The OECD Test Guideline (TG) 497 on Defined Approaches (DA) for Skin Sensitisation was adopted in 2021 with two chapters: one chapter on skin sensitisation hazard prediction with 2o3 DA and another on skin sensitisation hazard/potency prediction with ITS DAs. The TG 497 was updated as the current version with an addition of a third chapter on derivation of Point of Departure (PoD) in 2025 with inclusion of SARA-ICE DA.
Second commenting round on the draft Updated Test Guideline 497 on Defined Approaches for Skin Sensitisation
- Submission period
- 25 Nov 2025 - 16 Jan 2026
Background public consultation
Project description
The project to include a new DA based on regression models which rely on data from the kinetic DPRA (kDPRA, TG 442C) and cell-based assay data from TG 442D and TG 442E to obtain a PoD was proposed by Germany and Switzerland in 2023. The proposed DA uses a simple, publicly available, and transparent data interpretation procedure to derive a PoD directly from quantitative experimental data according to existing OECD TGs.
How to contribute
The draft updated Test Guideline 497 is currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programme and open for comments from the public at the same time. Interested parties are invited to contact their National Coordinators at least a week before 16 January 2026.
Document for public comments
Supporting documents:
