دورية أكاديمية
Reliability and relevance evaluations of REACH data.
| العنوان: | Reliability and relevance evaluations of REACH data. |
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| المؤلفون: | Ingre-Khans E; Department of Environmental Science and Analytical Chemistry , Stockholm University , 106 91 Stockholm , Sweden . Email: ellen.ingre-khans@aces.su.se ; Tel: +46 (0)8 6747337., Ågerstrand M; Department of Environmental Science and Analytical Chemistry , Stockholm University , 106 91 Stockholm , Sweden . Email: ellen.ingre-khans@aces.su.se ; Tel: +46 (0)8 6747337., Beronius A; Institute of Environmental Medicine , Karolinska Institutet , 171 77 Stockholm , Sweden., Rudén C; Department of Environmental Science and Analytical Chemistry , Stockholm University , 106 91 Stockholm , Sweden . Email: ellen.ingre-khans@aces.su.se ; Tel: +46 (0)8 6747337. |
| المصدر: | Toxicology research [Toxicol Res (Camb)] 2018 Oct 15; Vol. 8 (1), pp. 46-56. Date of Electronic Publication: 2018 Oct 15 (Print Publication: 2019). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 101587950 Publication Model: eCollection Cited Medium: Print ISSN: 2045-452X (Print) Linking ISSN: 2045452X NLM ISO Abbreviation: Toxicol Res (Camb) Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Publication: 2020- : Oxford : Oxford University Press Original Publication: Cambridge : RSC Publishing |
| مستخلص: | Regulatory authorities rely on hazard and risk assessments performed under REACH for identifying chemicals of concern and to take action. Therefore, these assessments must be systematic and transparent. This study investigates how registrants evaluate and report data evaluations under REACH and the procedures established by the European Chemicals Agency (ECHA) to support these data evaluations. Data on the endpoint repeated dose toxicity were retrieved from the REACH registration database for 60 substances. An analysis of these data shows that the system for registrants to evaluate data and report these evaluations is neither systematic nor transparent. First, the current framework focuses on reliability, but overlooks the equally important aspect of relevance, as well as how reliability and relevance are combined for determining the adequacy of individual studies. Reliability and relevance aspects are also confused in the ECHA guidance for read-across. Second, justifications for reliability evaluations were mainly based on studies complying with GLP and test guidelines, following the Klimisch method. This may result in GLP and guideline studies being considered reliable by default and discounting non-GLP and non-test guideline data. Third, the reported rationales for reliability were frequently vague, confusing and lacking information necessary for transparency. Fourth, insufficient documentation of a study was sometimes used as a reason for judging data unreliable. Poor reporting merely affects the possibility to evaluate reliability and should be distinguished from methodological deficiencies. Consequently, ECHA is urged to improve the procedures and guidance for registrants to evaluate data under REACH to achieve systematic and transparent risk assessments. |
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| تواريخ الأحداث: | Date Created: 20190205 Latest Revision: 20240606 |
| رمز التحديث: | 20240606 |
| مُعرف محوري في PubMed: | PMC6334497 |
| DOI: | 10.1039/c8tx00216a |
| PMID: | 30713660 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2045-452X |
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| DOI: | 10.1039/c8tx00216a |