There is currently a lack of harmonised or regulatory-accepted test methods or approaches for respiratory sensitisation. The objective of this Detailed Review Paper (DRP) is to contribute to the regulatory acceptance of test methods or integrated approaches that address key events in the Adverse Outcome Pathway (AOP) for respiratory sensitisation by low molecular weight organic chemicals. This DRP reviews our current understanding of the mechanisms of respiratory sensitisation, including via the AOP, summarises available models and approaches and their fitness for purpose, human biological relevance, and technical characterisation, and addresses regulatory needs, with a view towards a future project developing one or more IATAs for this endpoint.
Detailed Review Paper (DRP) to facilitate the Development of Test Methods to Predict the Respiratory Sensitisation Potential of Low Molecular Weight Chemicals
- Submission period
- 16 Dec 2025 - 4 Feb 2026
Background public consultation
Project description
The project to develop a Detailed Review Paper (DRP) to facilitate the Development of Test Methods to Predict the Respiratory Sensitisation Potential of Substances, was included in the Test Guideline Programme workplan in April 2023, on a joint proposal from Austria, Luxembourg, Netherlands, United States and ICAPO. In July 2025, the draft DRP was submitted to the Working Party of the National Coordinators of the Test Guidelines Programme (WNT) for a first commenting round. The leads addressed the comments received and revised the draft DRP with the support of the OECD Expert group on respiratory sensitisation.
How to contribute
The draft new Detailed Review Paper on Respiratory Sensitisation is currently under a second commenting round by the WNT and is open for comments from the public at the same time. Interested parties are invited to submit comments to/contact their National Coordinators at least a week before 4 February 2026.
Documents for public comments
- Draft new DRP on Respiratory Sensitisation
- Annex I on method evaluations: Annex I collects self-assessments from some test method developers, with information and readiness scores from 1-5 for the criteria developed by the drafting group to demonstrate maturity of a particular method or approach, where 1 is only briefly considered and 5 is full consideration given.
- Annex II on tested chemicals: Annex II lists the chemicals tested in some of the methods or approaches discussed in the text and discussed in Annex I. In some cases, chemicals are labelled according to the developers’ designations as certain kinds of reference chemicals (i.e. skin or respiratory sensitiser). Absence of label does not imply absence of designation.
