Genetic toxicology

Abstract

This chapter on genetic toxicology is designed to serve as a reference guide to toxicologists and regulatory specialists developing mutagenicity data for product evaluation and regulatory submission. The individual sections are designed to provide a general understanding of the principles of each test and a consideration of factors that must be weighed in assay performance and data evaluation. In addition, historical data are provided that can aid in the determination of the validity of individual test results. Finally, a summary is provided of regulatory requirements for regulatory agencies in the United States, in the European Community, and in Japan.