Toxicidad Glutaraldehido Ingles

The following information was generated from the
Hazardous Substances Data Bank (HSDB),
a database of the National Library of Medicine's TOXNET system
(http://toxnet.nlm.nih.gov) on November 20, 2019.
Query: Records containing the term 949
1 - HSDB
NAME: Glutaraldehyde
RN: 111-30-8
TOXICITY SUMMARY:
IDENTIFICATION AND USE: Glutaraldehyde is a colorless liquid. It is registered for pesticide use in
the U.S. but approved pesticide uses may
change periodically and so federal, state and local authorities must be
consulted for currently approved uses. It is used as algaecide,
bacteriocide and fungicide. Glutaraldehyde is used as a tissue fixative in
histology and electron and light microscopy, generally as a 1.5-6% aqueous
solution. Glutaraldehyde is used, generally in conjunction with wetting
agents, to control viruses and other micro-organisms in fish farming.
Glutaraldehyde is allowed as a preservative in cosmetics in Europe at
concentrations up to 0.1%. It is not allowed in aerosols and sprays.
Glutaraldehyde is a biocide commonly used in a 2% concentration for cold
sterilization of surgical and dental equipment. Biocides, such as
glutaraldehyde, are added to eliminate bacterial growth in fracturing
fluids. HUMAN EXPOSURE AND TOXICITY: Exposure to concentrations < 1 ppm
by inhalation or skin contact may cause irritation of the skin and/or
mucous membranes. The critical effects of glutaraldehyde exposure are eye,

skin, and respiratory irritation, skin sensitization and occupational
asthma. Nose and throat irritation has been observed in humans at vapor
concentrations below 0.2 ppm. Occupational asthma has also been reported
in workers exposed to dilute solutions of glutaraldehyde. Contact
dermatitis and eye irritation have been reported in workers using
glutaraldehyde solutions, usually 2% or higher. Skin sensitization has
been confirmed in workers using dilute solutions. Other symptoms that may
be brought on by glutaraldehyde exposure include heart palpitations and
tachycardia. The incidence of death and incidence of cancer deaths in 186
male employees at a glutaraldehyde production unit were compared to those
of US white males and to 29,000 other chemical workers during the period
1959 - 1978. All subjects were observed for 10 yr. The number of deaths
was less than expected, as was the incidence of cancer deaths. ANIMAL
STUDIES: Glutaraldehyde was corrosive to the skin and eyes of rabbits at
high concentrations, with signs of skin irritation evident at 2%, and eye
irritation at 0.2%. In an inhalation study where mice were exposed to
glutaraldehyde at concentrations of 33 or 133 ppb for 24 hours, the
animals exhibited panting and increased grooming, mice that inhaled the
highest concentration developed toxic hepatitis. Following a single
whole-body inhalation exposure at 1 ppm for 1 day, rats and mice developed
coagulation pathology of the upper respiratory tract squamous epithelium.
After 4 days of such exposures, inflammatory granulocytic infiltrate into
the squamous epithelium and lamina propria with thickened epithelium of
the nasal lumen ensued. In those animals inhaling 0.5 or 1 ppm
glutaraldehyde for four days, the nasal passages became obstructed with
intraluminal debris; degenerative/hyperplastic erosions with epithelial
abscesses extended as far as the nasopharyngeal meatus in the 1-ppm
exposure group. A study of male and female rats given glutaraldehyde in
drinking water at concentrations of 0, 50, 250, or 100 ppm through two

generations indicated a dose-related decrease in parental water
consumption and body weight (attributed to adverse taste) and decrease in
offspring (1000-ppm group) body weights. No adverse reproductive effects
were observed. In other study there was a significant dose-dependent
reduction in the average of maternal body weight gain and a significant
increase in the number of stunted (body weight) and malformed fetuses at
the 5 mL/mg/day dose level. Early mutagenicity studies were negative, but
more recent studies have indicated that glutaraldehyde is mutagenic in
vitro in bacterial assays and tests in mammalian cells. In vivo
genotoxicity tests to date have proven negative. Groups of 50 male and 50
female rats and mice were exposed to glutaraldehyde vapor at
concentrations of 0, 0.25, 0.50, or 0.75 (rats) and 0, 0.062, 0.12, or
0.25 ppm (mice) 6 hr/day, 5 days /week. The incidences of non-neoplastic
lesions of the nose were reported to be significantly increased in the
0.50 and 0.75-ppm exposed rats and in the 0.12 and 0.25-ppm exposed male
and female mice. ECOTOXICITY STUDIES: Available chronic toxicity data for
glutaraldehyde indicate that continuous exposure results in measurable
effects on coldwater fish at a concentration of 5.1 mg a.i./L. A second
study on coldwater fish resulted in measurable effects at 2.5 mg a.i./L.
Measurable effects on freshwater invertebrates were noted at
concentrations of 8.5 mg/L product and 4.9 mg a.i./L. **PEER REVIEWED**
EVIDENCE FOR CARCINOGENICITY:
A4; Not classifiable as a human carcinogen. /Glutaraldehyde/[American
Conference of Governmental Industrial Hygienists. Documentation of the
TLVs and BEIs with Other World Wide Occupational Exposure Values. 7th Ed.
CD-ROM Cincinnati, OH 45240-1634 2013., p. 1] **PEER REVIEWED**
HUMAN TOXICITY EXCERPTS:

/HUMAN EXPOSURE STUDIES/ The purpose of this study was to evaluate
bronchoalveolar lavage fluid (BALF) components and Clara cell protein
(CC16) concentration in serum and BALF in patients with glutaraldehyde
(GA)-induced asthma, before and after a specific inhalatory provocation
test (SIPT) with GA, in comparison to atopic asthmatics and healthy
individuals. Spirometry and bronchoalveolar lavage were performed before
and after SIPT. The serum and BALF concentrations of CC16 and cytogram
content in BALF were evaluated. In GA-sensitized asthmatics, the level of
CC16 in BALF and serum was significantly lower at 24 hr after SIPT in
comparison with the values recorded prior to the experiment. There was a
significant increase in the proportion of eosinophils, basophils and
lymphocytes in BALF of GA-sensitized asthmatics obtained after SIPT. ...
The determination of CC16 either in serum or in BALF is a non-invasive
test to detect Clara cell damage.[Palczynski C et al; Occup Med (Lond) 55
(7): 572-4 (2005)] **PEER REVIEWED** <a
href="http://www.ncbi.nlm.nih.gov/pubmed/16251377?dopt=Abstract"
target=new>PubMed Abstract
/HUMAN EXPOSURE STUDIES/ /The objective of the study was to make an/
assessment of olfactory and chemesthetic sensitivity (feel, sensory
irritation) to vapor of glutaraldehyde in young adult females. For
chemesthetic sensitivity, assessment included the variable of duration,
with focus on whether concentrations initially too low to evoke feel in
the eye or upper airway might do so in exposures up to 15 min. Experiment
1 probed sensitivity with forced-choice testing of detection over ranges
of concentrations appropriate to three endpoints: odor, feel in the eye,
and feel in the nose. A subject participated in hours of testing per
endpoint to yield enough data to erect a psychometric
(concentration-response) function. Exposure in Experiment 1 entailed use

of a vapor-delivery system that stimulated sites of interest separately.
Exposure in Experiment 2 occurred in the ambient environment of a chamber,
with the sites stimulated simultaneously. In that case, subjects rated
confidence by the minute that they felt the presence of vapor in the eyes,
nose, and throat during exposures of 15 minutes to 35, 50, 75, and 100
ppb, a blank, and an odor control of mild heptane. In Experiment 1, the
typical subject achieved 50% detection (threshold) of odor at 0.3 ppb. The
typical subject achieved 50% detection of feel in the eye and nose at 390
and 470 ppb, respectively. Psychometric functions for feel showed much
sharper dependence on concentration than those for odor. In Experiment 2,
confidence in detection of feel migrated progressively away from no-with
certainty toward the zone of uncertainty, with bigger change when the
exposures contained any glutaraldehyde. The ratings of confidence failed,
however, to show distinguish among these concentrations. Glutaraldehyde
has much higher odor potency than previously thought. Its green-apple odor
should signal presence of the vapor at levels more than a 100-fold below
any that might evoke sensory irritation in brief exposures. Exposures that
start decidedly below irritating (100 ppb and below) seem unlikely to turn
irritating over time. Although the effects from these concentrations
differentiated themselves from those of air and an odor control, they
exhibited none of the concentration dependence seen for sensations of
feel. They seemed likely driven by the penetrating odor of
glutaraldehyde.[Cain WS et al; Int Arch Occup Environ Health 80 (8):
721-31 (2007).] **PEER REVIEWED** <a
/HUMAN EXPOSURE STUDIES/ Patch test in humans, 109 male and female test
subjects (86 Caucasians, 18 Hispanics, 5 Blacks). The same concentrations

were used for induction and challenge. 0.1%: no reaction; 0.2% 2/109
questionable reaction during induction, no reaction to challenge; 0.5%:
16/109 reaction during induction, questionable in 9, erythema in 7/109,
2/109 reaction at challenge, 1 with local erythema and edema.[European
Commission, ESIS; IUCLID Dataset, Glutaral (111-30-8) p.109 (2000 CD-ROM
edition). Available from, as of June 9, 2010:
http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
/HUMAN EXPOSURE STUDIES/ Products containing glutaraldehyde can be used in
dentists' offices as hand dips to prevent transmission of microbes between
a dentist's hands and a patient's mouth. Sporicidin is one such product.
It has been reported that while Sporicidin is effective, the dermal
irritation, sensitivity and yellowing caused by its use is objectionable.
Ten of the eleven participants in this five-day study who dipped their
hands in Sporicidin experienced some degree of irritation, sensitivity or
yellowing of the skin.[USEPA/Office of Pesticide Programs; Risk Assessment
for the Reregistration Eligibility Decision (RED) Document -
Glutaraldehyde p.40 EPA-HQ-OPP-2007-0364-0003 (June 2007). Available from,
as of June 1, 2010: http://www.regulations.gov] **PEER REVIEWED**
/HUMAN EXPOSURE STUDIES/ In one study, 468 people were patch tested to
glutaraldehyde. A comparison of the results was made between those
employed in a healthcare related field and those who were not. Health care
workers were 8x as likely to be allergic to glutaraldehyde as people
working in other fields.[USEPA/Office of Pesticide Programs; Risk
Assessment for the Reregistration Eligibility Decision (RED) Document -

/HUMAN EXPOSURE STUDIES/ Dilute aqueous glutaraldehyde (0.005, 0.01, 0.02,
0.05%) was applied to 2 sites on the backs of 52 volunteers for 24 hr,
with one of the sites irradiated with UV light. A third site was
irradiated with UV light. Two subjects experienced very slight erythema
with 0.05% glutaraldehyde/UV light.[Organization for Economic Cooperation
and Development; Screening Information Data Set for Glutaraldehyde, CAS
111-30-8 p.66 (October 1998). Available from, as of June 1, 2010:
http://www.chem.unep.ch/irptc/sids/OECDSIDS/sidspub.html] **PEER
REVIEWED**
/HUMAN EXPOSURE STUDIES/ Dilute aqueous glutaraldehyde (0.0005, 0.01,
0.02, 0.05%) was applied to 2 sites on the backs of 99 volunteers 2/week
for 3 weeks, with one of the sites irradiated with UV light 24 hr after
each application. On challenge testing, no significant erythema or edema
was noted.[Organization for Economic Cooperation and Development;
Screening Information Data Set for Glutaraldehyde, CAS 111-30-8 p.67
(October 1998). Available from, as of June 1, 2010:
REVIEWED**
/HUMAN EXPOSURE STUDIES/ One controlled study with human volunteer
subjects indicated a threshold concentration for the induction of skin
sensitization in humans of approximately 0.5% glutaraldehyde (in
water).[American Conference of Governmental Industrial Hygienists.
Documentation of the TLVs and BEIs with Other World Wide Occupational
Exposure Values. 7th Ed. CD-ROM Cincinnati, OH 45240-1634 2013., p. 6]
**PEER REVIEWED**
/SIGNS AND SYMPTOMS/ Glutaraldehyde is considered a high-level surgical

disinfectant commonly used in the United States in gastrointestinal lab
environments. Glutaraldehyde requires proper ventilation when used as
glutaraldehyde vapors are known irritants to the skin, eyes, nose, and
lungs without proper ventilation in the work environment. ...
Unfortunately, uncontrolled glutaraldehyde exposure in selected work
environments is contributing to occupational asthma. ...[Cohen NL, Patton
CM; Gastroenterol Nurs 29 (2): 100-4 (2006).] **PEER REVIEWED** <a
/SIGNS AND SYMPTOMS/ Exposure to concentrations < 1 ppm by inhalation
or skin contact may cause irritation of the skin and/or mucous
membranes.[European Commission, ESIS; IUCLID Dataset, Glutaral (111-30-8)
p.167 (2000 CD-ROM edition). Available from, as of June 9, 2010:
/SIGNS AND SYMPTOMS/ Short term exposure: Irritates the eyes, skin, and
respiratory tract. Inhalation: 0.3 ppm can cause nose and throat
irritation. 0.4 ppm has caused headaches. 0.5 ppm has been described as
intolerably irritating. Skin: can cause irritation. Contact with a 5%
solution can sensitize the skin and cause an allergic response to
subsequent contact of much lower concentrations. Eyes: vapors of a 2%
solution (0.4 ppm) have produced irritation. Ingestion: can cause
irritation of the mouth and stomach. Long term exposure: repeated or
prolonged contact with skin may cause chemical sensitization, skin
allergy, and asthma. Exposure may cause liver and nervous system damage.
Glutaraldehyde may cause mutations; handle with extreme caution. Testing
has not been completed to determine the carcinogenicity of glutaraldehyde.
However, the limited studies to date indicate that these substances have
chemical reactivity and mutagenicity similar to acetaldehyde and
malonaldehyde.[Pohanish, R.P. (ed). Sittig's Handbook of Toxic and
Hazardous Chemical Carcinogens 6th Edition Volume 1: A-K,Volume 2: L-Z.
William Andrew, Waltham, MA 2012, p. 1385] **PEER REVIEWED**
/SIGNS AND SYMPTOMS/ The critical effects /of glutaraldehyde exposure/ are
eye, skin, and respiratory irritation, skin sensitization and occupational
in workers exposed to dilute solutions of glutaraldehyde ... Contact
been confirmed in workers using dilute solutions.[Organization for
Economic Cooperation and Development; Screening Information Data Set for
Glutaraldehyde, CAS 111-30-8 p.16 (October 1998). Available from, as of
June 1, 2010: http://www.chem.unep.ch/irptc/sids/OECDSIDS/sidspub.html]
**PEER REVIEWED**
/SIGNS AND SYMPTOMS/ Other symptoms that may be brought on by
glutaraldehyde exposure include heart palpitations and
tachycardia.[USEPA/Office of Pesticide Programs; Risk Assessment for the
Reregistration Eligibility Decision (RED) Document - Glutaraldehyde p.41
EPA-HQ-OPP-2007-0364-0003 (June 2007). Available from, as of June 1,
2010: http://www.regulations.gov] **PEER REVIEWED**
/SIGNS AND SYMPTOMS/ When a hospital in Nairobi switched to glutaraldehyde
for instrument decontamination, doctors reported itchy and watery eyes as
well as sneezing and nasal irritation whereas nurses reported periorbital
swellings, itching and watery eyes, headaches, nausea, skin swelling,

coughing, breathlessness and wheezing, acute rhinitis and
bronchitis.[USEPA/Office of Pesticide Programs; Risk Assessment for the
/SIGNS AND SYMPTOMS/ Glutaraldehyde vapor or mist can be a strong irritant
or corrosive to the eyes, nose throat, and lungs. Inhalation of
glutaraldehyde vapor may cause sudden headache. Ingestion may cause a
burning sensation in the chest, severe abdominal pain and cramping,
vomiting, diarrhea, anuria, vascular collapse, and coma.[Dart, R.C. (ed).
Medical Toxicology. Third Edition, Lippincott Williams & Wilkins.
Philadelphia, PA. 2004., p. 1249] **PEER REVIEWED**
/CASE REPORTS/ ... This report details the clinical course of 2 patients
who suffered acute glutaraldehyde exposure during office injection
procedures. Clinical records of 2 outpatients undergoing office injection
procedures were reviewed. One patient underwent bilateral injections of
hydroxyapatite, and 1 underwent voice gel injection. Both patients
developed acute mucosal injury in the form of supraglottitis and
laryngitis. Both patients required inpatient admission with airway
monitoring (1 requiring admission to the intensive care unit) and were
treated with steroids and antibiotics. The same channel endoscope was used
for both procedures and was noted after careful examination to have
retained glutaraldehyde inside the scope due to a perforation of the
lining of the working channel. Glutaraldehyde can cause acute mucosal
injury to supraglottic and glottic structures, and diligent procedures
must be maintained for flushing the channels and monitoring glutaraldehyde
retention in the channels ...[Krishna PD et al; Ann Otol Rhinol Laryngol

119 (3): 150-4 (2010)] **PEER REVIEWED** <a
/CASE REPORTS/ Glutaraldehyde is a widely used disinfectant, especially in
developing countries, for rapid and effective disinfection of laparoscopic
instruments that are not suitable for sterilization in an autoclave. This
incident report demonstrates that even remarkably small residual amounts
of glutaraldehyde on inadequately cleaned laparoscopic instruments can
cause chemical burns during laparoscopic surgery ...[Nazik H et al; J
Minim Invasive Gynecol 19 (6): 756-7 (2012)] **PEER REVIEWED** <a
/CASE REPORTS/ Glutaraldehyde-induced colitis is an uncommon colitis in
clinical practice. Because the involvement of colonic segment is
determined by the endoscopic part where glutaraldehyde remains, a recent
history of endoscopy and a demarcated involvement of colonic segment are
the most characteristic signs of glutaraldehyde-induced colitis. The
typical clinical scenario is acute onset of lower abdominal pain, fever,
and bloody stool. Laboratory data usually show leukocytosis and elevated
C-reactive protein. The endoscopic pictures of involved segments are
compatible with acute colitis, including hyperemic, edematous, with or
without multiple erosions. Acute ischemic colitis and infectious colitis
should be differentiated at the outset of the disease. Stool pathogen
tests are usually negative. Parenteral empiric antibiotic may be
considered if severe transmural edema of the involved segment is observed
in computed tomography. Conservative treatment, including bowel rest and
parenteral hydration, is able to stabilize the condition in a week.

Herein, we present two cases of acute proctocolitis caused by
glutaraldehyde after uneventful colonoscopy.[Shih HY et al; Kaohsiung J
Med Sci 27 (12): 577-80 (2011)] **PEER REVIEWED** <a
/CASE REPORTS/ Chemical colitis can occur as a result of accidental
contamination of endoscopes or by intentional/accidental administration of
enemas containing various chemicals. We present three cases of
glutaraldehyde induced colitis and review the cases in the literature.
Glutaraldehyde induced colitis presents clinically with severe abdominal
pain, bloody and mucoid diarrhea, rectal bleeding, and tenesmus 48-72 hr
after colonoscopy. Endoscopic findings are nonspecific and mimic ischemic
colitis, inflammatory bowel disease, and infectious colitis. The timing of
symptoms and the knowledge that glutaraldehyde is a chemical irritant to
colonic mucosa is important for the diagnosis. The treatment is mainly
supportive but sometimes necessitates mesalamine, prednisolone, or
metronidazole and the resolution is rapid. In endoscopy units, strict
adherence to published disinfection protocols is very important and the
cleaning, rinsing and drying protocols also deserve the same
attention.[Ahishali E et al; Dig Dis Sci 54 (12): 2541-5 (2009)] **PEER
REVIEWED** <a
/CASE REPORTS/ Glutaraldehyde (2% solution) is an effective and widely
used disinfecting solution for cold sterilization of endoscopic
instruments. Direct contact of glutaraldehyde solution with colonic mucosa
can cause self-limited colitis. As it rarely occurs as a complication of

colonoscopy, glutaraldehyde-induced colitis is generally reported only as
case reports in the literature. We report three cases of
glutaraldehyde-induced colitis after colonoscopy. All lesions resolved
with supportive treatment. We stress the need for thorough rinsing of the
surface and channels of the endoscope with water to avoid the occurrence
of this complication.[Kurdas OO et al; Indian J Gastroenterol 28 (6):
221-3 (2009)] **PEER REVIEWED** <a
/CASE REPORTS/ Dermatitis of the hands in 13 health care workers exposed
regularly to glutaraldehyde solution. Positive patch test in 9 workers
after 48 hr and positive in all after 96 hr.[Organization for Economic
Cooperation and Development; Screening Information Data Set for
**PEER REVIEWED**
/CASE REPORTS/ Dermatitis of hands and fingers in three dental assistants
and two patients being treated therapeutically with glutaraldehyde. Patch
testing positive.[Organization for Economic Cooperation and Development;
REVIEWED**
/CASE REPORTS/ Asthma in 4 endoscopy nurses, including 3 atopics. Adverse
reaction in 2 cases on provocation testing with
glutaraldehyde.[Organization for Economic Cooperation and Development;

REVIEWED**
/CASE REPORTS/... A 32-year-old laboratory technician presented with
adult-onset asthma 2 years after daily exposure to gluteraldehyde which
was used to sterilize the mouthpieces used for lung function testing.
Specific inhalational challenge (SIC) testing showed a 25% drop in FEV1
after exposure to gluteraldehyde but not after exposure to a control, thus
confirming the diagnosis. Alternative arrangements were made for
sterilization of the mouthpieces so that gluteraldehyde could be removed
from the workplace. There was a marked improvement in her asthmatic
control thereafter...[Ong TH et al; Ann Acad Med Singapore 33 (2): 275-8
(2004).] **PEER REVIEWED** <a
/CASE REPORTS/ A 19-year-old woman presented after deliberate ingestion of
a biocide containing glutaraldehyde and a quaternary ammonium compound.
She developed respiratory distress and severe metabolic acidosis 10 hours
after admission. Marked laryngeal edema was noted when she was being
intubated. She eventually improved following supportive care and was
discharged alive after 9 hospital days. ... As both these substances are
known to cause metabolic acidosis, localized edema, erosion and
sensitization of both the respiratory and alimentary tract. The clinical
effect may be additive or synergistic. ... Omnicide ingestion should be
closely monitored for metabolic acidosis and laryngeal edema which may
progress to upper airway obstruction requiring urgent airway

stabilization.[Perera PM et al; Clin Toxicol (Phila) 46 (9): 858-60
/CASE REPORTS/ The medical records of patients with acute rectocolitis
following endoscopy treated at Kaohsiung Veterans General Hospital since
2001 were reviewed. The indication of endoscopy was health check-up for
all patients. Published English-language studies regarding acute
rectocolitis following endoscopy were also reviewed. RESULTS: An outbreak
of six patients occurred in April 2002 and one cirrhotic patient was
admitted in July 2008. All patients developed a self-limited syndrome of
abdominal pain and bloody diarrhea within 48 h of uncomplicated endoscopy.
One severely ill patient required hospitalization to receive intravenous
fluid and antibiotics. After the investigation in April 2002,
glutaraldehyde-induced colitis was diagnosed due to a defect in the
endoscope-cleansing procedure. There were no deficiencies in the cleansing
procedure in July 2008. Considering the patient's concomitant disease, we
postulated that ischemic colitis with cirrhosis-related intestinal
inflammation and endotoxemia was the possible diagnosis in this sporadic
case.[Hsu CW et al; Int J Colorectal Dis 24 (10): 1193-200 (2009)] **PEER
REVIEWED** <a
/CASE REPORTS/ Seven patients occupationally exposed to glutaraldehyde are
described to have presented with palpitations or tachycardia that were
temporally associated with glutaraldehyde exposure.[European Commission,
ESIS; IUCLID Dataset, Glutaral (111-30-8) p.168 (2000 CD-ROM edition).

