リスクアセスメントにおける遺伝毒性

—海外の動向と視点—

抄録

Global new perspectives on genotoxicity, i.e., threshold and germ cell mutagenicity, are summarized. On the aspect of threshold, proposal of a flow scheme toward risk assessment and standard setting for chemical carcinogens from European Academy, guideline on the limits of genotoxic impurities in pharmaceutical from the European Medicines Agency, and the concept of thresholds of toxicological concern (TTC) are introduced. On germ cell mutagenicity, health hazard classification criteria by a system of Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and examples of classification by EU or Germany MAK Commission are also explained. These give major impacts to genotoxicity evaluation, risk assessment and hazard classification of chemicals.