Teratological assessment of the oxidative dye 4-methyl-N-ethylamino phenol sulfate.

The oxidative dye 4-methyl-N-ethylamino phenol sulfate was evaluated for teratogenic potential. The dye was administered by gavage to pregnant Sprague-Dawley rats at dose levels of 300, 600, and 1200 mg/kg on gestation days six through fifteen. 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 1200 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 abnormal fetuses.