GLUTARALDEHYDE
CASRN: 111-30-8

See Occupational Exposure Standards

Human Health Effects:

Evidence for Carcinogenicity:

A4; Not classifiable as a human carcinogen.
[American Conference of Governmental Industrial Hygienists. TLVs & BEIs: Threshold limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices for 2002. Cincinnati, OH. 2002.34]**QC REVIEWED**

Human Toxicity Excerpts:

WATER SOLNS OF ... GLUTARALDEHYDE ... ARE RELATIVELY STRONG IRRITANTS TO THE SKIN OR EYES. THEIR LOWER VAPOR PRESSURES, HOWEVER, REDUCE THE LIKELIHOOD THAT INHALATION WOULD BE A SUBSTANTIAL ROUTE OF EXPOSURE.
[Clayton, G.D., F.E. Clayton (eds.) Patty's Industrial Hygiene and Toxicology. Volumes 2A, 2B, 2C, 2D, 2E, 2F: Toxicology. 4th ed. New York, NY: John Wiley & Sons Inc., 1993-1994. 311]**PEER REVIEWED**

...SEVERE EYE, PLUS NOSE & THROAT IRRITATION WERE FELT BY OPERATOR & INVESTIGATORS /IN COLD-STERILIZING PROCEDURE/, WHO ALSO EXPERIENCED SUDDEN HEADACHE.
[American Conference of Governmental Industrial Hygienists. Documentation of the Threshold Limit Values for Substances in Workroom Air. Third Edition, 1971. Cincinnati, Ohio: American Conference of Governmental Industrial Hygienists, 1971. (Plus supplements to 1979)447]**PEER REVIEWED**

IT CAN...CAUSE SENSITIZATION (ALLERGIC CONTACT DERMATITIS) FROM OCCASIONAL OR INCIDENTAL OCCUPATIONAL EXPOSURE.
[American Conference of Governmental Industrial Hygienists. Documentation of the Threshold Limit Values for Substances in Workroom Air. Third Edition, 1971. Cincinnati, Ohio: American Conference of Governmental Industrial Hygienists, 1971. (Plus supplements to 1979)447]**PEER REVIEWED**

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**

Although glutaraldehyde is a weak allergen, the vapors from glutaraldehyde may act as an irritant to bronchial & laryngeal mucous membranes, & prolonged exposure could produce localized edema & other symptoms suggestive of an allergic response.
[Sullivan, J.B. Jr., G.R. Krieger (eds.). Hazardous Materials Toxicology-Clinical Principles of Environmental Health. Baltimore, MD: Williams and Wilkins, 1992. 983]**PEER REVIEWED**

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, 1991.703]**PEER REVIEWED**

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**

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. Concern about respiratory disease has been expressed within the radiography profession.
[Cullman P et al; Lancet 340 (8833): l477 (1992)]**PEER REVIEWED**

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. /It was/ concluded that cases like this can be expected to become more common since benzalkonium chloride and glutaraldehyde are being used more frequently to sterilize dental and other medical instruments and equipment.
[Cusano F, Luciano S; Contact Dermatitis 28 (2): 127 (1993)]**PEER REVIEWED**

Proctitis has been reported after the use of glutaraldehyde as a disinfectant of flexible sigmoidoscopes. Within hours of an exam patients may have acute tenesmus & bloody diarrhea. The prognosis is good. Recovery follows in a few weeks.
[Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997. 1219]**PEER REVIEWED**

Skin, Eye and Respiratory Irritations:

A severe skin and eye irritant in humans.
[Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996. 1734]**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**

Eye and respiratory irritation are noted at a level of 0.3 ppm.
[Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997. 1219]**PEER REVIEWED**

Drug Warnings:

This disinfectant may cross-react with formaldehyde.
[American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994. 1620]**PEER REVIEWED**

Probable Routes of Human Exposure:

Occupational exposure to health care workers is common.
[Sullivan, J.B. Jr., G.R. Krieger (eds.). Hazardous Materials Toxicology-Clinical Principles of Environmental Health. Baltimore, MD: Williams and Wilkins, 1992. 983]**PEER REVIEWED**

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. 983]**PEER REVIEWED**

Minimum Fatal Dose Level:

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**

Emergency Medical Treatment:

Emergency Medical Treatment:

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The following Overview, *** GLUTARALDEHYDE ***, is relevant for this HSDB record chemical.

