ABSTRACT

I. INTRODUCTION Genetic toxicological tests are among the early animal studies designed to establish a safety profile for a compound. Of a battery of short-term genetic assays, the Salmonella typhimurium-rmcTosome test developed by Ames and associates (1,2), is the most commonly used genotoxicity test. The design, statistical analyses, and the interpretation of the results will be discussed in this chapter. Section II includes the background for the relevance of Ames tests to the toxicological safety profile. Section III describes the designs of the Ames tests. Section IV provides a review of some statistical methods employed for the evaluation of the mutagenicity of a compound. In Section V, we discuss the methods reviewed and some important issues in the evaluation of mutagenicity based on Ames assay results, and in Section VI, we draw concluding remarks to summarize this chapter.