Enalapril maleate NEW

• MOLECULAR WEIGHT :

• 492.58

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - woman

• DOSE/DURATION :

• 4 mg/kg/10D-I

• TOXIC EFFECTS :

• Liver - hepatitis (hepatocellular necrosis), zonal Liver - liver function tests impaired

• REFERENCE :

• APHRER Annals of Pharmacotherpy. (Harvey Whitney Books Co., POB 42696, Cincinnati, OH 45242) V. 26- 1992- Volume(issue)/page/year: 27,1405,1993

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - woman

• DOSE/DURATION :

• 400 ug/kg/2D-I

• TOXIC EFFECTS :

• Skin and Appendages - dermatitis, other (after systemic exposure)

• REFERENCE :

• BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 294,91,1987

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - man

• DOSE/DURATION :

• 357 ug/kg/3D-I

• TOXIC EFFECTS :

• Lungs, Thorax, or Respiration - acute pulmonary edema

• REFERENCE :

• AJEMEN American Journal of Emergency Medicine. (WB Saunders, Philadelphia, PA) V.1- 1983- Volume(issue)/page/year: 8,124,1990

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - woman

• DOSE/DURATION :

• 39500 ug/kg/56W-I

• TOXIC EFFECTS :

• Lungs, Thorax, or Respiration - acute pulmonary edema Lungs, Thorax, or Respiration - dyspnea Lungs, Thorax, or Respiration - cyanosis

• REFERENCE :

• JFAPDE Journal of Family Practice. (Appleton and Lange, East Norwalk, CT) V.1- 1974- Volume(issue)/page/year: 34,201,1992

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - man

• DOSE/DURATION :

• 143 ug/kg

• TOXIC EFFECTS :

• Skin and Appendages - dermatitis, other (after systemic exposure)

• REFERENCE :

• BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 294,91,1987

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - woman

• DOSE/DURATION :

• 2800 ug/kg/4W-I

• TOXIC EFFECTS :

• Kidney, Ureter, Bladder - renal function tests depressed Kidney, Ureter, Bladder - other changes in urine composition

• REFERENCE :

• BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 291,450,1985

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - man

• DOSE/DURATION :

• 71 ug/kg

• TOXIC EFFECTS :

• Vascular - BP lowering not characterized in autonomic section

• REFERENCE :

• BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 291,1309,1985

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - woman

• DOSE/DURATION :

• 5600 ug/kg/4W-I

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Olfaction) - effect, not otherwise specified

• REFERENCE :

• LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823- Volume(issue)/page/year: 2,1395,1986

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 2973 mg/kg

• TOXIC EFFECTS :

• Behavioral - convulsions or effect on seizure threshold Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory depression

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,413,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Subcutaneous

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 1418 mg/kg

• TOXIC EFFECTS :

• Behavioral - convulsions or effect on seizure threshold Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory depression

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,413,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intravenous

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 849 mg/kg

• TOXIC EFFECTS :

• Behavioral - convulsions or effect on seizure threshold Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory depression

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,413,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 3507 mg/kg

• TOXIC EFFECTS :

• Behavioral - convulsions or effect on seizure threshold Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory depression

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,413,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Subcutaneous

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 1160 mg/kg

• TOXIC EFFECTS :

• Behavioral - convulsions or effect on seizure threshold Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory depression

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,413,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intravenous

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 859 mg/kg

• TOXIC EFFECTS :

• Behavioral - convulsions or effect on seizure threshold Behavioral - ataxia Lungs, Thorax, or Respiration - respiratory depression

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,413,1985 ** OTHER MULTIPLE DOSE TOXICITY DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 900 mg/kg/30D-C

• TOXIC EFFECTS :

• Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol) Nutritional and Gross Metabolic - weight loss or decreased weight gain Nutritional and Gross Metabolic - changes in potassium

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,425,1985

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 8190 mg/kg/13W-C

• TOXIC EFFECTS :

