*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : BU2625000
CHEMICAL NAME : Amphotericin B
CAS REGISTRY NUMBER : 1397-89-3
OTHER CAS REGISTRY NOS. : 54482-28-9
8055-20-7
30782-62-8
BEILSTEIN REFERENCE NO. : 0078342
REFERENCE : 5-18-10-00525 (Beilstein Handbook Reference)
LAST UPDATED : 199612
DATA ITEMS CITED : 33
MOLECULAR FORMULA : C47-H73-N-O17
MOLECULAR WEIGHT : 924.21
WISWESSER LINE NOTATION : T6-36- A AO RVO A&U C&U E&U G&U I&U K&U M&UTJ CVQ DQ
FQ HQ JQ KQ NQ PQ T1 U1 VQ W1 O&O- BT6OT
COMPOUND DESCRIPTOR : Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Ampho-moronal
* Amphotericine B
* Amphozone
* Fungilin
* Fungizone
* Mysteclin-F
* NSC 527017
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 22 mg/kg/4D-I
TOXIC EFFECTS :
Blood - leukopenia
REFERENCE :
SMJOAV Southern Medical Journal. (Southern Medical Assoc., POB 2446,
Birmingham, AL 35205) V.1- 1908- Volume(issue)/page/year: 76,409,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 20 ug/kg
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - other changes
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
315,836,1986
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - man
DOSE/DURATION : 164 ug/kg/5H-I
TOXIC EFFECTS :
Cardiac - other changes
REFERENCE :
DICPBB Drug Intelligence and Clinical Pharmacy. (POB 42435, Cincinnati, OH
45242) V.3- 1969- Volume(issue)/page/year: 17,547,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - infant
DOSE/DURATION : 15 mg/kg/4D-I
TOXIC EFFECTS :
Nutritional and Gross Metabolic - changes in potassium
Biochemical - Enzyme inhibition, induction, or change in blood or tissue
levels - transaminases
REFERENCE :
JTCTDW Journal of Toxicology, Clinical Toxicology. (Marcel Dekker, 270
Madison Ave., New York, NY 10016) V.19- 1982- Volume(issue)/page/year:
28,371,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 1 mg/kg/1H-C
TOXIC EFFECTS :
Cardiac - pulse rate
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 341,372,1993
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >5 gm/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 : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >5 gm/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 : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1600 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
JACHDX Journal of Antimicrobial Chemotherapy. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1975- Volume(issue)/page/year:
28(Suppl B),49,1991
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >5 gm/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 : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >8 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
PMDCAY Progress in Medical Chemistry. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1961- Volume(issue)/page/year:
14,105,1977
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 27740 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NCISP* National Cancer Institute Screening Program Data Summary,
Developmental Therapeutics Program. (Bethesda, MD 20205)
Volume(issue)/page/year: JAN1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 1200 ug/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
PHINDQ Pharmacy International. (Elsevier Science Pub. Co., Inc., 52
Vanderbilt Ave., New York, NY 10017) V.1- 1980- Volume(issue)/page/year:
6,164,1985
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >5 gm/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 : LD - Lethal dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >50 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
JANTAJ Journal of Antibiotics. (Japan Antibiotics Research Assoc., 2-20-8
Kamiosaki, Shinagawa-ku, Tokyo, 141, Japan) V.2-5, 1948-52; V.21- 1968-
Volume(issue)/page/year: 24,561,1971
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 6 mg/kg
TOXIC EFFECTS :
Kidney, Ureter, Bladder - other changes
REFERENCE :
BIOHAO Biokhimiya (Moscow). For English translation, see BIORAK. (V/O
Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936-
Volume(issue)/page/year: 43,2043,1978
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : 5 mg/kg
TOXIC EFFECTS :
Behavioral - tremor
Behavioral - convulsions or effect on seizure threshold
REFERENCE :
ABANAE Antibiotics Annual. (New York, NY) 1953-60. For publisher
information, see AMACCQ. Volume(issue)/page/year: 5,53,1957/1958
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 490 mg/kg/14W-I
