ABSTRACT
The potential toxicity of N-methylpyrrolidone was evaluated following dietary administration for 13 weeks to male and female beagle dogs at dosage levels of 25, 79 and 250 mg per kg body weight per day. Body weight gain and food consumption, hematological and clinical chemical data, and ophthalmic, gross and histopathological examinations were used to study possible toxicological or pathological effects. No statistically significant treatment-related effects that were judged to be biologically meaningful were seen in any parameters of either male or female animals exposed to N-methylpyrrolidone at any dose level. However, a dose-dependent decrease in body weight and increase in platelet count that correlated with increased megakaryocytes was observed. Serum cholesterol in males decreased with increasing doses.
Subject(s)
Pyrrolidinones/toxicity , Animals , Body Weight/drug effects , Cell Count , Dogs , Female , Food , Hematologic Tests , Male , Megakaryocytes , Platelet Count , Time FactorsABSTRACT
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.
