset are technically handled as one record in IUCLID :see the IUCLID 5 ,nd User 4anual chapter D#*#/#+ Differences &etween sections 6 % ( and sections * % +( <' individual annotations can &e created for each su&section# The following hands%on e1a ple de onstrates how to anage an annotation record for an ,ndpoint study record# The sa e principles apply for annotating any other IUCLID ele ent' e1cept

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Getting Started with IUCLID 5

that the $nnotation te plate for ,ndpoint study records provides additional endpoint%related annotation fields#
Step-b&-step guide

To add an annotation related to the sa ple ,ndpoint study record +# Find the record ;Dorgerloh :+33"<-5ey; in the section tree and dou&le%clic5 it to open it# "# In the Infor ation window' clic5 the $nnotations ta& to access this feature#

(# An the $nnotations tool&ar' clic5 the Add &utton

*# In the $nnotation te plate appearing' co plete the appropriate fields' as shown in the screenshot &elow# In the fields Conclusions and E.ecuti%e summary' the su& itter@s proposal ay &e adopted or revised as appropriate# 5# Clic5 the Save or Save with comment &utton if you wish to add any co ent' which will appear in the odification history only#

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Getting Started with IUCLID 5

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Getting Started with IUCLID 5

$fter clic5ing the Save &utton' the annotation record is displayed in ta&le%view as follows!

#.". $nnotating a %ossier


The $nnotations feature can also &e used to a5e annotations on any Dossier co ponent and any record withing each co ponent# $s a general rule' the $nnotations ta& provided in the Infor ation window is related to the very record displayed in the Data entry window# This can &e the Dossier' an ,ndpoint study or su ary record of any Su&stance contained in the Dossier' the Legal entity or the Legal entity site etc#

Important
$ny annotations ade on raw data are not included in Dossiers# >ice versa' any annotations and are not related to the corresponding raw data records#
Step-b&-step guide

ade on Dossier data are confined to the Dossier

First the Dossier needs to &e opened as follows! +# Go Do e to the Tas5 panel if you are not already there#

"# Under ,ossier ' clic5 'iew# $ screen co es up with e pty windows on the right side and a Query results pane on the left :&elow the title &ar Navigation< showing all Dossiers availa&le in your local IUCLID installation or the networ5 you are connected to# (# Dou&le%clic5 the desired Dossier to display it in the Co ponents pane together with all its co ponents' as shown in the screenshot &elow# 0*

Getting Started with IUCLID 5

*# If there is a large nu &er of Dossiers listed' run a 8uery as descri&ed for Su&stances in the IUCLID 5 ,nd User 4anual chapter D#*#(#" Buerying for a Su&stance in the Buery results pane # 5# 9hen the desired Dossier has &een selected' it is displayed in the Co ponents pane together with all its co ponents' i#e#!

The Dossier itself!

The Dossier title includes the Dossier te plate type' the na e of the Su&stance - )eference su&stance' the C$S 7o#' Legal entity' date and the user%defined na e# The Dossier infor ation entered during the process of Dossier creation is displayed :read%only< in the Data entry window# The Dossier%related Infor ation window including the $nnotations ta&#

The source Su&stance dataset :in bold<# The )eference su&stance referred to in the Su&stance# The Legal entity the Su&stance is assigned to#

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Getting Started with IUCLID 5

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Getting Started with IUCLID 5

To add annotations to the Dossier' open the desired Dossier co ponent and navigate to the ele ent where you wish to co ent on# For e1a ple' add an annotation to the Dossier itself or open the Su&stance dataset' navigate to ,ndpoint record:s< and add annotations related to these records# $s to how to create annotations see the preceding e1ercise#

14. Logging out


To log out fro your user account or e1it IUCLID' select the respective -ogout or Exit co and fro the File enu#

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European Commission
IUCLID 5 .uidance and support /ol )$ .etting "tarted 0une )**+ http$%%iuclid eu

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