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人类安全评估中的暴露因素考量:欧洲公共卫生协会合作伙伴论坛报告

Exposure considerations in human safety assessment: Report from an EPAA Partners' Forum.

作者信息

Cronin Mark T D, Ball Nicholas, Beken Sonja, Bender Hans, Bercaru Ofelia, Caneva Laura, Corvaro Marco, Currie Richard A, Dawson Jeffrey L, Desert Paul, Escher Sylvia E, Franco Antonio, Irizar Amaia, Mehta Jyotigna M, Rogiers Vera, Tremblay Raphaël T, Westmoreland Carl, Maxwell Gavin

机构信息

School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, United Kingdom.

Dow Europe GmbH, Bachtobelstrasse, 8810, Horgen, Switzerland.

出版信息

Regul Toxicol Pharmacol. 2023 Oct;144:105483. doi: 10.1016/j.yrtph.2023.105483. Epub 2023 Aug 26.

DOI:10.1016/j.yrtph.2023.105483
PMID:37640101
Abstract

Understanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners' Forum (PF) to explore exposure considerations in human safety assessment of industrial products to agree key conclusions for the regulatory acceptance of exposure assessment approaches and priority areas for further research investment. The PF recognised the widescale use of exposure information across industrial sectors with the possibilities of creating synergies between different sectors. Further, the PF acknowledged that the EPAA could make a significant contribution to promote the use of exposure data in human safety assessment, with an aim to address specific regulatory needs. To achieve this, research needs, as well as synergies and areas for potential collaboration across sectors, were identified.

摘要

了解和估算对某种物质的接触情况是安全制造和使用的基本要求之一。人们采用了多种方法来确定对物质的接触情况,这主要是由潜在用途和监管需求驱动的。在化学安全方面,有很多机会来改进和优化接触信息的使用。因此,欧洲替代动物试验方法伙伴关系组织(EPAA)召开了一次伙伴论坛(PF),以探讨工业产品人体安全评估中的接触因素,就接触评估方法的监管认可达成关键结论,并确定进一步研究投资的优先领域。伙伴论坛认识到接触信息在各工业部门的广泛使用以及不同部门之间产生协同效应的可能性。此外,伙伴论坛承认,EPAA可以为促进在人体安全评估中使用接触数据做出重大贡献,旨在满足特定的监管需求。为实现这一目标,确定了研究需求以及各部门之间的协同效应和潜在合作领域。

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