Validation of the GARD™skin assay for assessment of chemical skin sensitizers – ring trial results of predictive performance and reproducibility

Proactive identification of chemicals with skin sensitizing properties is a key toxicological endpoint within chemical safety assessment. In order to meet recent legislations and increase animal welfare, considerable efforts have been made to develop non-animal approaches to replace current animal testing. Genomic Allergen Rapid Detection (GARD™) is a state-of-the-art technology platform, the most advanced application of which is the assay for assessment of skin sensitizing chemicals, GARD™skin. The methodology is based on a dendritic cell (DC)-like cell line, thus mimicking the mechanistic events leading to initiation and modulation of downstream immunological responses. Induced transcriptional changes are measured following exposure to test chemicals, providing a detailed evaluation of cell activation. These changes are associated with the immunological decision-making role of DCs in vivo and include among other phenotypic modifications, up-regulation of co-stimulatory molecules, ind...