Life Support:
  o   This overview assumes that basic life support measures
      have been instituted.
Clinical Effects:
  SUMMARY OF EXPOSURE
   0.2.1.1 ACUTE EXPOSURE
     o   Glutaraldehyde may be irritating to the eyes, skin, and
         mucous membranes.  Exposure may induce asthma in some
         individuals and can cause an allergic contact
         dermatitis.
     o   Vapor exposure in humans has been associated with
         coryza, epistaxis, headache, asthma, chest pain,
         palpitations, tachycardia, and nausea and vomiting.
      1.  Additional symptoms from exposure may include cough,
          rhinitis, respiratory difficulty, and lacrimation.
     o   Human exposure data are minimal.  Symptoms and
         treatments may be similar to that of formaldehyde and
         are dependent on route and concentration of exposure.
     o   CNS depression has occurred in experimental animals
         given intravenous injections.
  HEENT
   0.2.4.1 ACUTE EXPOSURE
     o   Topical glutaraldehyde has caused severe eye injury in
         rabbits.  A 2% solution may cause severe inflammation,
         lacrimation, and edema.
     o   Glutaraldehyde is particularly irritating to the nose
         and throat.
  CARDIOVASCULAR
   0.2.5.1 ACUTE EXPOSURE
     o   Tachycardia has been reported with occupational
         exposures (dermal and inhalation).  Hypotension has
         been reported with formaldehyde and may be a concern
         with glutaraldehyde.
  RESPIRATORY
   0.2.6.1 ACUTE EXPOSURE
     o   Occupational asthma has been reported following
         inhalation.  It is delayed in onset.
     o   Hemorrhagic pulmonary congestion and pneumonitis were
         common effects reported in animals regardless of
         whether glutaraldehyde was administered IV, orally, or
         by inhalation.
  NEUROLOGIC
   0.2.7.1 ACUTE EXPOSURE
     o   Seizures and CNS depression were noted in animals given
         intravenous glutaraldehyde.
  GASTROINTESTINAL
   0.2.8.1 ACUTE EXPOSURE
     o   Glutaraldehyde may cause irritation of the
         gastrointestinal tract and frank gastrointestinal
         hemorrhages in higher concentrations.  Sigmoidoscopy
         instruments disinfected with glutaraldehyde and
         inadequately rinsed may cause bloody diarrhea and
         proctitis.
  DERMATOLOGIC
   0.2.14.1 ACUTE EXPOSURE
     o   Dermal solutions of 2% to 10% are used therapeutically,
         but may result in staining of skin and nails a brown or
         golden brown color.  A 10% solution is a potential skin
         irritant and has caused pruritus and dermatitis.
         Allergic contact dermatitis has also been reported.
  CARCINOGENICITY
   0.2.21.2 HUMAN OVERVIEW
     o   At the time of this review, no studies were found on
         the possible carcinogenic activity of glutaraldehyde in
         humans.
     o   Nasal cancers have been reported in rat inhalational
         studies.
   0.2.21.3 ANIMAL OVERVIEW
     o   NASAL CANCERS - Glutaraldehyde was tested against the
         known rat nasal carcinogen, formaldehyde, and found to
         be 5 times as potent as formaldehyde.  Preliminary data
         suggest that a chronic inhalation study is needed to
         assess the carcinogenic potential of glutaraldehyde (St
         Clair et al, 1989).
     o   Glutaraldehyde was not carcinogenic in rats or mice by
         inhalation in a 13-week exposure.
  GENOTOXICITY
    o   Glutaraldehyde, in a dentin bonding agent, has been
        shown to be mutagenic in an Ames assay using Salmonella
        typhimurium strains (RTECS, 2001; Schweikl et al, 1994)
        as well as in sister chromatid exchange and mutations in
        mouse lymphocyte cells and cytogenetic changes in
        hamster ovary cells (RTECS, 2001).                  
Laboratory:
  o   Blood gases or bicarbonate levels should be monitored for
      possible development of acidosis.  Liver function tests
      should be monitored.
  o   If respiratory tract irritation or respiratory depression
      are clinically evident, consider monitoring pulse
      oximetry, arterial blood gases, chest x-ray, and pulmonary
      function tests.                      
Treatment Overview:
  SUMMARY EXPOSURE
    o   The treatment of glutaraldehyde is nearly identical to
        that of formaldehyde.  It appears to be slightly less
        toxic except for intravenous or ocular exposures.
        Because of its lower vapor pressure, glutaraldehyde is
        less likely to be inhaled.  Treatment should be aimed at
        recognition and management of gastrointestinal
        hemorrhage, ulceration and perforation, and any systemic
        effects such as CNS depression and hypotension.
  ORAL EXPOSURE
    o   SUMMARY - Glutaraldehyde treatment is nearly identical
        to formaldehyde.  It appears to be slightly less toxic
        except for IV and ocular exposures.  Treatment:  observe
        for and manage any gastrointestinal hemorrhage,
        ulceration, or perforation; supportive care is indicated
        for CNS depression and hypotension.
    o   DILUTION:  Immediately dilute with 4 to 8 ounces (120 to
        240 mL) of milk or water (not to exceed 4 ounces/120 mL
        in a child).
    o   Because of the potential for gastrointestinal tract
        irritation or CNS depression and subsequent aspiration,
        do NOT induce emesis.  Significant caustic injury burns
        may occur following ingestion.  The possible benefit of
        early removal of some ingested material by cautious
        gastric lavage must be weighed against its potential
        complications such as bleeding or perforation or
        aspiration.
    o   ACTIVATED CHARCOAL:  Administer charcoal as a slurry
        (240 mL water/30 g charcoal).  Usual dose:  25 to 100 g
        in adults/adolescents, 25 to 50 g in children (1 to 12
        years), and 1 g/kg in infants less than 1 year old.
    o   HYPOTENSION:  Infuse 10 to 20 mL/kg isotonic fluid,
        place in Trendelenburg position.  If hypotension
        persists, administer dopamine (5 to 20 mcg/kg/min) or
        norepinephrine (0.1 to 0.2 mcg/kg/min), titrate to
        desired response.
    o   ESOPHAGOSCOPY - Should be considered following oral
        ingestion of concentrated glutaraldehyde solutions to
        assess the severity of caustic injury.
  INHALATION EXPOSURE
    o   Move patient to fresh air and monitor for respiratory
        distress.  Hemorrhagic pneumonitis has been reported in
        animals exposed to glutaraldehyde.
    o   If respiratory tract irritation or respiratory
        depression is evident, monitor arterial blood gases,
        chest x-ray, and pulmonary function tests.
  EYE EXPOSURE
    o   Exposed eyes should be irrigated copiously with water
        for at least 15 minutes.  An ophthalmic examination
        should be considered if irritation or pain persists
        thereafter.  Glutaraldehyde in concentrations as low as
        2% may cause ocular damage (severe inflammation,
        lacrimation, and edema).
  DERMAL EXPOSURE
    o   DECONTAMINATION:  Remove contaminated clothing and wash
        exposed  area thoroughly with soap and water.  A
        physician may need to  examine the area if irritation or
        pain persists.                                       
Range of Toxicity:
  o   The toxic dose has not been established in man.  Ten
      percent solutions have caused dermatitis when applied
      therapeutically.  Two percent solutions have caused ocular
      damage.

