Assessing the potency of respiratory allergens: uncertainties and challenges.

In contrast to skin sensitisation, there are no accepted tests for the identification of chemicals or proteins with the potential to cause sensitisation of the respiratory tract. Although progress has been made, the assessment of respiratory sensitisation potential remains associated with significant challenges and uncertainties. Nevertheless, there is interest in determining whether it is possible to assess the relative potency of respiratory sensitisers. The second Adaptation to Technical Progress (ATP) to the EU Classification, Labelling and Packaging (CLP) Regulation recently introduced changes to criteria for classification and labelling of chemicals and preparations, bringing it in line with the 3rd revision to the UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS). Among other things, the second ATP introduces sub-categories for respiratory and skin sensitisers, discriminating between strong sensitisers and other sensitisers. Here we examine whether such categorisation of protein and/or chemical respiratory allergens is realistic and/or feasible. For this purpose comparisons have been drawn with skin sensitisation, where potency categorisation has now been widely accepted and successfully integrated into the regulatory process. The conclusion drawn is that, on the basis of the currently available information, potency categorisation for respiratory sensitisers is premature and could potentially be misleading.