A framework for chemical safety assessment incorporating new approach methodologies within REACH.
A framework for chemical safety assessment incorporating new approach methodologies within REACH.
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DOI：
10.1007/s00204-021-03215-9
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发表时间：
2022-03
影响因子：
6.1
通讯作者：
van Ravenzwaay B
中科院分区：
文献类型：
--
作者：
Ball N;Bars R;Botham PA;Cuciureanu A;Cronin MTD;Doe JE;Dudzina T;Gant TW;Leist M;van Ravenzwaay B
欧盟和世界其他地区对新方法学的长期投资正在开始形成一种共识，即如何利用来自计算机模拟、体外和有针对性的体内来源的信息来评估化学品的安全性。然而，为监管目的，这种方法的采用非常缓慢。在此，我们开发了一个框架，该框架结合了计算机模拟、体外和体内方法，旨在满足REACH的要求，其中可以使用分层方法评估危害和暴露。每一层的输出是分类类别、安全剂量和风险评估，各层的进展取决于前一层的输出。我们用三个例子来说明框架的使用。输出与基于常规研究的平行评估相同或更保守。该框架允许在化学品安全评估中透明和分阶段地引入适合本国的监测措施，并使基于科学的安全决策能够使用更少的动物、花费更少的时间、使用更少的财政和专家资源来提供相同水平的公共卫生保护。此外，它还将允许新方法通过持续的选择性进化而不是周期性的革命来发展。在线版本包含补充材料，可通过10.1007/s 00204 -021-03215-9获得。
The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety of chemicals. However, this methodology is being adopted very slowly for regulatory purposes. Here, we have developed a framework incorporating in silico, in vitro and in vivo methods designed to meet the requirements of REACH in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers. We have exemplified the use of the framework with three examples. The outputs were the same or more conservative than parallel assessments based on conventional studies. The framework allows a transparent and phased introduction of NAMs in chemical safety assessment and enables science-based safety decisions which provide the same level of public health protection using fewer animals, taking less time, and using less financial and expert resource. Furthermore, it would also allow new methods to be incorporated as they develop through continuous selective evolution rather than periodic revolution. The online version contains supplementary material available at 10.1007/s00204-021-03215-9.
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影响因子：
6.1
作者：
Daston, George;Knight, Derek J.;Whelan, Maurice
通讯作者：
Whelan, Maurice
影响因子：
3.8
作者：
Beames, Tyler;Moreau, Marjory;Hartman, Jessica K.
通讯作者：
Hartman, Jessica K.
影响因子：
2.7
作者：
Fentem, Julia;Malcomber, Ian;Westmoreland, Carl
通讯作者：
Westmoreland, Carl
替代测试方法的参考化合物指示化学物质的发育神经毒性（DNT）的潜力：示例列表及其选择和使用标准。
DOI：
10.14573/altex.1604201
发表时间：
2017
期刊：
ALTEX
影响因子：
--
作者：
Aschner M;Ceccatelli S;Daneshian M;Fritsche E;Hasiwa N;Hartung T;Hogberg HT;Leist M;Li A;Mundi WR;Padilla S;Piersma AH;Bal-Price A;Seiler A;Westerink RH;Zimmer B;Lein PJ
通讯作者：
Lein PJ
影响因子：
3.8
作者：
Bal-Price A;Pistollato F;Sachana M;Bopp SK;Munn S;Worth A
通讯作者：
Worth A