Establishment of test method and validation of evaluation criteria for high sensitivity miniaturized Ames test

Abstract

Evaluation of Ames test with small amount of sample is requested not only for pharmaceutical impurities and early stage drugs, but also for compounds that are difficult to synthesize or expensive. In this study, we used 24 well plate as a miniaturized Ames test and compared it with the existing test methods for four strains of TA100, TA98, TA97 and WP2 uvrA/pKM101. We report on the optimal test design for miniaturized Ames tests, the consistency of miniaturized Ames tests with existing test methods, evaluation methods, and usefulness for pre-incubation methods for miniaturized Ames tests.