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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]

The aim of the study was toxicological testing of an innovative and efficient antimicrobial agent based on photoactive phthalocyanine (Pc) derivative. A promising Aluminium phthalocyanine (AlPc) with efficient and stable antimicrobial effects was subjected to a battery of toxicological tests to avoid local and systemic toxicity hazard. In compliance with the current European legislation restricting the use of experimental animals, the methods comprised exclusively in vitro procedures based on cellular and tissue models of human origin or mimicking human tissues. The battery of toxicological tests to identify local toxicity included skin corrosion/irritation, eye irritation, and phototoxicity. The basic systemic toxicity tests included acute toxicity, skin sensitization, genotoxicity, and endocrine disruption. The results showed that AlPc induced skin and eye irritation, exhibited borderline sensitization potential and mutagenic potential in one test strain of the Ames test, which was not confirmed in the chromosome aberration test. The AlPc was found to be phototoxic. The results from the cytotoxicity test designed for acute oral toxicity estimation were not conclusive, the acute toxicity potential has to be determined by conventional tests in vivo. Regarding endocrine disruption, no agonistic activity of the AlPc on human estrogen receptor α, nor human androgen receptor was observed. The skin penetration/absorption test revealed that the AlPc has not penetrated into the dermis and receptor fluid, confirming no risk of systemic exposure via the bloodstream. • A novel antimicrobial phthalocyanine AlPc was tested by methods in vitro. • AlPc is a skin and eye irritant, borderline sensitizer, mutagenic in Ames test. • AlPc is phototoxic, acute toxicity was not possible to estimate in vitro. • AlPc does not penetrate through skin into the bloodstream posing no systemic risk. [ABSTRACT FROM AUTHOR]