TOXIC EFFECTS :
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Blood - changes in erythrocyte (RBC) count
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
5,737,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 55 mg/kg/13W-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - urine volume increased
Kidney, Ureter, Bladder - changes in bladder weight
Blood - changes in erythrocyte (RBC) count
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
5,737,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 37 mg/kg/30D-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
AMACCQ Antimicrobial Agents and Chemotherapy. (American Soc. for
Microbiology, 1913 I St., NW, Washington, DC 20006) V.1- 1972-
Volume(issue)/page/year: 10,687,1976
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE : 5500 ug/kg
SEX/DURATION : female 6-16 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death,
e.g., stunted fetus)
REFERENCE :
ANKHEW Antibiotiki i Khimioterapiya. Antibiotics and Chemotherapy. (V/O Me
zhdunarodnaya Kniga, 113095 Moskow, USSR) V.33- 1988-
Volume(issue)/page/year: 37(3),25,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Mammal - dog
DOSE : 600 mg/kg
SEX/DURATION : male 30 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
accessory glands
REFERENCE :
INURAQ Investigative Urology. (Baltimore, MD) V.1-19, 1963-81. For
publisher information, see JOURAA. Volume(issue)/page/year: 7,90,1969
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 20 mg/kg
SEX/DURATION : male 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
REFERENCE :
JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot,
POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-
Volume(issue)/page/year: 7,13,1964
** MUTATION DATA **
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Microorganism - not otherwise specified
DOSE/DURATION : 10 mg/L
REFERENCE :
NNGADV Nippon Noyaku Gakkaishi. Journal of the Pesticide Science Society of
Japan. (Nippon Noyaku Gakkai, 1-43-11, Komagome, Toshima-ku, Tokyo 170,
Japan) V.1- 1976- Volume(issue)/page/year: 5,69,1980
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Yeast - Saccharomyces cerevisiae
DOSE/DURATION : 500 ug/L
REFERENCE :
AMACCQ Antimicrobial Agents and Chemotherapy. (American Soc. for
Microbiology, 1913 I St., NW, Washington, DC 20006) V.1- 1972-
Volume(issue)/page/year: 2,61,1972
TYPE OF TEST : Sex chromosome loss and nondisjunction
TEST SYSTEM : Mold - Aspergillus nidulans
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: 79,169,1980
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Human Cells - not otherwise specified
DOSE/DURATION : 100 mg/L
REFERENCE :
AMACCQ Antimicrobial Agents and Chemotherapy. (American Soc. for
Microbiology, 1913 I St., NW, Washington, DC 20006) V.1- 1972-
Volume(issue)/page/year: 2,61,1972
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 10 umol/L
REFERENCE :
STBIBN Studia Biophysica. (Akademie-Verlag GmbH, Postfach 1233, Berlin
DDR-1086, Ger. Dem. Rep.) V.1- 1966- Volume(issue)/page/year: 50,97,1975
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Rodent - hamster Lung
DOSE/DURATION : 50 mg/L
REFERENCE :
BBACAQ Biochimica et Biophysica Acta. (Elsevier Science Pub. B.V., POB 211,
1000 AE Amsterdam, Netherlands) V.1- 1947- Volume(issue)/page/year:
652,266,1981
TYPE OF TEST : Mutation test systems - not otherwise specified
TEST SYSTEM : Rodent - hamster Lung
DOSE/DURATION : 50 mg/L
REFERENCE :
BBACAQ Biochimica et Biophysica Acta. (Elsevier Science Pub. B.V., POB 211,
1000 AE Amsterdam, Netherlands) V.1- 1947- Volume(issue)/page/year:
652,266,1981
TYPE OF TEST : Sperm Morphology
ROUTE OF EXPOSURE : Intravenous
TEST SYSTEM : Rodent - rabbit
DOSE/DURATION : 20 mg/kg/11D
REFERENCE :
JRPFA4 Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot,
POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-
Volume(issue)/page/year: 7,13,1964
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOHS - National Occupational Hazard Survey (1974)
NOHS Hazard Code - 84491
No. of Facilities: 561 (estimated)
No. of Industries: 2
No. of Occupations: 2
No. of Employees: 6392 (estimated)
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - 84491
No. of Facilities: 386 (estimated)
No. of Industries: 2
No. of Occupations: 10
No. of Employees: 15048 (estimated)
No. of Female Employees: 12218 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Positive: Aspergillus-aneuploidy
*** END OF RECORD ***