Isosorbide 5-mononitrate NEW

• MOLECULAR WEIGHT :

• 191.16

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 2010 mg/kg

• TOXIC EFFECTS :

• Behavioral - ataxia Kidney, Ureter, Bladder - urine volume increased Nutritional and Gross Metabolic - body temperature decrease

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 29,327,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 1760 mg/kg

• TOXIC EFFECTS :

• Sense Organs and Special Senses (Eye) - lacrimation Behavioral - altered sleep time (including change in righting reflex) Nutritional and Gross Metabolic - body temperature decrease

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 29,327,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intravenous

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 1750 mg/kg

• TOXIC EFFECTS :

• Behavioral - altered sleep time (including change in righting reflex) Behavioral - ataxia

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 29,327,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 1771 mg/kg

• TOXIC EFFECTS :

• Details of toxic effects not reported other than lethal dose value

• REFERENCE :

• BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica, Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- Volume(issue)/page/year: 128,74,1989

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intraperitoneal

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 1810 mg/kg

• TOXIC EFFECTS :

• Behavioral - ataxia Skin and Appendages - hair Nutritional and Gross Metabolic - weight loss or decreased weight gain

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 29,327,1985

• TYPE OF TEST :

• LD50 - Lethal dose, 50 percent kill

• ROUTE OF EXPOSURE :

• Intravenous

• SPECIES OBSERVED :

• Rodent - mouse

• DOSE/DURATION :

• 1820 mg/kg

• TOXIC EFFECTS :

• Behavioral - altered sleep time (including change in righting reflex) Behavioral - ataxia

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 29,327,1985 ** OTHER MULTIPLE DOSE TOXICITY DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 147 gm/kg/26W-C

• TOXIC EFFECTS :

• Kidney, Ureter, Bladder - other changes in urine composition Endocrine - changes in spleen weight Blood - other changes

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 33,171,1987

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• SPECIES OBSERVED :

• Rodent - rat

• DOSE/DURATION :

• 182 gm/kg/13W-C

• TOXIC EFFECTS :

• Liver - changes in liver weight Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol) Blood - other changes

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 30,1079,1985 ** REPRODUCTIVE DATA **

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 91 gm/kg

• SEX/DURATION :

• male 91 day(s) pre-mating

• TOXIC EFFECTS :

• Reproductive - Paternal Effects - testes, epididymis, sperm duct Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland, accessory glands

• REFERENCE :

• OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 30,1079,1985

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 27 gm/kg

• SEX/DURATION :

• female 17-22 day(s) after conception lactating female 21 day(s) post-birth

• TOXIC EFFECTS :

• Reproductive - Fertility - pre-implantation mortality (e.g. reduction in number of implants per female; total number of implants per corpora lutea) Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4 per # born alive) Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)

• REFERENCE :

• KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960- Volume(issue)/page/year: 20,6911,1986

• TYPE OF TEST :

• TDLo - Lowest published toxic dose

• ROUTE OF EXPOSURE :

• Oral

• DOSE :

• 27 gm/kg

• SEX/DURATION :

• female 17-22 day(s) after conception lactating female 21 day(s) post-birth

• TOXIC EFFECTS :

• Reproductive - Effects on Newborn - physical Reproductive - Effects on Newborn - delayed effects

• REFERENCE :

• KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960- Volume(issue)/page/year: 20,6911,1986

• TYPE OF TEST :

• TCLo - Lowest published toxic concentration

• ROUTE OF EXPOSURE :

• Inhalation

• DOSE :

• 860 ug/m3

• SEX/DURATION :

• female 1-7 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Specific Developmental Abnormalities - hepatobiliary system Reproductive - Effects on Newborn - weaning or lactation index (e.g., # alive at weaning per # alive at day 4) Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)

• REFERENCE :

• TOVEFN Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown Volume(issue)/page/year: (5),28,1996

• TYPE OF TEST :

• TCLo - Lowest published toxic concentration

• ROUTE OF EXPOSURE :

• Inhalation

• DOSE :

• 100 ug/m3

• SEX/DURATION :

• female 1-7 day(s) after conception

• TOXIC EFFECTS :

• Reproductive - Effects on Newborn - delayed effects

• REFERENCE :

• TOVEFN Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown Volume(issue)/page/year: (5),28,1996