*** CHEMICAL IDENTIFICATION ***

RTECS NUMBER            : LY2450000
CHEMICAL NAME           : Gentamicin
CAS REGISTRY NUMBER     : 1403-66-3
LAST UPDATED            : 199806
DATA ITEMS CITED        : 68
COMPOUND DESCRIPTOR     : Drug
                          Mutagen
                          Reproductive Effector
                          Human
                          Natural Product
SYNONYMS/TRADE NAMES :
   * Gentacycol
   * Gentamycin
   * Gentamycin-creme
   * Gentavet
   * Refobacin TM
   * Uromycine
 
                       *** HEALTH HAZARD DATA ***
 
                        ** ACUTE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human - woman
DOSE/DURATION           : 8200 ug/kg/12D
TOXIC EFFECTS :
   Sense Organs and Special Senses (Ear) - changes in vestibular functions
   Behavioral - hallucinations, distorted perceptions
   Behavioral - changes in motor activity (specific assay)
REFERENCE :
   APMIBM Acta Pathologica et Microbiologica Scandinavica, Section B:
   Microbiology and Immunology. (Copenhagen, Denmark)  V.78-82, 1970-74.  For
   publisher information, see ACPADQ.  Volume(issue)/page/year: 81(Suppl
   241),73,1973
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human
DOSE/DURATION           : 2 mg/kg
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - 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:
   303,1002,1980
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Human
DOSE/DURATION           : 23 mg/kg/1Y-I
TOXIC EFFECTS :
   Peripheral Nerve and Sensation - sensory change involving trigeminal nerve
REFERENCE :
   AIMDAP Archives of Internal Medicine.  (AMA, 535 N. Dearborn St., Chicago,
   IL 60610)  V.1-    1908-  Volume(issue)/page/year: 138,1621,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Human - man
DOSE/DURATION           : 8 mg/kg/2W-I
TOXIC EFFECTS :
   Sense Organs and Special Senses (Eye) - visual field changes
   Sense Organs and Special Senses (Eye) - hemorrhage
   Skin and Appendages - hair
REFERENCE :
   JAMAAP JAMA, Journal of the American Medical Association.  (AMA, 535 N.
   Dearborn St., Chicago, IL 60610)  V.1-    1883-  Volume(issue)/page/year:
   211,123,1970
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Human - infant
DOSE/DURATION           : 20 mg/kg
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
REFERENCE :
   PEDIAU Pediatrics.  (American Academy of Pediatrics, P.O. Box 1034,
   Evanston, IL 60204) V.1-    1948-  Volume(issue)/page/year: 77,848,1986
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 6600 mg/kg
TOXIC EFFECTS :
   Behavioral - tremor
   Behavioral - convulsions or effect on seizure threshold
   Gastrointestinal - other changes
REFERENCE :
   AMPMAR Archives des Maladies Professionnelles de Medecine du Travail et de
   Securite Sociale.  (SPPIF, B.P.22, F-41353 Vineuil, France)  V.7-    1946-
   Volume(issue)/page/year: 39,259,1978
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 735 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   JIMRBV Journal of International Medical Research.  (Cambridge Medical Pub.
   Ltd., 435/437 Wellingborough Rd., Northampton, NN1 4EZ, UK)  V.1-    1972-
   Volume(issue)/page/year: 2,100,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 710 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   JIMRBV Journal of International Medical Research.  (Cambridge Medical Pub.
   Ltd., 435/437 Wellingborough Rd., Northampton, NN1 4EZ, UK)  V.1-    1972-
   Volume(issue)/page/year: 2,100,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 70 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   JIMRBV Journal of International Medical Research.  (Cambridge Medical Pub.
   Ltd., 435/437 Wellingborough Rd., Northampton, NN1 4EZ, UK)  V.1-    1972-
   Volume(issue)/page/year: 2,100,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 463 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: 35,461,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 10 gm/kg
TOXIC EFFECTS :
   Behavioral - altered sleep time (including change in righting reflex)
   Behavioral - convulsions or effect on seizure threshold
   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: 30,386,1977
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 235 mg/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   JIMRBV Journal of International Medical Research.  (Cambridge Medical Pub.
   Ltd., 435/437 Wellingborough Rd., Northampton, NN1 4EZ, UK)  V.1-    1972-
   Volume(issue)/page/year: 2,100,1974
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 274 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:
   25,398,1973
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 43500 ug/kg
TOXIC EFFECTS :
   Details of toxic effects not reported other than lethal dose value
REFERENCE :
   ANTBAL Antibiotiki.  (Moscow, USSR)  V.1-29, 1956-84.  For publisher
   information, see AMBIEH.  Volume(issue)/page/year: 21,532,1976
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 167 mg/kg
TOXIC EFFECTS :
   Behavioral - changes in motor activity (specific assay)
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - respiratory stimulation
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: 35,461,1982
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 710 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 184 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 750 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Mammal - cat
DOSE/DURATION           : 304 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Mammal - cat
DOSE/DURATION           : 88 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Mammal - cat
DOSE/DURATION           : 430 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 1350 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 1230 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intravenous
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 81 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 780 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 530 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
TYPE OF TEST            : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 740 mg/kg
TOXIC EFFECTS :
   Behavioral - convulsions or effect on seizure threshold
   Behavioral - ataxia
   Lungs, Thorax, or Respiration - dyspnea
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 16,11,1966
 
