Draft new Test Guideline SENS-IS assay for the testing of skin sensitisation

The proposed method is an in vitro reconstructed human epidermis (RhE) system designed to discriminate between skin sensitisers and non-sensitisers. It analyses the expression of three groups of genes: i) genes associated with the antioxidant / electrophile response element (ARE)-dependent pathway, ii) genes involved in inflammation, keratinocytes activation, and dendritic cell stimulation and iii) genes for detecting excessive skin irritation. It is proposed as a test method that captures, within a single RhE, the first three Key Events of the skin sensitisation Adverse Outcome Pathway.

The draft SENS-IS assay 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 10 February 2026.

• Draft New Test Guideline of the SENS-IS
• Main validation study:
  • Validation report (2024) – Attachments and data available from the Secretariat upon request (nathalie.delrue@oecd.org)
  • Peer review report (2024)
• Draft Performance Standards
• Performance-based validation of the IS-Skin RhE for use of the SENS-IS:
  • Validation report – IS-SKIN (2025) - data available from the Secretariat upon request (nathalie.delrue@oecd.org)
  • Peer review report – IS-SKIN (2025)