The project for the development of the SENS-IS assay, a toxicogenomic analysis on 3D reconstructed human epidermis for measuring skin sensitisation potency, was included in the OECD Test Guideline Programme workplan in 2016, on a proposal from France.
The assay underwent several steps of validation studies between 2011 and 2022, coordinated by ImmunoSearch (test developer). The results have been consolidated into a validation report subsequently peer reviewed by an independent panel.
The SENS-IS is based on the use of a reconstructed human skin model, to allow the testing of chemicals under exposure conditions close to the human use. It measures a set of biomarkers selected according to their relevance in the biological processes leading to the acquisition of skin sensitisation.
Comments collected on the draft TG and the validation report will be discussed by an OECD expert group on alternative methods for skin sensitisation, supporting the project. This discussion, aimed at advancing the project toward the development of a Test Guideline or the inclusion of the test method in an existing Test Guideline for skin sensitisation, will consider the recommendations from the peer review report and the WNT comments.
The draft TG and validation report were circulated in parallel to the OECD Expert group on alternative methods for skin sensitisation and to the WNT for a first commenting round in July 2024. Comments were requested by 20 September 2024. Documents in a WNT commenting round are normally open to public consultation and available on the OECD public website. However, public access was unavailable during the summer due to the redesign of the OECD public website. Thus, the document is now open for public consultation. Interested parties are invited to send their comments to the Secretariat (nathalie.delrue@oecd.org) by 13 December 2024.
