Epi2SensA Method now included in OECD Test Guideline 442D
The Epi2SensA Method on EpiDerm™ for Skin Sensitization Testing is now included in OECD TG442D Guidelines.
The new version of the OECD TG 442D includes the Epi2SensA assay, run on the EpiDerm™ reconstructed human epidermis (RhE) model. This toxicogenomic assay was previously validated in a multi‑laboratory validation study conducted in four independent laboratories using 20 blinded reference chemicals and followed OECD validation principles.
Existing validated methods for skin sensitization are based on 2D cell cultures which impact their applicability domain (not metabolically active, soluble products or forming stable suspension in medium in culture.) Methods using the RhE model overcome these limitations.
What Is Epi2SensA Assay on the EpiDerm™ Model?
Epi2SensA is a non-animal, gene expression-based skin sensitization assay performed on the EpiDerm™ reconstructed human epidermis (RhE) model. The assay has been shown to be suitable for hydrophobic compounds and substances requiring metabolic activation (pre/pro‑haptens), which are often difficult to evaluate with simpler in vitro systems.
- Measures a defined 4‑gene biomarker panel after topical application
- Uses an optimized protocol with a ≥60% viability threshold and requires ≥2 genes positive for sensitization classification
- Validated across 4 independent laboratories with88.3% accuracy and 85% between-laboratory reproducibility
By combining a well‑characterized RhE platform (EpiDerm) with a rigorously validated gene expression‑based assay (Epi2SensA), you gain a powerful, non‑animal tool for skin sensitization hazard identification that is aligned with current and emerging regulatory expectations.
If you are considering strengthening or expanding your in vitro skin sensitization test battery, EpiDerm‑based Epi2SensA offers a validated and future‑proof option for your workflows.
Click here to download the Epi2SensA Assay on EpiDerm™ Flyer
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