[Rumack BH: POISINDEX(R) Information System. Micromedex, Inc., Englewood, CO, 2003; CCIS Volume 116, edition exp May, 2003. Hall AH & Rumack BH (Eds): TOMES(R) Information System. Micromedex, Inc., Englewood, CO, 2003; CCIS Volume 116, edition exp May, 2003.]**PEER REVIEWED**

Antidote and Emergency Treatment:

Skin that becomes contaminated with glutaraldehyde should be washed immediately or showered.
[Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997. 1219]**PEER REVIEWED**

Basic treatment: Establish a patent airway. Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if necessary. Aggressive airway management may be necessary. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Anticipate seizures and treat if necessary ... . Monitor for shock and treat if necessary ... . Monitor for pulmonary edema and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with normal saline during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool. Administer activated charcoal ... . /Aldehydes and related compounds/
[Bronstein, A.C., P.L. Currance; Emergency Care for Hazardous Materials Exposure. 2nd ed. St. Louis, MO. Mosby Lifeline. 1994.,p. 234-35]**PEER REVIEWED**

Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious or in respiratory arrest. Intubation should be considered at the first sign of upper airway obstruction caused by edema. Positive pressure ventilation techniques with a bag-valve-mask device may be beneficial. Start an IV with D5W /SRP: "To keep open", minimal flow rate/. Use lactated Ringer's if signs of hypovolemia are present. Watch for signs of fluid overload. Treat seizures with diazepam ... . For hypotension with signs of hypovolemia, administer fluid cautiously. Consider vasopressors if patient is hypotensive with a normal fluid volume. Watch for signs of fluid overload ... . Consider drug therapy for pulmonary edema ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Aldehydes and related compounds/
[Bronstein, A.C., P.L. Currance; Emergency Care for Hazardous Materials Exposure. 2nd ed. St. Louis, MO. Mosby Lifeline. 1994. 235]**PEER REVIEWED**

Animal Toxicity Studies:

Evidence for Carcinogenicity:

A4; Not classifiable as a human carcinogen.
[American Conference of Governmental Industrial Hygienists. TLVs & BEIs: Threshold limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices for 2002. Cincinnati, OH. 2002.34]**QC REVIEWED**

Non-Human Toxicity Excerpts:

IRRITANT EFFECT ON SKIN OF RABBITS IS MODERATE. /FROM TABLE/
[Clayton, G.D., F.E. Clayton (eds.) Patty's Industrial Hygiene and Toxicology. Volumes 2A, 2B, 2C, 2D, 2E, 2F: Toxicology. 4th ed. New York, NY: John Wiley & Sons Inc., 1993-1994. 312]**PEER REVIEWED**

... A 25% AQ SOLN ON RABBIT EYES, CAUSED SEVERE INJURY, GRADED 9 ON A SCALE OF 10. A 1% SOL 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. 462]**PEER REVIEWED**

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**

Solutions of 1 and 2% glutaral destroy Bacillus anthracis spores more rapidly than 4% formaldehyde. ... In addition to sporicidal activity glutaral has inactivated enteroviruses and other viruses.
[Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982. 714]**PEER REVIEWED**

Alkanes, alcohols, ketones, and aldehydes reported not to produce neurotoxicity after chronic and subchronic exposures. Test substance: Glutaraldehyde, Species: Rat, Route: Water, Exposure conditions: 0.25, 0.5, and 1.0% in drinking water for 11 weeks. /From table/
[O'Donoghue, J.L. (ed.). Neurotoxicity of Industrial and Commercial Chemicals. Volume II. Boca Raton, FL: CRC Press, Inc., 1985. 81]**PEER REVIEWED**

Percutaneous lethal dose in rabbits 0.6 g/kg.
[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**

... When mice were exposed at 8 and 33 ppm (33 and 133 mg/cu m) of alkalinized glutaraldehyde for 24 hr, the animals reacted with distinctly nervous behavior, panting and washing of the face and limbs, with symptoms disappearing after a few hours. Fifty percent of the mice in each group were sacrificed immediately postexposure, and the remaining animals were killed the following day. Lungs and kidneys showed no histopathologic damage, but the livers of the mice exposed at 33 ppm showed definite signs of toxic hepatitis, possibly reversible, since it was present to somewhat lesser degree in the animals necropsied one day postexposure.
[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, 1991.703]**PEER REVIEWED**

... CONCLUSIONS: Under the conditions of these 2 yr inhalation studies, there was no evidence of carcinogenic activity of glutaraldehyde in male or female F344/N rats exposed to 250, 500 750 ppb. There was no evidence of carcinogenic activity in male or female B6C3F1 mice exposed to 62.5, 125 or 250 ppb.
[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]**PEER REVIEWED**

National Toxicology Program Studies:

... 2 yr study in rats: 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/wk for 104 wk. ... 2 yr study in mice: 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/wk for 104 wk. ... CONCLUSIONS: Under the conditions of these 2 yr inhalation studies, there was no evidence of carcinogenic activity of glutaraldehyde in male or female F344/N rats exposed to 250, 500 750 ppb. There was no evidence of carcinogenic activity in male or female B6C3F1 mice exposed to 62.5, 125 or 250 ppb.
[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]**PEER REVIEWED**

Non-Human Toxicity Values:

LD50 Rat oral 134 mg/kg
[Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996. 1734]**PEER REVIEWED**