Available from, as of June 9, 2010: http://esis.jrc.ec.europa.eu/] **PEER
REVIEWED**
/CASE REPORTS/ A woman in charge of an endoscopy unit complained of
irritant conjunctivitis and breathlessness thought to be due to exposure
to 2% Glutaral. Lowered air flow to her lungs was observed during the work
week, but showed improvement on weekends. When a different disinfectant
was used, there was only one significant fall in peak flow, which
coincided with the time at which a different staff person was using
Glutaral in an adjoining room.[Cosmetic Ingredient Review; Final Report on
the Safety Assessment of Glutaral. J Am Coll Toxicol 15 (2): 98-139 (1996)
http://www.cir-safety.org/ingredients] **PEER REVIEWED**
/CASE REPORTS/ ... A 46-year-old endoscopy nurse developed symptoms of
occupational asthma after seven years of exposure to
glutaraldehyde.[USEPA/Office of Pesticide Programs; Risk Assessment for
the Reregistration Eligibility Decision (RED) Document - Glutaraldehyde
p.39 EPA-HQ-OPP-2007-0364-0003 (June 2007). Available from, as of June 1,
/CASE REPORTS/ ... A nurse who cleaned equipment with glutaraldehyde ...
developed occupational asthma, including an irritating cough and frequent
episodes of upper respiratory tract symptoms. There was considerable
improvement in her symptoms after she had been away for a year on
maternity leave, but after the maternity leave the symptoms returned
including a cough that produced yellow sputum, wheezing and a rash on her
arms.[USEPA/Office of Pesticide Programs; Risk Assessment for the

/CASE REPORTS/ An orthodontic patient received a chemical burn in her
mouth when a dental instrument was used that had not been thoroughly
rinsed after being sterilized in a solution containing
/CASE REPORTS/ One study documented a case where a radiologist and an
x-ray technician both exhibited chronic, fissured dermatitis of the
fingers and both had strongly positive patch test reactions to a 1%
aqueous glutaraldehyde solution. With greater care to avoid exposure,
their dermatitis healed.[USEPA/Office of Pesticide Programs; Risk
/CASE REPORTS/ Two hospital workers acquired an allergic contact
dermatitis of the hands after disinfecting endoscopes with Sporicidin.
Both showed strong positive reactions to a 1% aqueous solution of
/CASE REPORTS/ Another product containing glutaraldehyde, Korsolin, was
blamed for the development of dermatitis and eczema on the hands and
forearms of a 50-year-old cleaning woman and a 42-year-old assistant nurse
in an intensive care section of a hospital. They gave positive patch tests
to glutaraldehyde.[USEPA/Office of Pesticide Programs; Risk Assessment for
/CASE REPORTS/ A 22-year-old woman using a hair conditioner containing
glutaraldehyde at less than 1% was treated for acute and chronic
eczematous changes to the scalp with secondary infection and hair loss.
This began when she began using the glutaraldehyde containing conditioner.
She was patch tested for glutaraldehyde and tested positive. Once she
discontinued use of the conditioner, her hair grew back.[USEPA/Office of
Pesticide Programs; Risk Assessment for the Reregistration Eligibility
Decision (RED) Document - Glutaraldehyde pp.40-1 EPA-HQ-OPP-2007-0364-0003
(June 2007). Available from, as of June 1, 2010:
http://www.regulations.gov] **PEER REVIEWED**
/CASE REPORTS/ Glutaraldehyde can have very serious effects on the skin
including deep ulcers that leave a scar as in the case of a young woman
who applied 25% aqueous glutaraldehyde nightly for 2 weeks as a treatment
for warts.[USEPA/Office of Pesticide Programs; Risk Assessment for the
/CASE REPORTS/ There was a case of keratopathy induced by a Hoskin lens,
which had been inadequately rinsed after soaking in buffered
glutaraldehyde. This happened to an 88-year-old woman who underwent

cataract extraction. When the Hoskin lens was placed, a white plaque
formed that covered one third of her cornea. The next day the upper third
of the cornea was opaque and edemous. The surgeon also noticed a painless
white lesion on his finger where he had held the Hoskin lens. After three
weeks the inflammation and keratopathy was resolved.[USEPA/Office of
Pesticide Programs; Risk Assessment for the Reregistration Eligibility
Decision (RED) Document - Glutaraldehyde p.41 EPA-HQ-OPP-2007-0364-0003
/CASE REPORTS/ ... A case of severe tongue swelling /was/ reported in a 67
year old male after he had surgery under general anesthesia. One of the
instruments used in his tracheal intubation had been sterilized in a 2%
glutaraldehyde solution. After surgery when the tube was removed, his
tongue started swelling until it filled his entire oral cavity and forced
his mouth wide open. His tongue returned to normal size after four hours
and it was speculated that this whole episode may have been due to prior
sensitization to glutaraldehyde[USEPA/Office of Pesticide Programs; Risk
/CASE REPORTS/ Dermatitis of hands and fingers and around eyes and mouth
in hospital cleaner exposed to 2% glutaraldehyde solution. Patch testing
positive.[Organization for Economic Cooperation and Development; Screening
Information Data Set for Glutaraldehyde, CAS 111-30-8 p.68 (October 1998).
Available from, as of June 1, 2010:
REVIEWED**
/CASE REPORTS/ A hospital maintenance employee developed an airborne
contact dermatitis when cleaning respiratory therapy equipment.
Patch-testing determined that she is allergic to glutaraldehyde, an
ingredient in a commercial germicidal product.[Fowler JF Jr; J Occup Med
31 (10): 852-3 (1989)] **PEER REVIEWED** <a
/CASE REPORTS/ A report was made of five cases of allergic contact
dermatitis to glutaraldehyde. Three of the cases involved cleaning women
working in an infectious disease department, disinfecting crockery using
Cidex. The fourth case involved a woman who cleaned and disinfected
endoscopy material, also using Cidex. The fifth case reported was a nurses
aid who used Cidex for sterilization of hemodialysis material. In each
case, the reactions began within 4 to 6 months after the workers started
using Cidex on the job. In patch tests using the standard series,
activated Cidex, Cidex activating powder, and glutaraldehyde, all patients
reacted to several of the activated Cidex concentrations and to
glutaraldehyde. ...[Goncalo S et al; Contact Dermatitis 10 (3): 183-184
(1984)] **PEER REVIEWED**
/CASE REPORTS/ A 33 year old respiratory technologist developed
occupational asthma as a result of exposure to glutaraldehyde. The case
was documented by preshift and postshift spirometry, appropriate changes
in peak expiratory flow rate, provocative concentration causing a 20% fall
in forced expiratory volume in 1 second, and workplace challenge test. The
subject had a history of asthma as a child with mild symptoms, readily
relieved by bronchodilators. As an adult, she had symptoms briefly

following colds. At age 29 she began working in a bronchoscopy unit at a
local hospital; her asthma worsened since that time and she was using an
albuterol inhalant three to four times a day. The subject also
intermittently received courses of prednisone for acute exacerbations. The
subject assisted physicians in fiberoptic bronchoscopy and also cleaned
bronchoscopes after use with Sporicidin which contained 3.6%
glutaraldehyde, 7% phenol, and 1.2% sodium-phenolate. Cleaning was
performed in a small room with no ventilation. Sporicidin was placed in a
basin that was not covered during cleaning. After diagnosis, the subject
continued work but no longer performed the cleaning operation. As a
result, her symptoms have decreased and she has been able to gradually
reduce the dose of inhaled beclomethasone to 500 ug/day without
recurrence. Lung function tests have returned to normal levels.[Chan-Yeung
M et al; Journal of Allergy and Clinical Immunology 91 (5): 974-8 (1993)]
**PEER REVIEWED** <a
/CASE REPORTS/ This letter reports two cases of work-related asthma in
radiographers, each case attributable to a different agent. Tests on one
patient revealed an asthmatic response on exposure to glutaraldehyde, a
hardener used during developing, while tests on the other showed adverse
reactions to fixative chemicals. Although it is likely that, under the
best conditions, concentrations of glutaraldehyde in radiographic
departments are below the occupational exposure standard, higher levels
may occur during maintenance or where ventilation is inadequate.[Cullman P
et al; Lancet 340 (8833): l477 (1992)] **PEER REVIEWED**
/CASE REPORTS/ A case of contact allergic dermatitis due to occupational

exposure to benzalkonium chloride and glutaraldehyde in a dental nurse was
described. A 36 year old female dental nurse with an intensely itchy
eczena on her hands, forearms, upper arms, and face was examined. The
eczema began on her hands and forearms 4 months previously and gradually
spread to her upper arms and face. She was patch tested with the standard
Italian allergen series, a nurse series, and products she used at work.
She reacted to thiuram mix and nickel sulfate in the standard series,
glutaraldehyde and benzalkonium chloride in the nurse series, and three
products she used at work (Sanipull, Ster-l, and Cidex). Sanipull
contained 1% benzalkonium chloride, Ster-l contained glutaraldehyde, and
Cidex contained 2% acidic glutaraldehyde. The reactions to benzalkonium
chloride and glutaraldehyde and the products containing these were judged
to reflect her current symptoms. The reactions to nickel sulfate and
thiuram mix were judged to reflect episodes of contact dermatitis induced
by jewelry and latex rubber gloves.[Cusano F, Luciano S; Contact
Dermatitis 28 (2): 127 (1993)] **PEER REVIEWED**
/CASE REPORTS/ ... A case of toxic eye injury caused by leakage of
retained glutaraldehyde solution from a defective anesthesia mask. In this
case, no changes were observed immediately after exposure to
glutaraldehyde; however, at six hours post-exposure, conjunctival
inflammation, swelling of the eyelids, burning pain, and photophobia were
reported. The inflammation completely resolved with therapy, and no visual
disturbances ensued.[American Conference of Governmental Industrial
Hygienists. Documentation of the TLVs and BEIs with Other World Wide
Occupational Exposure Values. 7th Ed. CD-ROM Cincinnati, OH 45240-1634
2013., p. 7] **PEER REVIEWED**
/CASE REPORTS/ /Investigators/ described a case of recurrent epistaxis,

upper respiratory tract irritation, and skin rash in a female hospital
employee using glutaraldehyde for sterilization of endoscopy equipment.
This patient also complained of headaches, eye and throat irritation, and
chest tightness. The symptoms resolved on weekends and days away from
work. Her primary work duties involved diluting a 50% glutaraldehyde
solution to a 2% solution and washing and sterilizing fiberoptic
endoscopes. Glutaraldehyde levels were not measured; however, her symptoms
were eliminated by proper personal protection practices and by the
installation of a fume hood.[American Conference of Governmental
Industrial Hygienists. Documentation of the TLVs and BEIs with Other World
Wide Occupational Exposure Values. 7th Ed. CD-ROM Cincinnati, OH
45240-1634 2013., p. 7] **PEER REVIEWED**
/CASE REPORTS/ Daily application of a 20% solution of glutaraldehyde for
treatment of plantar warts was implicated in necrosis of the pads of a toe
in a 7-year-old child; necrosis was evidently due to the caustic, rather
than allergenic, activity of glutaraldehyde.[Dart, R.C. (ed). Medical
Toxicology. Third Edition, Lippincott Williams & Wilkins.
Philadelphia, PA. 2004., p. 1249] **PEER REVIEWED**
/EPIDEMIOLOGY STUDIES/ In an investigation of 541 members of a hospital
cleaning department, a prevalence rate of occupational skin diseases of
15.3% was found. During their hospital employment, 39.1% had a skin
disease. Higher prevalence in the younger age groups can be explained by
the selection of those with skin diseases for work away from the cleaning
department. A large number developed their disease shortly after
employment began. This was an indication that the observed prevalent
conditions were irritant diseases. The distribution by diagnosis confirms
this conclusion in as much as 75% of the occupational skin diseases were

irritant dermatitis, 21% allergic contact dermatitis, and 4% monilia of
the finger webs. The causes of allergic contact dermatitis were found to
be formaldehyde, glutaraldehyde and chloramine in addition to nickel and
rubber. ...[Hansen KS; Contact Dermatitis 9 (5): 343-51(1983)] **PEER
REVIEWED** <a
/EPIDEMIOLOGY STUDIES/ 84 funeral service workers and 38 control workers
were evaluated for the presence of skin disease by history, clinical
examination and patch tests with formaldehyde and glutaraldehyde. No
relationship between either personal or family history of cutaneous or
respiratory manifestations of atopy and clinical parameters of cutaneous
disease or patch test results was found. Cutaneous disease was reported in
apprentices, active embalmers and inactive embalmers in decreasing order
of frequency. Positive patch test reactions to formaldehyde and
glutaraldehyde were found in 4% and 7% of the exposed workers, but in none
of the controls. Although exposure to glutaraldehyde was less frequent,
the prevalence of positive patch test reactions did not differ.[Nethercott
JR, Holness DL; Contact Dermatitis 18 (5): 263-7 (1988)] **PEER REVIEWED**
<a href="http://www.ncbi.nlm.nih.gov/pubmed/2970932?dopt=Abstract"
/EPIDEMIOLOGY STUDIES/ ... In an extended follow up using death
certificates, ... standardized mortality ratios (SMRs) and 95% confidence
intervals (CIs) /were calculated/ for three cumulative exposure categories
of glutaraldehyde. There were 99,730 person-years of observation among
unexposed workers, 2934 person-years in the lower exposure category, <
0-100.0 parts per billion (ppb)-years, and 2805 person-years in the higher
exposure category of 100.0+ ppb-years. RESULTS: For all respiratory
cancers for these exposure categories, the SMRs were 0.9 (95% CI =
0.7-1.1), 1.0 (95% CI = 0.2-3.0), and 0.3 (95% CI = 0.0-1.5). No
increasing trend of SMR with increasing exposure is observed for any cause
of death examined. We observed no cancers of the nasal cavity and sinus
(0.03 expected), nasopharynx (0.02 expected), or leukemia (0.6 expected)
among all glutaraldehyde-exposed workers. CONCLUSIONS: Although /the/
study findings should be tempered by the small size and the potentially
low prevalence of smoking among glutaraldehyde workers, ... no increased
rates of respiratory tract cancer or leukemia related to glutaraldehyde
exposure /were found/.[Collins JJ et al; J Occup Environ Med 48 (2):
199-203 (2006).] **PEER REVIEWED** <a
/EPIDEMIOLOGY STUDIES/ The incidence of death and incidence of cancer
deaths in 186 male employees at a glutaraldehyde production unit were
compared to those of US white males and to 29,000 other chemical workers
during the period 1959 - 1978. All subjects were observed for 10 yr. The
number of deaths ... was less than expected, as was the incidence of
cancer deaths.[Organization for Economic Cooperation and Development;
REVIEWED**
/EPIDEMIOLOGY STUDIES/ An epidemiology study of 218 workers assigned to
glutaraldehyde production or distribution from 1959 to 1992 indicated an
absence of glutaraldehyde-induced skin or respiratory sensitizations,

allergic blepharoconjunctivitis, or excess cancers. Routine occupational
hygiene monitoring results from 1977 to 1992 indicate few excursions
greater than 0.2 ppm glutaraldehyde. During the period of 1989 to 1992, 88
random 15-minute samples were collected with airborne glutaraldehyde
concentrations ranging from 0.01 to 0.34 ppm.[American Conference of
Governmental Industrial Hygienists. Documentation of the TLVs and BEIs
with Other World Wide Occupational Exposure Values. 7th Ed. CD-ROM
Cincinnati, OH 45240-1634 2013., p. 5] **PEER REVIEWED**
/SURVEILLANCE/ ... Work-related asthma (WRA) accounts for a significant
proportion of adult asthma that causes serious personal and economic
consequences. METHODS: Cases were identified using physician reports and
hospital discharge data, as part of four state-based surveillance systems.
... Structured interviews /were used/ to confirm cases and identify
occupations and exposures associated with WRA. RESULTS: Health care
workers (HCWs) accounted for 16% (n = 305) of the 1,879 confirmed WRA
cases, but only 8% of the states' workforce. Cases primarily were employed
in hospitals and were nurses. The most commonly reported exposures were
cleaning products, latex, and poor air quality...[Pechter E et al; Am J
Ind Med 47 (3): 265-75 (2005).] **PEER REVIEWED** <a
/SURVEILLANCE/ ... Environmental glutaraldehyde (GA) levels /were
measured/ during the disinfection of endoscopes and ... subjective
symptoms of the workers engaged in that work /were investigated/. At 6
hospitals in the Tokyo and Kanagawa area, 8 rooms for endoscope washing
and disinfecting the endoscopy equipment were surveyed. The geometric mean
environmental GA levels in the 8 rooms were 1.3 to 19.6 ppb. The personal
exposure levels at the time of replacing the antiseptic solution
containing GA in two of the disinfecting rooms were 94.2 and 84.9 ppb.
Subjective symptoms such as ophthalmic, nasal, respiratory, pharyngeal
symptoms and nausea were more prevalent among workers than controls as
evidenced from the questionnaire survey.[Katagiri H et al; Ind Health 44
(2): 225-9 (2006).] **PEER REVIEWED** <a
/SURVEILLANCE/ ... To evaluate the effect of work practices and general
ventilation system on employees' peak exposure to glutaraldehyde, 42
breathing zone personal air samples were taken in five hospitals. In
addition, work practices were observed and recorded during the course of
sampling and were classified into three categories. Presence of local or
general ventilation system, air change per hour, and quantity of
glutaraldehyde used were also recorded. Geometric mean concentration of
all samples was 0.025 ppm (GSD = 3.05). Statistical analysis indicated
that work practice was the most important factor affecting the level of
exposure to glutaraldehyde. In locations where "poor" or "unsafe" work
practices were employed, the geometric mean concentrations were much
higher (GM = 0.05, GSD = 2.11 and GM = 0.08, GSD = 1.52, respectively).
The result has indicated higher prevalence of headache and itchy eyes
among employees who worked where unsafe work practices were
observed.[Nayebzadeh A; Ind Health 45 (2): 289-95 (2007).] **PEER
REVIEWED** <a
/SURVEILLANCE/ To clarify the actual condition of endoscope sterilization

work and the adverse health effects of disinfectants on personnel, a
questionnaire was sent to 173 medical institutions in Osaka Prefecture.
Glutaraldehyde (GA), ortho-phtalaldehyde (OPA), and hyperacetic acid were
used as disinfectants of endoscopes by 55.5%, 32.4%, and 8.7% of the
medical institutions respectively. The kind of disinfectant used had been
changed in 57.8% of these institutions during the past five years, and it
was confirmed that the use of substitutes for GA, such as OPA and
hyperacetic acid, has increased. Personnel in 35.8% of the institutions
complained about symptoms during sterilization work. The kind of
disinfectant being used when they complained was GA in many cases and OPA
in others. A general ventilation system has now been installed in 72.3% of
the institutions; local exhaust systems have been installed in fewer, only
23.4%. Protective gloves were used at about half of the institutions, but
protective masks and glasses were seldom used.[Miyajima K et al; Sangyo
Eiseigaku Zasshi 48 (5): 169-75 (2010).] **PEER REVIEWED** <a
/SURVEILLANCE/ ... Occupational and chest physicians in the West Midlands
/UK/ were invited to submit details of newly diagnosed cases with
occupational asthma (OA). Data were then transferred to the regional
center for occupational lung diseases for analysis. RESULTS: A total of
1461 cases were reported to the scheme. Sixty-eight per cent were males
with mean (standard deviation) age of 44 (12) years. The annual incidence
of OA was 42 per million of working population (95% CI = 37-45). OA was
most frequently reported in welders (9%) and health care-related
professions (9%) while < 1% of cases were reported in farmers.
Isocyanates were the commonest offending agents responsible for 21% of
reports followed by metal working fluids (MWFs) (11%), adhesives (7%),

chrome (7%), latex (6%) and glutaraldehyde (6%). Flour was suspected in 5%
of cases while laboratory animals only in 1%... CONCLUSIONS: Our data
confirm a high annual incidence of OA in this part of the UK.[Bakerly ND
et al; Occup Med (Lond) 58 (3): 169-74 (2008).] **PEER REVIEWED** <a
/SURVEILLANCE/ Long term exposure levels among hospital workers performing
cold sterilization procedures were below detection ( < 0.04 mg/cu m);
short term exposure (15 min) levels measured did not exceed 0.57 mg/cu m.
A dose-response relationship between frequency of exposure and number of
symptoms could be demonstrated. Symptoms included eye, nasal, and
respiratory irritation, headache, fatigue, nausea, and rashes on the hands
and face and itching on the hands and face. No case of dermal
sensitization to glutaraldehyde was found.[European Commission, ESIS;
IUCLID Dataset, Glutaral (111-30-8) p.168 (2000 CD-ROM edition).
REVIEWED**
/SURVEILLANCE/ Medical records of 218 current and former workers assigned
to glutaraldehyde production or drumming between 1959 and 1992 were
reviewed to determine the incidence of skin sensitization, respiratory
sensitization, and allergic blepharoconjunctivitis. There was no evidence
of sensitization for 199 (95%) of the study group; five had cases related
to other chemicals. Six individuals (3%) had had symptoms of sensitization
which were not ascribable to a particular chemical. There were no
indications that glutaraldehyde induced sensitization or allergic
blepharoconjunctivitis in workers exposed at or below the OSHA permissible
exposure limit (ceiling) of 0.2 ppm.[European Commission, ESIS; IUCLID

