GARD Models for Identifying Sensitizers

Skin sensitizers are substances with the potential to cause allergic contact dermatitis. Several non-animal NAMs are now internationally accepted for identifying skin sensitizers. One method, the GARD®skin sensitization assay, uses a genomic profile to identify potential skin sensitizers. The GARDskin assay is included in OECD Test Guideline 442E, which describes in vitro methods for skin sensitization. It has also been evaluated for inclusion and added to Guideline 497, Defined Approaches on Skin Sensitisation. Defined approaches provide a structured and reproducible means for combining information from several methods to inform a decision on a substance’s hazard.

A NICEATM report on a comprehensive evaluation of the GARDskin assay is planned for publication later in 2025. NICEATM is also evaluating the GARD®air assay for its ability to identify potential respiratory sensitizers, an endpoint for which animal models have failed to adequately represent human response.