Respiratory Sensitisation is a serious health condition that can have life-threatening consequences and that is regulated under GHS and CLP. Classification relies on clinical evidence of causation of substance-specific respiratory hypersensitivity, typically seen as occupational asthma. Significant advances have been made in recent years in the phenotyping of both asthma and occupational asthma since the introduction of criteria and guidance for classification. Typically generated clinical data, including specific inhalation challenge tests, while sufficient for diagnosis and health management is often deficient for regulatory classification purposes as it fails to reliably distinguish between occupational asthma and non-specific irritant exacerbation of pre-existing asthma that is regulated under another classification endpoint. A multistakeholder forum is proposed to facilitate revision of the now outdated criteria and guidance. Differences between underlying mechanisms of respiratory sensitisation and occupational asthma jeopardise establishment of an Adverse Outcome Pathway for respiratory sensitisation and development of alternative methods, including non-animal methods.
Mark Pembertona (Wed,) studied this question.