                 ** OTHER MULTIPLE DOSE TOXICITY DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 1 gm/kg/10D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - other changes
   Biochemical - Enzyme inhibition, induction, or change in blood or tissue
   levels - catalases
   Biochemical - Enzyme inhibition, induction, or change in blood or tissue
   levels - other Enzymes
REFERENCE :
   JJATDK JAT, Journal of Applied Toxicology.  (John Wiley & Sons Ltd., Baffins
   Lane, Chichester, W. Sussex PO19 1UD, UK)  V.1-    1981-
   Volume(issue)/page/year: 17,405,1997
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 140 mg/kg/14D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - other changes
REFERENCE :
   ATSUDG Archives of Toxicology, Supplement.  (Springer-Verlag New York, Inc.,
   Service Center, 44 Hartz Way, Secaucus, NJ 07094)  No.1-    1978-
   Volume(issue)/page/year: 7,459,1984
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 400 mg/kg/5D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - other changes in urine composition
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
   TXAPA9 Toxicology and Applied Pharmacology.  (Academic Press, Inc., 1 E.
   First St., Duluth, MN 55802) V.1-    1959-  Volume(issue)/page/year:
   78,386,1985
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 4200 mg/kg/4W-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 31,816,1981
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 120 mg/kg/6D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - urine volume increased
   Kidney, Ureter, Bladder - other changes in urine composition
   Biochemical - Enzyme inhibition, induction, or change in blood or tissue
   levels - phosphatases
REFERENCE :
   TOLED5 Toxicology Letters.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1977-  Volume(issue)/page/year: 13,23,1982
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 560 mg/kg/14D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Kidney, Ureter, Bladder - other changes in urine composition
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
   AMACCQ Antimicrobial Agents and Chemotherapy.  (American Soc. for
   Microbiology, 1913 I St., NW, Washington, DC 20006)  V.1-    1972-
   Volume(issue)/page/year: 13,34,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 720 mg/kg/12D-I
TOXIC EFFECTS :
   Immunological Including Allergic - decrease in cellular immune response
   Immunological Including Allergic - hypersensitivity delayed
REFERENCE :
   TOXID9 Toxicologist.  (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway,
   Akron, OH 44311) V.1-    1981-  Volume(issue)/page/year: 6,69,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 1890 mg/kg/30D-C
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in bladder weight
   Blood - changes in leukocyte (WBC) count
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
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: 30,386,1977
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 1050 mg/kg/21D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Kidney, Ureter, Bladder - urine volume increased
   Kidney, Ureter, Bladder - changes in bladder weight
REFERENCE :
   NKRZAZ Chemotherapy (Tokyo).  (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
   Shinagawa-Ku, Tokyo 141, Japan)  V.1-    1953- Volume(issue)/page/year:
   33(Suppl 5),47,1985
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 700 mg/kg/10D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - other changes in urine composition
   Kidney, Ureter, Bladder - changes in bladder weight
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
   NKRZAZ Chemotherapy (Tokyo).  (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
   Shinagawa-Ku, Tokyo 141, Japan)  V.1-    1953- Volume(issue)/page/year:
   43,416,1995
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 7280 mg/kg/26W-I
TOXIC EFFECTS :
   Blood - changes in erythrocyte (RBC) count
   Blood - changes in leukocyte (WBC) count
   Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
   NKRZAZ Chemotherapy (Tokyo).  (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
   Shinagawa-Ku, Tokyo 141, Japan)  V.1-    1953- Volume(issue)/page/year:
   15,490,1967
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Unreported
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 560 mg/kg/14D-I
TOXIC EFFECTS :
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
   CLREAS Clinical Research.  (Slack Inc., 6900 Grove Rd., Thorofare, NJ 08086)
    V.6-    1958-  Volume(issue)/page/year: 26,141A,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Unreported
SPECIES OBSERVED        : Rodent - rat
