Mutagenesis Advance Access published online on June 17, 2009
Mutagenesis, doi:10.1093/mutage/gep014
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Mutagenicity testing for chemical risk assessment: update of the WHO/IPCS Harmonized Scheme
Environmental Toxicology Graduate Program, University of California, Riverside, CA, USA 1Institut für Lebensmitteltechnologie und Lebensmittelchemie, Technische Universität Berlin, Berlin, Germany 2Department of Biomedical Sciences, University of Bradford, Bradford, West Yorkshire, UK 3Department of Community, Environmental and Occupational Medicine, Faculty of Medicine, Ain Shams University, Abassya, Cairo, Egypt 4Risk Assessment Division, Science Support Branch, Office of Pollution Prevention and Toxics, Environmental Protection Agency, Washington, DC, USA 5Department of Chemical Risk Assessment, Fraunhofer Institute for Toxicology and Experimental Medicine, Hanover, Germany 6Mechanistic Studies Division, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, Ontario, Canada 7Division of Genetics and Mutagenesis, National Institute of Health Sciences, Tokyo, Japan 8Section of Molecular Carcinogenesis, Institute of Cancer Research, Sutton, UK 9International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland
Since the publication of the International Programme on Chemical Safety (IPCS) Harmonized Scheme for Mutagenicity Testing, there have been a number of publications addressing test strategies for mutagenicity. Safety assessments of substances with regard to genotoxicity are generally based on a combination of tests to assess effects on three major end points of genetic damage associated with human disease: gene mutation, clastogenicity and aneuploidy. It is now clear from the results of international collaborative studies and the large databases that are currently available for the assays evaluated that no single assay can detect all genotoxic substances. The World Health Organization therefore decided to update the IPCS Harmonized Scheme for Mutagenicity Testing as part of the IPCS project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals. The approach presented in this paper focuses on the identification of mutagens and genotoxic carcinogens. Selection of appropriate in vitro and in vivo tests as well as a strategy for germ cell testing are described.
* To whom correspondence should be addressed. Tel: +41 22 791 1286; Fax: +41 22 791 4848; Email: ipcsmail{at}who.int
Received on February 2, 2009; revised on April 14, 2009; accepted on April 15, 2009.