The Registry of Toxic Effects of Chemical Substances

Glutaraldehyde

RTECS #: MA2450000

CAS #: 111-30-8

UPDATE: February 2005 MW: 100.13 MF: C5H8O2


NOTE:

TABLE OF CONTENTS:
  1. SYNONYMS:
  2. SKIN AND EYE IRRITATION DATA:
  3. MUTATION DATA:
  4. REPRODUCTIVE EFFECTS DATA:
  5. TUMORIGENIC DATA:
  6. ACUTE TOXICITY DATA:
  7. OTHER MULTIPLE DOSE DATA:
  8. REVIEWS:
  9. STANDARDS AND REGULATIONS:
  10. NIOSH DOCUMENTATION AND SURVEILLANCE:
  11. STATUS IN FEDERAL AGENCIES:
  12. REFERENCES:

SYNONYMS:

  1. Aldehyd glutarowy (Polish)
  2. Cidex
  3. 1,3 - Diformylpropane
  4. Glutaraldehyd (Czech)
  5. Glutaral
  6. Glutaric dialdehyde
  7. Glutaraldehyde (ACGIH)
  1. Glutardialdehyde
  2. NCI - C55425
  3. 1,5 - Pentanedial
  4. 1,5 - Pentanedione
  5. Potentiated acid glutaraldehyde
  6. Sonacide


SKIN AND EYE IRRITATION DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
eye
rabbit 		1 mg severe UCDS** 1/30/1970
eye
rabbit 		250 µg/24 hour severe 85JCAE -,272,1986
eye
woman 		200 ppb severe TOXID9 72,292,2003
skin
human 		6 mg/3 day- intermittent severe 85DKA8 -,127,1977
skin
rabbit 		13 mg open irritation test mild UCDS** 1/30/1970
skin
rabbit 		2 mg/24 hour severe 85JCAE -,272,1986


MUTATION DATA AND REFERENCES:

SYSTEM TEST ROUTE/
ORGANISM/
TISSUE 		DOSE REFERENCE
cytogenetic analysis hamster ovary 160 µg/L ENMUDM 7,1,1985
cytogenetic analysis inhalation
mouse 		0.5 ppb EMMUEG 39,69,2002
cytogenetic analysis inhalation
rat 		0.5 ppb EMMUEG 39,69,2002
DNA damage chicken leukocyte 8 pph CELLB5 5,45,1975
DNA damage hamster fibroblast 2,500 ppm SFCRAO 23,346,1970
DNA damage human lymphocyte 10 µmol/L EMMUEG 17(Suppl 19),71,1991
DNA damage human leukocyte 5 µmol/L MUREAV 468,93,2000
DNA damage mammal (species unspecified) lymphocyte 2,500 µmol/L MUREAV 283,131,1992
DNA repair Bacillus subtilis 1 mg/L MUREAV 193,21,1988
mutation in microorganisms Escherichia coli 62,500 ng/plate (-enzymatic activation step) MUREAV 412,17,1998
mutation in microorganisms Salmonella typhimurium 500 nmol/L (+enzymatic activation step) MUREAV 148,25,1985
mutation in microorganisms Salmonella typhimurium 150 µg/plate (-enzymatic activation step) ENMUDM 5(Suppl 1),3,1983
mutation in microorganisms Salmonella typhimurium 0.5 mg/plate/48 hour (+enzymatic activation step) JAPTO* 22,45,2001
mutation in microorganisms Salmonella typhimurium 0.25 mg/plate/3 day (-enzymatic activation step) MUREAV 521,19,2002
mutation in mammalian somatic cells mouse lymphocyte 8 mg/L EMMUEG 11,91,1988
other mutation test systems non-mammalian species other cell types 50 mmol/L ECREAL 95,233,1975
sister chromatid exchange hamster ovary 110 µg/L ENMUDM 7,1,1985
specific locus test inhalation
mouse 		0.5 ppb EMMUEG 39,69,2002
specific locus test inhalation
rat 		0.5 ppb EMMUEG 39,69,2002


