*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : LY2625000
CHEMICAL NAME : Gentamicin, sulfate
CAS REGISTRY NUMBER : 1405-41-0
LAST UPDATED : 199512
DATA ITEMS CITED : 32
COMPOUND DESCRIPTOR : Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Garamycin
* Genoptic
* Genoptic S.O.P.
* Gentalline
* Gentamycin sulfate
* GM sulfate
* NSC-82261
* Refobacin
* Sch 9724
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 45 mg/kg/1W-I
TOXIC EFFECTS :
Nutritional and Gross Metabolic - changes in metals, not otherwise specified
REFERENCE :
DICPBB Drug Intelligence and Clinical Pharmacy. (POB 42435, Cincinnati, OH
45242) V.3- 1969- Volume(issue)/page/year: 18,596,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Human - man
DOSE/DURATION : 21 mg/kg/6D-I
TOXIC EFFECTS :
Nutritional and Gross Metabolic - changes in metals, not otherwise specified
REFERENCE :
DICPBB Drug Intelligence and Clinical Pharmacy. (POB 42435, Cincinnati, OH
45242) V.3- 1969- Volume(issue)/page/year: 18,596,1984
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >5 gm/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Skin and Appendages - hair
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
8,219,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 630 mg/kg
TOXIC EFFECTS :
Behavioral - muscle contraction or spasticity
Lungs, Thorax, or Respiration - 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: 26,221,1973
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 873 mg(base)/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ANKHEW Antibiotiki i Khimioterapiya. Antibiotics and Chemotherapy. (V/O Me
zhdunarodnaya Kniga, 113095 Moskow, USSR) V.33- 1988-
Volume(issue)/page/year: 35(9),26,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 96 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - convulsions or effect on seizure threshold
Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
8,219,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 384 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
18,185,1971
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >11269 mg/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: 6,268,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 245 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - convulsions or effect on seizure threshold
Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
8,219,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 478 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: 23,551,1970
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 47 mg/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Behavioral - convulsions or effect on seizure threshold
Lungs, Thorax, or Respiration - dyspnea
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: 39,3164,1986
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 250 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Lungs, Thorax, or Respiration - respiratory stimulation
REFERENCE :
JZKEDZ Jitchuken Zenrinsho Kenkyuho. Central Institute for Experimental
Animals, Research Reports. (Jikken Dobutsu Chuo Kenkyusho, 1433 Nogawa,
Takatsu-ku, Kawasaki 211, Japan) V.1- 1975- Volume(issue)/page/year:
8,219,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intracerebral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 17300 ug/kg
TOXIC EFFECTS :
Peripheral Nerve and Sensation - sensory change involving peripheral nerve
Sense Organs and Special Senses (Eye) - ptosis
Behavioral - convulsions or effect on seizure threshold
REFERENCE :
NKRZAZ Chemotherapy (Tokyo). (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
Shinagawa-Ku, Tokyo 141, Japan) V.1- 1953- Volume(issue)/page/year:
15,483,1967
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 600 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NKRZAZ Chemotherapy (Tokyo). (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
Shinagawa-Ku, Tokyo 141, Japan) V.1- 1953- Volume(issue)/page/year:
16,105,1968
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 200 mg/kg/5D-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - other changes in urine composition
Nutritional and Gross Metabolic - changes in calcium
Biochemical - Enzyme inhibition, induction, or change in blood or tissue
levels - other Enzymes
REFERENCE :
TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1977- Volume(issue)/page/year: 53,203,1990
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 280 mg(base)/kg/7D-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - other changes in urine composition
Nutritional and Gross Metabolic - changes in calcium
Biochemical - Enzyme inhibition, induction, or change in blood or tissue
levels - dehydrogenases
REFERENCE :
APTOA6 Acta Pharmacologica et Toxicologica. (Copenhagen, Denmark) V.1-59,
1945-86. For publisher information, see PHTOEH Volume(issue)/page/year:
53,358,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 240 mg/kg/6D-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