Dataset, Glutaral (111-30-8) p.167 (2000 CD-ROM edition). Available from,
as of June 9, 2010: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
/SURVEILLANCE/ ... 348 nurses from endoscopy units in hospitals in the
United Kingdom ... were surveyed for symptoms possibly related to
glutaraldehyde exposure. Forty-four percent reported work related contact
dermatitis, 13.5% reported eye irritation, 19.8% reported nose irritation
and 8.5% reported lower respiratory symptoms. In another survey of 167
nurses exposed to glutaraldehyde, 49% complained of eye irritation, 41%
complained of skin discoloration or irritation, 36% complained of headache
and 34% complained of a cough or shortness of breath. Yet another survey
of 150 staff in two hospitals who were exposed to glutaraldehyde showed
that 30.7% had runny eyes, 22.7% skin irritation, 18.7% runny nose, 16.7%
discoloration of the skin, 14.7% upper respiratory tract irritation, 14.0%
cough, 11.3% unpleasant taste, 9.3% wheezy chest and 3.3% chronic
dermatitis. A fourth survey of 135 endoscopy nurses in Australia found
that nurses exposed to glutaraldehyde were significantly more likely to
report headache, lethargy and skin, eye and throat symptoms compared with
controls.[USEPA/Office of Pesticide Programs; Risk Assessment for the
/SURVEILLANCE/ The prevalence of certain symptoms (eye, skin and airway
symptoms, headache, nausea, and fatigue) were studied among hospital
workers with and without exposure to glutaraldehyde during cold
sterilization work. The exposure to glutaraldehyde and formaldehyde was
quantified by hygienic measurements in the breathing zone of the workers.
Aldehydes were measured by a specific method, using sorbent tubes with

Amberlite XAD-2 coated with 2,4-dinitrophenylhydrazine (2,4-DNF) and
analyzed by liquid chromatography. The exposure measurements revealed that
the present exposure to glutaraldehyde was intermittent and well below the
Swedish occupational exposure limit. In spite of this low exposure, the
exposed group exhibited a significantly increased frequency of skin and
airway symptoms, as well as headache, in comparison with the unexposed
group. A dose-response relationship between the frequency of exposure and
the number of symptoms could also be demonstrated. No case of contact
allergy to glutaraldehyde was found.[Norback D; Scand J Work Environ
Health 14 (6): 366-71 (1988)] **PEER REVIEWED** <a
/SURVEILLANCE/ Nine medical and nursing staff (4 male, 5 female) working
in a endoscopy unit (with 2% glutaraldehyde on the disinfecting trolley)
were offered a questionnaire to determine the symptoms associated with
glutaraldehyde. Eight members of the staff (3 male, 5 female), who had
been affected by the vapor, underwent clinical assessment, including
details of any history of atopy. None of the staff affected had any
previous history of allergy. Air samples obtained by a personal sampler
over a period of 1 hr, from the breathing zone of the nurse carrying a
cold sterilization process, contained 0.12 ppm glutaraldehyde. Air at the
corridor bench contained 0.05 ppm. Clinical manifestations included
watering of eyes, rhinitis, dermatitis, respiratory difficulty, nausea and
headache.[Jachuck SF et al; J Soc Occup Med 39 (2): 69-71 (1989)] **PEER
REVIEWED** <a
/SURVEILLANCE/ In a study simulating a complete cold sterilizing procedure
lasting 12 min, the integrated sample of activated, 2% aqueous sol
resulted in 0.38 ppm of glutaraldehyde measured at the operator's
breathing zone. Although some irritation was recorded throughout this
procedure, it was not until the end of the operation, when the equipment
undergoing sterilization was being air-hose dried, that severe irritation
of the eye, nose, and throat was experienced by the operator and by the
investigators, who also experienced sudden headaches.[American Conference
of Governmental Industrial Hygienists, Inc. Documentation of the Threshold
Limit Values and Biological Exposure Indices. 6th ed. Volumes I, II, III.
Cincinnati, OH: ACGIH, 1991., p. 703] **PEER REVIEWED**
/SURVEILLANCE/ A South Australian study of endoscopy nurses in 26
hospitals included a retrospective survey of symptoms for the prior year,
72 personal samples (15-minute duration), area samples, and survey
conducted at the conclusion of the workday during which the air sampling
was performed. The retrospective study indicated that nurses exposed to
glutaraldehyde were significantly more likely to report skin, eye, and
throat symptoms; headache and lethargy compared with a control group. Of
the 72 samples, 58 indicated airborne glutaraldehyde concentrations below
0.2 ppm, 10 were between 0.1 and 0.2 ppm, and 4 were greater than 0.2 ppm
The workday conclusion survey compared responses from nurses exposed to
airborne glutaraldehyde concentrations greater than and less than 0.032
ppm(arbitrarily selected as cut-off point). This comparison did not
indicate a statistically significant difference among reported symptoms
for the high and low exposure groups, and a positive association between
airborne glutaraldehyde and the incidence of symptoms was not
demonstrated. No acute symptoms were reported for the four exposures that
were greater than 0.2 ppm. However, the authors of this study noted a
possible survivor bias: it was probable that those nurses who had
experienced health problems working with glutaraldehyde had stopped
working with it and thus were not included in the study. This suggested
that the most glutaraldehyde-tolerant nurses may have been
over-represented among the exposed group.[American Conference of
/SURVEILLANCE/ A survey of 107 Swedish medical workers exposed to
glutaraldehyde at or below a ceiling limit of 0.2 ppm during cold
sterilization activities indicated an excess of nose and throat symptoms.
Short-term (15-minute) personal sampling results for samples collected
during manual cold sterilization ranged from < 0.0025 to 0.035 ppm, and
one personal sample was 0.14 ppm. Short-term (15-minute) personal sampling
results for samples collected during automatic sterilization ranged from
0.0025 to 0.0075 ppm with good ventilation conditions and from 0.032 to
0.045 ppm with poor ventilation conditions. The geometric mean of the
short-term personal sampling results was 0.12 ppm for both the manual and
automatic sterilization operations. Concurrent monitoring for formaldehyde
was also conducted with all results less than the analytical limit of
detection (0.01 ppm). Nausea, headache, and rashes on the hand were
reported. ... Questionnaire survey results indicated the prevalence of
most symptoms to be higher for workers regularly exposed to glutaraldehyde
than in a group with limited glutaraldehyde exposure.[American Conference
of Governmental Industrial Hygienists. Documentation of the TLVs and BEIs

/SURVEILLANCE/ /Investigators/ reported nasal and eye irritation,
dermatitis, respiratory difficulties, nausea, and headache in staff
members of an endoscopy unit, with airborne concentrations ranging from
0.05 to 0.12 ppm based on a 1-hour sampling period. The authors noted that
0.2 ppm may have been exceeded for short periods of time during the
sampling period. The low concentration was from a sample taken at the side
of the endoscopy room, while the high concentration was from a sample at
the breathing zone of a nurse carrying out the cold sterilization process
with a 2% glutaraldehyde solution. This nurse experienced rhinitis, facial
dermatitis, and nausea. There were no other personal or area
samples.[American Conference of Governmental Industrial Hygienists.
**PEER REVIEWED**
/SURVEILLANCE/ An occupational hygiene study was conducted at seven
different sites in South Australia to evaluate occupational exposures to
glutaraldehyde and to evaluate workplace practices. Study participants
included endoscopy nurses, a dental assistant, a radiographer, a
radiography technician, an embalmer, and egg collectors at a chick breeder
farm. Air monitoring included 15-minute personal samples as well as area
and longer term samples. All personal sampling results for glutaraldehyde
were less than 0.05 ppm except for samples collected during manual cold
sterilization of endoscopes and colonoscopies at one site. Personal
glutaraldehyde sampling results at this site were 0.077 and 0.105 ppm for
15-minute samples and 0.043 ppm for one 133-minute sample. It is
noteworthy that the endoscopy nurses reported headaches and tingling of
the face during the monitoring period, while adverse health effects were
not noted by the authors during the other monitored activities. Facial
irritation and respiratory problems were reported by the egg collectors;
however, substantial skin contact with glutaraldehyde occurred from direct
spray on their hands and indirect contact from hands to face.[American
/GENOTOXICITY/ ... The results obtained using conventional cytogenetic
analysis do not suggest a statistically significant clastogenic or
genotoxic activity of glutaraldehyde (GA) when concentrations in the range
of 10-6 to 10-2 mM were applied. However, a 24-hr pre-irradiation exposure
of human peripheral blood lymphocytes (PBLs) to non-genotoxic doses of GA
showed a statistically significant (P > 0.05) increase in chromosomal
radiosensitivity. The observed increase may be an effect of GA-induced
alterations in the cell-cycle and feedback control mechanisms during the
cell-cycle transition points or it may be a consequence of an effect of GA
either on the DNA repair capacity of the cells after irradiation or on the
initial induction of radiation-induced chromosomal damage. To elucidate
the mechanism underlying the obtained radiosensitization, conventional
cytogenetics, the G2 chromosomal radiosensitivity assay and premature
chromosome condensation methodologies were applied. The results support
the hypothesis that pre-irradiation exposure of PBLs to GA induces
radiosensitization by increasing the initial yield of chromosomal
aberrations following irradiation.[Hatzi VI et al; Mutagenesis 23 (2):
101-9 (2008).] **PEER REVIEWED** <a
/ALTERNATIVE and IN VITRO TESTS/ ... Nine topical cross-linking agents

(five nitroalcohols, glyceraldehyde [GLYC], genipin [GP], paraformaldehyde
[FA], and glutaraldehyde [GLUT]) were tested with four different cell
lines (immortalized human corneal epithelial cells, human skin
fibroblasts, primary bovine corneal endothelial cells, and immortalized
human retinal pigment epithelial cells [ARPE-19]). The cells were grown in
planar culture and exposed to each agent in a range of concentrations
(0.001 mM to 10 mM) for 24 hours followed by a 48-hour recovery phase.
Toxicity thresholds were determined by using the trypan blue exclusion
method. A semiquantitative analysis using five categories of
toxicity/fixation was carried out, based on plate attachment, uptake of
trypan blue stain, and cellular fixation. The toxicity levels varied by a
factor of 10(3) with the least toxic being mononitroalcohols and GLYC,
intermediate toxicity for a nitrodiol and nitrotriol, and the most toxic
being GLUT, FA, GP, and bronopol, a brominated nitrodiol. When comparing
toxicity between different cell lines, the levels were generally in
agreement ...[Kim M et al; Invest Ophthalmol Vis Sci 55 (5): 3247-57
(2014)] **PEER REVIEWED** <a
target=new>PubMed Abstract Full text: <a
href='https://www.ncbi.nlm.nih.gov/pmc/?term=PMC4037937'
target=new>PMC4037937
/ALTERNATIVE and IN VITRO TESTS/ ... This study aimed to assess that
cytotoxicity in a 3-dimensional culture system using HeLa cells grown in
matrices composed of collagen. Plastic materials were soaked in the use
solutions of the widely used high-level disinfectants, glutaraldehyde
(GA), ortho-phthalaldehyde (OPA) and peracetic acid (PAA). After being
rinsed, they were allowed to dry and were embedded into the cell medium to
investigate the cytotoxicity of the residual disinfectants. Cytotoxicity

was observed with the polyvinyl chloride, polyurethane and silicon tubes
soaked in GA and OPA, indicating that both disinfectants were absorbed in
the test pieces, whereas for PAA, none was observed. As for the
polytetrafluoroethylene (PTFE) tubes, no disinfectant displayed
cytotoxicity. GA and OPA are primary irritants, having a potential to
cause anaphylaxis and other forms of allergic reactions. There should be
consideration not only about the toxicity of the residual disinfectant
from poor rinsing, but also about the toxicity that would result from the
disinfectants that were absorbed and consequently released from the
medical devices or materials.[Ryu M et al; Biocontrol Sci 18 (4): 217-20
/ALTERNATIVE and IN VITRO TESTS/ In vitro skin penetration. Compared
glutaraldehyde penetration through human skin and preparations from rats,
mice, guinea pigs, and rabbits. Two concentrations (0.75% and 7.5%) were
used. A total of 0.006 mg/cq cm for the low dose and 0.08 mg/sq cm for the
high dose was absorbed through the skin for all animal species tested.
0.002 (0.75%) and 0.02 mg/sq cm (7.5%) was absorbed through the human
skin. Potential absorption may be less for humans than for common
laboratory animal species.[European Commission, ESIS; IUCLID Dataset,
Glutaral (111-30-8) p.163 (2000 CD-ROM edition). Available from, as of
June 9, 2010: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
/OTHER TOXICITY INFORMATION/ Biocides are critical components of hydraulic
fracturing ("fracking") fluids used for unconventional shale gas
development. Bacteria may cause bioclogging and inhibit gas extraction,
produce toxic hydrogen sulfide, and induce corrosion leading to downhole

equipment failure. The use of biocides such as glutaraldehyde and
quaternary ammonium compounds has spurred a public concern and debate
among regulators regarding the impact of inadvertent releases into the
environment on ecosystem and human health. This work provides a critical
review of the potential fate and toxicity of biocides used in hydraulic
fracturing operations. We identified the following physicochemical and
toxicological aspects as well as knowledge gaps that should be considered
when selecting biocides: (1) uncharged species will dominate in the
aqueous phase and be subject to degradation and transport whereas charged
species will sorb to soils and be less bioavailable; (2) many biocides are
short-lived or degradable through abiotic and biotic processes, but some
may transform into more toxic or persistent compounds; (3) understanding
of biocides' fate under downhole conditions (high pressure, temperature,
and salt and organic matter concentrations) is limited; (4) several
biocidal alternatives exist, but high cost, high energy demands, and/or
formation of disinfection byproducts limits their use. This review may
serve as a guide for environmental risk assessment and identification of
microbial control strategies to help develop a sustainable path for
managing hydraulic fracturing fluids.[Kahrilas GA et al; Environ Sci
Technol 49 (1): 16-32 (2015)] **PEER REVIEWED** <a
/OTHER TOXICITY INFORMATION/ There is a disproportionately high number of
cases of work-related asthma occurring in health care occupations due to
agents such as glutaraldehyde, latex and cleaning products. We reviewed OA
notifications from the Midland Thoracic Society's Surveillance Scheme of
Occupational Asthma (SHIELD) database in the West Midlands, UK, from 1991
to 2011 and gathered data on occupation, causative agent and annual number
of notifications. There were 182 cases of OA in HCWs (median annual
notifications = 7; interquartile range [IQR] = 5-11), representing 5-19%
of annual SHIELD notifications. The modal annual notification was 20 (in
1996); notifications have declined since then, in line with total SHIELD
notifications. The majority of cases (136; 75%) occurred in nursing,
operating theatre, endoscopy and radiology staff. The most frequently
implicated agents were glutaraldehyde (n = 69), latex (n = 47) and
cleaning products (n = 27), accounting for 79% of the 182 cases. Cleaning
product-related OA was an emerging cause with 22 cases after 2001 and only
5 cases between 1991 and 2000. Control measures within the UK National
Health Service have seen a decline in OA in HCWs due to latex and
glutaraldehyde, though OA remains a problem amongst HCWs exposed to
cleaning products. Continuing efforts are required to limit the number of
cases in this employment sector.[Walters GI et al; Occup Med (Lond) 63
(7): 513-6 (2013)] **PEER REVIEWED** <a
/OTHER TOXICITY INFORMATION/ Glutaraldehyde (GA) is widely used in the
industrial, scientific and biomedical fields. Many adverse health effects
on humans have been reported in association with biomedical uses of GA,
with 2-3.5% aqueous GA solution generally used for cold sterilization and
GA exposure ranges of 0.001 to 2.6 ppm for this type of use. GA is
metabolized extensively to CO(2), but urinary excretion of it is low.
Sensory irritant effects, sensitization of skin and respiratory organs and
other symptoms have been reported among endoscopy nurses and medical
radiation technologists. The prevalence of chronic bronchitis and nasal

symptoms in humans is significantly correlated with peak concentrations of
GA exposure. The extent of primary skin irritation depends on the duration
and site of contact, and the severity of symptoms is dose-related. Chronic
inhalation affects the nose and respiratory tract, and lesions become
severe with prolonged duration of exposure. Increases in neither mortality
nor tumor incidence have been found in workers with less than 0.2 ppm GA
exposure, no evidence of carcinogenic activity has been obtained in
experimental animal studies. There has been no clear evidence of genetic
toxicity of GA in either in vitro or in vivo studies, and neither
developmental nor reproductive toxicity has been found in humans or
animals. To prevent hazards from GA exposure, use of closed-system, fully
automated washing machines is recommended, since numerous symptoms have
been found in individuals with less than 0.05 ppm GA exposure, the
recommended peak exposure limit in many countries.[Takigawa T, Endo Y; J
Occup Health 48 (2): 75-87 (2006)] **PEER REVIEWED** <a
SKIN, EYE AND RESPIRATORY IRRITATIONS:
A severe eye and human skin irritant.[Lewis, R.J. Sr. (ed) Sax's Dangerous
Properties of Industrial Materials. 11th Edition. Wiley-Interscience,
Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 1864] **PEER REVIEWED**
Contact with liquid causes severe irritation of eyes and irritation of
skin.[U.S. Coast Guard, Department of Transportation. CHRIS - Hazardous
Chemical Data. Volume II. Washington, D.C.: U.S. Government Printing
Office, 1984-5.] **PEER REVIEWED**
Glutaraldehyde vapor or mist can be a strong irritant or corrosive to the

eyes, nose throat, and lungs.[Dart, R.C. (ed). Medical Toxicology. Third
Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p.
1249] **PEER REVIEWED**
Eye and respiratory irritation are noted at a level of 0.3 ppm.[Dart, R.C.
(ed). Medical Toxicology. Third Edition, Lippincott Williams &
Wilkins. Philadelphia, PA. 2004., p. 1248] **PEER REVIEWED**
The critical effects /of glutaraldehyde exposure/ are eye, skin, and
respiratory irritation, skin sensitization and occupational asthma. Nose
and throat irritation has been observed in humans at vapor concentrations
below 0.2 ppm. Occupational asthma has also been reported in workers
exposed to dilute solutions of glutaraldehyde ... Contact dermatitis and
eye irritation have been reported in workers using glutaraldehyde
solutions, usually 2% or higher. Skin sensitization has been confirmed in
workers using dilute solutions.[Organization for Economic Cooperation and
Development; Screening Information Data Set for Glutaraldehyde, CAS
REVIEWED**
DRUG WARNINGS:
... A 43-year-old woman /developed/ an acute hemorrhagic colitis after
colonoscopy with ambulatory anesthesia. The diagnosis is likely to have
been glutaraldehyde induced colitis (used for disinfection of the
endoscope). The patient recovered spontaneously completely.[Grenet M et
al; Ann Fr Anesth Reanim 23 (5): 499-500 (2004).] **PEER REVIEWED** <a
Six eyes of 6 patients developed toxic anterior segment syndrome (TASS)
after uneventful phacoemulsification cataract surgery with implantation of
a 3-piece acrylic IOL performed by 2 ophthalmologists on the same day.
Clinical findings included corneal edema, Descemet's membrane folds,
anterior chamber reaction, fibrin formation, and irregular, dilated, and
unreactive pupils. ... Glutaraldehyde 2% solution was used inadvertently
by the operating room staff who cleaned and sterilized reusable ocular
instruments before autoclaving. None of the affected corneas improved.
Additional surgical procedures were required and included penetrating
keratoplasty, trabeculectomy, and glaucoma tube implantation. CONCLUSIONS:
Glutaraldehyde in concentrations generally used for cold sterilization is
highly toxic to the corneal endothelium. The operating room staff involved
in sterilizing instruments should be well educated about and careful to
follow the protocols to properly clean and sterilize reusable ocular
instruments.[Unal M et al; J Cataract Refract Surg 32 (10):
1696-701(2006).] **PEER REVIEWED** <a
The sequelae of the inadvertent introduction of glutaraldehyde into the
peritoneal cavity /are documented/. ... The clinical course, progressive
histological changes to the bowel at different periods over the course of
1 year, and what long-term morbidity remains /are described/. The chemical
structure, effects, and pathogenesis of glutaraldehyde are described as
well as suggestions for avoiding similar problems in the
future.[Karpelowsky JS et al; J Pediatr Surg 41 (6): e23-5 (2006).] **PEER
REVIEWED** <a
The medical records of patients with acute rectocolitis following
endoscopy treated at Kaohsiung Veterans General Hospital since 2001 were
reviewed. The indication of endoscopy was health check-up for all
patients. Published English-language studies regarding acute rectocolitis
following endoscopy were also reviewed. RESULTS: An outbreak of six
patients occurred in April 2002 and one cirrhotic patient was admitted in
July 2008. All patients developed a self-limited syndrome of abdominal
pain and bloody diarrhea within 48 h of uncomplicated endoscopy. One
severely ill patient required hospitalization to receive intravenous fluid
and antibiotics. After the investigation in April 2002,
case. CONCLUSIONS: Endoscopists should be aware of this iatrogenic
complication in patients presenting with acute rectocolitis, especially in
those who have undergone recent endoscopic examination. An outbreak of
acute rectocolitis following endoscopy should be considered
glutaraldehyde-induced and should lead to an investigation of cleansing
and equipment-disinfection procedures. In the absence of strong evidence
of an outbreak, an infectious disease, or contamination of glutaraldehyde,
a sporadic case should be considered ischemic colitis especially in
patients with relevant concomitant diseases or predisposing factors.[Hsu
CW et al; Int J Colorectal Dis 24 (10): 1193-200 (2009)] **PEER REVIEWED**
A 19-year-old woman presented after deliberate ingestion of a biocide
containing glutaraldehyde and a quaternary ammonium compound. She
developed respiratory distress and severe metabolic acidosis 10 hours
... Occupational and chest physicians in the West Midlands /UK/ were
invited to submit details of newly diagnosed cases with occupational
asthma (OA). Data were then transferred to the regional center for
occupational lung diseases for analysis. RESULTS: A total of 1461 cases
were reported to the scheme. Sixty-eight per cent were males with mean
(standard deviation) age of 44 (12) years. The annual incidence of OA was
42 per million of working population (95% CI = 37-45). OA was most
frequently reported in welders (9%) and health care-related professions
(9%) while < 1% of cases were reported in farmers. Isocyanates were the
commonest offending agents responsible for 21% of reports followed by
metal working fluids (MWFs) (11%), adhesives (7%), chrome (7%), latex (6%)
and glutaraldehyde (6%). Flour was suspected in 5% of cases while