DOSE/DURATION           : 420 mg/kg/7D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Biochemical - Enzyme inhibition, induction, or change in blood or tissue
   levels - dehydrogenases
   Biochemical - Enzyme inhibition, induction, or change in blood or tissue
   levels - other Enzymes
REFERENCE :
   DTESD7 52 Vanderbilt Ave., New York, NY 10017)  V.1-15, 1977-87.
   Discontinued 52 Vanderbilt Ave., New York, NY 10017)  V.1-    1977-
   Volume(issue)/page/year: 14,27,1986
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - mouse
DOSE/DURATION           : 560 mg/kg/7D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - other changes in urine composition
   Biochemical - Enzyme inhibition, induction, or change in blood or tissue
   levels - other Enzymes
REFERENCE :
   CBPCEE Comparative Biochemistry and Physiology, C: Pharmacology, Toxicology
   and Endocrinology. (Elsevier Science, 660 White Plains Rd., Tarrytown, NY
   10591)  V.74-    1983-  Volume(issue)/page/year: 112C,15,1995
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 600 mg/kg/30D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - proteinuria
REFERENCE :
   NKRZAZ Chemotherapy (Tokyo).  (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
   Shinagawa-Ku, Tokyo 141, Japan)  V.1-    1953- Volume(issue)/page/year:
   15,490,1967
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 1890 mg/kg/30D-C
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Kidney, Ureter, Bladder - changes in bladder weight
   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: 30,408,1977
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Mammal - dog
DOSE/DURATION           : 420 mg/kg/2W-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in bladder weight
REFERENCE :
   ARZNAD Arzneimittel-Forschung. Drug Research.  (Editio Cantor Verlag,
   Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.)  V.1-    1951-
   Volume(issue)/page/year: 31,816,1981
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Primate - monkey
DOSE/DURATION           : 525 mg/kg/21D-I
TOXIC EFFECTS :
   Behavioral - ataxia
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
   Related to Chronic Data - death
REFERENCE :
   JIDIAQ Journal of Infectious Diseases.  (Univ. of Chicago Press, Journals
   Div., POB 37005, Chicago, IL 60637)  V.1-    1904- Volume(issue)/page/year:
   137,476,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Primate - monkey
DOSE/DURATION           : 630 mg/kg/21D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - changes in tubules (including acute renal failure,
   acute tubular necrosis)
   Kidney, Ureter, Bladder - changes in bladder weight
   Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
REFERENCE :
   NKRZAZ Chemotherapy (Tokyo).  (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
   Shinagawa-Ku, Tokyo 141, Japan)  V.1-    1953- Volume(issue)/page/year:
   26(Suppl 3),85,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 300 mg/kg/3D-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - proteinuria
   Kidney, Ureter, Bladder - other changes in urine composition
   Biochemical - Enzyme inhibition, induction, or change in blood or tissue
   levels - other Enzymes
REFERENCE :
   CHHTAT Zhonghua Yixue Zazhi.  Chinese Medical Journal.  (China International
   Book Trading Corp., POB 2820, Beijing, Peop. Rep. China) V.1-    1915-   
   Suspended 1967-72.  Volume(issue)/page/year: 70,108,1990
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rabbit
DOSE/DURATION           : 364 mg/kg/4W-I
TOXIC EFFECTS :
   Kidney, Ureter, Bladder - proteinuria
REFERENCE :
   ANTBAL Antibiotiki.  (Moscow, USSR)  V.1-29, 1956-84.  For publisher
   information, see AMBIEH.  Volume(issue)/page/year: 21,532,1976
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Subcutaneous
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 1072 mg/kg/16D-I
TOXIC EFFECTS :
   Sense Organs and Special Senses (Ear) - changes in cochlear structure or
   function
REFERENCE :
   TXAPA9 Toxicology and Applied Pharmacology.  (Academic Press, Inc., 1 E.
   First St., Duluth, MN 55802) V.1-    1959-  Volume(issue)/page/year:
   65,222,1982
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - guinea pig
DOSE/DURATION           : 2800 mg/kg/4W-I
TOXIC EFFECTS :
   Sense Organs and Special Senses (Ear) - changes in vestibular functions
   Sense Organs and Special Senses (Ear) - changes in cochlear structure or
   function
REFERENCE :
   NKRZAZ Chemotherapy (Tokyo).  (Nippon Kagaku Ryoho Gakkai, 2-20-8 Kamiosaki,
   Shinagawa-Ku, Tokyo 141, Japan)  V.1-    1953- Volume(issue)/page/year:
   26(Suppl 3),70,1978
 
