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EC number: 240-357-1 | CAS number: 16245-77-5
The reproductive and developmental toxicity study of test chemical was performed in female New Zealand White Rabbit. The test material dissolved in distilled water and administered in dose concentration 0, 10, 25, 50 mg/kg bw/d, by oral gavage route from day 6 to 18 of gestation while positive control Vitamin A in rape seed oil in dose concentration 6 mg/kg bw/d given by same route. The females were fertilised by natural mating. After coitus HCG was given i.v. to ensure ovulation. The animals were examined daily for mortality and clinical signs. The body weights were determined on days 0, 6, 18 and 28 of gestation. On day 28 of gestation the animals were sacrificed, the foetuses were dissected and examined for congenital abnormalities and macroscopic changes. The common section parameters were recorded. Half of the foetuses were examined for skeletal and the other half for visceral abnormalities. 1 female at 10 and 1 female at 25 mg/kg bw/d died, at 50 mg/kg 3 females died presumably because of the intubation procedure. No clinical signs were observed. Body weights of the females in the dose groups were similar to the controls. The changes in the incidences of intrauterine death observed were not dose-related. The number and sex of the foetuses as well as the foetal body weights were not influenced by substance treatment. The frequencies of external abnormalities, visceral malformations and variations as well as skeletal defects exhibited no substance-related changes. The positive control (Vitamin A) did not show teratogenicity and only slight embryotoxicity. Hence No Observed Adverse Effect Level (NOAEL) for maternal toxicity and embryotoxicity was considered to be 50 mg/kg/day. When female New Zealand White Rabbit were treated with test chemical orally from day 6 to 18 of gestation.
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