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
oral
mouse 		lowest published toxic dose: 50 gm/kg (6-15 day pregnant) Reproductive: Specific developmental abnormalities: Central nervous system

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Specific developmental abnormalities: Musculoskeletal system 		TJADAB 22,51,1980
oral
mouse 		lowest published toxic dose: 8 gm/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) TJADAB 22,51,1980
oral
rat 		lowest published toxic dose: 875 mg/kg (35 day male) Reproductive: Paternal effects: Testes, epididymis, sperm duct

Reproductive: Paternal effects: Prostate, seminal vesicle, Cowper's gland, accessory glands 		OYYAA2 12,11,1976
oral
rat 		lowest published toxic dose: 4,370 mg/kg (35 day prior to copulation) Reproductive: Maternal effects: Uterus, cervix, vagina OYYAA2 12,11,1976
oral
rat 		lowest published toxic dose: 1 gm/kg (6-15 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) TOLED5 63,147,1992
oral
rat 		lowest published toxic dose: 5.3 gm/kg (84 day male/70 day prior to copulation-4 week after birth) Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain)

Reproductive: Effects on newborn: Other postnatal measures or effects

Reproductive: Effects on newborn: Delayed effects 		JTEHD6 61,107,2000
oral
rat 		lowest published toxic dose: 167.4 mg/kg (multigenerations) Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain)

Reproductive: Effects on newborn: Delayed effects 		JTEHD6 61,107,2000
oral
rabbit 		lowest published toxic dose: 585 mg/kg (7-19 day pregnant) Reproductive: Other effects on female

Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) 		NTIS** OTS0526410


TUMORIGENIC DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
oral
rat 		lowest published toxic dose: 2,912 mg/kg/104 week- continuous Tumorigenic: Carcinogenic by RTECS criteria

Blood: Leukemia

Tumorigenic: Increased incidence of tumors in susceptible strains 		TXCYAC 175,177,2002
oral
rat 		lowest published toxic dose: 2,912 mg/kg/104 week- intermittent Tumorigenic: Carcinogenic by RTECS criteria

Blood: Leukemia

Tumorigenic: Increased incidence of tumors in susceptible strains 		TXCYAC 175,177,2002


ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
inhalation
rat 		lethal concentration (50 percent kill): 480 mg/m3/4 hour N/R EPASR* 8EHQ-1290-1008
inhalation
rabbit 		lowest published toxic concentration: 500 ppm Eye: Conjunctiva irritation

Lung, Thorax, or Respiration: Cough 		VCVGK* -,404,1984
inhalation
woman 		lowest published toxic concentration: 200 ppb Olfaction: Other olfaction effects TOXID9 72,292,2003
intraperitoneal
mouse 		lethal dose (50 percent kill): 13,900 µg/kg N/R IYKEDH 10,232,1979
intraperitoneal
rat 		lethal dose (50 percent kill): 17,900 µg/kg N/R IYKEDH 10,232,1979
intravenous
mouse 		lethal dose (50 percent kill): 15,400 µg/kg N/R OYYAA2 19,503,1980
intravenous
rat 		lethal dose (50 percent kill): 9,800 µg/kg N/R EPASR* 8EHQ-1290-1008
oral
duck 		lethal dose (50 percent kill): 820 mg/kg Behavioral: Somnolence (general depressed activity)

Behavioral: Food intake (animal) 		NTIS** OTS0526410-1
oral
guinea pig 		lethal dose (50 percent kill): 50 mg/kg Behavioral: Altered sleep time (including change in righting reflex)

Behavioral: Somnolence (general depressed activity)

Behavioral: Excitement 		GISAAA 52(3),77,1987
oral
mouse 		lethal dose (50 percent kill): 100 mg/kg N/R OYYAA2 19,503,1980
oral
mouse 		lethal dose (50 percent kill): 231 mg/kg Lung, Thorax, or Respiration: Other changes

