*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : EC5991990
CHEMICAL NAME : Bleomycin, sulfate
CAS REGISTRY NUMBER : 9041-93-4
LAST UPDATED : 199706
DATA ITEMS CITED : 40
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Blenoxane
* Bleomycin, sulfate (salt)
* Blexane
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 20 ug/kg
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - cyanosis
Skin and Appendages - dermatitis, allergic (after systemic exposure)
REFERENCE :
ARHEAW Arthritis and Rheumatism. (Arthritis Foundation, 1314 Spring St.,
NW, Atlanta, GA 30309) V.1- 1958- Volume(issue)/page/year: 28,459,1985
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - man
DOSE/DURATION : 0.286 units/kg/1D-I
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - fibrosis (interstitial)
Lungs, Thorax, or Respiration - acute pulmonary edema
REFERENCE :
SMJOAV Southern Medical Journal. (Southern Medical Assoc., POB 2446,
Birmingham, AL 35205) V.1- 1908- Volume(issue)/page/year: 80,646,1987
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 240 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho
Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970-
Volume(issue)/page/year: 7,108,1976
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 86 mg/kg
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
Kidney, Ureter, Bladder - urine volume increased
Skin and Appendages - hair
REFERENCE :
JJANAX Japanese Journal of Antibiotics. (Japan Antibiotics Research Assoc.,
2-20-8 Kamiosaki, Shinagawa-ku, Tokyo 141, Japan) V.21- 1968-
Volume(issue)/page/year: 29,894,1976
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 59 mg/kg
TOXIC EFFECTS :
Behavioral - ataxia
REFERENCE :
JJANAX Japanese Journal of Antibiotics. (Japan Antibiotics Research Assoc.,
2-20-8 Kamiosaki, Shinagawa-ku, Tokyo 141, Japan) V.21- 1968-
Volume(issue)/page/year: 29,894,1976
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 210 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
YAKUD5 Gekkan Yakuji. Pharmaceuticals Monthly. (Yakugyo Jihosha, Inaoka
Bldg., 2-36 Jinbo-cho, Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1959-
Volume(issue)/page/year: 17,455,1975
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 103 mg/kg
TOXIC EFFECTS :
Sense Organs and Special Senses (Eye) - ptosis
Gastrointestinal - hypermotility, diarrhea
Nutritional and Gross Metabolic - body temperature decrease
REFERENCE :
JJANAX Japanese Journal of Antibiotics. (Japan Antibiotics Research Assoc.,
2-20-8 Kamiosaki, Shinagawa-ku, Tokyo 141, Japan) V.21- 1968-
Volume(issue)/page/year: 29,894,1976
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 74 mg/kg
TOXIC EFFECTS :
Behavioral - ataxia
REFERENCE :
JJANAX Japanese Journal of Antibiotics. (Japan Antibiotics Research Assoc.,
2-20-8 Kamiosaki, Shinagawa-ku, Tokyo 141, Japan) V.21- 1968-
Volume(issue)/page/year: 29,894,1976
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 14 mg/kg/68W-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Kidney, Ureter, Bladder - Kidney tumors
Tumorigenic - tumors at site of application
REFERENCE :
ONCOBS Oncology. (S. Karger AG, Postfach CH-4009 Basel, Switzerland) V.21-
1967- Volume(issue)/page/year: 41,114,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 18 mg/kg/52W-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Kidney, Ureter, Bladder - Kidney tumors
Tumorigenic - tumors at site of application
REFERENCE :
PAACA3 Proceedings of the American Association for Cancer Research. (Waverly
Press, 428 E. Preston St., Baltimore, MD 21202) V.1- 1954-
Volume(issue)/page/year: 24,96,1983
TYPE OF TEST : TD - Toxic dose (other than lowest)
ROUTE OF EXPOSURE : Parenteral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 36 mg/kg/52W-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Kidney, Ureter, Bladder - Kidney tumors
Tumorigenic - tumors at site of application
REFERENCE :
PAACA3 Proceedings of the American Association for Cancer Research. (Waverly
Press, 428 E. Preston St., Baltimore, MD 21202) V.1- 1954-
Volume(issue)/page/year: 24,96,1983
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 8 mg/kg
SEX/DURATION : female 6-9 day(s) after conception
TOXIC EFFECTS :
Reproductive - 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)
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: PB261-972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 20400 ug/kg
SEX/DURATION : female 14 day(s) pre-mating
female 1-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4
per # born alive)
Reproductive - Effects on Newborn - weaning or lactation index (e.g., #
alive at weaning per # alive at day 4)
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: PB261-972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 8700 ug/kg
SEX/DURATION : female 15-22 day(s) after conception
lactating female 21 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: PB261-972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 17400 ug/kg
SEX/DURATION : female 15-22 day(s) after conception