laboratory animals only in 1%... CONCLUSIONS: Our data confirm a high
annual incidence of OA in this part of the UK.[Bakerly ND et al; Occup Med
(Lond) 58 (3): 169-74 (2008).] **PEER REVIEWED** <a
Undesirable effects occur very occasionally and mostly involve mild local
skin rashes and irritation. Very rarely, a severe reaction may occur
particularly on the hands or when the product is used excessively and
allowed to spread onto surrounding normal skin. If mild irritation should
occur, apply a reduced amount (taking special care to avoid spreading
beyond the wart or verruca) and apply less often. If the irritation is
severe, patients should stop treatment immediately and seek medical
advice.[Datapharm Communications Ltd; Electronic Medicines Compendium
(eMC), Summary of Product Characteristics (SPC) for Glutarol (Last updated
September 2005). Available from, as of July 9, 2010:
http://www.medicines.org.uk/EMC/medicine/482/SPC/Glutarol+10%25+w+v+Cutaneous+Solution
/]
**PEER REVIEWED**
Keep away from the eyes and mucous membranes. Avoid spreading onto
surrounding uninvolved skin.[Datapharm Communications Ltd; Electronic
Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for
Glutarol (Last updated September 2005). Available from, as of July 9,
2010:
/]
**PEER REVIEWED**
Not to be used on the face, anal or perineal region. Not to be used on
moles or on any other skin lesion for which it is not indicated.[Datapharm
Communications Ltd; Electronic Medicines Compendium (eMC), Summary of
Product Characteristics (SPC) for Glutarol (Last updated September 2005).
Available from, as of July 9, 2010:
/]
**PEER REVIEWED**
PROBABLE ROUTES OF HUMAN EXPOSURE:
According to the 2012 TSCA Inventory Update Reporting data, 5 reporting
facilities estimate the number of persons reasonably likely to be exposed
in manufacturing, processing, or use of glutaraldehyde in the United
States may be as low as < 10 workers and as high as 50-99 workers per
plant; the data may be greatly underestimated due to confidential business
information (CBI) or unknown values(1).[(1) US EPA; Chemical Data
Reporting (CDR). Non-confidential 2012 Chemical Data Reporting information
on chemical production and use in the United States. Available from, as of
Feb 27, 2015: http://www.epa.gov/cdr/pubs/guidance/cdr_factsheets.html]
**PEER REVIEWED**
NIOSH (NOES Survey 1981-1983) has statistically estimated that 367,330
workers (265,564 of these were female) were potentially exposed to
glutaraldehyde in the US(1). The NOES Survey does not include farm
workers. Occupational exposure to glutaraldehyde may occur through
inhalation and dermal contact with this compound at workplaces where
glutaraldehyde is produced or used. Use and limited monitoring data
indicate that the general population may be exposed to glutaraldehyde via

inhalation of ambient air and dermal contact with consumer products
containing glutaraldehyde(SRC).[(1) NIOSH; NOES. National Occupational
Exposure Survey conducted from 1981-1983. Estimated numbers of employees
potentially exposed to specific agents by 2-digit standard industrial
classification (SIC). Available from, as of Feb 26, 2015:
http://www.cdc.gov/noes/] **PEER REVIEWED**
Occupational exposure to health care workers is common. Sensitization has
occurred mainly through its use as a cold sterilizing solution in
hospitals and dental clinics where medical and allied professionals
including x-ray film handlers may be exposed to activated glutaraldehyde
in concentrations of 0.13-2%.[Sullivan, J.B. Jr., G.R. Krieger (eds.).
Hazardous Materials Toxicology-Clinical Principles of Environmental
Health. Baltimore, MD: Williams and Wilkins, 1992., p. 983] **PEER
REVIEWED**
REPORTED FATAL DOSE:
3-4. 3= Moderately toxic, probable oral lethal dose (human) 0.5-5 g/kg,
between 1 ounce & 1 pint for 70 kg person (150 lb). 4=Very toxic,
probable oral lethal dose (human) 50-500 mg/kg, between 1 teaspoon and 1
ounce for 70 kg person (150 lb).[Gosselin, R.E., R.P. Smith, H.C. Hodge.
Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams
and Wilkins, 1984., p. II-187] **PEER REVIEWED**
TOXICITY SUMMARY:
IDENTIFICATION AND USE: Glutaraldehyde is a colorless liquid. It is
registered for pesticide use in the U.S. but approved pesticide uses may
change periodically and so federal, state and local authorities must be
consulted for currently approved uses. It is used as algaecide,

bacteriocide and fungicide. Glutaraldehyde is used as a tissue fixative in
histology and electron and light microscopy, generally as a 1.5-6% aqueous
solution. Glutaraldehyde is used, generally in conjunction with wetting
agents, to control viruses and other micro-organisms in fish farming.
Glutaraldehyde is allowed as a preservative in cosmetics in Europe at
concentrations up to 0.1%. It is not allowed in aerosols and sprays.
Glutaraldehyde is a biocide commonly used in a 2% concentration for cold
sterilization of surgical and dental equipment. Biocides, such as
glutaraldehyde, are added to eliminate bacterial growth in fracturing
fluids. HUMAN EXPOSURE AND TOXICITY: Exposure to concentrations < 1 ppm
by inhalation or skin contact may cause irritation of the skin and/or
mucous membranes. The critical effects of glutaraldehyde exposure are eye,
skin, and respiratory irritation, skin sensitization and occupational
in workers exposed to dilute solutions of glutaraldehyde. Contact
been confirmed in workers using dilute solutions. Other symptoms that may
be brought on by glutaraldehyde exposure include heart palpitations and
tachycardia. The incidence of death and incidence of cancer deaths in 186
male employees at a glutaraldehyde production unit were compared to those
of US white males and to 29,000 other chemical workers during the period
1959 - 1978. All subjects were observed for 10 yr. The number of deaths
was less than expected, as was the incidence of cancer deaths. ANIMAL
STUDIES: Glutaraldehyde was corrosive to the skin and eyes of rabbits at
high concentrations, with signs of skin irritation evident at 2%, and eye
irritation at 0.2%. In an inhalation study where mice were exposed to
glutaraldehyde at concentrations of 33 or 133 ppb for 24 hours, the

animals exhibited panting and increased grooming, mice that inhaled the
highest concentration developed toxic hepatitis. Following a single
whole-body inhalation exposure at 1 ppm for 1 day, rats and mice developed
exposure group. A study of male and female rats given glutaraldehyde in
drinking water at concentrations of 0, 50, 250, or 100 ppm through two
generations indicated a dose-related decrease in parental water
consumption and body weight (attributed to adverse taste) and decrease in
offspring (1000-ppm group) body weights. No adverse reproductive effects
were observed. In other study there was a significant dose-dependent
reduction in the average of maternal body weight gain and a significant
increase in the number of stunted (body weight) and malformed fetuses at
the 5 mL/mg/day dose level. Early mutagenicity studies were negative, but
more recent studies have indicated that glutaraldehyde is mutagenic in
vitro in bacterial assays and tests in mammalian cells. In vivo
genotoxicity tests to date have proven negative. Groups of 50 male and 50
female rats and mice were exposed to glutaraldehyde vapor at
0.25 ppm (mice) 6 hr/day, 5 days /week. The incidences of non-neoplastic
lesions of the nose were reported to be significantly increased in the
0.50 and 0.75-ppm exposed rats and in the 0.12 and 0.25-ppm exposed male
and female mice. ECOTOXICITY STUDIES: Available chronic toxicity data for
glutaraldehyde indicate that continuous exposure results in measurable

effects on coldwater fish at a concentration of 5.1 mg a.i./L. A second
study on coldwater fish resulted in measurable effects at 2.5 mg a.i./L.
Measurable effects on freshwater invertebrates were noted at
concentrations of 8.5 mg/L product and 4.9 mg a.i./L. **PEER REVIEWED**
EVIDENCE FOR CARCINOGENICITY:
A4; Not classifiable as a human carcinogen. /Glutaraldehyde/[American
NON-HUMAN TOXICITY EXCERPTS:
/LABORATORY ANIMALS: Acute Exposure/ Draize Test in rabbits. Effects
produced on rabbit skin by occlusive contact with 0.5 mL of various
concentrations of glutaraldehyde solutions: 1%: no effect; 2%: minor
erythema of 1-7 days duration; 5%: minor to moderate erythema persisting
2-14 days, minor edema persisting for 7 days; 10%: moderate erythema of
14-21 days duration, mild to moderate edema persisting 7-14 days; 25%
minor to moderate erythema and edema persisting 7-14 days, punctate foci
of necrosis; 45% moderate to severe erythema persisting up to 3 weeks,
mild to severe edema persisting up to 14 days, foci of necrosis; 50%:
persistent moderate erythema, marked edema, multiple foci of
necrosis.[European Commission, ESIS; IUCLID Dataset, Glutaral (111-30-8)
/LABORATORY ANIMALS: Acute Exposure/ Occluded contact /in rabbit/ with 50%
glutaraldehyde solutions in water. Two products tested: Ucarcide 250 and
BASF 50% Glutaraldehyde. Severity of irritation was dependent on the

duration of contact. Application of 50% glutaraldehyde for 60 min caused
severe irritation and necrosis; 3 min produced transient minor irritation
and some discoloration of the skin.[European Commission, ESIS; IUCLID
/LABORATORY ANIMALS: Acute Exposure/ > 5% glutaraldehyde solutions
caused severe conjunctivitis and corneal injury /in rabbit/. No effect
concentration for corneal injury = 5%; no effect concentration for
conjuncitivitis = 0.1%.[European Commission, ESIS; IUCLID Dataset,
Glutaral (111-30-8) p.100 (2000 CD-ROM edition). Available from, as of
June 9, 2010: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
/LABORATORY ANIMALS: Acute Exposure/ Installation of 0.5 mL of diluted
Ucarcide glutaraldehyde solutions /into eye of rabbit/; corneal effects
after 24 hr: 2.5% severe keratitis; 1.25% severe keratitis; 1.0% moderate
keratitis; 0.5% mild superficial corneal injury. The threshold for
induction of inflammatory effects is between 0.25 - 0.5%.[European
Commission, ESIS; IUCLID Dataset, Glutaral (111-30-8) p.101 (2000 CD-ROM
edition). Available from, as of June 9, 2010:
/LABORATORY ANIMALS: Acute Exposure/ Glutaraldehyde was corrosive to the
skin and eyes of rabbits at high concentrations, with signs of skin
irritation evident at 2%, and eye irritation at 0.2%.[Organization for
**PEER REVIEWED**
/LABORATORY ANIMALS: Acute Exposure/ Eight male Hartley Guinea pigs were
exposed (head only) to 14 ppm vapor for 1hr/day for 5 days, followed by
challenge with 4-5 ppm on days 19, 26, 40. No change in respiratory
waveform, and respiratory rate decrease in exposed animals similar to
controls in each challenge phase.[Organization for Economic Cooperation
and Development; Screening Information Data Set for Glutaraldehyde, CAS
REVIEWED**
/LABORATORY ANIMALS: Acute Exposure/ Ucarcide Antimicrobial 250, 50.9% ai,
was administered via a single 4 hr whole body inhalation exposure at
concentrations of 3 (static), 14.5, or 16.3 (dynamic bubble) ppm to 5
Sprague-Dawley albino rats/sex/group. On day of treatment, blepharospasm
was observed for all treated animals and in addition, periocular,
perioral, and/or perinasal wetness and encrustation, and audible
respiration were observed for the mid and high dose groups. No other
treatment related effects reported.[California Environmental Protection
Agency/Department of Pesticide Regulation; Summary of Toxicology Data on
Glutaraldehyde p.17 (2001). Available from, as of June 9, 2010:
http://www.cdpr.ca.gov/docs/risk/toxsums/toxsumlist.htm] **PEER REVIEWED**
/LABORATORY ANIMALS: Acute Exposure/ Ucarcide containing 50%
glutaraldehyde was given by oral intubation to 5 per sex per dose at 100,
200, or 400 mg/kg to males and 100, 141, or 200 mg/kg to females as
aqueous dilutions. The doses were not adjusted for the 50% content of
glutaraldehyde. Mortality was: males, 0/5, 1/5 and 5/5 with increasing
dose; females: 0/5, 2/5 and 4/5 with increasing dose ... Clinical signs
included sluggishness, piloerection, red crust on perinasal fur at 400
(males) and 200 (females). At 100 mg/kg in males, there were no signs of
toxicity but in females, 1 showed sluggishness, 2 had trace amount of
blood in the urine, but these animals recovered by day 4. Observation was
for 14 days. Gross necropsy findings included red lungs, glandular portion
of the stomach dark maroon, hemorrhaged at the high dose in each
sex.[California Environmental Protection Agency/Department of Pesticide
Regulation; Summary of Toxicology Data on Glutaraldehyde p.17 (2001).
/LABORATORY ANIMALS: Acute Exposure/ ... A 25% aq soln on rabbit eyes,
caused severe injury, graded 9 on a scale of 10.[Grant, W.M. Toxicology of
the Eye. 3rd ed. Springfield, IL: Charles C. Thomas Publisher, 1986., p.
/LABORATORY ANIMALS: Acute Exposure/ 18 6-8 wk old male and female mice of
various strains (Swiss, Balb/c, DBA/2, CBA, C57B1/6, and B6D2F1) received
a topical application of 10% glutaraldehyde in ethanol on both sides of
the right ear on days 0 and 2, and a scapular sc injection of 0.05 mL of
complete Freunds adjuvant on day 2. On day 9, left ear thickness was
measured immediately before topical application of 1% glutaraldehyde in
ethanol, on both sides of the ear, and again 24 hr later (day 10). A
statistically significant incr in ear thickness was seen.[Descotes J; J
Toxicol Cutan Ocular Toxicol 7 (4): 263-72 (1988)] **PEER REVIEWED**
/LABORATORY ANIMALS: Acute Exposure/ In an inhalation study where mice
were exposed to glutaraldehyde (Hospex) at concentrations of 33 or 133 ppb
for 24 hours, the animals exhibited panting and increased grooming. No

other signs of toxicity or changes in behavior were observed; however,
mice that inhaled the highest concentration developed toxic
hepatitis.[American Conference of Governmental Industrial Hygienists.
**PEER REVIEWED**
/LABORATORY ANIMALS: Acute Exposure/ Following a single whole-body
inhalation exposure at 1 ppm for 1 day, rats and mice developed
exposure group.[American Conference of Governmental Industrial Hygienists.
**PEER REVIEWED**
/LABORATORY ANIMALS: Acute Exposure/ Respiratory sensory irritation was
investigated using male mice exposed to seven different vapor
concentrations /of glutaraldehyde/ in the range of 1.6 to 36.7 ppm.
Concentration-related reductions in respiratory rate were measured by
plethysmography. A 50% decrease in respiratory rate (RD50) was calculated
to be 14 ppm.[American Conference of Governmental Industrial Hygienists.

**PEER REVIEWED**
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ ... We evaluated
the alterations in Glutaraldehyde (GA) or ortho-phtalaldehyde (OPA) in
rats after subacute inhalation exposure by determining levels of
neurotransmitters (norepinephrine [NE], dopamine [DA], DA metabolites,
dihydroxyphenylacetic acid [DOPAC] and homovanillic acid [HVA],
indoleamine serotonin [5-HT] and 5-HT metabolite, 5-hydroxyindoleacetic
acid [5-HIAA]) in discrete brain regions using high performance liquid
chromatography (HPLC) equipped with an electrochemical detector. Female
Wistar rats were exposed to 0, 50, 100, or 200 ppb gaseous GA or OPA by
inhalation for 1 hr per day, 5 d per week for 4 wk. Following the
exposure, the brain of each rat was removed and dissected into cerebrum,
cerebellum, medulla oblongata, midbrain, corpus striatum and hypothalamus.
The neurotransmitters and their metabolites were extracted from each brain
region, and determined by HPLC. Regarding GA, the daily water intake of
the 50 or the 200 ppb exposed groups was significantly lower than that of
the control. DA and 5-HIAA levels in the medulla oblongata among the GA
exposed groups were significantly lower than those of the control. For
OPA, the mean final body weight and daily food intake of the 100 or 200
ppb exposed groups were significantly lower than those of the control. The
mean DA concentrations in the cerebrum in the groups exposed to OPA were
significantly lower than those of the control. OPA may modulate DA
metabolism in the cerebrum of female rats. The levels GA or OPA that
induced alienations in neurotransmitters were comparable to those levels
usually found in hospitals ...[Katagiri H et al; Ind Health 49 (3): 328-37
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Male and female
Fischer 344 rats, 10 animals/sex/group, /were exposed to glutaraldehyde by
inhalation/ 6 hr/day, 5 days/week for 9 days, dosage: 0.00083, 0.0026,
0.0087 mg/L (0.2, 0.63, 2.1 ppm). Control group received no treatment.
Result: signs of irritation, food consumption, and body weight loss
produced in concentration-related fashion. Organ weight changes only for
intermediate dose group. 9/10 (male) and 7/10 (female) died from exposure
to 0.0087 mg/L; 1/10 (male) died in 0.0026 mg/L group. Deaths occurred
between the third and ninth day of exposure.[European Commission, ESIS;
IUCLID Dataset, Glutaral (111-30-8) pp.116-7 (2000 CD-ROM edition).
REVIEWED**
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ C3H/HeJ mice, 10
animals/sex/group, 10 daily applications of 50 uL /glutaraldehyde/ to the
clipped dorsal skin, dosage: 0.025, 0.125, 0.25, 1.25, 2.5, 12.5, or 25
mg/animal. Concentrations tested were 0.05%, 0.25%, 1.25%, 5%, 25%, and
50% w/w glutaraldehyde dilutions in water. NOAEL: 1.25 mg. Results: < /=
1.25 mg: no effects noted; 2.5 mg: decreased body weight after 4 to 6
applications, but not thereafter; > /= 12.5 mg: weight loss and death
after 4 to 9 applications.[European Commission, ESIS; IUCLID Dataset,
Glutaral (111-30-8) pp.129-30 (2000 CD-ROM edition). Available from, as
of June 9, 2010: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Male and female
Fischer 344 rats were given glutaraldehyde in their drinking water
continuously for 13 weeks, doses: male: 5, 25, 100 mg/kg; female: 7, 35,
120 mg/kg (50, 250, 1000 ppm in drinking water). Control group received no
treatment. 4 week post observational period. Results: male: 5 mg/kg: no
effects noted; 25 mg/kg: decreased water consumption, decreased urine
volume with increased specific gravity, increased absolute kidney weight;
100 mg/kg: decreased food and water consumption, decreased body weight and
body weight gain, decreased urine volume with increased specific gravity,
increased relative kidney weight. Females: 7 mg/kg: no effects noted; 35
mg/kg: decreased water consumption, decreased urine volume with increased
specific gravity, increased relative and absolute kidney weight, increased
blood urea nitrogen; 120 mg/kg: decreased food and water consumption,
decreased body weight and body weight gain, decreased urine volume with
increased specific gravity, increased relative and absolute kidney weight,
increased blood urea nitrogen. Three additional tissues (skin,
submandibular lymph nodes, harderian glands) were examined histologically
... There were no treatment related lesions. Minimal to moderate adenitis
of the harderian glands occurred with similar frequency in control and
treated groups with the exception of the 50 ppm dose group animals who had
no adenitis. There was a statistically significant increase in lymphatic
ectasia of the submandibular lymph nodes in the 1000 ppm group. The lesion
was graded as mild and usually involved only one node. The apparent
increase in lymphatic ectasia in the high dose animals was considered of
no biological significance and may be an artifact of sectioning
technique.[European Commission, ESIS; IUCLID Dataset, Glutaral (111-30-8)
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ 50 uL
glutaraldehyde was applied dermally to male C3H/HeJ mice for 10 days at
concentrations of 0.05, 0.25, 0.5, 2.5, 5.0, 25 and 50% aqueous solution.
Control received vehicle only. All mice lost weight and died after 4-9
doses of the 25% or 50% solutions. For a 5% solution, the mice lost weight
after 4-6 doses, but not thereafter. For 2.5% solutions and less, no signs
of toxicity were observed.[Organization for Economic Cooperation and
111-30-8 pp.53-4 (October 1998). Available from, as of June 1, 2010:
REVIEWED**
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Glutaraldehyde was
applied dermally to male and female Fischer 344 rats daily for 28 days,
dosage: 2.0 mL/kg bw/day of 0, 2.5, 5.0 or 7.5% of solution of test
substance (0, 50, 100, 150 mg/kg bw/day). NOEL: not determined. LOEL: 50
mg/kg bw/day (lowest dose). 15 animals/sex/dose for control and high
doses, 10 for low and mid doses. No treatment-related mortality. Clinical
signs of toxicity during study included slight erythema, little edema and
persistent skin color change. Dose-related incidence of skin lesions
confirmed by microscopic examination at necropsy. Reduced body weight gain
in males, dose-related increase in platelet count in females.[Organization
for Economic Cooperation and Development; Screening Information Data Set
for Glutaraldehyde, CAS 111-30-8 p.54 (October 1998). Available from, as
of June 1, 2010: http://www.chem.unep.ch/irptc/sids/OECDSIDS/sidspub.html]
**PEER REVIEWED**
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Fischer 344 rats
(both sexes) were exposed to 0, 0.3, 1.1, 3.1 ppm glutaraldehyde via
inhalation 6 hr/day for 9 days. 12 male and 12 females were in each group.
At 3.1 ppm, 7 of the males and 6 of the females died (days 8 or 9). Nasal
cavity lesions occurred at 1.1 and 3.1 ppm, atrophy of the liver at 3.1
ppm. Body weight decrease occurred at 1.1 and 3.1 ppm, where signs of
respiratory irritation were also observed. Significant weight decreases
were noted for the liver, heart, lungs, kidney and testes at 3.1 ppm,
smaller decreases at 1.1 ppm for the liver, heart, kidney and testes, and
a small increase in lung weight for males at 0.3 ppm.[Organization for
**PEER REVIEWED**
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Glutaraldehyde,
50% a.i., was administered at concentrations of 0, 50, 150, and 250 ppm
(males: 3.3, 9.6 and 14.1 mg/kg and females: 3.2, 9.9 and 15.1 mg/kg) for
13 weeks in the drinking water of 4 Beagle dogs/sex/group. Food- and
fluid-like vomitus were observed in all groups but were more frequent in
mid and high dose groups. Body weight was reduced at least 10% for mid and
high dose females (initial body weights, however, were 6 and 4% lower at
week 0, respectively) and cumulative change in bodyweight at least 28%
lower for all female groups. Food and water consumption of females was
slightly lower at 250 ppm. In males, food and water consumption values
were reduced 28% and 51%, respectively and statistically significant only
during week 2 for high dose males. Kidney weight increase was reported as
treatment related, but not toxicologically important since there was no
evidence of toxicity from histopathology or clinical chemistry/urinalysis
data. The significance of ovary weight increase was reported as unclear.
Overall, the NOEL = 50 ppm, based on lower body weights, primarily in
female dogs, at the mid dose.[California Environmental Protection

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Glutaraldehyde as
a 25.9% aqueous solution with > 99% purity of glutaraldehyde was
administered at concentrations of 0, 100, 250, or 1000 ppm (w/w) for 13
weeks in the drinking water of 20 CD-1 mice/sex/group. Ten extra mice in
control and high dose groups served as a recovery group of six weeks.
Doses were equivalent to 25, 61, and 200 mg/kg/day for males and 31, 74,
and 238 mg/kg/day for females. Water consumption decreased for the high
dose groups; urinalysis indicated osmolality increased for the high dose
group and urine volume decreased for mid and high dose males and high dose
females; however, these effects were absent during the recovery period.
There were no clinical signs, effects on hematology, clinical chemistry,
ophthalmology or histopathology. NOEL = 100 ppm based on marginal effects
at 250 ppm on urine volume. No adverse effects were noted at 1000 ppm
other than decreased water consumption, reported as due to
palatability.[California Environmental Protection Agency/Department of
Pesticide Regulation; Summary of Toxicology Data on Glutaraldehyde pp.5-6
(2001). Available from, as of June 9, 2010:
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ 13-week inhalation
studies /were conducted/ with groups of ten rats and ten mice of each sex
exposed to glutaraldehyde 6 hours/day, 5 days/week at concentration of 0,
0.06, 0.12, 0.25, 0.50, and 1 ppm. There were no exposure-related deaths
in rats, but all mice exposed at 1 ppm and two female mice exposed at 0.50
ppm died before the end of the study. There was no definitive evidence of
systemic toxicity in the rats or mice by clinical pathology or
histopathologic evaluations. Exposure-related lesions in the upper
respiratory tract were observed (necrosis, inflammatory, and regenerative

lesions) ... The NOAEL was 0.12 ppm for respiratory lesions in rats. An
NOAEL was not reached for mice since inflammation was evidenced in the
anterior nasal passage at the lowest concentration employed, 0.06
ppm.[American Conference of Governmental Industrial Hygienists.
**PEER REVIEWED**
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ A 13-week
subchronic glutaraldehyde whole-body inhalation bioassay /was/ carried out
in male and female F344 rats and B6C3F1 mice. Concentrations studied were
0, 0.06, 0.12, 0.25, 0.5, and 1 ppm; exposures at the higher
concentrations resulted in obvious distress (bloating, gasping). During
the third week, two male and three female rats in the highest exposure
group died; ten male and ten female mice in the 1 ppm group and one female
mouse in the 0.50 ppm group also died. Neutrophilic infiltrate of the
squamous epithelium of the vestibule was severe, and localized epithelial
hyperplasia and hypertrophy were considered mildin the mice inhaling the
highest concentration. The locally severe changes in the upper respiratory
tract (naso- and maxilloturbinate destruction, bone remodeling,
nasoturbinate fusions) in rats were similar to those observed after
similar bioassays with other irritants. It is noteworthy that the
karyomegaly observed in the rodent nasal passages after formaldehyde
inhalation was not seen in the subchronic inhalation bioassay with
glutaraldehyde. No changes in tissues, other than those of the upper
respiratory tract, of rats and mice were observed. The NOAEL for
glutaraldehyde was 0.125 ppm in rats. Effects were observed at 0.60 ppm in
mice; however, similar changes were also observed in the
controls.[American Conference of Governmental Industrial Hygienists.

