The proposed method is an update to the EpiSensA, a test method proposed to address the second key event of the skin sensitisation Adverse Outcome Pathway, namely keratinocyte activation, by quantifying changes in the expression of marker genes associated with keratinocyte activation in reconstructed human epidermis models following exposure to sensitisers.
Commenting round on the EpiDerm-Epidermal Sensitisation Assay (Epi2SensA) proposed as an update to Appendix C (EpiSensA) in Test Guideline 442D
- Submission period
- 18 Dec 2025 - 5 Feb 2026
Background public consultation
Project description
The project for a Me-Too validation of the reconstructed human epidermis (RhE) Epiderm model for the EpiSensA method for skin sensitisation, was proposed by France and Japan in order to validate the use of an additional RhE model for inclusion in the EpiSensA, in Appendix IC of TG 442D on in vitro Skin Sensitisation Assays addressing the Adverse Outcome Pathway Key Event on keratinocyte activation. The project was included in the Test Guidelines Programme workplan in 2024.
How to contribute
The draft Epi2SensA is currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programmes. It is open for comments from the public at the same time. Interested parties are invited to contact their National Coordinators at least a week before 5 February 2026.
