Authors
Yax Thakkar, Danielle Botelho, Anne Marie Api
Published in
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. Pages 116423. Oct 05, 2026. Epub Oct 05, 2026.
Abstract
The European Union's ban on in vivo genotoxicity testing for cosmetic ingredients (Directive 2003/15/EC), followed by the Scientific Committee on Consumer Safety (SCCS) 7th amendment, has created an urgent need for robust, non-animal genotoxicity testing strategies. Standard regulatory in vitro assays - including the Ames test, the in vitro micronucleus test, and chromosomal aberration assays - are prone to high rates of misleading positive results (up to 93% for cosmetic ingredients), primarily because they lack sufficient phase II metabolic competence. This review describes a tiered, mechanism-informed, fully in vitro testing strategy that integrates: (1) the ToxTracker assay, a green fluorescent protein (GFP)-reporter stem cell platform for mechanistic follow-up; (2) the 3D Reconstructed Skin Micronucleus (RSMN) assay, which provides a physiologically relevant dermal exposure model; (3) the Chicken Egg Genotoxicity Assay (CEGA) and Hen's Egg Test for Micronucleus Induction (HET-MN), which leverage the metabolic competence of fetal chicken systems; and (4) in silico metabolism prediction using OASIS TIMES. A proposed decision-making flow chart is provided. Two case studies, 2-octen-4-one and p-methoxycinnamaldehyde, illustrate how this strategy can resolve ambiguous in vitro findings and distinguish true genotoxic hazards from non-biologically relevant positives.
PMID:
42833342
Bibliographic data and abstract were imported from PubMed on 06 Oct 2026.
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