                          ** REPRODUCTIVE DATA **
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Oral
SPECIES OBSERVED        : Human - woman
DOSE                    : 10769 units/kg
SEX/DURATION            : female 20 week(s) after conception
TOXIC EFFECTS :
   Reproductive - Specific Developmental Abnormalities - hepatobiliary system
REFERENCE :
   CHFCA2 Zhonghua Fuchanke Zazhi (Beijing).  Chinese Journal of Obstetrics and
   Gynecology.  (China International Book Trading Corp., POB 2820, Beijing,
   Peop. Rep. China)  V.1-    1953- Suspended 1967-77. Volume(issue)/page/year:
   27,157,1992
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intraperitoneal
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 750 mg/kg
SEX/DURATION            : female 7-18 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Newborn - physical
REFERENCE :
   DPTHDL Developmental Pharmacology and Therapeutics.  (S. Karger Pub., Inc.,
   79 Fifth Ave., New York, NY 10003)  V.1-    1980-  Volume(issue)/page/year:
   7(Suppl 1),89,1984
 
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 - Effects on Newborn - delayed effects
REFERENCE :
   TJADAB Teratology, The International Journal of Abnormal Development. (Alan
   R. Liss, Inc., 41 E. 11th St., New York, NY 10003)  V.1-    1968-
   Volume(issue)/page/year: 33,13A,1986
 