Liver: Other changes

Kidney, Ureter, and Bladder: Other changes 		VCVGK* -,404,1984
oral
rat 		lethal dose (50 percent kill): 134 mg/kg N/R OYYAA2 19,503,1980
oral
rat 		lethal dose (50 percent kill): 140 mg/kg Lung, Thorax, or Respiration: Other changes

Liver: Other changes

Kidney, Ureter, and Bladder: Other changes 		VCVGK* -,404,1984
subcutaneous
mouse 		lethal dose (50 percent kill): >590 mg/kg N/R NIIRDN -,395,1995
subcutaneous
rat 		lethal dose (50 percent kill): >750 mg/kg N/R NIIRDN -,395,1995
skin
mouse 		lethal dose (50 percent kill): >5,840 mg/kg Skin: After systemic exposure: Dermatitis, other OYYAA2 12,11,1976
skin
rat 		lethal dose (50 percent kill): >2,500 mg/kg Skin: After systemic exposure: Dermatitis, other OYYAA2 12,11,1976
skin
rabbit 		lethal dose (50 percent kill): 560 µL/kg N/R UCDS** 11/4/1971


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
inhalation
mouse 		lowest published toxic concentration: 16 ppm/6 hour/2 week- intermittent Olfaction: Other olfaction effects

Lung, Thorax, or Respiration: Other changes

Related to Chronic Data: Death in the "MULTIPLE DOSE" data type field 		NTPTR* NIH-93-3348
inhalation
mouse 		lowest published toxic concentration: 1,000 ppb/6 hour/13 week- intermittent Olfaction: Other olfaction effects

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Related to Chronic Data: Death in the "MULTIPLE DOSE" data type field 		NTPTR* NIH-93-3348
inhalation
mouse 		lowest published toxic concentration: 250 ppb/6 hour/2 year- intermittent Olfaction: Other olfaction effects

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		TOXID9 48,341,1999
inhalation
rat 		lowest published toxic concentration: 5 ppm/6 hour/2 week- intermittent Olfaction: Other olfaction effects

Lung, Thorax, or Respiration: Other changes

Related to Chronic Data: Death in the "MULTIPLE DOSE" data type field 		NTPTR* NIH-93-3348
inhalation
rat 		lowest published toxic concentration: 1,000 ppb/6 hour/13 week- intermittent Olfaction: Other olfaction effects

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		NTPTR* NIH-93-3348
inhalation
rat 		lowest published toxic concentration: 500 ppb/6 hour/2 year- intermittent Olfaction: Other olfaction effects

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Related to Chronic Data: Death in the "MULTIPLE DOSE" data type field 		TOXID9 48,341,1999
oral
rat 		lowest published toxic dose: 12,376 mg/kg/2 year- continuous Kidney, Ureter, and Bladder: Other changes in urine composition

Kidney, Ureter, and Bladder: Changes in bladder weight

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		TOXID9 15,203,1995
oral
rat 		lowest published toxic dose: 54,600 µg/kg/26 week- intermittent Liver: Fatty liver degeneration

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: True cholinesterase 		GISAAA 52(3),77,1987
oral
rat 		lowest published toxic dose: 11,410 mg/kg/7 day- intermittent Nutritional and Gross Metabolic: Weight loss or decreased weight gain NTIS** OTS0535072
oral
rat 		lowest published toxic dose: 122.5 mg/kg/1 week- continuous Behavioral: Fluid intake JTEHD6 61,107,2000
oral
rat 		lowest published toxic dose: 967 mg/kg/2 week- continuous Behavioral: Food intake (animal) JTEHD6 61,107,2000
oral
rat 		lowest published toxic dose: 688.8 mg/kg/1 week- continuous Behavioral: Food intake (animal) JTEHD6 61,107,2000
oral
rat 		lowest published toxic dose: 117.5 mg/kg/235 day- intermittent Endocrine: Changes in thymus weight

Blood: Normocytic anemia

Blood: Changes in other cell count (unspecified) 		VCVGK* -,404,1994
oral
rat 		lowest published toxic dose: 1,547 mg/kg/13 week- intermittent Kidney, Ureter, and Bladder: Urine volume decreased or anuria

Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: Multiple enzyme effects 		TXCYAC 175,177,2002
oral
rat 		lowest published toxic dose: 9,282 mg/kg/78 week- intermittent Kidney, Ureter, and Bladder: Urine volume decreased or anuria

Kidney, Ureter, and Bladder: Changes in kidney weight

Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels: Multiple enzyme effects 		TXCYAC 175,177,2002
subcutaneous
rat 		lowest published toxic dose: 175 mg/kg/35 day- continuous Liver: Changes in liver weight

Endocrine: Changes in spleen weight

Blood: Normocytic anemia 		OYYAA2 12,11,1976


REVIEWS:

ORGANIZATION STANDARD
REFERENCE
American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value Not Classifiable as a Human Carcinogen DTLVS* TLV/BEI,2003
American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value ceiling concentration 0.05 ppm (sen) DTLVS* TLV/BEI,2003
TOXICOLOGY REVIEW
DPIRDU 1(7),2,1981
TOXICOLOGY REVIEW
CRTXB2 22,143,1992
TOXICOLOGY REVIEW
JACTDZ 15,98,1996
TOXICOLOGY REVIEW
MUREAV 5432012003


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE
Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1988 PESTICIDE SUBJECT TO REGISTRATION OR RE-REGISTRATION FEREAC 54,7740,1989
Occupational Exposure Limit - AUSTRALIA time-weighted average 0.2 ppm (0.7 mg/m3), JAN1993
Occupational Exposure Limit - AUSTRIA MAK 0.2 ppm (0.8 mg/m3), JAN1999
Occupational Exposure Limit - BELGIUM time-weighted average 0.2 mg/m3, short term exposure limit 0.82 mg/m3, JAN1993
Occupational Exposure Limit - DENMARK time-weighted average 0.2 ppm (0.8 mg/m3), JAN1999
Occupational Exposure Limit - FINLAND CEILING 0.1 ppm, JAN1999
Occupational Exposure Limit - FRANCE VLE 0.2 ppm (0.8 mg/m3), JAN1999
Occupational Exposure Limit - GERMANY MAK 0.21ppm (0.4 mg/m3), JAN1999
Occupational Exposure Limit - NORWAY time-weighted average 0.2 ppm (0.8 mg/m3), JAN1999
Occupational Exposure Limit - THE NETHERLANDS MAC- continuous 0.25 mg/m3, 2003
Occupational Exposure Limit - RUSSIA short term exposure limit 5 mg/m3, JAN1993
Occupational Exposure Limit - SWEDEN short term exposure limit 0.2 ppm (0.8 mg/m3), Skin, JAN1999
Occupational Exposure Limit - SWITZERLAND MAK- week 0.2 ppm (0.8 mg/m3), KZG- week 0.4 ppm (1.6 mg/m3), JAN1999
Occupational Exposure Limit - UNITED KINGDOM time-weighted average 0.05 ppm (0.2 mg/m3), SEP2000
Occupational Exposure Limit IN ARGENTINA, BULGARIA, COLOMBIA, JORDAN, KOREA American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value;

ceiling concentration 0.05 ppm (sen)
Occupational Exposure Limit IN NEW ZEALAND, SINGAPORE, VIETNAM American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value
ceiling concentration 0.05 ppm (sen)


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE
National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Level TO GLUTARALDEHYDE-air ceiling concentration 0.2 ppm NIOSH* DHHS #92-100,1992
National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 84349;
Number of Industries 11;
Total Number of Facilities 2,069;
Number of Occupations 25;
Total Number of Employees Exposed 12,954
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: 84349;
Number of Industries 35;
Total Number of Facilities 9,475;
Number of Occupations 63;
Total Number of Employees Exposed 367,330;
Total Number of Female Employees Exposed 265,564


