*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : SC6082000
CHEMICAL NAME : Pepleomycin sulfate
CAS REGISTRY NUMBER : 70384-29-1
OTHER CAS REGISTRY NOS. : 69880-92-8
70223-26-6
70732-46-6
LAST UPDATED : 199609
DATA ITEMS CITED : 18
MOLECULAR FORMULA : C61-H88-N18-O21-S2.H2-O4-S
MOLECULAR WEIGHT : 1571.87
COMPOUND DESCRIPTOR : Tumorigen
Drug
Primary Irritant
SYNONYMS/TRADE NAMES :
* Bleomycinamide, N(sup 1)-(3-((1-phenylethyl)amino)propyl)-, (S)-, sulfate
(1:1) (salt)
* NK 631
* Pepleo
* Peplomycin sulfate
* 3-((S)-1'-Phenylethylamino)propylamino-bleomycin sulfate
*** HEALTH HAZARD DATA ***
** SKIN/EYE IRRITATION DATA **
TYPE OF TEST : Standard Draize test
ROUTE OF EXPOSURE : Administration into the eye
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 1 mg
REACTION SEVERITY : Mild
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: 31,859,1978
** ACUTE TOXICITY DATA **
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >2 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,762,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 155 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
40WDA5 "Bleomycin: Current Status and New Development, Papers Presented in a
Symposium, Oakland, CA, 1977," Carter, S.K., et al., eds., New York,
Academic Press, Inc., 1978 Volume(issue)/page/year: -,311,1978
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 199 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
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: 31,719,1978
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 215 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
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: 31,719,1978
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >1 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: 6,762,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 77 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
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: 31,719,1978
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 80 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
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: 31,719,1978
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 45 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
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: 31,719,1978
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intratracheal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 1572 ng/kg
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - fibrosis (interstitial)
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
56,326,1980
TYPE OF TEST : LD - Lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : >50 mg/kg
TOXIC EFFECTS :
Liver - hepatitis (hepatocellular necrosis), diffuse
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
Gastrointestinal - other changes
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: 31,719,1978
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 54 mg/kg/26W-I
TOXIC EFFECTS :
Nutritional and Gross Metabolic - weight loss or decreased weight gain
Related to Chronic Data - death
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: 31,803,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 45800 ug/kg/37D-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Biochemical - Enzyme inhibition, induction, or change in blood or tissue
levels - transaminases
Related to Chronic Data - death
REFERENCE :
40WDA5 "Bleomycin: Current Status and New Development, Papers Presented in a
Symposium, Oakland, CA, 1977," Carter, S.K., et al., eds., New York,
Academic Press, Inc., 1978 Volume(issue)/page/year: -,311,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 72 mg/kg/30D-I
TOXIC EFFECTS :
Liver - other changes
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
Blood - normocytic anemia
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: 31,767,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 54 mg/kg/26W-I
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - fibrosis, focal (pneumoconiosis)
Skin and Appendages - dermatitis, other (after systemic exposure)
Related to Chronic Data - death
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: 32,387,1979
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 23 mg/kg/61W-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 : 17 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 : 33 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
*** END OF RECORD ***