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Triclosan and Triclocarban, preservatives widely used in cosmetics and other consumer products, underwent evaluation using a battery of new-approach methodologies in vitro (NAMs). Specifically, the Microplate Ames Test (MPF™ Test, Xenometrix, Allschwil, Switzerland) was employed to assess mutagenicity, the Comet assay in vitro on the HaCat cell line and the Mammalian Chromosome Aberration Test were utilized to evaluate genotoxicity, and the XenoScreen® YES/YAS assay was applied to investigate endocrine disruption. The chemicals did not exhibit any positive responses for mutagenicity. However, the mammalian chromosome aberration test identified both chemicals as being positive for genotoxicity at 10 µg/mL. In the Comet assay, the percentage of DNA in the tail significantly increased in a concentration-dependent manner (at 5 and 10 µg/mL for Triclosan, at 2.5, 5, and 10 µg/mL for Triclocarban). The positive response depended on the increasing concentration and the duration of exposure. Triclosan, but not Triclocarban in any of the endocrine assays performed, indicated a potential for endocrine activity in the anti-estrogenic and anti-androgenic assays. The positive in vitro results detected were obtained for concentrations relevant to final products. The alarming findings obtained with the use of new-approach methodologies (NAMs) justify the current precautionary regulatory approach, limiting the use of these preservatives. [ABSTRACT FROM AUTHOR]

Three preservatives used as ingredients in cosmetics and other consumer products (triclosan, triclocarban and resorcinol) were evaluated for their genotoxic/mutagenic potential by means of a set of in vitro alternative methods, namely Ames Test (MPF Test, Xenometrix, OECD TG 471) with strains TA 98, TA 100, TA 1535 and TA 1537, Comet assay on HaCat cell line (non-tumor human keratinocytes) and Mammalian chromosome aberration test (OECD TG 473) using human peripheral lymphocytes. In the chromosome aberration test all three chemicals were positive in the highest tested concentrations. Similarly, in the Comet assay the percentage of DNA in tail was significantly increased in the highest concentrations. Moreover, the genotoxic effects were clearly dependent on the increasing concentration and duration of exposure. The Ames Test revealed positivity only for resorcinol using strain TA 1537, detecting frameshift mutations. The positive results were recorded for extremely high concentrations which under foreseeable conditions could not be present in the human body, however, the results justify the need to regulate and limit the use of these preservatives in final products. [ABSTRACT FROM AUTHOR]