LD50 Rabbit skin 2,560 mg/kg
[Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996. 1734]**PEER REVIEWED**

LD50 Rat oral 0.82 g/kg
[Clayton, G.D., F.E. Clayton (eds.) Patty's Industrial Hygiene and Toxicology. Volumes 2A, 2B, 2C, 2D, 2E, 2F: Toxicology. 4th ed. New York, NY: John Wiley & Sons Inc., 1993-1994. 312]**PEER REVIEWED**

LD50 Rabbit skin 0.64 ml/kg
[Clayton, G.D., F.E. Clayton (eds.) Patty's Industrial Hygiene and Toxicology. Volumes 2A, 2B, 2C, 2D, 2E, 2F: Toxicology. 4th ed. New York, NY: John Wiley & Sons Inc., 1993-1994. 312]**PEER REVIEWED**

LC50 Rat inhalation 5000 ppm/4 hr exposure
[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, 1991.703]**PEER REVIEWED**

LD50 Rat oral 1.30 ml/kg 50% aqueous soln (w/w)
[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, 1991.704]**PEER REVIEWED**

LC50 Rat (male) inhalation 24 ppm/ 4 hr
[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, 1991.704]**PEER REVIEWED**

LC50 Rat (female) inhalation 40 ppm/ 4 hr
[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, 1991.704]**PEER REVIEWED**

LD50 Rat oral 1.87 ml/kg 25% aqueous soln (w/w)
[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, 1991.704]**PEER REVIEWED**

LD50 Rat oral 3.3 ml/kg 5% aqueous soln (w/w)
[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, 1991.704]**PEER REVIEWED**

LD50 Rat oral 12.3 ml/kg 1% aqueous soln (w/w)
[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, 1991.704]**PEER REVIEWED**

LD50 Rat oral 96.1 mg/kg 2% Cidex formulation
[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, 1991.704]**PEER REVIEWED**

LD50 Mouse oral 100 mg/kg
[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, 1991.704]**PEER REVIEWED**

LD50 Mouse oral 1300 mg/kg 25% olive oil soln
[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, 1991.704]**PEER REVIEWED**

LD50 Mouse (male) oral 122 mg/kg 2% Cidex formulation
[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, 1991.704]**PEER REVIEWED**

LD50 Rabbit oral 1.59 ml/kg 50% aqueous soln (w/w)
[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, 1991.704]**PEER REVIEWED**

LD50 Rabbit oral 8.0 ml/kg 25% aqueous soln (w/w)
[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, 1991.704]**PEER REVIEWED**

LD50 Rabbit oral >16 ml/kg 5% aqueous soln (w/w)
[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, 1991.704]**PEER REVIEWED**

LD50 Rat sc 2390 mg/kg
[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, 1991.704]**PEER REVIEWED**

LD50 Mouse (male) sc 1430 mg/kg
[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, 1991.704]**PEER REVIEWED**

LD50 Rat ip 17900 ug/kg
[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, 1991.704]**PEER REVIEWED**

LD50 Mouse ip 13900 ug/kg
[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, 1991.704]**PEER REVIEWED**

LD50 Rat iv 15300 ug/kg
[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, 1991.704]**PEER REVIEWED**

LD50 Mouse iv 15400 ug/kg
[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, 1991.704]**PEER REVIEWED**

LD50 Rat iv 9800 ug/kg
[Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996. 1734]**PEER REVIEWED**

Metabolism/Pharmacokinetics:

Metabolism/Metabolites:

... The probable major metabolic pathway /is/ initial oxidation to the corresponding mono- or dicarboxylic acid by aldehyde dehydrogenase & then further oxidation of the acidic intermediate to carbon dioxide.
[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, 1991.704]**PEER REVIEWED**

Absorption, Distribution & Excretion:

Material balance & pharmacokinetic studies were conducted with rats & rabbits including iv or topical dosing with [14C]glutaraldehyde. IV dosing resulted in radiochemical recovery from 86% to 101%. Principal route of recovery was as CO2 at 22% to 80% of the admin dose (7%-28% urinary, 0.2%-5% feces). Epicutaneous dosing resutled in radiochemical recovery primarily in the skin at the site of application (31%-61%) with no consistent accumulation in any other tissue. Rabbits absorbed 33% to 53% of the epicutaneously administered dose & rats absorbed 4.1% to 8.7%. Pharmacokinetic studies indicated percutaneous radiochemical absorption of 0.3% to 2.1% for rats & 2.5% to 15.6% for rabbits under conservative study conditions that are likely to overestimate potential human exposure conditions.
[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, 1991.704]**PEER REVIEWED**

Mechanism of Action:

Cross-linking of the peptidoglycan in the bacterial cell wall with intermolecular bonding between techoic acid chains & glutaraldehyde may cause a partial sealing & contraction of the outer cell envelope.
[Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997. 1219]**PEER REVIEWED**

Pharmacology:

Therapeutic Uses:

Disinfectants; Fixatives
[National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)]**PEER REVIEWED**

...USED ON LIVING TISSUES IN TREATMENT OF WARTS & HYPERHIDROSIS.
[American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977. 894]**PEER REVIEWED**

Glutaral 2% in a buffered solution (pH 7.5) ... has an anhidrotic effect when applied to the palms and soles but not the axillae.
[American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994. 1213]**PEER REVIEWED**

IT...POSSESSES TUBERCULOCIDAL ACTION.
[American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977. 894]**PEER REVIEWED**

Drug Warnings:

This disinfectant may cross-react with formaldehyde.
[American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994. 1620]**PEER REVIEWED**

Minimum Fatal Dose Level:

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:

Probable Routes of Human Exposure:

Occupational exposure to health care workers is common.
[Sullivan, J.B. Jr., G.R. Krieger (eds.). Hazardous Materials Toxicology-Clinical Principles of Environmental Health. Baltimore, MD: Williams and Wilkins, 1992. 983]**PEER REVIEWED**

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. 983]**PEER REVIEWED**

Environmental Standards & Regulations:

FIFRA Requirements:

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 future use. Under this pesticide reregistration program, EPA examines health and safety data for pesticide active ingredients initially registered before November 1, 1984, and determines whether they are eligible for reregistration. In addition, all pesticides must meet the new safety standard of the Food Quality Protection Act of 1996. Pesticides for which EPA had not issued Registration Standards prior to the effective date of FIFRA, as amended in 1988, were divided into three lists based upon their potential for human exposure and other factors, with List B containing pesticides of greater concern and List D pesticides of less concern. 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 has made commitments to conduct the studies and pay the fees required for reregistration, and are meeting those commitments in a timely manner.
[USEPA/OPP; Status of Pesticides in Registration, Reregistration and Special Review p.184 (Spring, 1998) EPA 738-R-98-002]**PEER REVIEWED**

TSCA Requirements:

Section 8(a) of TSCA requires manufacturers of this chemical substance to report preliminary assessment information concerned with production, use, and exposure to EPA as cited in the preamble in 51 FR 41329.
[40 CFR 712.30 (7/1/2000)]**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.
[40 CFR 716.120 (7/1/2000)]**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 araabic and gelatin.
[21 CFR 172.230 (4/1/2000)]**PEER REVIEWED**

Glutaraldehyde is an indirect food additive for use only as a component of adhesives.
[21 CFR 175.105 (4/1/2000)]**PEER REVIEWED**

Chemical/Physical Properties:

Molecular Formula:

C5-H8-O2
**PEER REVIEWED**

Molecular Weight:

100.13
[Howard PH, Neal M; Dictionary of Chemical Names and Synonyms. Boca Raton, FL: Lewis Publishers, p. I-263 (1992)]**PEER REVIEWED**

Color/Form:

Colorless liquid
[Ashford, R.D. Ashford's Dictionary of Industrial Chemicals. London, England: Wavelength Publications Ltd., 1994. 450]**PEER REVIEWED**

Oil
[Budavari, S. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 1996. 761]**PEER REVIEWED**

Odor:

Pungent odor
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 152]**PEER REVIEWED**

Boiling Point:

188 deg C (decomp)
[Lide, DR (ed.). CRC Handbook of Chemistry and Physics. 81st Edition. CRC Press LLC, Boca Raton: FL 2000,p. 3-240]**PEER REVIEWED**

Melting Point:

FP: -14 deg C
[Lewis, R.J., Sr (Ed.). Hawley's Condensed Chemical Dictionary. 13th ed. New York, NY: John Wiley & Sons, Inc. 1997. 541]**PEER REVIEWED**

Density/Specific Gravity:

0.72
[Lewis, R.J., Sr (Ed.). Hawley's Condensed Chemical Dictionary. 13th ed. New York, NY: John Wiley & Sons, Inc. 1997. 541]**PEER REVIEWED**

Solubilities:

Miscible in ethanol and water; sol in benzene
[Lide, DR (ed.). CRC Handbook of Chemistry and Physics. 81st Edition. CRC Press LLC, Boca Raton: FL 2000,p. 3-240]**PEER REVIEWED**

SOL IN ETHER
[American Conference of Governmental Industrial Hygienists. Documentation of the Threshold Limit Values for Substances in Workroom Air. Third Edition, 1971. Cincinnati, Ohio: American Conference of Governmental Industrial Hygienists, 1971. (Plus supplements to 1979)447]**PEER REVIEWED**

Spectral Properties:

Index of refraction: 1.4338 @ 25 deg C
[Budavari, S. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 1996. 761]**PEER REVIEWED**

MASS: NIST 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. 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:

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. 1981]**PEER REVIEWED**

Hydroxyl radical reaction rate constant = 2.38X10-11 cu cm/molecule-sec @ 25 deg C
[Atkinson R; J Phys Chem Ref Data Monograph 1 p. 137 (1989)]**PEER REVIEWED**

Polymerizes in water to a glassy form which regenerates the dialdehyde on vacuum distillation.
[Budavari, S. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 1996. 761]**PEER REVIEWED**

VP = 17 mm Hg @ 20 deg C; FP = -7 deg C /25% aqueous solution/; FP = -14 deg C /50% aqueous solution/
[Flick, E.W. (ed.). Industrial Solvents Handbook 4 th ed. Noyes Data Corporation., Park Ridge, NJ., 1991. 511]**PEER REVIEWED**

VP = 17 mm Hg @ 20 deg C; FP = -7 deg C /25% aqueous solution/
[Budavari, S. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 1996. 761]**PEER REVIEWED**

Chemical Safety & Handling:

Skin, Eye and Respiratory Irritations:

A severe skin and eye irritant in humans.
[Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996. 1734]**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**

Eye and respiratory irritation are noted at a level of 0.3 ppm.
[Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997. 1219]**PEER REVIEWED**

Hazardous Reactivities & Incompatibilities:

Strong oxidizers, strong bases [Note: Alkaline solutions of glutaraldehyde (i.e., activated glutaraldehyde) react with alcohol, ketones, amines, hydrazines & proteins].
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 152]**PEER REVIEWED**

Hazardous Decomposition:

When heated to decomposition it emits acrid smoke and irritating fumes.
[Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996. 1734]**PEER REVIEWED**

Protective Equipment & Clothing:

Goggles or face shield; rubber gloves.
[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**

