Retrospective analysis of the mutagenicity/genotoxicity data of the cosmetic ingredients present on the Annexes of the Cosmetic EU legislation (2000–12)

Ates, Gamze; Doktorova, Tatyana Y.; Pauwels, Marleen; Rogiers, Vera

doi:10.1093/mutage/get068

Cited by 19 publications

(16 citation statements)

References 13 publications

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“…The different assays generated a high percentage of misleading positive results. As concluded by the authors of this study, there is a need of better regulatory strategies for cosmetic ingredients [48].…”

Section: Genotoxicitymentioning

confidence: 74%

Alternative Methods to Animal Testing for the Safety Evaluation of Cosmetic Ingredients: An Overview

Vinardell

Mitjans

2017

Cosmetics

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Abstract:The safety of cosmetics sold in Europe is based on the safety evaluation of each individual ingredient conducted by those responsible for putting the product on the market. However, those substances for which some concern exists with respect to human health (e.g., colorants, preservatives, UV-filters, nanomaterials) are evaluated at the European Commission level by a scientific committee, currently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulation (European Commission, 2009), it is prohibited in the European Union (EU) to market cosmetic products and ingredients that have been tested on animals. However, the results of studies performed before the ban continue to be accepted. In the current study, we evaluated the use of in vitro methods in the dossiers submitted to the SCCS in the period between 2013 and 2016 based on the published reports issued by the scientific committee, which provides a scientific opinion on these dossiers. The results of this evaluation were compared with those of an evaluation conducted four years previously. We found that, despite a slight increase in the number of studies performed in vitro, the majority of studies submitted to the SCCS is still done principally in vivo and correspond to studies performed before the ban.

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Section: Genotoxicitymentioning

confidence: 74%

Alternative Methods to Animal Testing for the Safety Evaluation of Cosmetic Ingredients: An Overview

Vinardell

Mitjans

2017

Cosmetics

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“…It is worth noting that animal test for cosmetics ingredients has been banned by European union (EU) since 2009, and the sale of animal tested cosmetics has also been banned from March 2013 25 , 26 . Furthermore, more and more countries have legislated against animal testing for cosmetic products; for instance, Taiwan has become the first Asian country to ban cosmetics animal testing in 2016.…”

Section: Discussionmentioning

confidence: 99%

Tyrosinase-based TLC Autography for anti-melanogenic drug screening

Hsu

Chan

Chen

et al. 2018

Sci Rep

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Tyrosinase-based TLC (thin layer chromatography) was developed for screening of anti-melanogenic drugs. In particular, this technique enables researchers to identify melanogenic inhibitor(s) in tested mixtures with the naked eye. In comparison with traditional colorimetric screening assays for tyrosinase inhibitor(s), not only is tyrosinase-based TLC a more cost-effective option (nearly one-tenth the enzyme cost of colorimetric methods) but also is a more sensitive detection approach for kojic acid (KA), a standard anti-melanogenic drug. The detection limit of tyrosinase-based TLC and colorimetric tyrosinase assay for KA was 0.0125 and 1.25 μg, respectively, demonstrating that the former was 100-fold more sensitive than the latter to determine the tyrosinase inhibitory rate of KA. Furthermore, the results of this method have demonstrated excellent precision by Gage Repeatability and Reproducibility (Gage R&R), with the variation of total Gage R&R being 28.24%. To verify the applicability of tyrosinase-based TLC, this platform was employed to screen melanogenic inhibitor(s) from Ganoderma formosanum extracts and two of all fractions (GFE-EA F4, F5) obtained showed depigmenting activity. It is noteworthy that these two fractions also exerted anti-melanogenesis activity on zebrafish, therefore verifying the credibility of tyrosinase-based TLC. In sum, this technique provides new insight into the discovery of novel melanogenic inhibitor(s).

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“…Using the in vitro and in vivo genotoxicity data of cosmetic annex substances (colorants, preservatives, UV-filters and hair dyes), available in the different opinions of the Scientific Committee on Consumer Safety (SCCS) issued between 2000 and 2012, important discrepancies were noticed between the in vitro and in vivo results. Indeed, positive results found through the application of the in vitro 3-test battery could most often not be confirmed in vivo because of the high sensitivity and very low specificity of the test battery (72). Therefore, the 3-test battery was replaced by a 2-test…”

Section: Strategic Approach To Animal-free Testing For Genotoxicity Imentioning

confidence: 99%

Workshop on acceleration of the validation and regulatory acceptance of alternative methods and implementation of testing strategies

Piersma

Burgdorf

Louekari

et al. 2018

Toxicology in Vitro

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This report describes the proceedings of the BfR-RIVM workshop on validation of alternative methods which was held 23 and 24 March 2017 in Berlin, Germany. Stakeholders from governmental agencies, regulatory authorities, universities, industry and the OECD were invited to discuss current problems concerning the regulatory acceptance and implementation of alternative test methods and testing strategies, with the aim to develop feasible solutions. Classical validation of alternative methods usually involves one to one comparison with the gold standard animal study. This approach suffers from the reductionist nature of an alternative test as compared to the animal study as well as from the animal study being considered as the gold standard. Modern approaches combine individual alternatives into testing strategies, for which integrated and defined approaches are emerging at OECD. Furthermore, progress in mechanistic toxicology, e.g. through the adverse outcome pathway approach, and in computational systems toxicology allows integration of alternative test battery results into toxicity predictions that are more fine-tuned to the human situation. The road towards transition to a mechanistically-based human-focused hazard and risk assessment of chemicals requires an open mind towards stepping away from the animal study as the gold standard and defining human biologically based regulatory requirements for human hazard and risk assessment.

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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)

Cited by 19 publications

References 13 publications

Alternative Methods to Animal Testing for the Safety Evaluation of Cosmetic Ingredients: An Overview

Alternative Methods to Animal Testing for the Safety Evaluation of Cosmetic Ingredients: An Overview

Tyrosinase-based TLC Autography for anti-melanogenic drug screening

Workshop on acceleration of the validation and regulatory acceptance of alternative methods and implementation of testing strategies

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