Mutagenicity study of the new cognition-enhancing agent nefiracetam.

ABSTRACT

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