Initial Submission: Teratological and Postnatal Evaluation of Aniline Hydrochloride in the Rat (final Report) with Cover Letter dated 032792.

摘要

Aniline hydrochloride (142-04- 1) was evaluated for developmental effects in groups of 20 female Fischer rats administered the test substance by gavage on days 7 through 20 of gestation at dose levels of 0, 10, 30, and 100 mg/kg/day. A positive control group was administered hydroxyurea by gavage at 200 mg/kg/day. Animals were sacrificed on day 20 of gestation. Animals in the 100 mg/kg/day group showed significantly increased methemoglobin, reticulocyte count, white blood cell count, red blood cell size, increased red blood cell distribution width, and decreased red blood cell count. Maternal animals in all treated groups had significantly increased relative spleen weight when compared with the vehicle control. Fetuses from the 100 mg/kg/day group showed increased relative liver weight, increased red blood cell size, and decreased red blood cell distribution width. No other signs of maternal toxicity, reproductive performance, embryotoxicity or developmental effects were observed in any of the treated groups at a frequency significantly different from controls. The positive control group exhibited maternal toxicity, fetal toxicity, and developmental effects. The level of significance was not indicated.