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE
EPA GENETOX PROGRAM 1988, Negative: CHO gene mutation
EPA TSCA Section 8(b) CHEMICAL INVENTORY
Used in leather tanning and in embalming fluids and as a germicide and crosslinking agent
EPA TSCA Section 8(d) unpublished health/safety studies
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001
NIOSH CURRENT INTELLIGENCE BULLETIN #55, September 1991
NIOSH Analytical Method, 1994: Glutaraldehyde, 2532
NCI Carcinogenesis Studies (inhal);no evidence:mouse,rat
NTP Toxicity studies, RPT# TOX-25, October 2000
OSHA ANALYTICAL METHOD #ID-64


REFERENCES:

CODEN
REFERENCE
85DKA8 "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977
85JCAE "Prehled Prumyslove Toxikologie; Organicke Latky," Marhold, J., Prague, Czechoslovakia, Avicenum, 1986
CELLB5 Cell (Cambridge, Mass.). (MIT Press, 28 Carleton St., Cambridge, MA 02142) V.1- 1974-
CRTXB2 CRC Critical Reviews in Toxicology. (CRC Press, Inc., 2000 Corporate Blvd., NW, Boca Raton, FL 33431) V.1- 1971-
DPIRDU Dangerous Properties of Industrial Materials Report. (Van Nostrand Reinhold, 115 Fifth Ave., New York, NY 10003) V.1- 1981-
DTLVS* The Threshold Limit Values (TLVs) and Biological Exposure Indices (BEIs) booklet issues by American Conference of Governmental Industrial Hygienists (ACGIH), Cincinnati, OH, 1996
ECREAL Experimental Cell Research. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.10- 1950-
EMMUEG Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.10- 1987-
ENMUDM Environmental Mutagenesis. (New York, NY) V.1-9, 1979-87. For publisher information, see EMMUEG.
EPASR* United States Environmental Protection Agency, Office of Pesticides and Toxic Substances. (U.S. Environmental Protection Agency, 401 M St., SW, Washington, DC 20460) History unknown.
FEREAC Federal Register. (U.S. Government Printing Office, Supt. of Documents, Washington, DC 20402) V.1- 1936-
GISAAA Gigiena i Sanitariya. For English translation, see HYSAAV. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936-
IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970-
JACTDZ Journal of the American College of Toxicology. (Mary Ann Liebert, Inc., 1651 Third Ave., New York, NY 10128) V.1-12, 1982-1993. Discontinued.
JAPTO* Journal of Applied Toxicology (John Wiley & Sons, Ltd., Oldlands Way Bognor Regis West Sussex, PO22 9SA England) V.1- 1981-
JTEHD6 Journal of Toxicology and Environmental Health. (Hemisphere Pub., 1025 Vermont Ave., NW, Washington, DC 20005) V.1- 1975/76-
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan)
NIOSH* National Institute of Occupational Safety and Health, U.S. Dept. of Health, Education, and Welfare, Reports and Memoranda.
NTIS** National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information.
NTPTR* National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206-
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967-
SFCRAO Collection of Papers Presented at the Annual Symposium on Fundamental Cancer Research. (Baltimore, MD) V.1-29, 1946-76. For publisher information, see AFCPDR.
TJADAB Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977-
TOXID9 Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway, Akron, OH 44311) V.1- 1981-
TXCYAC Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973-
UCDS** Union Carbide Data Sheet. (Union Carbide Corp., 39 Old Ridgebury Rd., Danbury, CT 06817)
VCVGK* "Vrednie chemichescie veshestva, galogen I kislorod sodergashie organicheskie soedinenia". (Hazardous substances. Galogen and oxygen containing substances), Bandman A.L. et al., Chimia, 1994.

Used in leather tanning and in embalming fluids and as a germicide and crosslinking agent

NIOSH PROFILE (ALDEHYDES), SRC, 4/78

NIOSH PROFILE (GLUTARALDEHYDE), SRC, 4/81

NIOSH PROFILE (ALDEHYDES), SRI, 2/77

RTECS Compound Description:
   Tumorigen
   Mutagen
   Reproductive Effector
   Hormone
   Primary Irritant

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