**PEER REVIEWED**
/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Male and female
Fischer 344 rats were given glutaraldehyde in their drinking water for 2
yr. Doses: males: 0, 4, 17, 64 mg/kg bw; females: 0, 6, 25, 86 mg/kg bw.
Groups of 100 males and 100 females were treated , with 10 animals per sex
per dose sacrificed at 52 and 78 weeks, and the remainder at 104 weeks.
The main finding was a statistically significant increase in large
granular cell lymphatic leukaemia (LGLL) in the liver and spleen of
females only at all doses at 104 weeks; LGLL was also observed in males at
all doses (including controls), but the increase was not statistically
significant. No LGLL at 52 weeks and 4 (at 50 ppm only) at 78 weeks.
Fischer 344 rats have a high historical susceptibility to LGLL (NTP data:
10-72% in males, 6-31% in females), so the study was
inconclusive.[Organization for Economic Cooperation and Development;
Screening Information Data Set for Glutaraldehyde, CAS 111-30-8 pp.62-3
REVIEWED**
/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Fischer 344
rats, 100/sex/dose, were given glutaraldehyde (Ucarcide 250) in drinking
water at 0, 50, 250, or 1000 ppm for 104 weeks. There were interim
sacrifices of 10/sex/group at 52 and 78 weeks with the remaining survivors
sacrificed at 104 weeks. Acceptable parameters for hematology, clinical
chemistry, urinalysis and ophthalmology were examined. At 250 and 1000 ppm
the intake of water was significantly decreased with subsequent effects on

urine volume and osmolality. Body weights were also decreased at the mid
and, especially, at the high dose. There was evidence of gastric
irritation at 250 and 1000 ppm as early as 52 weeks. The lesions included
multifocal color change, thickening of the wall and ulceration of the
mucosa. Systemic NOEL = 50 ppm (gastric irritation). The major finding was
a statistical increase in the incidence of large granular lymphocyte (LGL)
leukemia in all doses in females (but not in males) when compared with
concurrent controls. The overall incidences for all females was: 24, 41,
41, and 53 per 100 animals. Although LGL leukemia is a common and
spontaneous neoplasm in Fischer 344 rats, a role of glutaraldehyde could
not be discounted. Possible adverse effect.[California Environmental
Protection Agency/Department of Pesticide Regulation; Summary of
Toxicology Data on Glutaraldehyde p.2 (2001). Available from, as of June
9, 2010: http://www.cdpr.ca.gov/docs/risk/toxsums/toxsumlist.htm] **PEER
REVIEWED**
/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Groups of 50
male and 50 female rats and mice /were exposed/ to glutaraldehyde vapor at
0.25 ppm (mice) 6 hr/day, 5 days /week. Although the incidences of
non-neoplastic lesions of the nose were reported to be significantly
increased in the 0.50 and 0.75-ppm exposed rats and in the 0.12 and
0.25-ppm exposed male and female mice, in their draft technical report of
the studies NTP states that, "Under the conditions for these 2-year
inhalation studies, there was no evidence of carcinogenic activity of
glutaraldehyde in male or female F344/N rats exposed to 250, 500, or 750
ppb. There was no evidence of carcinogenic activity in male or female
B6C3F1 mice exposed to 62.5, 125, or 250 ppb."[American Conference of

/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ Male and
female F344/N rats were exposed to glutaraldehyde via inhalation 6 hr/day,
5 days/week, for 13 weeks at doses of 0, 62.5, 250, 1000 ppb. Sperm
morphology measurements for the males were normal. Estrous cycle lengths
for the females were normal.[Organization for Economic Cooperation and
REVIEWED**
/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ / Male and
female B6C3F1 mice were exposed to glutaraldehyde 6 hr/day, 5 days/week
for 13 weeks at doses of 0, 62.5, 250, 500 ppb. Sperm morphology
measurements for the males were normal. There were significant differences
in estrous cycle length for females at 250 and 500p.[Organization for
Glutaraldehyde, CAS 111-30-8 pp.63-4 (October 1998). Available from, as of
**PEER REVIEWED**
/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/
Glutaraldehyde (Ucarcide Antimicrobial 250), purity 51% glutaraldehyde, at
concentrations of 0, 50, 250 or 1000 ppm in the drinking water during two
generations, 28 albino CD rats/sex/group. Water consumption decreased
(considered an aversion affect) up to 15-20% and 25-35% throughout dosing
for mid and high dose groups and on occasion 9-11% for low dose females.
Other treatment-related effects reported were reduced food consumption up
to 9-10% for high dose groups and reduced body weight gain without an
apparent similar affect on body weight for F0 mid and high dose groups;
Adult NOEL = 50 ppm. Body weight of F1 and F2 high dose pups decreased
5-7% during lactation Day 21; Pup NOEL = 250 ppm. Reproductive NOEL =
> 1000 ppm.[California Environmental Protection Agency/Department of
Pesticide Regulation; Summary of Toxicology Data on Glutaraldehyde p.6
(2001). Available from, as of June 9, 2010:
/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ Female Wistar
rats were given glutaraldehyde in their drinking water on days 6 - 16 post
coitum, doses: 0, 5, 36, 68 mg/kg bw (25 per group). A control group
received vehicle only. NOEL Maternal Toxicity: 5 mg/kg. A dose-related
decrease in water consumption occurred for dams at 26 and 68 mg/kg. For
fetuses, no significant findings were observed in the sex distribution,
placental weight, or fetal weight. No significant malformations or
variations were noted in soft tissue and skeletal examination of the
fetuses.[Organization for Economic Cooperation and Development; Screening
REVIEWED**
/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ Female
Himalayan rabbits were given glutaraldehyde via gavage daily on days 7 -
19 post insemination, doses: 0, 5, 15, 45 mg/kg bw (15 per group). A
control group received vehicle only. NOEL Maternal Toxicity: 15 mg/kg.
Five of the 15 does died at 45 mg/kg, with only 4 live fetuses produced
(from one doe). In the does, food consumption and body weight gain were
reduced, and at necropsy, irritation of the gastrointestinal tract was
noted. No significant effects were observed for does or fetuses at 5 and
15 mg/kg. There was no evidence of teratogenicity at any
dose.[Organization for Economic Cooperation and Development; Screening
REVIEWED**
/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ A study of
male and female rats given glutaraldehyde in drinking water at
concentrations of 0, 50, 250, or 100 ppm through two generations indicated
a dose-related decrease in parental water consumption and body weight
(attributed to adverse taste) and decrease in offspring (1000-ppm group)
body weights. No adverse reproductive effects were observed.[American
/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/
/Investigators/ studied 2% potentiated (activated) acidic glutaraldehyde
(Sonacide) at doses of 0.8, 1.0, 1.2, 2.0, 2.5, and 5.0 mL/kg/day in a
study of potential developmental toxicity in CD-1 mice. Doses were by
gavage on days 6 through 15 of gestation. Sonacide was judged highly toxic
at 2 mL/kg/day and above, with 17% to 54% maternal mortality on days 6 to
15. There was a significant dose-dependent reduction in the average of
maternal body weight gain and a significant increase in the number of
stunted (body weight) and malformed fetuses at the 5 mL/mg/day dose level.
Terata included cleft palate, fused sternbrae, missing or fused ribs, and
exencephaly. There was no indication of teratogenic effects at doses that
were not highly toxic to the dams.[American Conference of Governmental
45240-1634 2013., p. 4] **PEER REVIEWED**
/LABORATORY ANIMALS: Neurotoxicity/ After Sprague-Dawley rats drank 0.1%
to 0.5% glutaraldehyde in tap water ad libitum for 14 weeks, body weight
gain and clinical condition of these animals were normal. Histopathologic
examination of the spinal cord and posterior fibial nerve, sciatic nerve,
and spinal ganglia found no evidence of neurotoxicity.[American Conference
/GENOTOXICITY/ ... It has been extensively tested for genetic activity in
vitro and in vivo, and there is disagreement in the literature with regard
to glutaraldehyde's genetic activity. Glutaraldehyde produced DNA damage
in bacteria and some cultured mammalian cell systems. In vitro, it was
mutagenic in Salmonella and E. coli, produced inconsistent positive
responses in mammalian cells, weak and inconsistent responses in
chromosome aberration and SCE studies, and did not induce transformation
in cultured SHE cells. In vivo, inhalation of glutaraldehyde induced cell
proliferation in nasal tissue in rats and mice, but DNA damage and UDS
were not induced at these sites in rats. Chromosome aberrations in bone
marrow cells were reported in only one of eight studies using rats and
mice, micronuclei were not induced in bone marrow cells of mice, and
dominant lethal mutations were not induced in mice. Glutaraldehyde did not
induce cell transformation in SHE cells in vitro. Bone marrow hyperplasia
and low, but statistically significant, levels of leukemia were seen in
one chronic drinking water study in rats, but not in a chronic inhalation
study in rats or two chronic inhalation studies in mice.[Zeiger E et al;
Mutat Res 589 (2): 136-51 (2005).] **PEER REVIEWED** <a
/GENOTOXICITY/ ... The genotoxic and mutagenic potential of glutaraldehyde
(GA) /was characterized/ in V79 cells using the alkaline comet assay. ...
The induction of DNA-protein crosslinks (DPX) by GA (reduction of gamma
ray-induced DNA migration) /was demonstrated/ at a concentration of 10 uM
and above. The standard comet assay did not reveal a significant DNA
strand-breaking activity of GA. Cross-linking concentrations of GA were
also cytotoxic, i.e. inhibited cell growth of treated V79 cultures.
Interestingly, a small but statistically significant increase in sister
chromatid exchange (SCE) and micronuclei (MN) was already measured at
lower concentrations (2 and 5 uM). FISH analysis revealed that the
majority of GA-induced MN was due to chromosome breaks. ... The genotoxic
activity of GA /was also compared/ to that of formaldehyde (FA). Similar
to GA, FA-induced DPX, SCE and MN, but distinct differences exist with
regard to the sensitivity of the endpoints and the relationship between
genotoxicity and cytotoxicity. However, the differences in genotoxicity
cannot readily explain the different carcinogenic activities of the two
compounds.[Speit G et al; Mutat Res 649 (1-2): 146-54 (2008).] **PEER
REVIEWED** <a
/GENOTOXICITY/ Early mutagenicity studies were negative, but more recent
studies have indicated that glutaraldehyde is mutagenic in vitro in
bacterial assays and tests in mammalian cells. In vivo genotoxicity tests
to date have proven negative.[Organization for Economic Cooperation and
REVIEWED**
/GENOTOXICITY/ Bacterial reverse mutation assay using S. typhimurium TA98,
TA100, TA102, TA104, TA1535, TA1537. Concentrations: 0, 300, 333, 3333
ug/plate, with and without S-9 metabolic activation. Results: positive
with and without activation.[Organization for Economic Cooperation and
REVIEWED**
/GENOTOXICITY/ Cytogenetic assay with Chinese hamster ovary cells,
concentration: 0.03 - 30 mg/mL, with and without metabolic activation.
Results: negative with and without activation.[Organization for Economic
**PEER REVIEWED**
/GENOTOXICITY/ Cytogenetic assay with Chinese hamster ovary cells.
Concentration: 0.3 - 16 ug/mL with and without S9 metabolic activation.
Results: negative with activation, positive without

activation.[Organization for Economic Cooperation and Development;
REVIEWED**
/GENOTOXICITY/ Sister chromatid exchange assay with Chinese hamster ovary
cells, concentration 0.36 - 16 ug/mL with and without S9 metabolic
activation. Results: In one laboratory, sister chromatid exchanges were
induced, with and without S9 metabolic activation. In the second
laboratory, the result was negative without S9, and weakly positive with
S9.[Organization for Economic Cooperation and Development; Screening
REVIEWED**
/GENOTOXICITY/ HGPRT forward mutation assay in Chinese hamster ovary
cells, concentration: 0.10 - 30 ug/mL with and without S9 metabolic
activation. Results: negative with and without activation.[Organization
for Economic Cooperation and Development; Screening Information Data Set
for Glutaraldehyde, CAS 111-30-8 p.60 (October 1998). Available from, as
of June 1, 2010: http://www.chem.unep.ch/irptc/sids/OECDSIDS/sidspub.html]
**PEER REVIEWED**
/GENOTOXICITY/ Mouse lymphoma assay, mouse lymphoma L5178Y cells,
concentration: 0 - 16 ug/L without metabolic activation. Results:
positive. Mutations were induced at the TK locus of cells at 8 ug/mL, but
no significant increase was observed at concentrations up to 4

ug/mL.[Organization for Economic Cooperation and Development; Screening
Information Data Set for Glutaraldehyde, CAS 111-30-8 pp.60-1 (October
1998). Available from, as of June 1, 2010:
REVIEWED**
/GENOTOXICITY/ Micronucleus assay with Swiss-Webster mice, both sexes.
Glutaraldehyde administered by gavage at doses of 0, 80, 160, 250 mg/kg.
Five animals per sex per group were dosed except for 250 mg/kg, where 8
per sex were dosed. No females died, but 2 mice at 250 mg/kg and one each
at 80 and 160 mg/kg died. No induction of micronuclei in the polychromatic
erythrocytes in the peripheral blood was observed.[Organization for
**PEER REVIEWED**
/GENOTOXICITY/ Cytogenetic assay in Sprague-Dawley rats, both sexes.
Glutaraldehyde administered by gavage. Dosage: males: 0, 25, 60, 120 mg/kg
bw; females: 0, 15, 40, 80 mg/kg. Five animals per sex per group were
dosed, with one male at 120 mg/kg dying. The number of aberrant cells in
bone marrow were similar to the vehicle controls for each time period (12,
24, 48hr), so no evidence of clastogenicity was observed.[Organization for
**PEER REVIEWED**
/GENOTOXICITY/ Drosophila SLRL test using male Drosophila melanogaster.

Glutaraldehyde administered through feed and via injection. Male Canton-S
wild-type flies were injected with glutaraldehyde solution, with the
number of lethal mutations from the mating of newly-emerged flies
determined. The results were negative. In a second series of tests, the
eggs of mated Canton-S flies were exposed to cornmeal containing
glutaraldehyde, with the results also negative.[Organization for Economic
**PEER REVIEWED**
/GENOTOXICITY/ Summary data from four tests: Salmonella typhimurium,
CHO/HGPRT gene mutation assay, Chinese Hamster Ovary (CHO) sister
chromatid exchange assay, and primary rat hepatocyte unscheduled DNA
synthesis assay. Under the conditions of the assays, all were negative for
genotoxicity. Glutaraldehyde used was approximately 50% aqueous solution.
Salmonella typhimurium assay: Strains TA1535, TA1537, TA1538, TA98, and
TA100 were tested with and without rat liver activation by plate
incorporation with three plates per concentration on each of two days at 0
(water), 0.15, 0.5, 1.5, 5.2, 15.4, and 51.6 (toxic) ug/plate without
activation and 0, 0.5, 1.5, 5.2, 15.4, and 51.6 ug/plate with activation.
No induction of revertants. CHO/HGPRT: CHO-K1-BH4 cells were exposed with
and without rat liver activation for 5 hr followed by 7 days for
expression. Mutation frequency was determined with 6-thioguanine.
Concentrations ranged from 2.6 to 40.8 (toxic) uM without activation and
0.03 to 40.8 uM with activation. Results were negative with cytotoxicity
at higher concentrations. Sister chromatid exchange assay: CHO cells were
exposed for 5 hr without activation or 2 hr with activation followed by 30
- 32 hr in the presence of BrdU. Concentrations were 0 (water), 0.6, 1.3

and 2.5 uM. Results were negative. Unscheduled DNA synthesis: Hepatocytes
were isolated from Hilltop-Wistar rats and exposed for 2 hr in two
separate trials. UDS was determined by the incorporation of (3)H-thymidine
as measured by liquid scintillation counting of DNA precipitated from
nuclei. Results were reported as dpm/106 viable cells and compared with
water controls. Concentrations ranged from 0.05 to 51 uM in the two
trials. Results were negative.[California Environmental Protection
/GENOTOXICITY/ /Investigators/ reported the genotoxicity of glutaraldehyde
in human TK6 lymphoblast cell line and primary rat hepatocytes. DNA
cross-linking increased linearly between 0 and 25 umol glutaraldehyde. An
increase in unscheduled DNA synthesis in the hepatocyte DNA repair assay
was noted at 50 and 100 umol.[American Conference of Governmental
45240-1634 2013., p. 4] **PEER REVIEWED**
/GENOTOXICITY/ ... The NTP reported that glutaraldehyde was mutagenic with
and without S9 metabolic activation in S. typhimurium strains TA100,
TA102, and TA104; in mouse L5178Y lymphoma cells in the absence of S9; and
induced sister-chromatid exchange in cultured Chinese hamster ovaries
cells with and without S9.[American Conference of Governmental Industrial

