Initial Submission: Teratogenicity Study of Ethylene Glycol Monoethyl Ether in Rats with Attachments and Cover Letter dated 052792.

摘要

2-Ethoxyethanol (CAS# 110-80-5) was evaluated for developmental toxicity. It was administered in groups of 24 Alderley Park rats exposed to 0, 10, 50, 250 ppm of the test material for 6 hours per day on days 6-15 of gestation. There were no effects on maternal body weight, and food consumption at 10 ppm or above. At autopsy on day 21 of gestation no treatment-related gross maternal abnormalities were observed. Maternal toxicity occurred at 250 ppm in the form of slight hematological changes [statistically significant (p<0.05) reductions in hemoglobin, hematocrit, and mean cell volume]. There were no differences in the mean number of corpora lutea, but the mean numbers of implantations were statistically significantly (p<0.05) lower at 10 ppm or above. Statistically significant (p<0.05) increased incidence of intra-uterine deaths, reduced fetal weights, and reduced fetal ossification observed at 250 ppm were indicative of fetotoxicity, but no evidence of teratogenicity was observed. Some evidence of reduced ossification was observed at 50 ppm. It was concluded that 2-ethoxyethanol was not teratogenic at 250 ppm or lower, but it was fetotoxic at 250 ppm and possibly at 50 ppm. No toxicologically significant effects were observed at 10 ppm.