Evaluation of the Teratogenic Potential of the Oxidattve Dye N-Phenyl-Para-Phenylenediamine

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Abstract
The oxidative dye N-phenyl-p-phenylenediamine was evaluated for teratogenic potential. The dye was administered by gavage to pregnant Sprague-Dawley rats at dose levels of 50, 100 and 200 mg/kg on gestation days 6-15. No signs of toxicity were observed during the treatment period. A significant reduction in mean maternal weight gain was noted during treatment at the high dose level of 200 mg/kg. The test material did not produce embryotoxic nor fetal toxic effects at dose levels utilized. Evaluation of fetal external visceral and skeletal anomalies revealed no statistically significant differences between dye-treated and control groups. Oral exposure of dams to the positive control, vitamin A, resulted in a significant increase in the number of litters with fetuses having external, visceral and skeletal anomalies.