The proposed method has been developed to evaluate the keratinocyte activation Key Event of the Adverse Outcome Pathway on skin sensitisation. Like the KeratinoSens™ and the LuSens test methods, the α-Sens® is an in vitro ARE-Nrf2 luciferase test method. It was developed to enable a Foetal bovine serum (FBS)-free protocol and simple operation procedure for the prediction of skin sensitisers. The α-Sens® employs a dual luciferase assay system to detect both antioxidant response element (ARE)-mediated transcriptional activity and cell viability.
First commenting round on the FBS-free ARE-Nrf2 Luciferase αSens® Test Method, proposed for inclusion in TG 442D as a new Appendix (Appendix ID)
- Submission period
- 7 November - 18 December 2025
Background public consultation
Project description
The project for the development of the FBS-free ARE-Nrf2 Luciferase αSens® Test Method is led by Japan. It was included in the Test Guidelines Programme workplan in 2023. The test method is proposed for inclusion as Appendix ID in Test Guideline 442D on in vitro Skin Sensitisation Assays addressing the Adverse Outcome Pathway Key Event on keratinocyte activation.
How to contribute
The draft αSens® test method is currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programmes and by the OECD expert group on skin sensitisation. 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 18 December 2025.
Documents for public comments
- Draft updated TG 442D with new Appendix ID
- Draft Validation Study Report for α-Sens® as FBS-free test system for detecting ARE-Nrf2 activation of skin sensitisation
- ⍺-Sens - Report of the Peer Review Panel
The Annexes listed in the draft validation report are available upon request to the Secretariat (by e-mail to nathalie.delrue@oecd.org).
