GARD™skin Models for Identifying Sensitizers
Evaluation of the GARD™skin Sensitization Test Method Using Substances of Regulatory Interest (June 2025)
DOI for Publication: https://doi.org/10.22427/NICEATM-06
DOI for CEBS Data Page: https://doi.org/10.22427/NICEATM-DATA-NICEATM-06
This NICEATM report summarizes an evaluation of the performance of the Genomic Allergen Rapid Detection (GARD)™skin assay for predicting skin sensitization hazard and potency for chemicals nominated by ICCVAM member agencies. The evaluation compared the results of the GARDskin assay alone and in applicable defined approaches for identifying skin sensitizers with reference results derived from the murine local lymph node assay, human skin sensitization reference data, and three other non-animal skin sensitization test methods. Overall, the GARDskin assay performed well against the other assays for predicting skin sensitization hazard and potency classifications. Performance statistics for the defined approaches that included the GARDskin assay suggested that its addition improved those defined approaches.
Data from Appendix A: In Vitro Results, In Silico Data, Physicochemical Data, In Vivo Reference Data, and Defined Approach Results
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 GARDskin 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 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.