Abstract

All information for the proper development, functioning and reproduction of organisms is coded in the sequence of matched base-pairs of DNA. DNA mutations can result in harmful effects and play a role in genetic disorders and cancer. As mutations can arise through exposure to chemical substances, testing needs to be done on substances that humans and animals can be exposed to. This review focuses on the different testing strategies for risk assessment of chemicals for genotoxicity and carcinogenicity. This review is not meant to cover all testing methodologies, but rather to give an overview of the main methodologies that are used in a regulatory context. In silico and in vitro tools are playing an increasingly important role, in order to reduce in vivo animal testing. Especially in silico tools like (Q)SARs are promising as they are non-testing methods and thereby also reduce the costs and time that are needed to perform in vitro assays. (Q)SARs are not sufficiently reliable to be used as stand-alone tools, and should be associated with expert judgment or used in combination with other Weight of Evidence such as in vitro and in vivo data and data derived from other similar molecules (read-across). For some product (sub) categories, testing (in vitro/in vivo) will be unavoidable; however the future may bring reliable approaches for ensuring human safety.

Authors and Affiliations