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Retrospective analysis of the mutagenicity/genotoxicity data of the cosmetic ingredients present on the Annexes of the Cosmetic EU legislation (2000–12)
- Source :
- Vrije Universiteit Brussel
- Publication Year :
- 2014
- Publisher :
- Oxford University Press (OUP), 2014.
-
Abstract
- To evaluate the mutagenicity/genotoxicity of cosmetic ingredients at the regulatory level, usually a battery of three in vitro tests is applied. This battery, designed to be very sensitive, produces a high number of positive results, imposing the need for in vivo follow-up testing to clear the substance under study. In Europe, the use of experimental animals has become impossible for cosmetic ingredients due to the implementation of animal testing and marketing bans. Consequently, the possibility to 'de-risk' substances with positive in vitro results disappear and potentially safe cosmetic substances will be lost for the EU market unless currently used in vitro assays can be adapted or new non-animal mutagenicity/genotoxicity studies become available. Described strategies to improve the specificity of existing in vitro assays include optimisation of the used cell type and cytotoxicity assay and lowering of the applied top concentration. A reduction of the number of tests in the battery from three to two also has been suggested. In this study, the performance of the 'standard' in vitro mutagenicity/genotoxicity testing battery is analysed for a number of cosmetic ingredients. We composed a database with toxicological information on 249 cosmetic ingredients, mainly present on the Annexes of the European cosmetic legislation. Results revealed that the in vitro mutagenicity/genotoxicity tests showed a low specificity for the cosmetic ingredients concerned, comparable to the specificity published for chemicals. Non-confirmed or 'misleading' positive results amounted up to 93% for the in vitro test batteries. The cell type and top concentrations did not have a major impact on the specificity. With respect to cytotoxicity determinations, different end points were used, potentially leading to different testing concentrations, suggesting the need for a consensus in this matter. Overall, the results of this retrospective analysis point to an urgent need of better regulatory strategies to assess the potential mutagenicity/genotoxicity of cosmetic ingredients.
- Subjects :
- In vitro test
Health, Toxicology and Mutagenesis
specificity
Cosmetics
Toxicology
medicine.disease_cause
Mutagenicity/genotoxicity
Genotoxicity testing
Government regulation
Toxicity Tests
Genetics
Retrospective analysis
medicine
media_common.cataloged_instance
False Positive Reactions
European Union
European union
Genetics (clinical)
Retrospective Studies
media_common
Mutagenicity Tests
business.industry
In vitro toxicology
cosmetic substances
in vitro test battery
Biotechnology
Databases as Topic
Government Regulation
business
Mutagenicity Test
Genotoxicity
Subjects
Details
- ISSN :
- 14643804 and 02678357
- Volume :
- 29
- Database :
- OpenAIRE
- Journal :
- Mutagenesis
- Accession number :
- edsair.doi.dedup.....be77578d1f8e5be49739a798f2b783cc