/ALTERNATIVE and IN VITRO TESTS/ Glutaraldehyde-stabilized bovine
pericardium is used for clinical application since 1970s because of its
desirable features such as less immunogenicity and acceptable durability.
However, a propensity for calcification is reported on account of
glutaraldehyde treatment. In this study, commercially available
glutaraldehyde cross-linked bovine pericardium was evaluated for its in
vitro cytotoxic effect, macrophage activation, and in vivo toxic response
in comparison to decellularized bovine pericardium. Glutaraldehyde-treated
bovine pericardium and its extract were observed to be cytotoxic and it
also caused significant inflammatory cytokine release from activated
macrophages. Significant antibody response, calcification response,
necrotic, and inflammatory response were noticed in glutaraldehyde-treated
bovine pericardium in comparison to decellularized bovine pericardium in a
rat subcutaneous implantation model. Glutaraldehyde-treated bovine
pericardium also failed in acute systemic toxicity testing and
intracutaneous irritation testing as per ISO 10993. With respect to
healing and implant remodeling, total lack of host tissue incorporation
and angiogenesis was noticed in glutaraldehyde-treated bovine pericardium
compared to excellent host fibroblast incorporation and angiogenesis
within the implant in decellularized bovine pericardium. In conclusion,
using in vitro and in vivo techniques, this study has demonstrated that
glutaraldehyde-treated bovine pericardium elicits toxic response compared
to decellularized bovine pericardium which is not congenial for long-term
implant performance.[Umashankar PR et al; Toxicol Int 19 (1): 51-8 (2012)]
**PEER REVIEWED** <a
/ALTERNATIVE and IN VITRO TESTS/ A 1% solution /of glutaraldehyde/ quickly
abolishes the b-wave of the rabbit retina in vitro.[Grant, W.M. Toxicology
of the Eye. 3rd ed. Springfield, IL: Charles C. Thomas Publisher, 1986.,
p. 462] **PEER REVIEWED**
/ALTERNATIVE and IN VITRO TESTS/ The ability of saturated and unsaturated
aldehydes to induce DNA/histones cross-linking was studied in vitro using
calf thymus DNA incubated with test compounds at concentrations ranging up
to 250 mmol. Glutaraldehyde induced one cross-link per kilobase pair of
DNA at concentration of 10.7 umol. The high cross-linking efficiency of
glutaraldehyde may be related to its bifunctional nature (difunctional
aldehyde).[American Conference of Governmental Industrial Hygienists.
**PEER REVIEWED**
/IMMUNOTOXICITY/ ... The purpose of these studies was to examine the
dose-response relationship between glutaraldehyde (Glut) exposure and the
development of T cell-mediated vs. IgE- mediated responses. Initial
evaluation of the sensitization potential was conducted using the local
lymph node assay (LLNA) at concentrations ranging from 0.75% to 2.5%. A
concentration-dependent increase in lymphocyte proliferation was observed
with EC3 values of 0.072% and 0.089% in CBA and BALB/c mice, respectively.
The mouse ear swelling test (MEST) was used to evaluate the potential for
Glut to elicit IgE (1/2 hr post challenge) and contact hypersensitivity
(24 and 48 hr post challenge) responses. An immediate response was
observed in animals induced and challenged with 2.5% Glut, whereas animals
induced with 0.1% or 0.75% and challenged with 2.5% exhibited a delayed
response 48 hr post challenge. IgE-inducing potential was evaluated by
phenotypic analysis of draining lymph node cells and measurement of total
serum IgE levels. Only the 2.5% exposed group demonstrated a significant
increase (P < 0.01) in the percentage of IgE(+)B220(+) cells and serum
IgE. Following 3 days of dermal exposure, a significant increase in IL-4
mRNA in the draining lymph nodes was observed only in the 2.5% exposed
group.[Azadi S et al; Toxicol Appl Pharmacol 197 (1): 1-8 (2004).] **PEER
REVIEWED** <a
/OTHER TOXICITY INFORMATION/ Most critical instruments are not designed
for heat sterilization and autoclaving. These items are usually treated
with chemical agents such as peracetic acid (PAA), glutaraldehyde (GA) and
ortho-phthalaldehyde (OPA). MTT assay is often used to evaluate the in
vitro cytotoxicity of these chemical agents. In this study, disinfectants
were allowed to come in direct contact with cells. Their cytotoxicity was
evaluated based on cell viability and adhesive properties. The results
obtained from the direct contact method were compared with those obtained
from the conventional MTT assay wherein the disinfectants were added into
a nutrient medium. It was found that the two methods yielded very
different results, especially when aldehyde- and halogen-containing
disinfectants were tested, and that toxicity may be underestimated in the
MTT assay. Hence, it can be assumed that the direct contact assay is more
accurate when evaluating the cytotoxicity of residual chemicals. It was
also observed that the cytotoxicity of PAA was lower than that of GA and
OPA.[Ryu M et al; Biocontrol Sci 18 (4): 221-5] **PEER REVIEWED** <a
NATIONAL TOXICOLOGY PROGRAM STUDIES:
Groups of 50 male and 50 female F344/N rats were exposed to 0, 250, 500,
or 750 ppb glutaraldehyde vapor by inhalation, 6 hr/day, 5 days/week, for
104 weeks. Survival of 500 and 750 ppb female rats was less than that of
the chamber controls. Mean body weights of all exposed groups of male rats
and 500 and 750 ppb female rats were generally less than those of the
chamber controls. Some female rats exposed to 750 ppb were thin to
emaciated at the time they were killed moribund. Increased incidences of
nonneoplastic nasal lesions occurred primarily within the anterior section
of the nose in 500 and 750 ppb rats and to a lesser extent in 250 ppb
rats. The more significant lesions included hyperplasia and inflammation
of the squamous and respiratory epithelia and squamous metaplasia of the
respiratory epithelium.[DHHS/NTP; Toxicology and Carcinogenesis Studies of
Glutaraldehyde (Inhalation Studies) (September 1999) Technical Rpt Series
No. 490 NIH Pub No. 99-3980. Available from, as of Jun 14, 2010:
http://ntp-server.niehs.nih.gov/] **PEER REVIEWED**
Groups of 50 male and 50 female B6C3F1 mice were exposed to 0, 62.5, 125,
or 250 ppb glutaraldehyde vapor by inhalation, 6 hr/day, 5 days/week, for
104 weeks. Survival of exposed mice was similar to that of the chamber
controls. Mean body weights of female mice exposed to 250 ppb were
generally less than those of the chamber controls throughout the study.
Incidences of squamous metaplasia of the respiratory epithelium were
increased in 250 ppb males and females and 125 ppb females. Incidences of
hyaline degeneration of the respiratory epithelium were increased in all
exposed groups of females. The incidence of inflammation of the nose was
marginally increased in 250 ppb females.[DHHS/NTP; Toxicology and
Carcinogenesis Studies of Glutaraldehyde (Inhalation Studies) (September

1999) Technical Rpt Series No. 490 NIH Pub No. 99-3980. Available from,
as of Jun 14, 2010: http://ntp-server.niehs.nih.gov/] **PEER REVIEWED**
In genetic toxicity studies, glutaraldehyde was mutagenic with and without
S9 metabolic activation in S. typhimurium strains TA100, TA102, and TA104.
Glutaraldehyde was mutagenic in mouse L5178Y lymphoma cells in the absence
of S9 and induced sister chromatid exchanges in cultured Chinese hamster
ovary cells with and without S9. No increase in chromosomal aberrations
was induced by glutaraldehyde in cultured Chinese hamster ovary cells with
or without S9 at one laboratory; at another laboratory, chromosomal
aberrations were induced in the absence of S9 only. Glutaraldehyde did not
induce sex-linked recessive lethal mutations in germ cells of male
/Drosophila/ melanogaster treated as adults by feeding or injection or
treated as larvae by feeding. In vivo, glutaraldehyde induced a
significant increase in chromosomal aberrations in mouse bone marrow cells
36 hr after a single intraperitoneal injection. In a subset of the 36 hr
chromosomal aberrations test, there was a small increase in the number of
micronucleated bone marrow polychromatic erythrocytes, which was judged to
be equivocal. Additional short-term (3 day) and subchronic (13 week)
micronucleus tests in mice, using the intraperitoneal or inhalation
routes, respectively, yielded negative results.[DHHS/NTP; Toxicology and
Carcinogenesis Studies of Glutaraldehyde (Inhalation Studies) (September
1999) Technical Rpt Series No. 490 NIH Pub No. 99-3980. Available from,
as of Jun 14, 2010: http://ntp-server.niehs.nih.gov/] **PEER REVIEWED**
NON-HUMAN TOXICITY VALUES:
LD50 Rat oral 134 mg/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of
Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons,
Inc. Hoboken, NJ. 2004., p. 1864] **PEER REVIEWED**

LD50 Rat male oral 246mg/kg[Organization for Economic Cooperation and
REVIEWED**
LD50 Rat female oral 154 mg/kg[Organization for Economic Cooperation and
REVIEWED**
LD50 Rat male oral 315 mg/kg[Organization for Economic Cooperation and
REVIEWED**
REVIEWED**
LD50 Rat male oral 352 mg/kg[Organization for Economic Cooperation and
REVIEWED**
REVIEWED**
LD50 Rat oral 252 mg/kg[Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's
Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y.
(2001)., p. V5 1032] **PEER REVIEWED**
(2001)., p. V5 1032] **PEER REVIEWED**
(2001)., p. V5 1032] **PEER REVIEWED**
LD50 Rat oral 1.30 mL/kg 50% aqueous soln (w/w)[American Conference of

LD50 Rat oral 12.3 ml/kg 1% aqueous soln (w/w)[American Conference of
LD50 Rat oral 96.1 mg/kg 2% Cidex formulation[American Conference of
LD50 Rat male oral 1330 mg/kg bw[Organization for Economic Cooperation and
REVIEWED**
LD50 Rat male oral 1470 mg/kg bw[Organization for Economic Cooperation and
REVIEWED**
LD50 Rat ip 17,900 ug/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous Properties
of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley &
Sons, Inc. Hoboken, NJ. 2004., p. 1864] **PEER REVIEWED**
LD50 Rat sc 2,390 mg/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of
LD50 Rat iv 15,300 ug/kg[American Conference of Governmental Industrial
LD50 Rat iv 9,800 ug/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of
LD50 Rat dermal > 2,000 mg/kg[Organization for Economic Cooperation and
REVIEWED**
LD50 Mouse oral 100 mg/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous Properties
LD50 Mouse oral 1300 mg/kg 25% olive oil soln[American Conference of
LD50 Mouse male oral 122 mg/kg 2% Cidex formulation[American Conference of
LD50 Mouse male sc 1430 mg/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous
LD50 Mouse ip 13,900 ug/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous Properties
LD50 Mouse iv 15,400 ug/kg[Lewis, R.J. Sr. (ed) Sax's Dangerous Properties
LD50 Rabbit oral 1.59 mL/kg 50% aqueous soln (w/w)[American Conference of
LD50 Rabbit oral 8.0 mL/kg 25% aqueous soln (w/w)[American Conference of

LD50 Rabbit oral > 16 mL/kg 5% aqueous soln (w/w)[American Conference
LD50 Rabbit dermal 2240 mg/kg[Organization for Economic Cooperation and
REVIEWED**
LD50 Rabbit dermal 1800 mg/kg[Organization for Economic Cooperation and
REVIEWED**
LD50 Rabbit skin 2,560 mg/kg of 25% glutaraldehyde[Bingham, E.; Cohrssen,
B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley &
Sons. New York, N.Y. (2001)., p. V5 1032] **PEER REVIEWED**
LD50 Rabbit skin 560 uL/kg (from table)[Bingham, E.; Cohrssen, B.; Powell,
C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New
York, N.Y. (2001)., p. V5 1034] **PEER REVIEWED**
LC50 Rat inhalation 5000 ppm/4 hr exposure[American Conference of

LC50 Rat male inhl 23.5 ppm v/v for 4 hr[Organization for Economic
**PEER REVIEWED**
LC50 Rat female inhl 40.1 ppm v/v for 4 hr[Organization for Economic
**PEER REVIEWED**
LC50 Rat male inhl 0.35 mg/L for 4 hr[Organization for Economic
**PEER REVIEWED**
LC50 Rat female inhl 0.28 mg/L for 4 hr[Organization for Economic
**PEER REVIEWED**
LC50 Rat inhl 0.80 mg/L for 4 hr[Organization for Economic Cooperation and
REVIEWED**
ECOTOXICITY VALUES:
LD50; Species: Anas platyrhynchos (Mallard duck) oral 820 mg/kg for 14
days /50% glutaraldehyde/[USEPA/Office of Pesticide Programs; Ecological
Hazard and Environmental Risk Assessment for the Reregistration
Eligibility Decision (RED) Document - Glutaraldehyde p.4
LD50; Species: Anas platyrhynchos (Mallard duck) oral 2109 mg/kg for 28
days /14% glutaraldehyde/[USEPA/Office of Pesticide Programs; Ecological
LC50; Species: Anas platyrhynchos (Mallard duck) dietary > 5125 ppm for
8 days /50% glutaraldehyde/[USEPA/Office of Pesticide Programs; Ecological
LC50; Species: Anas platyrhynchos (Mallard duck) dietary > 10,000 ppm
for 8 days /50% glutaraldehyde/[USEPA/Office of Pesticide Programs;
Ecological Hazard and Environmental Risk Assessment for the Reregistration

LC50; Species: Anas platyrhynchos (Mallard Duck) dietary 408 mg/kg for 8
days /25% glutaraldehyde/[Organization for Economic Cooperation and
REVIEWED**
LC50; Species: Anas platyrhynchos (Mallard Duck); dietary > 5000 ppm for
5 days, 3 day observation /50% glutaraldehyde/[Organization for Economic
**PEER REVIEWED**
LC50; Species: Colinus virginianus (Bobwhite quail) dietary > 2500 ppm
for 5 days, 3 day observation /25% glutaraldehyde/[Organization for
**PEER REVIEWED**
LC50; Species: /Colinus virginianus/ (Bobwhite quail) dietary > 5000 ppm
for 8 days /50% glutaraldehyde/[Organization for Economic Cooperation and
REVIEWED**
LC50; Species: Colinus virginianus (Bobwhite quail) dietary > 5100 ppm
for 8 days /50% glutaraldehyde/[USEPA/Office of Pesticide Programs;
LC50; Species: Colinus virginianus (Northern bobwhite) age 16 days; diet
(chemical incorporated into food) > 5620 ppm for 8 days[USEPA, Office of
Pesticide Programs; Pesticide Ecotoxicity Database (2013) on Pentanedial
(111-30-8). Available from, as of January 12, 2015:
http://cfpub.epa.gov/ecotox/quick_query.htm] **PEER REVIEWED**
LC50; Species: Lepomis macrochirus (Bluegill sunfish); Concentration: 22.6
ppm for 96 hr /Conditions of bioassay not specified in source examined/
/50% glutaraldehyde/[USEPA/Office of Pesticide Programs; Ecological Hazard
and Environmental Risk Assessment for the Reregistration Eligibility
LC50; Species: Lepomis macrochirus (Bluegill sunfish); Conditions: static,
closed system; Concentration: 11.2 mg/L for 96 hr /50%
glutaraldehyde/[Organization for Economic Cooperation and Development;
REVIEWED**
LC50; Species: Lepomis macrochirus (Bluegill sunfish); Conditions: static;
Concentration: 19 mg/L for 24 hr[European Commission, ESIS; IUCLID
LC50; Species: Pimephales promelas (Fathead minnow); Conditions: static;
Concentration: 5.4 ppm for 96 hr (untreated), 283 ppm at 2 mol Sodium
Bisulfite (SBS), 50 ppm at 3 mol SBS[USEPA/Office of Pesticide Programs;

LC50; Species: Pimephales promelas (Fathead minnow); Conditions: static;
Concentration: 3.78 ppm at 0.5 mol Dibasic Ammonium Phosphate (DAP), 1.38
ppm at 1.25 mol DAP, 0.76 ppm at 2.5 mol DAP for 96 hr[USEPA/Office of
Pesticide Programs; Ecological Hazard and Environmental Risk Assessment
LC50; Species: Oncorhynchus mykiss (Rainbow trout); Concentration: 23.9
mg/kg for 96 hr /Conditions of bioassay not specified in source
examined/[USEPA/Office of Pesticide Programs; Ecological Hazard and
Environmental Risk Assessment for the Reregistration Eligibility Decision
(RED) Document - Glutaraldehyde p.8 EPA-HQ-OPP-2007-0364-0014 (June 2007).
Available from, as of June 1, 2010: http://www.regulations.gov] **PEER
REVIEWED**
LC50; Species: Oncorhynchus mykiss (Rainbow trout); Conditions: static;

LC50; Species: Cyprinodon variegatus (Sheepshead minnow); Conditions:
flow-through; Concentration: 31.4 ppm for 96 hr[USEPA/Office of Pesticide
Programs; Ecological Hazard and Environmental Risk Assessment for the
static; Concentration: 40 ppm for 96 hr[USEPA/Office of Pesticide
Programs; Ecological Hazard and Environmental Risk Assessment for the
static, temperature 21 - 22 deg C, pH 7.6 - 7.7; Concentration: 46 mg/L
for 24 hr[European Commission, ESIS; IUCLID Dataset, Glutaral (111-30-8)

EC50; Species: Daphnia magna (Water Flea) age < 24 hr; Conditions:
freshwater, static; Concentration: 14600 ug/L for 48 hr (11000-18000
ug/L); Effect: intoxication, immobilization /50% purity/[USEPA, Office of
EC50; Species: Daphnia magna (Water Flea) age < 20 hr; Conditions:
freshwater, static; Concentration: 750 ug/L for 48 hr (560-1000 ug/L);
Effect: intoxication, immobilization /50% purity/[USEPA, Office of

LC50; Species: Daphnia magna (water flea); Conditions: static, closed
system; Concentration: 0.35 mg/L for 48 hr /50%
REVIEWED**
LC50; Species: Daphnia magna (water flea); Conditions: static, closed
system; Concentration: 16.3 mg/L for 48 hr /25%
glutaraldedhyde/[Organization for Economic Cooperation and Development;
REVIEWED**
LC50; Species: Daphnia magna (water flea); Conditions: semi-static, closed
system; Concentration: > 4.3 mg/L for 21 days /50%
REVIEWED**
LC50; Species: Americamysis bahia (Opossum Shrimp) age < 24 hr;
Conditions: saltwater, flow through; Concentration: 5500 ug/L for 96 hr
(4500-7600 ug/L) /50.2% purity/[USEPA, Office of Pesticide Programs;
Pesticide Ecotoxicity Database (2013) on Pentanedial (111-30-8). Available

from, as of January 12, 2015: http://cfpub.epa.gov/ecotox/quick_query.htm]
**PEER REVIEWED**
LC50; Species: Americamysis bahia (Opossum Shrimp) age < 24 hr;
Conditions: saltwater, flow through; Concentration: 7100 ug/L for 96 hr
(6000-8600 ug/L) /51% purity/[USEPA, Office of Pesticide Programs;
Pesticide Ecotoxicity Database (2013) on Pentanedial (111-30-8). Available
from, as of January 12, 2015: http://cfpub.epa.gov/ecotox/quick_query.htm]
**PEER REVIEWED**
LC50; Species: Americamysis bahia (Opossum Shrimp) adult; Conditions:
saltwater, static; Concentration: 20600 ug/L for 96 hr (12700-32200 ug/L)
/50% purity/[USEPA, Office of Pesticide Programs; Pesticide Ecotoxicity
Database (2013) on Pentanedial (111-30-8). Available from, as of January
12, 2015: http://cfpub.epa.gov/ecotox/quick_query.htm] **PEER REVIEWED**
LC50; Species: Palaemonetes vulgaris (Grass Shrimp); Conditions: static,
closed system; Concentration: 41 mg/L for 96 hr /25%
REVIEWED**
LC50; Species: Carcinus maenas (Green Crabs); Conditions: static, closed
system; Concentration: 465 mg/L for 96 hr /25%

REVIEWED**
LC50; Species: Marine amphipod (Chaetogammarus marinus); Conditions:
static, closed system; Concentration: 191 mg/L for 96 hr[Organization for
**PEER REVIEWED**
LC50; Species: Mysidopsis bahia (Mysid shrimp); Conditions: flow-through;
Concentration: 7.1 ppm for 96 hr /51% glutaraldehyde/[USEPA/Office of
Pesticide Programs; Ecological Hazard and Environmental Risk Assessment
LC50; Species: Crassostrea virginica (Oyster larvae); Conditions: static,
closed system; Concentration: 2.1 mg/L for 48 hr /25%
REVIEWED**
EC50; Species: Crassostrea virginica (Eastern oyster); Conditions:
flow-through; Concentration: 0.78 ppm for 96 hr; Effect: shell deposition
/51% glutaraldehyde/[USEPA/Office of Pesticide Programs; Ecological Hazard
and Environmental Risk Assessment for the Reregistration Eligibility

EC50; Species: Scenedesmus supspicatus (algae); Concentration: 2.1 mg/L
for 96 hr; Effect: biomass /Conditions of bioassay not specified in source
examined/ /50% glutaraldehyde/[Organization for Economic Cooperation and
REVIEWED**
EC50; Species: Selenastrum capricornutum (Green alga); Conditions: static;
Concentration: 0.31 mg/L for 96 hr; Effect: growth inhibition /50%
glutaraldehyde/[USEPA/Office of Pesticide Programs; Ecological Hazard and
(RED) Document - Glutaraldehyde p.18 EPA-HQ-OPP-2007-0364-0014 (June
2007). Available from, as of June 1, 2010: http://www.regulations.gov]
**PEER REVIEWED**
EC50; Species: Selenastrum capricornutum (Green alga); Conditions: static;
Concentration: 0.75 mg/L for 5 days, 2.1 mg/L for 5 days with sodium
hydroxide, 3.6 mg/L for 5 days with sodium bisulfite; Effect: growth
inhibition /50% glutaraldehyde plus sodium hydroxide and sodium
bisulfite/[USEPA/Office of Pesticide Programs; Ecological Hazard and
(RED) Document - Glutaraldehyde p.19 EPA-HQ-OPP-2007-0364-0014 (June
2007). Available from, as of June 1, 2010: http://www.regulations.gov]
**PEER REVIEWED**
EC50; Species: Pseudokirchneriella subcapitata (Green Algae); Conditions:
freshwater, static; Concentration: 310 ug/L for 96 hr (90-1040 ug/L);
Effect: population, abundance /50.7% purity/[USEPA, Office of Pesticide
Programs; Pesticide Ecotoxicity Database (2013) on Pentanedial (111-30-8).
Available from, as of January 12, 2015:
ONGOING TEST STATUS:
EPA has released the first beta version (version 0.5) of the Interactive
Chemical Safety for Sustainability (iCSS) Dashboard. The beta version of
the iCSS Dashboard provides an interactive tool to explore rapid,
automated (or in vitro high-throughput) chemical screening data generated
by the Toxicity Forecaster (ToxCast) project and the federal Toxicity
Testing in the 21st century (Tox21) collaboration. /The title compound was
tested by ToxCast and/or Tox21 assays; Click on the "Chemical Explorer"
button on the tool bar to see the data./[USEPA; ICSS Dashboard
Application; Available from, as of December 8, 2014:
http://actor.epa.gov/dashboard/]
The following link will take the user to the National Toxicology Program
(NTP) Test Agent Search Results page, which tabulates all of the "Standard
Toxicology & Carcinogenesis Studies", "Developmental Studies", and
"Genetic Toxicity Studies" performed with this chemical. Clicking on the
"Testing Status" link will take the user to the status (i.e., in review,
in progress, in preparation, on test, completed, etc.) and results of all
the studies that the NTP has done on this chemical.[Available from:
http://ntp-
apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=111-
30-8]
DRUG WARNINGS:
... A 43-year-old woman /developed/ an acute hemorrhagic colitis after
colonoscopy with ambulatory anesthesia. The diagnosis is likely to have
been glutaraldehyde induced colitis (used for disinfection of the
endoscope). The patient recovered spontaneously completely.[Grenet M et
al; Ann Fr Anesth Reanim 23 (5): 499-500 (2004).] **PEER REVIEWED** <a
Six eyes of 6 patients developed toxic anterior segment syndrome (TASS)
after uneventful phacoemulsification cataract surgery with implantation of
a 3-piece acrylic IOL performed by 2 ophthalmologists on the same day.
Clinical findings included corneal edema, Descemet's membrane folds,
anterior chamber reaction, fibrin formation, and irregular, dilated, and
unreactive pupils. ... Glutaraldehyde 2% solution was used inadvertently
by the operating room staff who cleaned and sterilized reusable ocular
instruments before autoclaving. None of the affected corneas improved.
Additional surgical procedures were required and included penetrating
keratoplasty, trabeculectomy, and glaucoma tube implantation. CONCLUSIONS:
Glutaraldehyde in concentrations generally used for cold sterilization is
highly toxic to the corneal endothelium. The operating room staff involved
in sterilizing instruments should be well educated about and careful to
follow the protocols to properly clean and sterilize reusable ocular
instruments.[Unal M et al; J Cataract Refract Surg 32 (10):
1696-701(2006).] **PEER REVIEWED** <a
The sequelae of the inadvertent introduction of glutaraldehyde into the
peritoneal cavity /are documented/. ... The clinical course, progressive
histological changes to the bowel at different periods over the course of
1 year, and what long-term morbidity remains /are described/. The chemical
structure, effects, and pathogenesis of glutaraldehyde are described as
well as suggestions for avoiding similar problems in the
future.[Karpelowsky JS et al; J Pediatr Surg 41 (6): e23-5 (2006).] **PEER
REVIEWED** <a
The medical records of patients with acute rectocolitis following
endoscopy treated at Kaohsiung Veterans General Hospital since 2001 were
reviewed. The indication of endoscopy was health check-up for all
patients. Published English-language studies regarding acute rectocolitis
following endoscopy were also reviewed. RESULTS: An outbreak of six
patients occurred in April 2002 and one cirrhotic patient was admitted in
July 2008. All patients developed a self-limited syndrome of abdominal
pain and bloody diarrhea within 48 h of uncomplicated endoscopy. One
severely ill patient required hospitalization to receive intravenous fluid
and antibiotics. After the investigation in April 2002,
case. CONCLUSIONS: Endoscopists should be aware of this iatrogenic
complication in patients presenting with acute rectocolitis, especially in
those who have undergone recent endoscopic examination. An outbreak of

