DABMEB Consultancy Ltd., Sharnbrook MK441PR, UK.
Regul Toxicol Pharmacol. 2011 Dec;61(3):365-72. doi: 10.1016/j.yrtph.2011.10.001. Epub 2011 Oct 10.
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.
与皮肤致敏相反，目前还没有公认的测试方法可以确定具有潜在呼吸道致敏性的化学品或蛋白质。尽管已经取得了一些进展，但评估呼吸道致敏潜能仍然存在很大的挑战和不确定性。尽管如此，人们还是有兴趣确定是否有可能评估呼吸道致敏剂的相对效力。欧盟分类、标签和包装（CLP）法规的第二次适应技术进步（ATP）最近对化学品和制剂的分类和标签标准进行了修改，使其与联合国化学品全球统一分类和标签制度（GHS）的第三次修订保持一致。除其他外，第二次 ATP 为呼吸道和皮肤致敏剂引入了子类别，区分了强致敏剂和其他致敏剂。在这里，我们研究了对蛋白质和/或化学性呼吸道变应原进行这种分类是否现实和/或可行。为此，我们与皮肤致敏进行了比较，皮肤致敏的效力分类现已被广泛接受，并成功地纳入了监管程序。得出的结论是，根据目前可用的信息，呼吸道致敏剂的效力分类还为时过早，可能具有误导性。
