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© 1982 Oxford University Press

research-article

Teratogenicity Study of N-Methylpyrrolidone after Dermal Application to Sprague-Dawley Rats

PETER J. BECCI, MICHAEL J. KNICKERBOCKER, ELIZABETH L. REAGAN, RICHARD A. PARENT and LLEWELLYN W. BURNETTEA,

Food and Drug Research Laboratories, Inc. Waverly, New York 14892 AGAF Corporation Wayne, New Jersey 07470

Teratogenicity Study of N-Metbylpyrrolidone after Dermal Application to Sprague-Dawley Rats. Becci, P.J., Knickerbocker, M.J., Reagan, E.L., Parent, R.A., and Burnette, L.W. (1982). Fundam. Appl. Toxicol. 2:73–76. Teratogenicity studies were performed in rats given N-methylpyrrolidone, a solvent used in chemical processing. Dosages of 75,237 and 750 mg of N-methylpyrrolidone/kg body weight/day were administered dermally to groups of 25 pregnant Sprague-Dawley rats on days 6 through 15 of gestation. Additionally, the study used a positive dermal control. Hexafluoroacetone, was chosen based on its dermal teratogenic activity. An oral positive control, aspirin, was included in order to add significance to the data generated in the experimental positive dermal control group. All animals were killed and subjected to uterine examination on day 20 of gestation. Maternal toxicity was indicated at 750 mg of N-methylpyrrolidone/kg by reduced body weight gain during gestation. Treatment with N-methylpyrrolidone resulted in dose-dependent brightly colored yellow urine and dry skin. Treatment at the high dosage level resulted in fewer live fetuses per dam, an increase in the percentage of resorption sites and skeletal abnormalities. These effects could be the result of maternal toxicity. There was no evidence of teratogenic effects nor effects on the dams at 75 and 237 mg/kg of body weight.


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