Genotoxicity, Carcinogenicity and Mutagenicity Studies

These studies are essential components of toxicological risk assessment. They are designed to evaluate the potential of substances (such as chemicals, drugs, or environmental agents) to cause genetic damage, cancer, or heritable mutations.

Genetic toxicology (genetox) studies are conducted to assess the mutagenic potential of various products prior to widespread use in humans. Since DNA-reactive substances may initiate the carcinogenic process, screening strategies with built-in mode of action information are becoming more useful for biologically assessing potential human risk. The operable mechanisms (i.e., biological key events) can then be evaluated in the context of an adverse outcome pathway to identify a probable molecular initiating event responsible for the positive test results. While genetic toxicology testing is required for all classes of chemicals and drugs, the testing strategy should be tailored to the applicable regulatory requirements and responses observed in vitro. While most studies are performed in vitro, we also incorporate in vivo genetic toxicology studies, when necessary.