Nutritional and Gross Metabolic - changes in metals, not otherwise specified
REFERENCE :
PHTOEH Pharmacology and Toxicology (Copenhagen). (Munksgaard International
Pub., POB 2148, DK-1016 Copenhagen K, Denmark) V.60- 1987-
Volume(issue)/page/year: 70,419,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 3840 mg/kg/4W-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
Related to Chronic Data - death
REFERENCE :
AACHAX Antimicrobial Agents and Chemotherapy (1961-70). (Ann Arbor, MI)
1961-70. For publisher information, see AMACCQ. Volume(issue)/page/year:
-,138,1963
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 2 gm/kg/50D-I
TOXIC EFFECTS :
Behavioral - ataxia
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
REFERENCE :
AACHAX Antimicrobial Agents and Chemotherapy (1961-70). (Ann Arbor, MI)
1961-70. For publisher information, see AMACCQ. Volume(issue)/page/year:
-,138,1963
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Mammal - cat
DOSE/DURATION : 1400 mg/kg/70D-I
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - ataxia
Related to Chronic Data - death
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: 23,559,1970
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Mammal - cat
DOSE/DURATION : 1365 mg/kg/91D-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Related to Chronic Data - death
REFERENCE :
DCTODJ Drug and Chemical Toxicology. (Marcel Dekker, 270 Madison Ave., New
York, NY 10016) V.1- 1977/78- Volume(issue)/page/year: 10,237,1987
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Mammal - cat
DOSE/DURATION : 4200 mg/kg/30W-I
TOXIC EFFECTS :
Sense Organs and Special Senses (Ear) - changes in cochlear structure or
function
Behavioral - altered sleep time (including change in righting reflex)
Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
acute tubular necrosis)
REFERENCE :
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year:
77,479,1985
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Mammal - cat
DOSE/DURATION : 2700 mg/kg/27D-I
TOXIC EFFECTS :
Behavioral - ataxia
Related to Chronic Data - death
REFERENCE :
AACHAX Antimicrobial Agents and Chemotherapy (1961-70). (Ann Arbor, MI)
1961-70. For publisher information, see AMACCQ. Volume(issue)/page/year:
-,138,1963
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - guinea pig
DOSE/DURATION : 6557 mg/kg/77D-I
TOXIC EFFECTS :
Sense Organs and Special Senses (Ear) - change in acuity
Sense Organs and Special Senses (Ear) - changes in cochlear structure or
function
Behavioral - muscle contraction or spasticity
REFERENCE :
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E.
First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year:
1,395,1981
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 660 mg/kg
SEX/DURATION : female 10-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
Reproductive - Specific Developmental Abnormalities - urogenital system
REFERENCE :
ARTODN Archives of Toxicology. (Springer-Verlag, Heidelberger Pl. 3, D-1000
Berlin 33, Fed. Rep. Ger.) V.32- 1974- Volume(issue)/page/year:
62,274,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 660 mg/kg
SEX/DURATION : female 15-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - biochemical and metabolic
REFERENCE :
ARTODN Archives of Toxicology. (Springer-Verlag, Heidelberger Pl. 3, D-1000
Berlin 33, Fed. Rep. Ger.) V.32- 1974- Volume(issue)/page/year:
62,274,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE : 375 mg/kg
SEX/DURATION : female 14-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
gain)
REFERENCE :
PPHAD4 Pediatric Pharmacology. (New York, NY) V.1-5, 1980-86. For
publisher information, see DPTHDL. Volume(issue)/page/year: 5,229,1986
** MUTATION DATA **
TYPE OF TEST : DNA adduct
TEST SYSTEM : Bacteria - Escherichia coli
DOSE/DURATION : 5 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 89,95,1981
TYPE OF TEST : DNA damage
ROUTE OF EXPOSURE : Intraperitoneal
TEST SYSTEM : Rodent - rat
DOSE/DURATION : 70 mg/kg/7D (Continuous)
REFERENCE :
AMACCQ Antimicrobial Agents and Chemotherapy. (American Soc. for
Microbiology, 1913 I St., NW, Washington, DC 20006) V.1- 1972-
Volume(issue)/page/year: 24,586,1983
TYPE OF TEST : Sperm Morphology
ROUTE OF EXPOSURE : Unreported
TEST SYSTEM : Rodent - rat
DOSE/DURATION : 9600 ug/kg/8D
REFERENCE :
JOURAA Journal of Urology. (Williams & Wilkins Co., 428 E. Preston St.,
Baltimore, MD 21202) V.1- 1917- Volume(issue)/page/year: 112,348,1974
*** REVIEWS ***
TOXICOLOGY REVIEW
PMMDAE Panminerva Medica. (Edizioni Minerva Medica, Casella Postale 491,
Turin, Italy) V.1- 1959- Volume(issue)/page/year: 16,9,1974
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X3126
No. of Facilities: 2125 (estimated)
No. of Industries: 7
No. of Occupations: 22
No. of Employees: 46715 (estimated)
No. of Female Employees: 34072 (estimated)
*** END OF RECORD ***