EpiSensA.
OECD TG 442D: Epidermal Sensitization Assay
EpiSensA is an in vitro assay for assessing skin sensitization hazard of chemicals based on a Reconstructed Human Epidermis (RhE) model.
The method provides a binary classification, identifying test substances as either skin sensitizers or non-sensitizers.
Targeting Key Event 2 of the skin sensitization AOP
Included in OECD Test Guideline 442D, EpiSensA addresses Key Event 2 (KE2) of the Adverse Outcome Pathway (AOP) for skin sensitization: keratinocyte activation.
For challenging substances, complementing GARD®skin in regulatory testing
Available data* indicate that EpiSensA is applicable to hydrophobic substances and indirectly acting haptens, providing an alternative to other KE2 assays with limited applicability for these substance types.
In regulatory contexts requiring multiple assays addressing different key events, EpiSensA serves as a complementary method to GARD®skin (OECD TG 442E), supporting a 2o3 defined approach for skin sensitization hazard assessment.
*Reference: OECD TG 442D, Appendix IC: EpiSensA
DOWNLOAD PRODUCT FACTS
Defined approaches for “difficult-to-test” substances (OECD TG 497)
For regulatory testing of “difficult-to-test” substances under Defined Approaches for Skin Sensitization (DASS, OECD TG 497), use GARD®skin as the central method and combine it with ADRA, EpiSensA, and in silico methods to tailored testing strategies:
