Use of clinical data in identification of respiratory sensitisers
RAC has for the first time made a Classification and labelling (CLH) proposal to classify a chemical as a respiratory sensitiser based upon national surveillance data and the presence of the late asthmatic response (LAR) in specific inhalation challenge (SIC) tests. If successful this will lead to listing under Article 57(f) of REACH and addition to the candidate list for the SVHCs requiring restriction over the next 1+ years. This sets an important precedence that urgently requires scientific input.
The following Terms of Reference have been defined:
- Based on a review of the relevant literature, summarise the current knowledge on the methods used for collecting, storing and analysing health surveillance data on occupational asthma across the EU (and UK), its predictive value in identifying respiratory sensitisers.
- Based on a review of the relevant literature, summarise the current knowledge on the available immunological/clinical data, including responses obtained in Specific Inhalation Challenge (SIC) tests for distinguishing irritant from immune responses and for predicting causation.
- Conclude on whether the available clinical methods and data can be regarded to be regarded as sufficient to justify classification as a respiratory sensitiser under REACH.
- Identify areas where further research might be beneficial in this regard.
Task Force objective
To date health surveillance and clinical case study data has been used in the clinical context for the management of occupational asthma (OA) where limitations in its predictive value are considered acceptable. This review is intended to highlight the state of knowledge with respect to the value of such data and to identify both the strengths and limitations of such data if used in the context of chemical regulations and potential areas for further research.
Task Force deliverables
The task force will write a technical report and a publication for the peer-reviewed literature. The draft report should be available within one year from the start of the task force. A workshop to discuss the outcome with a wider audience may be proposed and, possibly, a suitable networking within industry and beyond.
It is foreseen that the Task Force will complete its work in 12 months, starting in early 2022.