• Kidney, Ureter, Bladder - other changes in urine composition Blood - leukopenia Nutritional and Gross Metabolic - weight loss or decreased weight gain

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,425,1985

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Mammal - dog

• DOSE/DURATION :

• 600 mg/kg/4W-C

• TOXIC EFFECTS :

• Blood - normocytic anemia Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol) Related to Chronic Data - death

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,467,1985

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Mammal - dog

• DOSE/DURATION :

• 8190 mg/kg/13W-C

• TOXIC EFFECTS :

• Kidney, Ureter, Bladder - other changes Biochemical - Enzyme inhibition, induction, or change in blood or tissue levels - transaminases Related to Chronic Data - death

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,467,1985 ** REPRODUCTIVE DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 6800 ug/kg

• SEX/DURATION :

• female 32-34 week(s) after conception

• TOXIC EFFECTS :

• Reproductive - Specific Developmental Abnormalities - urogenital system

• REFERENCE :

• AIMEAS Annals of Internal Medicine. (American College of Physicians, 4200 Pine St., Philadelphia, PA 19104) V.1- 1927- Volume(issue)/page/year: 108,215,1988

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 95200 ug/kg

• SEX/DURATION :

• female 1-34 week(s) after conception

• TOXIC EFFECTS :

• Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) Reproductive - Specific Developmental Abnormalities - craniofacial (including nose and tongue) Reproductive - Specific Developmental Abnormalities - musculoskeletal system

• REFERENCE :

• AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920- Volume(issue)/page/year: 162,187,1990

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 95200 ug/kg

• SEX/DURATION :

• female 1-34 week(s) after conception

• TOXIC EFFECTS :

• Reproductive - Maternal Effects - other effects Reproductive - Specific Developmental Abnormalities - urogenital system Reproductive - Effects on Newborn - Apgar score (human only)

• REFERENCE :

• AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920- Volume(issue)/page/year: 162,187,1990

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 100 mg/kg

• SEX/DURATION :

• female 6-15 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Fertility - pre-implantation mortality (e.g. reduction in number of implants per female; total number of implants per corpora lutea) Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured before birth) Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus)

• REFERENCE :

• RCOCB8 Research Communications in Chemical Pathology and Pharmacology. (PJD Pub. Ltd., P.O. Box 966, Westbury, NY 11590) V.1- 1970- Volume(issue)/page/year: 77,347,1992

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 144 mg/kg

• SEX/DURATION :

• female 6-17 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Specific Developmental Abnormalities - musculoskeletal system

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 13,519,1985

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 100 mg/kg

• SEX/DURATION :

• female 6-15 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Effects on Embryo or Fetus - fetal death Reproductive - Specific Developmental Abnormalities - urogenital system

• REFERENCE :

• RCOCB8 Research Communications in Chemical Pathology and Pharmacology. (PJD Pub. Ltd., P.O. Box 966, Westbury, NY 11590) V.1- 1970- Volume(issue)/page/year: 77,347,1992

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 2520 mg/kg

• SEX/DURATION :

• female 15-22 day(s) after conception lactating female 20 day(s) post-birth

• TOXIC EFFECTS :

• Reproductive - Effects on Newborn - weaning or lactation index (e.g., # alive at weaning per # alive at day 4)

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 14,43,1986

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 280 mg/kg

• SEX/DURATION :

• female 15-22 day(s) after conception lactating female 20 day(s) post-birth

• TOXIC EFFECTS :

• Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain) Reproductive - Effects on Newborn - behavioral Reproductive - Effects on Newborn - delayed effects

• REFERENCE :

• YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972- Volume(issue)/page/year: 14,43,1986

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 39 mg/kg

• SEX/DURATION :

• female 6-18 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants)

• REFERENCE :

• FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year: 14,461,1990

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 70 mg/kg

• SEX/DURATION :

• female 14-20 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants)

• REFERENCE :

• FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year: 14,461,1990