lactating female 21 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Effects on Newborn - live birth index (measured after birth)
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: PB261-972
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 15600 ug/kg
SEX/DURATION : female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: PB261-972
** MUTATION DATA **
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Bacteria - Escherichia coli
DOSE/DURATION : 100 ug/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 171,83,1986
TYPE OF TEST : DNA repair
TEST SYSTEM : Bacteria - Escherichia coli
DOSE/DURATION : 250 ng/plate
REFERENCE :
NULSAK Nucleus (Calcutta). (Dr. A.K. Sharma, Centre of Advanced Studies in
Cell and Chromosome Research, Calcutta, 35 Baliygunge Circular Rd., Calcutta
700 019, India) V.1- 1958- Volume(issue)/page/year: 28,159,1985
TYPE OF TEST : Phage inhibition capacity
TEST SYSTEM : Bacteria - Escherichia coli
DOSE/DURATION : 6250 pg/well
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 260,349,1991
TYPE OF TEST : Specific locus test
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Insect - Drosophila melanogaster
DOSE/DURATION : 13 ppm
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 263,33,1991
TYPE OF TEST : Gene conversion and mitotic recombination
TEST SYSTEM : Yeast - Saccharomyces cerevisiae
DOSE/DURATION : 100 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 53,309,1978
TYPE OF TEST : Dominant lethal test
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Insect - not otherwise specified
DOSE/DURATION : 100 ppm
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 149,375,1985
TYPE OF TEST : Micronucleus test
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 5 mg/L
REFERENCE :
EMMUEG Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41 E.
11th St., New York, NY 10003) V.10- 1987- Volume(issue)/page/year:
25,31,1995
TYPE OF TEST : Micronucleus test
TEST SYSTEM : Rodent - rat Lymphocyte
DOSE/DURATION : 5 mg/L
REFERENCE :
EMMUEG Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41 E.
11th St., New York, NY 10003) V.10- 1987- Volume(issue)/page/year:
25,31,1995
TYPE OF TEST : Morphological transformation
ROUTE OF EXPOSURE : Intravenous
TEST SYSTEM : Rodent - rat
DOSE/DURATION : 25 units/kg
REFERENCE :
CRNGDP Carcinogenesis (London). (Oxford Univ. Press, Pinkhill House,
Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1980-
Volume(issue)/page/year: 13,703,1992
TYPE OF TEST : DNA damage
TEST SYSTEM : Rodent - rat Liver
DOSE/DURATION : 2 umol/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 368,59,1996
TYPE OF TEST : Micronucleus test
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 1 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 222,191,1989
TYPE OF TEST : Unscheduled DNA synthesis
ROUTE OF EXPOSURE : Parenteral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 1 gm/kg/10D (Continuous)
REFERENCE :
AJRBEL American Journal of Respiratory Cell and Molecular Biology. (American
Lung Association, 1740 Broadway, New York, NY 10019) V.1- 1989-
Volume(issue)/page/year: 6,190,1992
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 1 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 222,191,1989
TYPE OF TEST : Mutation in mammalian somatic cells
TEST SYSTEM : Rodent - mouse Lymphocyte
DOSE/DURATION : 1 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 222,191,1989
TYPE OF TEST : Host-mediated assay
TEST SYSTEM : Rodent - mouse Bacteria - Escherichia coli
DOSE/DURATION : 10 mg/kg
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 164,19,1986
TYPE OF TEST : DNA damage
TEST SYSTEM : Rodent - hamster Ovary
DOSE/DURATION : 10 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 93,149,1982
TYPE OF TEST : Cytogenetic analysis
TEST SYSTEM : Rodent - hamster Ovary
DOSE/DURATION : 10 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 93,149,1982
TYPE OF TEST : Mutation in mammalian somatic cells
TEST SYSTEM : Rodent - hamster Ovary
DOSE/DURATION : 50 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 135,199,1984
*** REVIEWS ***
IARC Cancer Review:Animal Limited Evidence
IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49
Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year:
7,134,1987
IARC Cancer Review:Human Inadequate Evidence
IMEMDT IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals
to Man. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210)
V.1- 1972- Volume(issue)/page/year: 26,97,1981
IARC Cancer Review:Group 2B
IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49
Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year:
7,134,1987
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X3576
No. of Facilities: 371 (estimated)
No. of Industries: 1
No. of Occupations: 5
No. of Employees: 15071 (estimated)
No. of Female Employees: 10631 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Positive: S cerevisiae gene conversion; S
cerevisiae-homozygosis
EPA GENETOX PROGRAM 1988, Positive: S cerevisiae-reversion
*** END OF RECORD ***