Genetic Toxicology: Opportunities to Integrate New Approaches

The genetic toxicity tests currently used to identify and characterize potential human mutagens and carcinogens rely on measurements of primary DNA damage, gene mutation, and chromosome damage in vitro and in rodents. The International Life Sciences Institute/Health and Environmental Sciences Institute (ILSI/HESI) Project Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity Testing held a Workshop to consider the impact that new understanding of biology and new technologies might have on the identification and characterization of genotoxic substances, and to identify new approaches to inform more accurate human risk assessment for genetic and carcinogenic effects. Workshop organizers and invited speakers were from industry, academe, and government organizations. The biological effects and technologies that were selected as topics were those that would potentially yield the most useful information relevant to human hazard and risk assessment for genetic damage. Also addressed was the impact that the improved understanding of biology and the availability the new techniques might have on genetic toxicology practices. The primary topics addressed were Alternative Experimental Models to Improve Genetic Toxicity Testing; Biomarkers of Epigenetic Changes and their Applicability to Genetic Toxicology, and; New Technologies and Approaches. The ability of these new tests/technologies to be developed into tests to identify and characterize genotoxic agents, serve as a bridge between in vitro and in vivo rodent, or preferably human, data, or be used to provide dose response information for quantitative risk assessment, was also addressed