Abstract
Asthma, a chronic respiratory disease, can be aggravated by exposure to certain chemical irritants. The objectives were first to investigate the extent to which experimental observations on asthmatic subjects are taken into consideration in connection with the registration process under the EU REACH regulation, and second, to determine whether asthmatics are provided adequate protection by the derived no‐effect levels (DNELs) for acute inhalation exposure. We identified substances for which experimental data on the pulmonary functions of asthmatics exposed to chemicals under controlled conditions are available. The effect concentrations were then compared with DNELs and other guideline and limit values. As of April 2015, only 2.6% of 269 classified irritants had available experimental data on asthmatics. Fourteen of the 22 identified substances with available data were fully registered under REACH and we retrieved 114 reliable studies related to these. Sixty‐three of these studies, involving nine of the 14 substances, were cited by the REACH registrants. However, only 17 of the 114 studies, involving four substances, were regarded as key studies. Furthermore, many of the DNELs for acute inhalation were higher than estimated effect levels for asthmatics, i.e., lowest observed adverse effect concentrations or no‐observed adverse effect concentrations, indicating low or no safety margin. We conclude that REACH registrants tend to disregard findings on asthmatics when deriving these DNELs. In addition, we found examples of DNELs, particularly among those derived for workers, which likely do not provide adequate protection for asthmatics. Copyright © 2016 The Authors Journal of Applied Toxicology Published by John Wiley & Sons Ltd.
Highlights
The European regulation REACH (EC, 1907/2006) concerning the registration, evaluation, authorization and restriction of chemicals entails major change in the approach to the regulation of industrial chemicals
We found 114 original experimental investigations related to these chemicals involving measurements of airway irritation and pulmonary function in asthmatic subjects
It should be noted that for the remaining substance, 2,4-toluene diisocyanate, classified as a respiratory sensitizer (H334, R42/43), the only study on exposure available involved non-sensitized subjects (Table 2; Supplemental Material, see Table S1) At the same time, all 23 substances are identified as respiratory irritants in the hazardous substances data base (HSDB), by the US National Library of Medicine (HSDB, website) and/or by the European Food Safety Authority (EFSA) Panel on Additives and Products or Substances used in Animal Feed (EFSA, 2011)
Summary
The European regulation REACH (EC, 1907/2006) concerning the registration, evaluation, authorization and restriction of chemicals entails major change in the approach to the regulation of industrial chemicals. As stated in article 1(3) of the regulation it “is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.”. This responsibility includes ensuring the availability of relevant toxicological data, as well as evaluation of these data in attempt to establish guidelines for safe use. Via the database of registered substances, the European Chemicals Agency (ECHA website, 2016) disseminates selected information from these dossiers (ECHA, 2012a), including the DNELs themselves and summaries of the toxicological data on which these are based
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