Initial Submission: Teratologic Evaluation of Thermolin 101 in Sprague-dawley Rats (final Report) with Attachments and Cover Letter dated 020592.

摘要

Tetrakis (2-chloroethyl) ethylene diphosphate (CAS# 33125-86-9) was evaluated for developmental toxicity. The test material was administered by gavage to 20 pregnant Sprague-Dawley rats per group on days 6-15 of gestation at 0, 15, 50, 150, or 500 mg/kg/day. At 500 mg/kg/day significantly increased maternal mortality was observed. Body weight and weight gains of the dams were comparable to controls. There were no significant differences in pregnancy, implantation, numbers of live fetuses, numbers of dead fetuses, or numbers of resorptions per dam compared to controls. Reduction in the size of the hyoid bone of fetuses was theonly skeletal effect observed. Soft tissue examinations revealed no significant differences. The authors concluded that the size reduction of the hyoid bone indicated retardation in maturity probably due to maternal toxicity rather than a malformation or teratogenic effect.