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.
A KE2 method to complement GARD®skin in regulatory testing
Included in OECD Test Guideline 442D, EpiSensA specifically addresses Key Event 2 (KE2) of the Adverse Outcome Pathway (AOP) for skin sensitization, keratinocyte activation.
Available data* indicate the applicability of EpiSensA to hydrophobic substances and indirectly acting haptens, making it a suitable alternative to other KE2 methods with limited applicability to these types of substances.
In regulatory context that require multiple methods covering different key events, EpiSensA serves as a useful complement to GARDskin (OECD TG 442E). Together, they enable a robust “2 out of 3” testing strategy for skin sensitization hazard assessment, particularly valuable when evaluating “difficult-to-test” substances.
*Reference: OECD TG 442D, Appendix IC: EpiSensA
Try our “2 out of 3” testing package for “difficult-to-test” samples
Use EpiSensA to complement GARDskin data in a robust “2 out of 3” defined approach for regulatory skin sensitization testing. This combination is particularly valuable for hazard assessment of substances with challenging properties, such as:
- Hydrophobic substances
- Complex mixtures
- Pre-haptens and pro-haptens
