13-WEEK ORAL TOXICITY STUDY OF THE NEW COGNITION-ENHANCING AGENT NEFIRACETAM IN RATS

Thirteen-week toxicity of nefircetam (N-(2,6-dimethylphenyl)-2-(2-oxo- 1-pyrrolidinyl) acetamide, DM-9384, CAS 77191-36-7) was examined in ra ts by oral administration of 30, 120, or 480 mg/kg. Rats receiving 480 mg/kg showed salivation, prone position, increased water consumption, increased levels of serum total cholesterol, total protein, albumin a nd total biblirubin, increased liver weight and hypertrophy of liver c ells. This hypertrophy of hepatocytes with increased liver weight was also observed in males at 120 mg/kg. The non-toxic dose of nefiracetam under th present experimental conditions was therefore determined as 30 mg/kg.