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How to assess the mutagenic potential of cosmetic products without animal tests?
Mutat Res. 2009 Aug; 678(2):108-12.MR

Abstract

Animal experiments (in vivo tests) currently play a key role in genotoxicity testing. Results from in vivo tests are, in many cases, decisive for the assessment of a mutagenic potential of a test compound. The Seventh Amendment to the European Cosmetics Directive will, however, ban the European marketing of cosmetic/personal care products that contain ingredients that have been tested in animal experiments. If genotoxicity testing is solely based on the currently established in vitro tests, the attrition rate for chemicals used in cosmetic products will greatly increase due to irrelevant positive in vitro test results. There is urgent need for new and/or improved in vitro genotoxicity tests and for modified test strategies. Test strategies should consider all available information on chemistry of the test substance/the chemical class (e.g. SAR, metabolic activation and dermal adsorption). Test protocols for in vitro genotoxicity tests should be sensitive and robust enough to ensure that negative results can be accepted with confidence. It should be excluded that positive in vitro test results are due to high cytotoxicity or secondary genotoxic effects which may be thresholded and/or only occur under in vitro test conditions. Consequently, further research is needed to establish the nature of thresholds in in vitro assays and to determine the potential for incorporation of mode of action data into future risk assessments. New/improved tests have to be established and validated, considering the use of (metabolically competent) primary (skin) cells, 3D skin models and cells with defined capacity for metabolic activation (e.g. genetically engineered cell lines). The sensitivity and specificity of new and improved genotoxicity tests has to be determined by testing a battery of genotoxic and non-genotoxic chemicals. New or adapted international guidelines will be needed for these tests. The establishment of such a new genotoxicity testing strategy will take time and the new in vitro genotoxicity testing will become much more complex and will require greater mechanistic understanding to build a weight of evidence decision, which will be demanding and time-consuming. At present, no validated alternative methods for the follow-up of positive results from the standard genotoxicity battery are available and an appropriate evaluation of the mutagenic potential of cosmetic ingredients without animal experiments is therefore not possible in many cases.

Authors+Show Affiliations

Universität Ulm, Institut für Humangenetik, Oberer Eselsberg M25, D-89069 Ulm, Germany. guenter.speit@uni-ulm.de

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19379833

Citation

Speit, Günter. "How to Assess the Mutagenic Potential of Cosmetic Products Without Animal Tests?" Mutation Research, vol. 678, no. 2, 2009, pp. 108-12.
Speit G. How to assess the mutagenic potential of cosmetic products without animal tests? Mutat Res. 2009;678(2):108-12.
Speit, G. (2009). How to assess the mutagenic potential of cosmetic products without animal tests? Mutation Research, 678(2), 108-12. https://doi.org/10.1016/j.mrgentox.2009.04.006
Speit G. How to Assess the Mutagenic Potential of Cosmetic Products Without Animal Tests. Mutat Res. 2009;678(2):108-12. PubMed PMID: 19379833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - How to assess the mutagenic potential of cosmetic products without animal tests? A1 - Speit,Günter, Y1 - 2009/04/18/ PY - 2008/11/30/received PY - 2009/04/08/accepted PY - 2009/4/22/entrez PY - 2009/4/22/pubmed PY - 2011/9/29/medline SP - 108 EP - 12 JF - Mutation research JO - Mutat Res VL - 678 IS - 2 N2 - Animal experiments (in vivo tests) currently play a key role in genotoxicity testing. Results from in vivo tests are, in many cases, decisive for the assessment of a mutagenic potential of a test compound. The Seventh Amendment to the European Cosmetics Directive will, however, ban the European marketing of cosmetic/personal care products that contain ingredients that have been tested in animal experiments. If genotoxicity testing is solely based on the currently established in vitro tests, the attrition rate for chemicals used in cosmetic products will greatly increase due to irrelevant positive in vitro test results. There is urgent need for new and/or improved in vitro genotoxicity tests and for modified test strategies. Test strategies should consider all available information on chemistry of the test substance/the chemical class (e.g. SAR, metabolic activation and dermal adsorption). Test protocols for in vitro genotoxicity tests should be sensitive and robust enough to ensure that negative results can be accepted with confidence. It should be excluded that positive in vitro test results are due to high cytotoxicity or secondary genotoxic effects which may be thresholded and/or only occur under in vitro test conditions. Consequently, further research is needed to establish the nature of thresholds in in vitro assays and to determine the potential for incorporation of mode of action data into future risk assessments. New/improved tests have to be established and validated, considering the use of (metabolically competent) primary (skin) cells, 3D skin models and cells with defined capacity for metabolic activation (e.g. genetically engineered cell lines). The sensitivity and specificity of new and improved genotoxicity tests has to be determined by testing a battery of genotoxic and non-genotoxic chemicals. New or adapted international guidelines will be needed for these tests. The establishment of such a new genotoxicity testing strategy will take time and the new in vitro genotoxicity testing will become much more complex and will require greater mechanistic understanding to build a weight of evidence decision, which will be demanding and time-consuming. At present, no validated alternative methods for the follow-up of positive results from the standard genotoxicity battery are available and an appropriate evaluation of the mutagenic potential of cosmetic ingredients without animal experiments is therefore not possible in many cases. SN - 0027-5107 UR - https://www.unboundmedicine.com/medline/citation/19379833/How_to_assess_the_mutagenic_potential_of_cosmetic_products_without_animal_tests L2 - https://linkinghub.elsevier.com/retrieve/pii/S1383-5718(09)00153-3 DB - PRIME DP - Unbound Medicine ER -