MUTAGENICITY STUDY OF THE NEW COGNITION-ENHANCING AGENT NEFIRACETAM

A new cognition-enhancing agent, nefiracetam (N-(2,6-dimethylphenyl) - 2- (2 - oxo - 1 - pyrrolidinyl) acetamide, DM-9384, CAS 77191-36-7) wa s studied for mutagenicity by using the following short-term in vitro and in vivo tests: 1. reverse mutation test (Ames method) on S. typhim urium and E. coli, 2. cytogenetic test on Chinese hamster cells, and 3 . mouse micronucleus test. In the cytogenetic study, nefiracetam cause d a slight but significant increase of chromosomal aberration at the h ighest dose in the 48 h treatment group, but no mutagenicity was obser ved with the same indicator in the in vivo micronucleus test. Furtherm ore, nefiracetam did not show any positive response in the reverse mut ation test. These results suggest that nefiracetam has no biologically significant respectively relevant mutagenic potential.