Neoprene or butyl rubber gloves are protective. Latex rubber gloves are not as protective.
[Sullivan, J.B. Jr., G.R. Krieger (eds.). Hazardous Materials Toxicology-Clinical Principles of Environmental Health. Baltimore, MD: Williams and Wilkins, 1992. 983]**PEER REVIEWED**

Wear appropriate personal protective clothing to prevent skin contact.
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 153]**PEER REVIEWED**

Wear appropriate eye protection to prevent eye contact.
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 153]**PEER REVIEWED**

Eyewash fountains should be provided in areas where there is any possbility that workers could be exposed to the substance; this is irrespective of the recommendation involving the wearing of eye protection.
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 153]**PEER REVIEWED**

Facilities for quickly drenching the body should be provided within the immediate work area for emergency use where there is a possibility of exposure. [Note: It is intended that these facilities provide a sufficient quantity or flow of water to quickly remove the substance from any body areas likely to be exposed. The actual determination of what constitutes an adequate quick drench facility depends on the specific circumstances. In certain instances, a deluge shower should be readily available, whereas in others, the availability of water from a sink or hose could be considered adequate.]
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 153]**PEER REVIEWED**

Preventive Measures:

SRP: The scientific literature for the use of contact lenses in industry is conflicting. The benefit or detrimental effects of wearing contact lenses depend not only upon the substance, but also on factors including the form of the substance, characteristics and duration of the exposure, the uses of other eye protection equipment, and the hygiene of the lenses. However, there may be individual substances whose irritating or corrosive properties are such that the wearing of contact lenses would be harmful to the eye. In those specific cases, contact lenses should not be worn. In any event, the usual eye protection equipment should be worn even when contact lenses are in place.
**PEER REVIEWED**

Containment of vapors and prevention of skin contact are important industrial hygiene principles to help avoid sensitization of the skin and respiratory irritation and/or asthma. Proper skin protection must be provided as well as ventilation controls.
[Sullivan, J.B. Jr., G.R. Krieger (eds.). Hazardous Materials Toxicology-Clinical Principles of Environmental Health. Baltimore, MD: Williams and Wilkins, 1992. 983]**PEER REVIEWED**

The worker should immediately wash the skin when it becomes contaminated.
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 153]**PEER REVIEWED**

Work clothing that becomes wet or significantly contaminated should be removed and replaced.
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 153]**PEER REVIEWED**

Contact lenses should not be worn when working with this chemical.
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 153]**PEER REVIEWED**

SRP: Contaminated protective clothing should be segregated in such a manner so that there is no direct personal contact by personnel who handle, dispose, or clean the clothing. Quality assurance to ascertain the completeness of the cleaning procedures should be implemented before the decontaminated protective clothing is returned for reuse by the workers. Contaminated clothing should not be taken home at end of shift, but should remain at employee's place of work for cleaning.
**PEER REVIEWED**

Stability/Shelf Life:

ACID GLUTARALDEHYDE IS MORE STABLE THAN ALKALINE GLUTARALDEHYDE
[Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975. 1103]**PEER REVIEWED**

STABLE IN LIGHT, OXIDIZES IN AIR, POLYMERIZES IN HEAT
[Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975. 1103]**PEER REVIEWED**

ALKALINE SOLUTION DEPOSITS POLYMERIC FILM AFTER FEW HR
[Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975. 994]**PEER REVIEWED**

GLUTARAL LOSES ACTIVITY WITHIN 2 WK AFTER PREPN
[American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994. 1620]**PEER REVIEWED**

Disposal Methods:

SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.
**PEER REVIEWED**

Occupational Exposure Standards:

Threshold Limit Values:

Ceiling Limit: 0.05 ppm, sensitizer. /Activated and inactivated/
[American Conference of Governmental Industrial Hygienists. TLVs & BEIs: Threshold limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices for 2002. Cincinnati, OH. 2002.34]**QC REVIEWED**

A4; Not classifiable as a human carcinogen.
[American Conference of Governmental Industrial Hygienists. TLVs & BEIs: Threshold limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices for 2002. Cincinnati, OH. 2002.34]**QC REVIEWED**

NIOSH Recommendations:

Recommended Exposure Limit: Ceiling value: 0.2 ppm (0.8 mg/cu m).
[NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 97-140. Washington, D.C. U.S. Government Printing Office, 1997. 152]**PEER REVIEWED**

Manufacturing/Use Information:

Major Uses:

For Glutaraldehyde (USEPA/OPP Pesticide Code: 043901) ACTIVE products with label matches. /SRP: Registered for 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./
[U.S. Environmental Protection Agency/Office of Pesticide Program's Chemical Ingredients Database on Glutaraldehyde (111-30-8). Available from the Database Query page at http://www.cdpr.ca.gov/docs/epa/epamenu.htm as of May 24, 2001.]**PEER REVIEWED**

EMBALMING FLUID
[Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976.,p. II-123]**PEER REVIEWED**

Intermediate; cross-linking protein and polyhydroxy materials; tanning of soft leathers
[Lewis, R.J., Sr (Ed.). Hawley's Condensed Chemical Dictionary. 13th ed. New York, NY: John Wiley & Sons, Inc. 1997. 542]**PEER REVIEWED**

CHEM INT FOR ADHESIVES, SEALANTS, ELECTRICAL PRODUCTS
[SRI]**PEER REVIEWED**

In sterilization of endoscopic instruments thermometers, rubber or plastic equipment which cannot be heat sterilized
[Budavari, S. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 1996. 761]**PEER REVIEWED**

