Published report by NICEATM: Evaluation of the GARDskin Sensitization Test Method Using Substances of Regulatory Interest

NICEATM’s report confirms the inclusion of GARDskin improved the overall performance of the Defined Approaches for Skin Sensitization (DASS)

The recent published report by NICEATM* summarizes an evaluation of the performance of the 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.

Full report

 

*NICEATM (National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods) is a U.S. government center that promotes the development, validation, and adoption of alternative test methods that reduce, refine, or replace animal use in toxicology. NICEATM evaluates new in vitro, computational, and integrated approaches for regulatory safety testing and coordinates with agencies like ICCVAM to support their regulatory acceptance.