Initial Submission: Teratogenic Evaluation of Ethylene Glycol Administered to Cd-1 Mice on Gestational Days 6 through 15 (final Report) with Cover Letter dated 030592.

摘要

Ethylene glycol (107-21-1) was evaluated for teratogenicity in groups of 23 to 25 female CD-1 mice administered the test substance by gavage at dose levels of 0 (25 mice), 750 (24 mice), 1500 (23 mice) and 3000 mg/kg/day (23 mice) on days 6-15 of gestation. Animals were sacrificed on day 17 of gestation. Maternal body weight and body weight gain were decreased in a dose-related manner in all treatment groups during exposure. There was a statistically higher percentage of malformed live fetuses in all treated groups (10.00%, 37.77%, and 56.5%, respectively) when compared to controls (0.25%). There was a statistically higher percentage of litters with at least one malformed live fetus in all treated groups (66.67%, 81.82% and 95.65%, respectively) when compared to controls (4.00%). Among the various visceral and skeletal malformation observed, those involving craniofacial and skeletal dysmorphogenesis were most characteristic. Since there were developmental effects at all dose levels, no NOEL was established.