Used as a biocide in the oil industry
[Gerhartz, W. (exec ed.). Ullmann's Encyclopedia of Industrial Chemistry. 5th ed.Vol A1: Deerfield Beach, FL: VCH Publishers, 1985 to Present.,p. VA16 (1990) 567]**PEER REVIEWED**

The most popular enzyme cross-linking reagent; microbiol cells are also cross-linked with glutaraldehyde to yield cell pellets
[Gerhartz, W. (exec ed.). Ullmann's Encyclopedia of Industrial Chemistry. 5th ed.Vol A1: Deerfield Beach, FL: VCH Publishers, 1985 to Present.,p. VA9 (1987) 386]**PEER REVIEWED**

Skin disinfectant
[Gerhartz, W. (exec ed.). Ullmann's Encyclopedia of Industrial Chemistry. 5th ed.Vol A1: Deerfield Beach, FL: VCH Publishers, 1985 to Present.,p. VA8 (1987) 555]**PEER REVIEWED**

DISINFECTANT THAT IS VERY GOOD NOT ONLY AGAINST VEGETATIVE BACTERIA BUT ALSO AGAINST SPORES. ITS EFFICACY AGAINST FUNGI & VIRUSES IS GOOD. ...DISINFECTANT OF CHOICE FOR COLD STERILIZATION OF SURGICAL INSTRUMENTS BUT IS BEING DISPLACED BY ETHYLENE OXIDE... GLUTARALDEHYDE AEROSOLS ARE ALSO USED TO "STERILIZE" HOSPITAL ROOMS; OPERATING AREAS, ETC. ACID GLUTARALDEHYDE IS MORE EFFECTIVE THAN ALKALINE GLUTARALDEHYDE...
[Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975. 1103]**PEER REVIEWED**

Disinfectant
[Farm Chemicals Handbook 2001. Willoughby, Ohio: Meister 2001.,p. C 210]**PEER REVIEWED**

Gelatine hardening agent; biocide (cosmetics, water treatment, oilfield applications); leather tannive auxiliary
[Ashford, R.D. Ashford's Dictionary of Industrial Chemicals. London, England: Wavelength Publications Ltd., 1994. 450]**PEER REVIEWED**

MEDICATION
**PEER REVIEWED**

TISSUE FIXATION
**PEER REVIEWED**

Manufacturers:

Polysciences, Inc., 400 Valley Rd., Warrington, PA 18976, (800) 523-2575; Production site: Warrington, PA 18976
[SRI International. 2000 Directory of Chemical Producers -- United States. SRI Consulting, Menlo Park: CA 2000 654]**PEER REVIEWED**

Union Carbide Corp., 39 Old Ridgebury Rd., Danbury, CT 06817-001, (203) 794-2000; Production site: Institute, WV 25103
[SRI International. 2000 Directory of Chemical Producers -- United States. SRI Consulting, Menlo Park: CA 2000 654]**PEER REVIEWED**

Vinings Industries, Inc., 245 TownPark Drive, Suite 200, Kennesaw, GA 30144, (800) 347-1542; Production site: Marietta, GA 30060
[SRI International. 2000 Directory of Chemical Producers -- United States. SRI Consulting, Menlo Park: CA 2000 654]**PEER REVIEWED**

Methods of Manufacturing:

THE 1:1 DIELS-ALDER ADDUCT OF ACROLEIN & VINYL ALKYL ETHER IS HYDROLYZED YIELDING GLUTARALDEHYDE & ALKANOL.
[Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975. 1102]**PEER REVIEWED**

Prepared by heating 2-ethoxy-3,4-dihydro-2H-pyran with aq HCl
[Budavari, S. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 1996. 761]**PEER REVIEWED**

General Manufacturing Information:

COST & LACK OF STABILITY ARE IMPORTANT DRAWBACKS TO ITS USE.
[American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977. 894]**PEER REVIEWED**

NEITHER ALKALINE NOR ACIDIC SOLN IS DAMAGING TO MOST SURGICAL INSTRUMENTS. ALKALINE DEPOSITS POLYMERIC FILM AFTER FEW HR.
[Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975. 994]**PEER REVIEWED**

...SUPERIOR TO FORMALDEHYDE AS STERILIZING AGENT. ... /AS 2% ALKALINE SOLN IN 70% ISOPROPANOL/...PERIOD OF 10 HR IS NECESSARY TO STERILIZE DRIED SPORES. ...ACIDIC /GLUTARALDEHYDE/ SOLN KILLS DRIED SPORES IN 20 MIN...
[Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975. 944]**PEER REVIEWED**

Formulations/Preparations:

USEPA/OPP Pesticide Code 043901; Trade Names: Cidex, component of; Odix, component of; Aldesan; Alhydex; Glutaralum; Hospex; NCI-C55425; Sonacide; Coldcide-25 Microbiocide Concentrate; GKN-O Microbiocide Concentrate (043901+069104+069154).
[U.S. Environmental Protection Agency/Office of Pesticide Program's Chemical Ingredients Database on Glutaraldehyde (111-30-8). Available from the Database Query page at http://www.cdpr.ca.gov/docs/epa/epamenu.htm as of May 24, 2001.]**PEER REVIEWED**

IT HAS BEEN MARKETED AS 2% ALKALINE SOLN IN 70% ISOPROPANOL...
[Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975. 994]**PEER REVIEWED**

CIDEX (ARBROOK) TOPICAL: SOLN (AQ) 2%.
[American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977. 894]**PEER REVIEWED**

Grades: 99%; 50% biological soln; 25% soln.
[Lewis, R.J., Sr (Ed.). Hawley's Condensed Chemical Dictionary. 13th ed. New York, NY: John Wiley & Sons, Inc. 1997. 541]**PEER REVIEWED**

