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.

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.

Complementing GARD®skin in regulatory testing

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

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 broadly applicable, including to substances with challenging properties such as:

  • Hydrophobic substances
  • Complex mixtures
  • Pre-haptens and pro-haptens
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