[Reverse mutation test of trandolapril (RU44570) with bacteria]

Mutagenicity of trandolapril (RU44570) was evaluated by the reverse mutation test with bacteria (test strains used: Salmonella typhimurium TA100, TA98, TA1535, TA1537 and Escherichia coli WP2uvrA). The test was conducted by the preincubation method without metabolic activation (in the absence of S9 mix) and with metabolic activation (in the presence of S9 mix). The number of revertant colonies in the bacterial strains did not exceed twice that obtained in the solvent control either in the presence or absence of S9 mix. There was no dose-dependent increase in the number of revertant colonies observed. Based on the above results, it is concluded that RU44570 has no mutagenicity (gene mutation) under the conditions of the present study.