acute rectocolitis following endoscopy should be considered
glutaraldehyde-induced and should lead to an investigation of cleansing
and equipment-disinfection procedures. In the absence of strong evidence
of an outbreak, an infectious disease, or contamination of glutaraldehyde,
a sporadic case should be considered ischemic colitis especially in
patients with relevant concomitant diseases or predisposing factors.[Hsu
CW et al; Int J Colorectal Dis 24 (10): 1193-200 (2009)] **PEER REVIEWED**
A 19-year-old woman presented after deliberate ingestion of a biocide
containing glutaraldehyde and a quaternary ammonium compound. She
developed respiratory distress and severe metabolic acidosis 10 hours
... Occupational and chest physicians in the West Midlands /UK/ were
invited to submit details of newly diagnosed cases with occupational
asthma (OA). Data were then transferred to the regional center for
occupational lung diseases for analysis. RESULTS: A total of 1461 cases
were reported to the scheme. Sixty-eight per cent were males with mean
(standard deviation) age of 44 (12) years. The annual incidence of OA was
42 per million of working population (95% CI = 37-45). OA was most
frequently reported in welders (9%) and health care-related professions
(9%) while < 1% of cases were reported in farmers. Isocyanates were the
commonest offending agents responsible for 21% of reports followed by
metal working fluids (MWFs) (11%), adhesives (7%), chrome (7%), latex (6%)
and glutaraldehyde (6%). Flour was suspected in 5% of cases while
laboratory animals only in 1%... CONCLUSIONS: Our data confirm a high
annual incidence of OA in this part of the UK.[Bakerly ND et al; Occup Med
(Lond) 58 (3): 169-74 (2008).] **PEER REVIEWED** <a
Undesirable effects occur very occasionally and mostly involve mild local
skin rashes and irritation. Very rarely, a severe reaction may occur
particularly on the hands or when the product is used excessively and
allowed to spread onto surrounding normal skin. If mild irritation should
occur, apply a reduced amount (taking special care to avoid spreading
beyond the wart or verruca) and apply less often. If the irritation is
severe, patients should stop treatment immediately and seek medical
advice.[Datapharm Communications Ltd; Electronic Medicines Compendium
(eMC), Summary of Product Characteristics (SPC) for Glutarol (Last updated
September 2005). Available from, as of July 9, 2010:
/]
**PEER REVIEWED**
Keep away from the eyes and mucous membranes. Avoid spreading onto
surrounding uninvolved skin.[Datapharm Communications Ltd; Electronic
Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for
Glutarol (Last updated September 2005). Available from, as of July 9,
2010:
/]
**PEER REVIEWED**
Not to be used on the face, anal or perineal region. Not to be used on
moles or on any other skin lesion for which it is not indicated.[Datapharm
Communications Ltd; Electronic Medicines Compendium (eMC), Summary of
Product Characteristics (SPC) for Glutarol (Last updated September 2005).
Available from, as of July 9, 2010:
/]
**PEER REVIEWED**
REPORTED FATAL DOSE:
3-4. 3= Moderately toxic, probable oral lethal dose (human) 0.5-5 g/kg,
between 1 ounce & 1 pint for 70 kg person (150 lb). 4=Very toxic,
probable oral lethal dose (human) 50-500 mg/kg, between 1 teaspoon and 1
ounce for 70 kg person (150 lb).[Gosselin, R.E., R.P. Smith, H.C. Hodge.
Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams
and Wilkins, 1984., p. II-187] **PEER REVIEWED**
ENVIRONMENTAL FATE/EXPOSURE SUMMARY:
Glutaraldehyde's production and use as a disinfectant, as a cross-linking

agent, as a tanning agent for leather and use in the paper and textile
industries to improve wet strength and dimensional stability of fibers may
result in its release to the environment through various waste streams.
Its use as a biocide in water treatment, hydraulic fracturing fluids and
oil-field applications and as a preservative in cosmetics and
personal-care products will result in its direct release to the
environment. Glutaraldehyde has been detected in gasoline and diesel
engine emissions. If released to air, a vapor pressure of 0.6 mm Hg at 30
deg C indicates glutaraldehyde will exist solely as a vapor in the
atmosphere. Vapor-phase glutaraldehyde will be degraded in the atmosphere
by reaction with photochemically-produced hydroxyl radicals; the half-life
for this reaction in air is estimated to be 16 hours. Glutaraldehyde may
be susceptible to direct photolysis in the atmosphere based upon aqueous
photolysis studies. If released to soil, glutaraldehyde is expected to
have very high to moderate mobility based upon measured Koc values ranging
from 5.1 to 500. Volatilization from moist soil surfaces is not expected
to be an important fate process based upon a Henry's Law constant of
3.3X10-8 atm-cu m/mole. Glutaraldehyde is expected to volatilize from dry
soil surfaces based upon its vapor pressure and it has been reported that
small amounts of glutaraldehyde will volatilize to the atmosphere. Results
of biodegradation screening tests indicate that glutaraldehyde is readily
biodegradable. A soil degradation study using a loamy sand soil observed a
pseudo-first order dissipation half-life of 1.7 days due primarily to soil
microorganisms. If released into water, glutaraldehyde is not expected to
adsorb to suspended solids and sediment based upon the Koc. In a closed
bottle test using seawater as inoculum, glutaraldehyde showed 73%
degradation in 28 days indicating that biodegradation is expected to be an
important fate process in water. Volatilization from water surfaces is not
expected to be an important fate process based upon this compound's

Henry's Law constant. An estimated BCF of 3 suggests the potential for
bioconcentration in aquatic organisms is low. At 25 deg C, glutaraldehyde
has measured hydrolysis half-lives of 508-628, 102-394 and 46-63.8 days at
pH 5, pH 7 and pH 9 respectively. The measured half-life for the
photolysis of aqueous solutions of glutaraldehyde exposed to natural
sunlight was 196 days. Occupational exposure to glutaraldehyde may occur
through inhalation and dermal contact with this compound at workplaces
where glutaraldehyde is produced or used. Use and limited monitoring data
containing glutaraldehyde. (SRC) **PEER REVIEWED**
PROBABLE ROUTES OF HUMAN EXPOSURE:
According to the 2012 TSCA Inventory Update Reporting data, 5 reporting
facilities estimate the number of persons reasonably likely to be exposed
in manufacturing, processing, or use of glutaraldehyde in the United
States may be as low as < 10 workers and as high as 50-99 workers per
plant; the data may be greatly underestimated due to confidential business
information (CBI) or unknown values(1).[(1) US EPA; Chemical Data
Reporting (CDR). Non-confidential 2012 Chemical Data Reporting information
on chemical production and use in the United States. Available from, as of
Feb 27, 2015: http://www.epa.gov/cdr/pubs/guidance/cdr_factsheets.html]
**PEER REVIEWED**
NIOSH (NOES Survey 1981-1983) has statistically estimated that 367,330
workers (265,564 of these were female) were potentially exposed to
glutaraldehyde in the US(1). The NOES Survey does not include farm
workers. Occupational exposure to glutaraldehyde may occur through
inhalation and dermal contact with this compound at workplaces where

glutaraldehyde is produced or used. Use and limited monitoring data
containing glutaraldehyde(SRC).[(1) NIOSH; NOES. National Occupational
Exposure Survey conducted from 1981-1983. Estimated numbers of employees
potentially exposed to specific agents by 2-digit standard industrial
classification (SIC). Available from, as of Feb 26, 2015:
http://www.cdc.gov/noes/] **PEER REVIEWED**
Occupational exposure to health care workers is common. Sensitization has
occurred mainly through its use as a cold sterilizing solution in
hospitals and dental clinics where medical and allied professionals
including x-ray film handlers may be exposed to activated glutaraldehyde
in concentrations of 0.13-2%.[Sullivan, J.B. Jr., G.R. Krieger (eds.).
Hazardous Materials Toxicology-Clinical Principles of Environmental
Health. Baltimore, MD: Williams and Wilkins, 1992., p. 983] **PEER
REVIEWED**
ARTIFICIAL POLLUTION SOURCES:
Glutaraldehyde's production and use as a disinfectant and sanitizer(1,2),
as a cross-linking agent, as a tanning agent for leather and use in the
paper and textile industries to improve wet strength and dimensional
stability of fibers(3) may result in its release to the environment
through various waste streams(SRC). Its use as a biocide in water
treatment, hydraulic fracturing fluids and oil-field applications(1,2) and
as a disinfectant in cosmetics and personal-care products(4) will result
in its direct release to the environment(SRC). Glutaraldehyde has been
detected in gasoline and diesel engine emissions(5).[(1) USEPA/OPPTS;
Reregistration Eligibility Decisions (REDs) Database on Glutaraldehyde

(111-30-8). USEPA 739-R-07-006. Available from, as of Mar 4, 2015:
http://www.epa.gov/pesticides/reregistration/status.htm (2) Kohlpaintner C
et al; Aldehydes, Aliphatic. Ullmann's Encyclopedia of Industrial
Chemistry. 7th ed. (1999-2015). New York, NY: John Wiley & Sons.
Online Posting Date: Jan 15, 2013. (3) U.S. Department of Energy . Modern
shale gas development in the United State: A primer. Pub Place: U.S.
Department of Energy, Office of Fossil Energy, National Energy Technology
Laboratory (2009). Available from, as of Feb 25, 2015:
http://energy.gov/sites/prod/files/2013/03/f0/ShaleGasPrimer_Online_4-2009.pdf
(4) OECD; SIDS Initial Assessment Report. Glutaraldehyde (CAS
No.111-30-8). Available from, as of Feb 25, 2015:
http://www.inchem.org/documents/sids/sids/FORMALDEHYDE.pdf (5) Ban-Weiss
GA et al; Environ Sci Technol 42: 3944-50 (2008)] **PEER REVIEWED**
ENVIRONMENTAL FATE:
TERRESTRIAL FATE: Based on a classification scheme(1), measured Koc values
ranging from 5.1 to 500(2,3) indicate that glutaraldehyde is expected to
have very high to moderate mobility in soil(SRC). Volatilization of
glutaraldehyde from moist soil surfaces is not expected to be an important
fate process(SRC) given a Henry's Law constant of 3.3X10-8 atm-cu
m/mole(2). Glutaraldehyde is expected to volatilize from dry soil
surfaces(SRC) based upon a vapor pressure of 0.6 mm Hg at 30 deg C(4), and
it has been reported that small amounts of glutaraldehyde will volatilize
to the atmosphere(4). Results of biodegradation screening tests indicate
that glutaraldehyde is readily biodegradable(2,3,5). A soil degradation
study using a loamy sand soil and and initial glutaraldehyde concentration
of 10 ppm observed a pseudo-first order dissipation half-life of 1.7 days
due primarily to soil microorganisms(3).[(1) Swann RL et al; Res Rev 85:
17-28 (1983) (2) Leung H-W; Ecotoxicol Environ Safety 49: 26-39 (2001) (3)
ECHA; Search for Chemicals. Glutaraldehyde (CAS 111-30-8) Registered
Substances Dossier. European Chemical Agency. Available from, as of Feb
25, 2015: http://echa.europa.eu/ (4) Heisler SL, Friedlander SK; Atmos
Environ 11: 157-168 (1977) (5) OECD; SIDS Initial Assessment Report.
Glutaraldehyde (CAS No.111-30-8). Available from, as of Feb 25, 2015:
http://www.inchem.org/documents/sids/sids/FORMALDEHYDE.pdf] **PEER
REVIEWED**
AQUATIC FATE: Based on a classification scheme(1), measured Koc values
ranging from 5.1 to 500(2,3) indicate that glutaraldehyde is not expected
to adsorb to suspended solids and sediment(SRC). Volatilization from water
surfaces is not expected(4) based upon a Henry's Law constant of 3.3X10-8
atm-cu m/mole(2). According to a classification scheme(5), an estimated
BCF of 3(SRC), from its log Kow of -0.33(2) and a regression-derived
equation(6), suggests the potential for bioconcentration in aquatic
organisms is low(SRC). Results of biodegradation screening tests indicate
that glutaraldehyde is readily biodegradable(2,3,7). In a closed bottle
test using seawater as inoculum, glutaraldehyde showed 73% degradation in
28 days(2). At 25 deg C, glutaraldehyde has measured hydrolysis half-lives
of 508-628, 102-394 and 46-63.8 days at pH 5, pH 7 and pH 9
respectively(2,3). The measured half-life for the photolysis of sterile
aqueous solutions of glutaraldehyde exposed to natural sunlight was 196
days(2).[(1) Swann RL et al; Res Rev 85: 17-28 (1983) (2) Leung H-W;
Ecotoxicol Environ Safety 49: 26-39 (2001) (3) ECHA; Search for Chemicals.
Glutaraldehyde (CAS 111-30-8) Registered Substances Dossier. European
Chemical Agency. Available from, as of Feb 25, 2015:
http://echa.europa.eu/ (4) Lyman WJ et al; Handbook of Chemical Property
Estimation Methods. Washington, DC: Amer Chem Soc pp. 15-1 to 15-29 (1990)
(5) Franke C et al; Chemosphere 29: 1501-14 (1994) (6) US EPA; Estimation
Program Interface (EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of
Feb 25, 2015: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm (7)
OECD; SIDS Initial Assessment Report. Glutaraldehyde (CAS No.111-30-8).
Available from, as of Feb 25, 2015:
REVIEWED**
ATMOSPHERIC FATE: According to a model of gas/particle partitioning of
semivolatile organic compounds in the atmosphere(1), glutaraldehyde, which
has a vapor pressure of 0.6 mm Hg at 30 deg C(2), is expected to exist
solely as a vapor in the ambient atmosphere. Vapor-phase glutaraldehyde is
degraded in the atmosphere by reaction with photochemically-produced
hydroxyl radicals(SRC); the half-life for this reaction in air is
estimated to be 15 hours(SRC), calculated from its rate constant of
2.52X10-11 cu cm/molecule-sec at 25 deg C(3). Aqueous solutions of
glutaraldehyde have an observed photolysis half-life of 196 days when
exposed to sunlight(4) suggesting that direct photolysis may occur in the
ambient atmosphere(SRC).[(1) Bidleman TF; Environ Sci Technol 22: 361-367
(1988) (2) Heisler SL, Friedlander SK; Atmos Environ 11: 157-168 (1977)
(3) NIST; NIST Chemistry WebBook. Glutaraldehyde (111-30-8). NIST Gas
Kinetics Database, 2013 Release. Washington, DC: US Sec Commerce.
Available from, as of Feb 25, 2015: http://webbook.nist.gov (4) Leung H-W;
Ecotoxicol Environ Safety 49: 26-39 (2001)] **PEER REVIEWED**
ENVIRONMENTAL BIODEGRADATION:
AEROBIC: Glutaraldehyde, present at 100 mg/L, reached 59% of its
theoretical BOD in 4 weeks using an activated sludge inoculum at 30 mg/L
in the Japanese MITI test(1). Using OECD Guideline 301C (Ready
biodegradability: Modified MITI Test (I)), glutaraldehyde reached 74% of

its theoretical BOD in 28 days and 80% DOC in 15 days with classified the
compound as readily biodegradable(2). Glutaraldehyde was found to be
readily biodegradable using OECD Guideline 301D (Closed Bottle Test)(2).
In a DOC die-away test, glutaradehyde, present at 25 mg/L, showed 83%
degradation in 5 days using a sewage inoculum(3). Glutaraldehyde, present
at 8.3 mg/L, degraded 60% in 28 days using sewage inoculum in a CO2
evolution test(3). In a closed bottle test, glutaraldehyde present at 2.0
mg/L, degraded 64% in 28 days using a Polyseed inoculum(3). A higher
biodegradability with a short lag time was observed when the
glutaraldehyde concentrations in the test systems were low ( < 2 mg/L)
than when the concentrations were high ( > 8 mg/L). Since bacterial
inhibition for glutaraldehyde occurs at about 5 mg/L, the lower
biodegradation rates observed in studies where high concentrations of
glutaraldehyde were used were likely due to inhibition of the inoculum(3).
In a closed bottle test using seawater as inoculum, glutaraldehyde showed
73% degradation in 28 days(3). The major metabolite of glutaraldehyde
produced by microbes in an aerobic sediment-river water system was carbon
dioxide, with glutaric acid formed as an intermediate in the water
phase(3). The calculated pseudo-first-order half-life of glutaraldehyde
catabolism in water (based on the loss of the parent compound) under
aerobic conditions was 10.6 hours(3). A soil degradation study using a
loamy sand soil and initial glutaraldehyde concentration of 10 ppm
observed a pseudo-first order biodegradation half-life of 1.7 days due
primarily to soil microorganisms(4).[(1) NITE; Chemical Risk Information
Platform (CHRIP). Biodegradation and Bioconcentration. Tokyo, Japan: Natl
Inst Tech Eval. Available from, as of Feb 26, 2015:
http://www.safe.nite.go.jp/english/db.html (2) OECD; SIDS Initial
Assessment Report. Glutaraldehyde (CAS No.111-30-8). Available from, as of
Feb 25, 2015: http://www.inchem.org/documents/sids/sids/FORMALDEHYDE.pdf

(3) Leung H-W; Ecotoxicol Environ Safety 49: 26-39 (2001) (4) ECHA; Search
for Chemicals. Glutaraldehyde (CAS 111-30-8) Registered Substances
Dossier. European Chemical Agency. Available from, as of Feb 25, 2015:
http://echa.europa.eu/] **PEER REVIEWED**
ANAEROBIC: The major metabolites of glutaraldehyde produced by microbes in
an anaerobic sediment-river water system were 1,5-pentanediol with
5-hydroxypentanal formed as an intermediate, and
3-formyl-6-hydroxy-2-cyclohexene-1-propanal, a cyclicized dimer of
glutaraldehyde. The calculated pseudo-first-order half-life of
glutaraldehyde catabolism in water (based on the loss of the parent
compound) under anaerobic conditions was 7.7 hours(1).[(1) Leung H-W;
ENVIRONMENTAL ABIOTIC DEGRADATION:
The rate constant for the vapor-phase reaction of glutaraldehyde with
photochemically-produced hydroxyl radicals has been measured as 2.52X10-11
cu cm/molecule-sec at 25 deg C(1). This corresponds to an atmospheric
half-life of about 15 hours at an atmospheric concentration of 5X10+5
hydroxyl radicals per cu cm(2). The measured first-order rate constants of
the hydrolysis of glutaraldehyde at pH 5 and 7 were 0.0014 and 0.0068 per
day (at 25 deg C), which corresponds to half-lives of 508 and 102 days,
respectively(3). At pH 9, the first-order rate constant was measured to be
0.015 per day, corresponding to a half-life of 46 days(4). The only major
degradate observed and identified was a cyclized dimer of glutaraldehyde,
3-formyl-6-hydroxy-2-cyclohexene-1-propanal(3). Hydrolysis tests conducted
at 40 and 50 deg C and pH 9 for 165 hours determined the hydrolysis
half-life is > 24 hours at 50 deg C and > 59 hours at 40 deg C(4). An
hydrolysis test according to OECD Guideline 111 (Hydrolysis as a Function

of pH) reported glutaraldehyde to be hydrolytically stable at pH 4 and pH
7 with decomposition at pH 9(4). At 25 deg C, hydrolysis half-lives were
628, 394 and 63.8 days respectively at pH 5, pH 7 and pH 9(4). The
measured first-order rate constant for the photolysis of sterile aqueous
solutions of glutaraldehyde exposed to natural sunlight was 0.0035 per day
with a corresponding half life was 196 days(3).[(1) NIST; NIST Chemistry
WebBook. Glutaraldehyde (111-30-8). NIST Gas Kinetics Database, 2013
Release. Washington, DC: US Sec Commerce. Available from, as of Feb 25,
2015: http://webbook.nist.gov (2) US EPA; Estimation Program Interface
(EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of Feb 25, 2015:
http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm (3) Leung H-W;
Ecotoxicol Environ Safety 49: 26-39 (2001) (4) ECHA; Search for Chemicals.
Glutaraldehyde (CAS 111-30-8) Registered Substances Dossier. European
Chemical Agency. Available from, as of Feb 25, 2015:
http://echa.europa.eu/] **PEER REVIEWED**
ENVIRONMENTAL BIOCONCENTRATION:
An estimated BCF of 3 was calculated for glutaraldehyde(SRC), using a log
Kow of -0.33(1) and a regression-derived equation(2). According to a
classification scheme(3), this BCF suggests the potential for
bioconcentration in aquatic organisms is low(SRC).[(1) Leung H-W;
Ecotoxicol Environ Safety 49: 26-39 (2001) (2) US EPA; Estimation Program
Interface (EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of Feb 25,
2015: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm (3) Franke C et
al; Chemosphere 29: 1501-14 (1994)] **PEER REVIEWED**
SOIL ADSORPTION/MOBILITY:
Aqueous solutions of [14C] glutaraldehyde in 0.01 M calcium chloride were
prepared at concentrations of 0.51, 1.0, 2.5, 5.0, and 10.3 g/L and used
to determine the adsorption/desorption characteristics of glutaraldehyde
in various soil types according to FIFRA 163-1 guidelines(1). Measured Koc
values were 210, 500, 340, 460, and 120 in sandy loam, silty clay loam,
silt loam, loamy sand, and sediment, respectively(1). Batch adsorption
studies determined Koc values of 22.2, 18.9 and 5.1 in New York loam,
Nebraska silt loam and Highview clay loam soils respectively(3). According
to a classification scheme(2), these Koc values suggest that
glutaraldehyde is expected to have very high to moderate mobility in
soil.[(1) Leung H-W; Ecotoxicol Environ Safety 49: 26-39 (2001) (2) ECHA;
Search for Chemicals. Glutaraldehyde (CAS 111-30-8) Registered Substances
Dossier. European Chemical Agency. Available from, as of Feb 25, 2015:
http://echa.europa.eu/ (3) Swann RL et al; Res Rev 85: 17-28 (1983)]
**PEER REVIEWED**
VOLATILIZATION FROM WATER/SOIL:
The Henry's Law constant for glutaraldehyde has been experimentally
determined to be 3.30X10-8 atm-cu m/mole(1). This Henry's Law constant
indicates that glutaraldehyde is expected to be essentially nonvolatile
from water surfaces(2). Glutaraldehyde's Henry's Law constant indicates
that volatilization from moist soil surfaces is not expected to
occur(SRC). Glutaraldehyde is expected to volatilize from dry soil
surfaces(SRC) based upon a vapor pressure of 0.6 mm Hg(3), and it has been
reported that small amounts of glutaraldehyde will volatilize to the
atmosphere(4).[(1) Leung H-W; Ecotoxicol Environ Safety 49: 26-39 (2001)
(2) Lyman WJ et al; Handbook of Chemical Property Estimation Methods.
Washington, DC: Amer Chem Soc pp. 15-1 to 15-29 (1990) (3) Heisler SL,
Friedlander SK; Atmos Environ 11: 157-168 (1977) (4) OECD; SIDS Initial
Assessment Report. Glutaraldehyde (CAS No.111-30-8). Available from, as of
Feb 25, 2015: http://www.inchem.org/documents/sids/sids/FORMALDEHYDE.pdf]

