Growing worldwide efforts to replace (reduce) animal testing and to improve alternative in vitro tests which may be more efficient in terms of both time, cost and scientific validity include also genotoxicity/mutagenicity endpoints. The aim of the review article was to summarize currently available in vitro testing approaches in this field, their regulatory acceptance and recommended combinations for classification of chemicals. A study using the combination of Comet Assay performed on two cell lines and the Chromosomal Aberration test on human peripheral lymphocytes was performed with the aim to predict the genotoxic potential of selected paraben esters, serving as a model chemical group. Parabens are widely used in consumer products as preservatives and have been reported to exhibit inconclusive results in numerous genotoxicity studies. The Comet Assay identified Ethylparaben and Benzylparaben as potentially genotoxic. The Chromosomal Aberration test revealed weak genotoxic potential in case of Ethylparaben and positive genotoxicity in case of Butylparaben, Propylparaben and Isopropylparaben. The main reasons for variability seem to be limited water solubility of parabens, determining their bioavailability at the cellular level, and absence of metabolic activation in the Comet Assay. The results confirmed that the Comet Assay should serve as a screening test and should not be used as a stand-alone method for classification of genotoxicity. The weight of evidence approach in risk assessment should be supported with data generated with the use of human relevant in vitro methods based on cells / tissues of human origin.
- MeSH
- alternativy testů na zvířatech * MeSH
- buněčné linie keratinocytů HaCaT MeSH
- chromozomální aberace chemicky indukované MeSH
- hodnocení rizik MeSH
- kometový test MeSH
- lidé MeSH
- lymfocyty účinky léků patologie MeSH
- mikrojaderné testy MeSH
- mikrojádra chromozomálně defektní chemicky indukované MeSH
- mutageneze účinky léků MeSH
- parabeny toxicita MeSH
- poškození DNA * MeSH
- testy genotoxicity * MeSH
- viabilita buněk účinky léků MeSH
- zvířata MeSH
- Check Tag
- lidé MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- srovnávací studie MeSH
Despite widespread and prolonged use of adult novelties, their health safety is not regularly tested or legally regulated. In the EU, adult novelties are subjected to the General Product Safety Directive, placing the burden of proof regarding safe products onto the manufacturers. The aim of our pilot study was to expand knowledge on potential application of in vitro methods for hazard prediction of extracts from final products. We subjected extracts of 20 adult novelties, purchased on the Czech market to toxicological tests including NRU cytotoxicity assay, sensitization tests DPRA and LuSens and the YES/YAS endocrine assay. Four samples produced cytotoxicity. Sensitization potential was recorded by DPRA (three samples) while the LuSens reported ten samples. Regarding endocrine disruption, three samples produced antiestrogen and antiandrogen effects. Six samples exhibited androgenic potential and one sample showed estrogenic potential. Positive results with possible health effects were recorded repeatedly for samples made of ABS, PVC and latex. The study has confirmed promising usefulness of our test methods combination with regard to safety testing of this type of consumer products. The results should be evaluated with care, however, the data bring added-value to the limited knowledge of mixture toxicology and are indicative for further testing.
- MeSH
- buňky BALB 3T3 MeSH
- endokrinní disruptory toxicita MeSH
- fibroblasty účinky léků fyziologie MeSH
- hra a hračky * MeSH
- lidé MeSH
- myši MeSH
- pilotní projekty MeSH
- plastické hmoty toxicita MeSH
- Saccharomyces cerevisiae účinky léků fyziologie MeSH
- sexuální chování účinky léků fyziologie MeSH
- spotřebitelská bezpečnost produktů normy MeSH
- techniky in vitro metody MeSH
- testy akutní toxicity metody MeSH
- zvířata MeSH
- Check Tag
- lidé MeSH
- myši MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
