Institute of Environmental Medicine, Karolinska Institutet, Sweden.
Institute of Environmental Medicine, Karolinska Institutet, Sweden.
Toxicology. 2022 Jun 30;476:153255. doi: 10.1016/j.tox.2022.153255. Epub 2022 Jul 8.
Identification of endocrine disruptors (EDs) is a highly prioritized issue in the EU. However, scientific criteria to identify EDs have so far only been implemented for biocidal and plant protection products. The European Commission is working on developing a horizontal approach to the identification of EDs across legislations, based on these scientific criteria. With this study, our aim was to evaluate evidence on endocrine disrupting properties of Bisphenol F (BPF) by applying the process set out for biocidal and plant protection products in Europe. BPF is not registered under REACH and therefore assumed not to be produced in the EU > 1 ton/year, yet the substance has been detected in urine, serum, and breast milk in populations from different countries in Europe. BPF is raising concern since it is an analogue of the known ED and reproductive toxicant Bisphenol A. Relevant evidence on endocrine disrupting properties of BPF from the open literature was collected using systematic review methodology. Pre-defined inclusion criteria were developed to select relevant studies, and data was extracted. The reliability of included studies was evaluated by the Science in Risk Assessment and Policy tool, and results were converted into Klimisch categories to allow for categorization of study reliability. A weight-of-evidence approach was used to analyze the evidence and draw conclusions on endocrine-related activity and/or endocrine adversity. We found that there is sufficient evidence to conclude on an endocrine mechanism, and while evidence for adversity was not considered sufficient, we still conclude that BPF could also cause endocrine-mediated adversity. Two modes of action were postulated based on the collected data for BPF. Challenges of performing the ED assessment for data-poor chemicals and the importance of adequate reporting of studies in the open literature, especially for new approach methods, are discussed.
确定内分泌干扰物（EDs）是欧盟的高度优先事项。然而，迄今为止，只有针对杀生物剂和植物保护产品制定了确定 EDs 的科学标准。欧盟委员会正在制定一种跨立法识别 EDs 的横向方法，该方法基于这些科学标准。通过这项研究，我们的目的是通过应用欧洲为杀生物剂和植物保护产品制定的程序，评估双酚 F（BPF）的内分泌干扰特性的证据。BPF 未在 REACH 下注册，因此假定在欧盟每年的产量不超过 1 吨/年，但该物质已在来自欧洲不同国家的人群的尿液、血清和母乳中被检测到。BPF 引起了人们的关注，因为它是已知的 ED 和生殖毒物双酚 A 的类似物。使用系统评价方法从公开文献中收集了有关 BPF 内分泌干扰特性的相关证据。制定了预定义的纳入标准来选择相关研究，并提取数据。使用科学风险评估和政策工具评估纳入研究的可靠性，并将结果转换为 Klimisch 类别，以允许对研究可靠性进行分类。使用证据权重方法分析证据，并就内分泌相关活性和/或内分泌逆境得出结论。我们发现，有足够的证据可以得出关于内分泌机制的结论，尽管对逆境的证据被认为不充分，但我们仍然得出结论，BPF 也可能导致内分泌介导的逆境。根据收集到的 BPF 数据，提出了两种作用模式。讨论了对数据匮乏化学品进行 ED 评估的挑战，以及在开放文献中充分报告研究的重要性，特别是对于新方法。
