ToxSci Advance Access originally published online on February 14, 2007
Toxicological Sciences 2007 97(2):237-240; doi:10.1093/toxsci/kfm019
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Genetic Toxicity Assessment: Employing the Best Science for Human Safety Evaluation Part IV:Recommendation of a Working Group of the Gesellschaft fuer Umwelt-Mutationsforschung (GUM) for a Simple and Straightforward Approach to Genotoxicity Testing
* P&G Prestige and Professional, Cosmital SA, Experimental Product Safety, CH-1723 Marly, Switzerland
Department of Toxicology, F. Hoffmann-La Roche AG, CH-4070 Basel, Switzerland
Kao Professional Salon Services GmbH, D-64297 Darmstadt, Germany
Bayer Healthcare AG, D-42096 Wuppertal, Germany
¶ Federal Institute for Risk Assessment (BfR), Safety of Substances and Preparations, D-14195 Berlin, Germany
|| Institute of Toxicology, Merck KGaA, D-64271 Darmstadt, Germany
||| RCC Cytotest Cell Research GmbH, D-64380 Rossdorf, Germany
1 To whom correspondence should be addressed at Department of RD-EPS, P&G Prestige and Professional, Cosmital SA, Rte de Chesalles 21, CH-1723 Marly, Switzerland. Fax: +41 26 435 26 66. E-mail: pfuhler.s{at}pg.com.
Received December 21, 2006; accepted February 12, 2007
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Abstract |
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Based on new scientific developments and experience of the regulation of chemical compounds, a working group of the Gesellschaft fuer Umweltmutationsforschung (GUM), a German-speaking section of the European Environmental Mutagen Society, proposes a simple and straightforward approach to genotoxicity testing. This strategy is divided into basic testing (stage I) and follow-up testing (stage II). Stage I consists of a bacterial gene mutation test plus an in vitro micronucleus test, therewith covering all mutagenicity endpoints. Stage II testing is in general required only if relevant positive results occur in stage I testing and will usually be in vivo. However, an isolated positive bacterial gene mutation test in stage I can be followed up with a gene mutation assay in mammalian cells. If this assay turns out negative and there are no compound-specific reasons for concern, in vivo follow-up testing may not be required. In those cases where in vivo testing is indicated, a single study combining the analysis of micronuclei in bone marrow with the comet assay in appropriately selected tissues is suggested. Negative results for both end points in relevant tissues will generally provide sufficient evidence to conclude that the test compound is nongenotoxic in vivo. Compounds which were recognized as in vivo somatic cell mutagens/genotoxicants in this hazard identification step will need further testing. In the absence of additional data, such compounds will have to be assumed to be potential genotoxic carcinogens and potential germ cell mutagens.
Key Words: genotoxicity testing; testing strategies; hazard identification.
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