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21st Century Approaches for Evaluating Exposures, Biological Activity, and Risks of Complex Substances: Workshop highlights.
Regulatory Toxicology and Pharmacology ( IF 3.4 ) Pub Date : 2020-01-11 , DOI: 10.1016/j.yrtph.2020.104583
Ursula G Sauer 1 , Robert A Barter 2 , Richard A Becker 3 , Emilio Benfenati 4 , Elisabet Berggren 5 , Bruno Hubesch 6 , Heli M Hollnagel 7 , Kunifumi Inawaka 8 , Athena M Keene 9 , Philipp Mayer 10 , Kathleen Plotzke 11 , Robert Skoglund 12 , Océane Albert 13
Affiliation  

The June 2019 workshop 21st Century Approaches for Evaluating Exposures, Biological Activity, and Risks of Complex Substances, co-organised by the International Council of Chemical Association's Long-Range Research Initiative and the European Commission's Joint Research Centre, is summarised. Focus was the need for improved approaches to evaluate the safety of complex substances. Approximately 10% and 20% of substances registered under the EU chemicals legislation are 'multi-constituent substances' and 'substances of unknown or variable compositions, complex reaction products and biological substances' (UVCBs), respectively, and UVCBs comprise approximately 25% of the U.S. Toxic Substances Control Act Inventory. Workshop participants were asked to consider how the full promise of new approach methodologies (NAMs) could be brought to bear to evaluate complex substances. Sessions focused on using NAMs for screening, biological profiling, and in complex risk evaluations; improving read-across approaches employing new data streams; and methods to evaluate exposure and dosimetry. The workshop concluded with facilitated discussions to explore actionable steps forward. Given the diversity of complex substances, no single 'correct' approach was seen as workable. The path forward should focus on 'learning by doing' by developing and openly sharing NAM-based fit-for-purpose case examples for evaluating biological activity, exposures and risks of complex substances.

中文翻译:

评估暴露,生物活性和复杂物质风险的21世纪方法:研讨会重点。

总结了由国际化学协会理事会的长期研究计划和欧洲委员会的联合研究中心共同组织的2019年6月的21世纪评估暴露,生物活性和复杂物质风险的方法研讨会。重点是需要改进的方法来评估复杂物质的安全性。根据欧盟化学品法规注册的物质中,分别约有10%和20%是“多成分物质”和“未知或可变成分的物质,复杂反应产物和生物物质”(UVCB),而UVCB约占25%美国有毒物质控制法案清单。要求研讨会参与者考虑如何利用新方法方法(NAM)的全部前景来评估复杂物质。会议的重点是使用NAM进行筛查,生物特征分析和复杂的风险评估;改进采用新数据流的跨读取方法;以及评估暴露和剂量的方法。研讨会结束时进行了便利的讨论,以探讨可行的步骤。考虑到复杂物质的多样性,没有单一的“正确”方法被视为可行。前进的道路应侧重于“边做边学”,方法是开发并公开分享基于NAM的适用案例,以评估生物活性,复杂物质的暴露和风险。会议的重点是使用NAM进行筛查,生物特征分析和复杂的风险评估;改进采用新数据流的跨读取方法;以及评估暴露和剂量的方法。研讨会结束时进行了便利的讨论,以探讨可行的步骤。考虑到复杂物质的多样性,没有单一的“正确”方法被视为可行。前进的道路应侧重于“边做边学”,方法是开发并公开分享基于NAM的适用案例,以评估生物活性,复杂物质的暴露和风险。会议的重点是使用NAM进行筛查,生物特征分析和复杂的风险评估;改进采用新数据流的跨读取方法;以及评估暴露和剂量的方法。研讨会结束时进行了便利的讨论,以探讨可行的步骤。考虑到复杂物质的多样性,没有单一的“正确”方法被视为可行。前进的道路应侧重于“边做边学”,方法是开发并公开分享基于NAM的适用案例,以评估生物活性,复杂物质的暴露和风险。研讨会结束时进行了便利的讨论,以探讨可行的步骤。考虑到复杂物质的多样性,没有单一的“正确”方法被视为可行。前进的道路应侧重于“边做边学”,方法是开发并公开分享基于NAM的适用案例,以评估生物活性,复杂物质的暴露和风险。研讨会结束时进行了便利的讨论,以探讨可行的步骤。考虑到复杂物质的多样性,没有单一的“正确”方法被视为可行。前进的道路应侧重于“边做边学”,方法是开发并公开分享基于NAM的适用案例,以评估生物活性,复杂物质的暴露和风险。
更新日期:2020-01-13
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