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 - Specific Developmental Abnormalities - urogenital system
REFERENCE :
   ZMAFA2 Zeitschrift fuer Mikroskopisch-Anatomische Forschung.  (Buchexport,
   Postfach 160, Leipzig DDR-7010, Ger. Dem. Rep.)  V.1-    1924-
   Volume(issue)/page/year: 104,385,1990
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 900 mg/kg
SEX/DURATION            : female 10-21 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Specific Developmental Abnormalities - urogenital system
   Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight
   gain)
   Reproductive - Effects on Newborn - physical
REFERENCE :
   TXCYAC Toxicology.  (Elsevier Scientific Pub. Ireland, Ltd., POB 85,
   Limerick, Ireland) V.1-    1973-  Volume(issue)/page/year: 43,301,1987
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 1050 mg/kg
SEX/DURATION            : female 8-14 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
   resorbed implants per total number of implants)
REFERENCE :
   ANKHEW Antibiotiki i Khimioterapiya.  Antibiotics and Chemotherapy. (V/O Me
   zhdunarodnaya Kniga, 113095 Moskow, USSR)  V.33-    1988-
   Volume(issue)/page/year: 34,779,1989
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Unreported
SPECIES OBSERVED        : Rodent - rat
DOSE                    : 90 mg/kg
SEX/DURATION            : female 9-14 day(s) after conception
TOXIC EFFECTS :
   Reproductive - Effects on Embryo or Fetus - fetal death
REFERENCE :
   ANTBAL Antibiotiki.  (Moscow, USSR)  V.1-29, 1956-84.  For publisher
   information, see AMBIEH.  Volume(issue)/page/year: 27,926,1982
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Mammal - dog
DOSE                    : 1456 mg/kg
SEX/DURATION            : male 91 day(s) pre-mating
TOXIC EFFECTS :
   Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland,
   accessory glands
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:
   4,73,1978
 
TYPE OF TEST            : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE       : Intramuscular
SPECIES OBSERVED        : Mammal - dog
DOSE                    : 1456 mg/kg
SEX/DURATION            : female 91 day(s) pre-mating
TOXIC EFFECTS :
   Reproductive - Maternal Effects - uterus, cervix, vagina
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:
   4,73,1978
 
                            ** MUTATION DATA **
 
TYPE OF TEST            : Mutation in microorganisms
TEST SYSTEM             : Bacteria - Escherichia coli
DOSE/DURATION           : 250 ug/L
REFERENCE :
   MUREAV Mutation Research.  (Elsevier Science Pub. B.V., POB 211, 1000 AE
   Amsterdam, Netherlands) V.1-    1964-  Volume(issue)/page/year: 140,13,1984
 
TYPE OF TEST            : DNA adduct
TEST SYSTEM             : Bacteria - Escherichia coli
DOSE/DURATION           : 2 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            : Sister chromatid exchange
TEST SYSTEM             : Human Fibroblast
DOSE/DURATION           : 75 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:
   21,67,1993
 
TYPE OF TEST            : Cytogenetic analysis
TEST SYSTEM             : Rodent - mouse Lymphocyte
DOSE/DURATION           : 500 mg/L
REFERENCE :
   EXPEAM Experientia.  (Birkhaeuser Verlag, POB 133, CH-4010 Basel,
   Switzerland)  V.1-    1945-  Volume(issue)/page/year: 31,341,1975

                              *** REVIEWS ***
 
   TOXICOLOGY REVIEW
   BJHMAB British Journal of Hospital Medicine.  (23-29 Emerald St., London
   WC1N 3QJ, UK)  V.1-    1968-  Volume(issue)/page/year: 12,837,1974

   TOXICOLOGY REVIEW
   CLANA4 Clinical Anesthesia.  (Philadelphia, PA 19103)  V.1-11, 1963-76.
   Volume(issue)/page/year: 10(Pt 1),283,1973

   TOXICOLOGY REVIEW
   INTEAG Internist.  (Springer-Verlag New York, Inc., Service Center, 44 Hartz
   Way, Secaucus, NJ 07094) V.1-    1960-  Volume(issue)/page/year: 15,7,1974

         *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***

NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
   NOES - National Occupational Exposure Survey (1983)
     NOES Hazard Code - X3140
       No. of Facilities: 635 (estimated)
       No. of Industries: 1
       No. of Occupations: 14
       No. of Employees: 27171 (estimated)
       No. of Female Employees: 22750 (estimated)

                          *** STATUS IN U.S. ***
 
   EPA GENETOX PROGRAM 1988, Negative: S cerevisiae-homozygosis

 
                            *** END OF RECORD ***