**PEER REVIEWED**
EFFLUENT CONCENTRATIONS:
Glutaraldehyde was detected at mean emission factors of 0.13 and 0.06
mg/kg fuel burned in the emissions from light-duty vehicles measured in a
San Francisco Bay area highway tunnel bore during the summers of 2001 and
2006, respectively(1). Glutaraldehyde was not detected in samples taken in
1999. The mean glutaraldehyde emission factor for medium- and heavy-duty
diesel trucks measured in 2006 in a separate mixed-traffic bore of the
tunnel was 0.55 mg/kg fuel burned(1). Glutaraldehyde concentrations of
170-3700 ug/L were detected in pharmaceutical wastewater effluents from
Rouen, France(2).[(1) Ban-Weiss GA et al; Environ Sci Technol 42: 3944-50
(2008) (2) Debska J et al; Critical Rev Anal Chem 34: 51-67 (2004)] **PEER
REVIEWED**
FIFRA REQUIREMENTS:
The Agency has completed its assessment of the dietary, occupational,
drinking water, and ecological risks associated with the use of pesticide
products containing the active ingredient glutaraldehyde. Based on a
review of these data and on public comments on the Agency's assessments
for the active ingredient glutaraldehyde, the Agency has sufficient
information on the human health and ecological effects of glutaraldehyde
to make decisions as part of the tolerance reassessment process under
FFDCA and reregistration process under FIFRA, as amended by FQPA. The
Agency has determined that glutaraldehyde-containing products are eligible
for reregistration provided that: (i) confirmatory data needs are
addressed; (ii) the risk mitigation measures outlined in this document are
adopted; and (iii) label amendments are made to reflect these measures.
... Based on its evaluation of glutaraldehyde, the Agency has determined

that glutaraldehyde products, unless labeled and used as specified in this
document, would present risks inconsistent with FIFRA. Accordingly, should
a registrant fail to implement the risk mitigation measures identified in
this document, the Agency may take regulatory action to address the risk
concerns from the use of glutaraldehyde. If all changes outlined in this
document are incorporated into the product labels, then all current risks
for glutaraldehyde will be substantially mitigated for the purposes of
this determination. Once an Endangered Species assessment is completed,
further changes to these registrations may be necessary as explained in
Section III of this document.[USEPA/Office of Prevention, Pesticides and
Toxic Substances; Reregistration Eligibility Decision Document -
Glutaraldehyde p.56 EPA 739-R-07-006 (September 2007). Available from, as
of February 24, 2015:
http://www.epa.gov/pesticides/reregistration/status.htm] **PEER REVIEWED**
As the federal pesticide law FIFRA directs, EPA is conducting a
comprehensive review of older pesticides to consider their health and
environmental effects and make decisions about their continued use. Under
this pesticide reregistration program, EPA examines newer health and
safety data for pesticide active ingredients initially registered before
November 1, 1984, and determines whether the use of the pesticide does
not pose unreasonable risk in accordance to newer safety standards, such
as those described in the Food Quality Protection Act of 1996. Pesticides
for which EPA had not issued Registration Standards prior to the
effective date of FIFRA '88 were divided into three lists based upon their
potential for human exposure and other factors, with List B containing
pesticides of greater concern than those on List C, and with List C
containing pesticides of greater concern than those on List D.
Glutaraldehyde is found on List B. Case No: 2315; Pesticide type:

fungicide, antimicrobial; Case Status: OPP is reviewing data from the
pesticide's producers regarding its human health and/or environmental
effects, or OPP is determining the pesticide's eligibility for
reregistration and developing the Reregistration Eligibility Decision
(RED) document.; Active ingredient (AI): Glutaraldhyde; Data Call-in (DCI)
Date(s): 06/10/91, 07/15/92, 10/13/95; AI Status: The producers of the
pesticide have made commitments to conduct the studies and pay the fees
required for reregistration, and are meeting those commitments in a timely
manner.[United States Environmental Protection Agency/ Prevention,
Pesticides and Toxic Substances; Status of Pesticides in Registration,
Reregistration, and Special Review. (1998) EPA 738-R-98-002, p. 184]
**PEER REVIEWED**
TSCA REQUIREMENTS:
Section 8(a) of TSCA requires manufacturers of this chemical substance to
report preliminary assessment information concerned with production,
exposure, and use to EPA as cited in the preamble in 51 FR 41329.
Effective date 9/30/91; Reporting date: 11/27/91.[40 CFR 712.30 (USEPA);
U.S. National Archives and Records Administration's Electronic Code of
Federal Regulations. Available from, as of February 4, 2015:
http://www.ecfr.gov] **PEER REVIEWED**
Pursuant to section 8(d) of TSCA, EPA promulgated a model Health and
Safety Data Reporting Rule. The section 8(d) model rule requires
manufacturers, importers, and processors of listed chemical substances and
mixtures to submit to EPA copies and lists of unpublished health and
safety studies. Pentanedial is included on this list. Effective date
9/30/91; Sunset date: 6/30/98.[40 CFR 716.120 (USEPA); U.S. National
Archives and Records Administration's Electronic Code of Federal

Regulations. Available from, as of February 4, 2015: http://www.ecfr.gov]
**PEER REVIEWED**
FDA REQUIREMENTS:
Microcapsules for flavoring substances. Microcapsules maybe safely used
for encapsulating discrete particles of flavoring substances that are
generally recognized as safe for their intended use or are regulated under
this part, in accordance with the following conditions: ... Component:
glutaraldehyde; Limitation: as cross-linking agent for insolubilizing a
coacervate of gum arabic and gelatin.[21 CFR 172.230 (USFDA); U.S.
National Archives and Records Administration's Electronic Code of Federal
Regulations. Available from, as of February 4, 2015: http://www.ecfr.gov]
**PEER REVIEWED**
Glutaraldehyde is an indirect food additive for use only as a component of
adhesives.[21 CFR 175.105 (USFDA); U.S. National Archives and Records
Administration's Electronic Code of Federal Regulations. Available from,
as of February 4, 2015: http://www.ecfr.gov] **PEER REVIEWED**
MOLECULAR FORMULA:
C5-H8-O2 **PEER REVIEWED**
MOLECULAR WEIGHT:
100.117[Haynes, W.M. (ed.). CRC Handbook of Chemistry and Physics. 95th
Edition. CRC Press LLC, Boca Raton: FL 2014-2015, p. 3-438] **PEER
REVIEWED**
COLOR/FORM:
Colorless liquid[NIOSH. NIOSH Pocket Guide to Chemical Hazards. Department

of Health & Human Services, Centers for Disease Control &
Prevention. National Institute for Occupational Safety & Health. DHHS
(NIOSH) Publication No. 2010-168 (2010). Available from:
http://www.cdc.gov/niosh/npg] **PEER REVIEWED**
Oil[O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals,
Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013.,
p. 827] **PEER REVIEWED**
ODOR:
Pungent odor[NIOSH. NIOSH Pocket Guide to Chemical Hazards. Department of
Health & Human Services, Centers for Disease Control & Prevention.
National Institute for Occupational Safety & Health. DHHS (NIOSH)
Publication No. 2010-168 (2010). Available from:
http://www.cdc.gov/niosh/npg] **PEER REVIEWED**
Sweetish[ECHA; Search for Chemicals. Glutaraldehyde (CAS 111-30-8)
Registered Substances Dossier. European Chemical Agency; Available from,
as of Feb 25, 2015: http://echa.europa.eu/] **PEER REVIEWED**
BOILING POINT:
187-189 deg C (decomposes)[O'Neil, M.J. (ed.). The Merck Index - An
Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal
Society of Chemistry, 2013., p. 827] **PEER REVIEWED**
MELTING POINT:
Freezing point: -14 deg C[O'Neil, M.J. (ed.). The Merck Index - An

DENSITY/SPECIFIC GRAVITY:
0.72[Lewis, R.J. Sr.; Hawley's Condensed Chemical Dictionary 15th
Edition. John Wiley & Sons, Inc. New York, NY 2007., p. 610] **PEER
REVIEWED**
HEAT OF COMBUSTION:
Standard Net Heat of Combustion: -2.569X10+9 J/kmol[Daubert TE, Danner RP;
Physical and Thermodynamic Properties of Pure Chemicals: Data Compilation.
Supplement 7. Design Institute for Physical Property Data American
Institute of Chemical Engineers NY, NY: Hemisphere Publishing Corp (1997)]
**PEER REVIEWED**
HEAT OF VAPORIZATION:
51.4-56.2 kJ/mol (327-436 K)[NIST; NIST Chemistry WebBook. Glutaraldehyde
(111-30-8). NIST Standard Reference Database, 2013 Release. Washington,
DC: US Sec Commerce. Available from, as of Feb 25, 2015:
http://webbook.nist.gov] **PEER REVIEWED**
OCTANOL/WATER PARTITION COEFFICIENT:
log Kow = -0.33[Leung H-W; Ecotoxicol Environ Safety 49: 26-39 (2001)]
**PEER REVIEWED**
PH:
Mildly acidic (50% solution)[OECD; SIDS Initial Assessment Report.
Glutaraldehyde (CAS No.111-30-8). Available from, as of Feb 25, 2015:
REVIEWED**
SOLUBILITIES:
Miscible with water[Haynes, W.M. (ed.). CRC Handbook of Chemistry and
Physics. 95th Edition. CRC Press LLC, Boca Raton: FL 2014-2015, p. 3-438]
**PEER REVIEWED**
Soluble in ethanol, benzene, ether[O'Neil, M.J. (ed.). The Merck Index -
An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK:
Royal Society of Chemistry, 2013., p. 827] **PEER REVIEWED**
Miscible with ethanol[Haynes, W.M. (ed.). CRC Handbook of Chemistry and
Physics. 95th Edition. CRC Press LLC, Boca Raton: FL 2014-2015, p. 3-438]
**PEER REVIEWED**
SPECTRAL PROPERTIES:
Index of refraction: 1.433 at 25 deg C[Haynes, W.M. (ed.). CRC Handbook of
Chemistry and Physics. 95th Edition. CRC Press LLC, Boca Raton: FL
2014-2015, p. 3-438] **PEER REVIEWED**
MASS: 1116 (NIST/EPA/MCDC Mass Spectral Database 1990 Version)[Lide, D.R.,
G.W.A. Milne (eds.). Handbook of Data on Organic Compounds. Volume I. 3rd
ed. CRC Press, Inc. Boca Raton ,FL. 1994., p. V4: 3838] **PEER REVIEWED**
VAPOR DENSITY:
3.4 (Air = 1)[Patty, F. (ed.). Industrial Hygiene and Toxicology: Volume
II: Toxicology. 2nd ed. New York: Interscience Publishers, 1963., p. 1981]
**PEER REVIEWED**
VAPOR PRESSURE:
0.6 mm Hg at 30 deg C[Heisler SL, Friedlander SK; Atmos Environ 11:

157-168 (1977)] **PEER REVIEWED**
OTHER CHEMICAL/PHYSICAL PROPERTIES:
Boiling point: 106-108 deg C at 50 mm Hg, 71-72 deg C at 10 mm Hg[O'Neil,
M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and
Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 827]
**PEER REVIEWED**
Vapor pressure (20 deg C): 0.0152 torr (50% aqueous solution); 0.0012 torr
(2% aqueous solution)[O'Neil, M.J. (ed.). The Merck Index - An
Polymerizes in water to a glassy form which regenerates the dialdehyde on
vacuum distillation.[O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia
of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of
Chemistry, 2013., p. 827] **PEER REVIEWED**
/Glutaraldehyde/ is only stable at acidic pH values and tends to
polymerize in alkaline media.[Uhr H et al; Biocides. Ullmann's
Encyclopedia of Industrial Chemistry. 7th ed. (1999-2015). New York, NY:
John Wiley & Sons. Online Posting Date: Oct 9, 2013.] **PEER
REVIEWED**
CONVERSION FACTORS: 1 MG/L= 245 PPM; 1 PPM= 4.1 MG/CU M[Patty, F. (ed.).
Industrial Hygiene and Toxicology: Volume II: Toxicology. 2nd ed. New
York: Interscience Publishers, 1963., p. 1981] **PEER REVIEWED**
Henry's Law constant = 3.30X10-8 atm-cu m/mol at 25 deg C[Leung H-W;

Hydroxyl radical reaction rate constant = 2.52X10-11 cu cm/molecule-sec at
25 deg C[NIST; NIST Chemistry WebBook. Glutaraldehyde (111-30-8). NIST Gas
Kinetics Database, 2013 Release. Washington, DC: US Sec Commerce.
Available from, as of Feb 25, 2015: http://webbook.nist.gov] **PEER
REVIEWED**
SKIN, EYE AND RESPIRATORY IRRITATIONS:
A severe eye and human skin irritant.[Lewis, R.J. Sr. (ed) Sax's Dangerous
Contact with liquid causes severe irritation of eyes and irritation of
skin.[U.S. Coast Guard, Department of Transportation. CHRIS - Hazardous
Chemical Data. Volume II. Washington, D.C.: U.S. Government Printing
Office, 1984-5.] **PEER REVIEWED**
Glutaraldehyde vapor or mist can be a strong irritant or corrosive to the
eyes, nose throat, and lungs.[Dart, R.C. (ed). Medical Toxicology. Third
Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p.
Eye and respiratory irritation are noted at a level of 0.3 ppm.[Dart, R.C.
(ed). Medical Toxicology. Third Edition, Lippincott Williams &
Wilkins. Philadelphia, PA. 2004., p. 1248] **PEER REVIEWED**
The critical effects /of glutaraldehyde exposure/ are eye, skin, and
respiratory irritation, skin sensitization and occupational asthma. Nose

and throat irritation has been observed in humans at vapor concentrations
below 0.2 ppm. Occupational asthma has also been reported in workers
exposed to dilute solutions of glutaraldehyde ... Contact dermatitis and
eye irritation have been reported in workers using glutaraldehyde
solutions, usually 2% or higher. Skin sensitization has been confirmed in
workers using dilute solutions.[Organization for Economic Cooperation and
REVIEWED**
ANALYTIC LABORATORY METHODS:
Method: NIOSH 2531, Issue 2; Procedure: gas chromatography with flame
ionization detector; Analyte: glutaraldehyde; Matrix: air; Detection
Limit: 1 ug per sample.[CDC; NIOSH Manual of Analytical Methods, 4th ed.
Glutaraldehyde (111-30-8). Available from, as of February 20, 2015:
http://www.cdc.gov/niosh/docs/2003-154/] **PEER REVIEWED**
Method: NIOSH 2532, Issue 1; Procedure: high performance liquid
chromatography with ultraviolet detection; Analyte: glutaraldehyde;
Matrix: air; Detection Limit: 0.3 ug per sample.[CDC; NIOSH Manual of
Analytical Methods, 4th ed. Glutaraldehyde (111-30-8). Available from, as
of February 20, 2015: http://www.cdc.gov/niosh/docs/2003-154/] **PEER
REVIEWED**
Method: OSHA 64; Procedure: high performance liquid chromatography with
ultraviolet detection; Analyte: glutaraldehyde; Matrix: air; Detection
Limit: 4.4 ppb (18 ug/cu m).[U.S. Department of Labor/Occupational Safety
and Health Administration's Index of Sampling and Analytical Methods.

Glutaraldehyde (111-30-8). Available from, as of February 20, 2015:
http://www.osha.gov/dts/sltc/methods/toc.html] **PEER REVIEWED**
SPECIAL REPORTS:
DHHS/NTP; NTP Technical Report on Toxicity Studies of Glutaraldehyde
Administered by Inhalation to F344/N Rats and B6C3F1 Mice. Toxicity Rpt
Series No. 25 NIH Publication No. 93-3348 (1993)
Cosmetic Ingredient Review; Final Report on the Safety Assessment of
Glutaral. J Am Coll Toxicol 15 (2): 98-139 (1996)[Available from, as of
March 24, 2015: http://www.cir-safety.org/ingredients]
Toxicology & Carcinogenesis Studies of Glutaraldehyde in F344/N Rats
and B6C3F1 Mice p.5 Technical Report Series No. 490 (1999) NIH Publication
No. 99-3980 U.S. Department of Health and Human Services, National
Toxicology Program, National Institute of Environmental Health Sciences,
Research Triangle Park, NC 27709
Organization for Economic Cooperation and Development; Screening
This OECD SIDS documents published by UNEP Chemicals to facilitate the
access to information needed for health and environmental risk assessments
of chemicals.[Available from, as of June 1, 2010:
http://www.chem.unep.ch/irptc/sids/OECDSIDS/sidspub.html]
USEPA/Office of Prevention, Pesticides and Toxic Substances;
Reregistration Eligibility Decision Document - Glutaraldehyde, EPA
739-R-07-006 (September 2007). The RED summarizes the risk assessment
conclusions and outlines any risk reduction measures necessary for the
pesticide to continue to be registered in the U.S.[Available from, as of
February 24, 2015:
http://www.epa.gov/pesticides/reregistration/status.htm]

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Toxicidad Glutaraldehido Ingles

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The following information was generated from the

Hazardous Substances Data Bank (HSDB),

a database of the National Library of Medicine's TOXNET system

(http://toxnet.nlm.nih.gov) on November 20, 2019.

Query: Records containing the term 949

change periodically and so federal, state and local authorities must be

consulted for currently approved uses. It is used as algaecide,

bacteriocide and fungicide. Glutaraldehyde is used as a tissue fixative in

histology and electron and light microscopy, generally as a 1.5-6% aqueous

solution. Glutaraldehyde is used, generally in conjunction with wetting

agents, to control viruses and other micro-organisms in fish farming.

Glutaraldehyde is allowed as a preservative in cosmetics in Europe at

concentrations up to 0.1%. It is not allowed in aerosols and sprays.

Glutaraldehyde is a biocide commonly used in a 2% concentration for cold

sterilization of surgical and dental equipment. Biocides, such as

glutaraldehyde, are added to eliminate bacterial growth in fracturing

fluids. HUMAN EXPOSURE AND TOXICITY: Exposure to concentrations < 1 ppm

by inhalation or skin contact may cause irritation of the skin and/or

mucous membranes. The critical effects of glutaraldehyde exposure are eye,

in workers exposed to dilute solutions of glutaraldehyde. Contact

dermatitis and eye irritation have been reported in workers using

glutaraldehyde solutions, usually 2% or higher. Skin sensitization has

be brought on by glutaraldehyde exposure include heart palpitations and

tachycardia. The incidence of death and incidence of cancer deaths in 186

male employees at a glutaraldehyde production unit were compared to those

STUDIES: Glutaraldehyde was corrosive to the skin and eyes of rabbits at

irritation at 0.2%. In an inhalation study where mice were exposed to

glutaraldehyde at concentrations of 33 or 133 ppb for 24 hours, the

highest concentration developed toxic hepatitis. Following a single

coagulation pathology of the upper respiratory tract squamous epithelium.

After 4 days of such exposures, inflammatory granulocytic infiltrate into

the squamous epithelium and lamina propria with thickened epithelium of

the nasal lumen ensued. In those animals inhaling 0.5 or 1 ppm

intraluminal debris; degenerative/hyperplastic erosions with epithelial

abscesses extended as far as the nasopharyngeal meatus in the 1-ppm

exposure group. A study of male and female rats given glutaraldehyde in

drinking water at concentrations of 0, 50, 250, or 100 ppm through two

consumption and body weight (attributed to adverse taste) and decrease in

offspring (1000-ppm group) body weights. No adverse reproductive effects

were observed. In other study there was a significant dose-dependent

reduction in the average of maternal body weight gain and a significant

increase in the number of stunted (body weight) and malformed fetuses at

more recent studies have indicated that glutaraldehyde is mutagenic in

vitro in bacterial assays and tests in mammalian cells. In vivo

genotoxicity tests to date have proven negative. Groups of 50 male and 50

female rats and mice were exposed to glutaraldehyde vapor at

concentrations of 0, 0.25, 0.50, or 0.75 (rats) and 0, 0.062, 0.12, or

0.25 ppm (mice) 6 hr/day, 5 days /week. The incidences of non-neoplastic

lesions of the nose were reported to be significantly increased in the

glutaraldehyde indicate that continuous exposure results in measurable

effects on coldwater fish at a concentration of 5.1 mg a.i./L. A second

study on coldwater fish resulted in measurable effects at 2.5 mg a.i./L.

Measurable effects on freshwater invertebrates were noted at

concentrations of 8.5 mg/L product and 4.9 mg a.i./L. **PEER REVIEWED**

EVIDENCE FOR CARCINOGENICITY:

A4; Not classifiable as a human carcinogen. /Glutaraldehyde/[American

Conference of Governmental Industrial Hygienists. Documentation of the

CD-ROM Cincinnati, OH 45240-1634 2013., p. 1] **PEER REVIEWED**

HUMAN TOXICITY EXCERPTS:

bronchoalveolar lavage fluid (BALF) components and Clara cell protein

(CC16) concentration in serum and BALF in patients with glutaraldehyde

(GA)-induced asthma, before and after a specific inhalatory provocation

test (SIPT) with GA, in comparison to atopic asthmatics and healthy

individuals. Spirometry and bronchoalveolar lavage were performed before

concentrations of 8.5 mg/L product and 4.9 mg a.i./L. PEER REVIEWED

CD-ROM Cincinnati, OH 45240-1634 2013., p. 1] PEER REVIEWED

(7): 572-4 (2005)] PEER REVIEWED <a

721-31 (2007).] PEER REVIEWED <a

http://esis.jrc.ec.europa.eu/] PEER REVIEWED

as of June 1, 2010: http://www.regulations.gov] PEER REVIEWED

as of June 1, 2010: http://www.regulations.gov] PEER REVIEWED