The absence of teratogenic hazard potential of p-phenylenediamine in Sprague-Dawley rats

Abstract

Para-phenylenediamine (PPD) was administered by gavage to pregnant Sprague-Dawley Rats at dose levels of 5, 10, 15, 20, and 30 mg/kg/day on days 6 through 15 of gestation (day 0=day sperm was found in the vagina). A sham control group and a pair fed control group were studied at the same time. Pregnant animals were killed on day 20 of gestation and 1/3 of the fetuses were examined for visceral malformations and 2/3 for skeletal malformations and variations. Significant reductions in food consumption and weight gain were noted in the 30 mg/kg and pair fed control groups. Two pregnant rats given PPD at 30 mg/kg/day died but there were no deaths in any other dose groups. Fetal evaluations showed no biologically or statistically significant increase in malformations or developmental variations in any group. Therefore, although maternal toxicity was demonstrated at the two highest dose levels, there was no evidence of teratogenic or other embryotoxic effects.