Initial Submission: Determination of Material Toxicity & Fetal Toxicity of Benzene in Rats Following Oral Exposure (Final Report) with Cover Letter (Sanitized)

摘要

Benzene (CAS No. 71-43-2) was evaluated for developmental toxicity. The test material was administered by oral gavage to pregnant female Sprague-Dawley rats from day 6-15 of gestation at dose levels of 0, 50, 250, 500, or 1000 mg/kg. Body weight and food consumption were measured and physical examinations were performed during gestation. Mated females that survived until the 20th day of gestation were sacrificed and gross necropsies were performed. Necropsy observations were unremarkable. Alopecia was observed on hindquarters, lateral lumbar areas, abdominal inguinal, ventral thoracic and cervical areas in all treatment groups with the effect being significantly different than controls at the 1000 mg/kg group. Maternal weight was significantly reduced in the 500 mg/kg group and above. Following the treatment period, the treated rats gained more weight than controls. Maternal food consumption was significantly reduced at the 250 mg/kg level and above. No statistically significant differences were found among treated groups and controls with respect to pregnancy rate, numbers of live fetuses, resorption implantations, corpora lutea, fetuses per implant, or resorptions per implant. There were no dead fetuses, and no external malformations observed. Live fetal body weight of male and female fetuses in the 500 mg/kg group and above were significantly lower than controls.