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首页> 外文期刊>Journal of applied toxicology >Does industry take the susceptible subpopulation of asthmatic individuals into consideration when setting derived no-effect levels?
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Does industry take the susceptible subpopulation of asthmatic individuals into consideration when setting derived no-effect levels?

机译：设定衍生的无效水平时，行业是否将哮喘个体的易感亚群纳入考虑？

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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 (c) 2016 The Authors Journal of Applied Toxicology Published by John Wiley & Sons Ltd.
机译：哮喘是一种慢性呼吸道疾病，接触某些化学刺激剂会加剧哮喘的发作。目的是首先研究在欧盟REACH法规的注册过程中考虑哮喘受试者的实验观察的程度，其次是确定衍生的无效水平是否为哮喘患者提供了足够的保护（ DNELs），用于急性吸入暴露。我们确定了在受控条件下可获得化学物质的哮喘患者肺功能的实验数据。然后将效果浓度与DNELs以及其他准则和极限值进行比较。截至2015年4月，在269种分类刺激物中，只有2.6％可获得哮喘病的实验数据。在22种已鉴定的具有可用数据的物质中，有14种已经在REACH下进行了完全注册，我们检索了114项与这些物质相关的可靠研究。 REACH注册者引用了这些研究中的63个，涉及14种物质中的9种。但是，在114项研究中，只有17项涉及四种物质，被认为是关键研究。此外，许多用于急性吸入的DNELs高于哮喘患者的估计疗效水平，即观察到的最低不良反应浓度或未观察到的不良反应浓度，表明安全裕度低或无。我们得出的结论是，在获得这些DNEL时，REACH注册人倾向于无视哮喘患者的发现。此外，我们发现了DNEL的示例，尤其是在为工人而衍生的DNEL中，可能无法为哮喘患者提供足够的保护。版权所有（c）2016 The Authors Journal of Applied Toxicology by John Wiley＆Sons Ltd.

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