The Safety Assessment of Cosmetic Perfumes by Using In Chemico and In Vitro Methods in Combination with GC-MS/MS Analysis

Markéta Dvořáková, Lada Svobodová, Marian Rucki, Václav Ševčík, Barbora Hošíková, Jan Chrz, Hana Bendová, Kristina Kejlová, Danuše Očadlíková, Marek Malý, Hana Kolářová, Marika Mannerström, Helena Kanďárová, Dagmar Jírová

    Research output: Contribution to journalArticleScientificpeer-review


    Animal testing has been prohibited for the safety assessment of cosmetic ingredients or finished products. Thus, alternative non-animal methods, followed by confirmatory clinical studies on human volunteers, should be used as the sole legally acceptable approach within the EU. The safety assessment of cosmetic products requires the involvement of multiple scientific disciplines, including analytical chemistry and biomedicine, as well as in chemico, in vitro and in silico toxicology. Recent data suggest that fragrance components may exert multiple adverse biological effects, e.g. cytotoxicity, skin sensitisation, (photo)genotoxicity, mutagenicity, reprotoxicity and endocrine disruption. Therefore, a pilot study was conducted with selected samples of fragrance-based products, such as deodorant, eau de toilette and eau de parfum, with the aim of integrating results from a number of alternative non-animal methods suitable for the detection of the following toxicological endpoints: cytotoxicity (with 3T3 Balb/c fibroblasts); skin sensitisation potential (in chemico method, DPRA); skin sensitisation potential (LuSens in vitro method, based on human keratinocytes); genotoxicity potential (in vitro Comet assay with 3T3 Balb/c cells); and endocrine disruption (in vitro YES/YAS assay). The presence of twenty-four specific known allergens in the products was determined by using GC-MS/MS. The strategies for estimation of the NOAEL of a mixture of allergens, which were proposed by the Scientific Committee on Consumer Products in their ‘Opinion on Tea tree oil’ document and by the Norwegian Food Safety Authority in their 'Risk Profile of Tea tree oil' report, were used as models for the NOAEL estimation of the mixtures of allergens that were identified in the individual samples tested in this study.

    Original languageEnglish
    Pages (from-to)224-248
    Number of pages25
    JournalAlternatives to Laboratory Animals
    Issue number4
    Publication statusPublished - 2023
    Publication typeA1 Journal article-refereed


    • 3Rs
    • allergens
    • alternative methods to animal testing
    • cosmetics
    • cytotoxicity
    • endocrine disruption
    • genotoxicity
    • in vitro methods
    • mixtures
    • perfumes
    • sensitisers
    • skin sensitisation
    • Three Rs

    Publication forum classification

    • Publication forum level 1

    ASJC Scopus subject areas

    • General Biochemistry,Genetics and Molecular Biology
    • Toxicology
    • Medical Laboratory Technology


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