Sotalol hydrochloride NEW

• MOLECULAR FORMULA :

• C12-H20-N2-O3-S.Cl-H

• MOLECULAR WEIGHT :

• 308.86

• WISWESSER LINE NOTATION :

• WS1&MR DYQ1MY1&1 &GH

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

• TYPE OF TEST :

• LDLo - Lowest published lethal dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human - man

• DOSE/DURATION :

• 45714 ug/kg

• TOXIC EFFECTS :

• Behavioral - convulsions or effect on seizure threshold Behavioral - excitement Lungs, Thorax, or Respiration - dyspnea

• REFERENCE :

• ARTODN Archives of Toxicology. (Springer-Verlag, Heidelberger Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.32- 1974- Volume(issue)/page/year: 43,221,1980

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Human

• DOSE/DURATION :

• 64 mg/kg/2W-I

• TOXIC EFFECTS :

• Cardiac - arrhythmias (including changes in conduction)

• REFERENCE :

• BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 291,544,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 3450 mg/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - ptosis Behavioral - somnolence (general depressed activity) Behavioral - ataxia

• REFERENCE :

• JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- Volume(issue)/page/year: 149,161,1965

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 680 mg/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - ptosis Behavioral - changes in motor activity (specific assay) Behavioral - ataxia

• REFERENCE :

• JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- Volume(issue)/page/year: 149,161,1965

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 2600 mg/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - ptosis Behavioral - changes in motor activity (specific assay) Behavioral - ataxia

• REFERENCE :

• JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- Volume(issue)/page/year: 149,161,1965

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 670 mg/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - ptosis Behavioral - changes in motor activity (specific assay) Behavioral - ataxia

• REFERENCE :

• JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- Volume(issue)/page/year: 149,161,1965

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Mammal - dog

• DOSE/DURATION :

• 330 mg/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - lacrimation Behavioral - changes in motor activity (specific assay) Behavioral - ataxia

• REFERENCE :

• JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- Volume(issue)/page/year: 149,161,1965

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rabbit

• DOSE/DURATION :

• 1 gm/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - ptosis Behavioral - changes in motor activity (specific assay) Behavioral - ataxia

• REFERENCE :

• JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- Volume(issue)/page/year: 149,161,1965 ** OTHER MULTIPLE DOSE TOXICITY DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 69450 mg/kg/30D-I

• TOXIC EFFECTS :

• Liver - changes in liver weight Nutritional and Gross Metabolic - weight loss or decreased weight gain 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: 23,2895,1995

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 281 gm/kg/1Y-I

• TOXIC EFFECTS :

• Cardiac - changes in heart weight Kidney, Ureter, Bladder - urine volume increased Endocrine - changes in spleen weight

• 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: 23,2913,1995 ** REPRODUCTIVE DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 126 gm/kg

• SEX/DURATION :

• male 9 week(s) pre-mating female 2 week(s) pre-mating - 7 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Paternal Effects - testes, epididymis, sperm duct 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)

• 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: 23,1995,1995

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 280 mg/kg

• SEX/DURATION :

• female 8-21 day(s) after conception

• TOXIC EFFECTS :

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

• REFERENCE :

• EJPHAZ European Journal of Pharmacology. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1967- Volume(issue)/page/year: 195,75,1991

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 8085 mg/kg

• SEX/DURATION :

• female 7-17 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Effects on Embryo or Fetus - fetal death Reproductive - Effects on Newborn - live birth index (measured after birth) Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4 per # born alive)

• 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: 23,2007,1995

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 24960 mg/kg

• SEX/DURATION :

• female 17-21 day(s) after conception lactating female 21 day(s) post-birth

• TOXIC EFFECTS :

• Reproductive - Maternal Effects - other effects Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced 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: 23,2031,1995

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 2340 mg/kg

• SEX/DURATION :

• female 6-18 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Effects on Embryo or Fetus - fetal 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: 23,2023,1995 *** REVIEWS *** TOXICOLOGY REVIEW FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1981- Volume(issue)/page/year: 6,395,1986