EMPLOYED AS 25% SOLN IN WATER FOR EMBALMING FLUID.
[Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976.,p. II-125]**PEER REVIEWED**

2% AQ SOLN BUFFERED WITH 0.3% SODIUM CARBONATE TO PH OF 7.5-8.5 IS USEFUL FOR DISINFECTION AND STERILIZATION OF ENDOSCOPIC INSTRUMENTS & PLASTIC & RUBBER APPARATUS USED FOR INHALATION THERAPY & ANESTHESIA.
[American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977. 894]**PEER REVIEWED**

Electron microscopy grade is highly purified
[Kuney, J.H., J.M. Mullican (eds.). Chemcyclopedia. Washington, DC: American Chemical Society, 1994. 82]**PEER REVIEWED**

Biocide; supplied in acid solution and subsequently buffered to pH 8
[Gerhartz, W. (exec ed.). Ullmann's Encyclopedia of Industrial Chemistry. 5th ed.Vol A1: Deerfield Beach, FL: VCH Publishers, 1985 to Present.,p. VA16 (1990) 567]**PEER REVIEWED**

U. S. Production:

(1974) PROBABLY GREATER THAN 4.54X10+5 GRAMS
[SRI]**PEER REVIEWED**

(1976) PROBABLY GREATER THAN 2.27X10+6 GRAMS
[SRI]**PEER REVIEWED**

Laboratory Methods:

Analytic Laboratory Methods:

OSHA Method No. 64 Glutaraldehyde Issue June 1987. HPLC/UV Reliable quantitation limit = 18 ug/cu m.
[OSHA; Analytical Methods Manual. 2nd ed., Part 1 Organic Substances, Vol I Meth 1-28, Vol II, meth 29-54, Vol III Meth 55-80. Jan 1990. Vol IV Meth 81-102, Apr 1993. US Dept Labor Occupational Safety and Health, Admin, Direct Tech Supp, OSHA Technical Center, Salt Lake City, Utah]**PEER REVIEWED**

NIOSH Method 2531. Determination of Glutaraldehyde by High Performance Liquid Chromatography with UV Detection. This method is applicable to air samples. Detection limit = 0.01 mg/cu m.
[U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health. NIOSH Manual of Analytical Methods. 4th ed. Methods A-Z & Supplements. Washington, DC: U.S. Government Printing Office, Aug 1994.]**PEER REVIEWED**

Special References:

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)

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

Synonyms and Identifiers:

Synonyms:

ALDESEN
**PEER REVIEWED**

CIDEX
**PEER REVIEWED**

1,3-Diformylpropane
**PEER REVIEWED**

Pesticide Code: 043901
**PEER REVIEWED**

GLUTARAL
**PEER REVIEWED**

GLUTARALDEHYD (CZECH)
**PEER REVIEWED**

GLUTARDIALDEHYDE
**PEER REVIEWED**

GLUTARIC ACID DIALDEHYDE
**PEER REVIEWED**

GLUTARIC ALDEHYDE
**PEER REVIEWED**

GLUTARIC DIALDEHYDE
**PEER REVIEWED**

HOSPEX
**PEER REVIEWED**

NCI-C55425
**PEER REVIEWED**

PENTANEDIAL
**PEER REVIEWED**

1,5-PENTANEDIAL
**PEER REVIEWED**

1,5-PENTANEDIONE
**PEER REVIEWED**

SONACIDE
**PEER REVIEWED**

Formulations/Preparations:

USEPA/OPP Pesticide Code 043901; Trade Names: Cidex, component of; Odix, component of; Aldesan; Alhydex; Glutaralum; Hospex; NCI-C55425; Sonacide; Coldcide-25 Microbiocide Concentrate; GKN-O Microbiocide Concentrate (043901+069104+069154).
[U.S. Environmental Protection Agency/Office of Pesticide Program's Chemical Ingredients Database on Glutaraldehyde (111-30-8). Available from the Database Query page at http://www.cdpr.ca.gov/docs/epa/epamenu.htm as of May 24, 2001.]**PEER REVIEWED**

IT HAS BEEN MARKETED AS 2% ALKALINE SOLN IN 70% ISOPROPANOL...
[Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975. 994]**PEER REVIEWED**

CIDEX (ARBROOK) TOPICAL: SOLN (AQ) 2%.
[American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977. 894]**PEER REVIEWED**

Grades: 99%; 50% biological soln; 25% soln.
[Lewis, R.J., Sr (Ed.). Hawley's Condensed Chemical Dictionary. 13th ed. New York, NY: John Wiley & Sons, Inc. 1997. 541]**PEER REVIEWED**

EMPLOYED AS 25% SOLN IN WATER FOR EMBALMING FLUID.
[Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976.,p. II-125]**PEER REVIEWED**

2% AQ SOLN BUFFERED WITH 0.3% SODIUM CARBONATE TO PH OF 7.5-8.5 IS USEFUL FOR DISINFECTION AND STERILIZATION OF ENDOSCOPIC INSTRUMENTS & PLASTIC & RUBBER APPARATUS USED FOR INHALATION THERAPY & ANESTHESIA.
[American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977. 894]**PEER REVIEWED**

Electron microscopy grade is highly purified
[Kuney, J.H., J.M. Mullican (eds.). Chemcyclopedia. Washington, DC: American Chemical Society, 1994. 82]**PEER REVIEWED**

Biocide; supplied in acid solution and subsequently buffered to pH 8
[Gerhartz, W. (exec ed.). Ullmann's Encyclopedia of Industrial Chemistry. 5th ed.Vol A1: Deerfield Beach, FL: VCH Publishers, 1985 to Present.,p. VA16 (1990) 567]**PEER REVIEWED**

 

Hazardous Substances Databank Number: 949