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DOI10.14573/altex.1601251
Toward Good Read-Across Practice (GRAP) Guidance
Ball, Nicholas1,2; Cronin, Mark T. D.3; Shen, Jie4; Blackburn, Karen5; Booth, Ewan D.6; Bouhifd, Mounir7; Donley, Elizabeth8; Egnash, Laura8; Hastings, Charles9,10; Juberg, Daland R.1,2; Kleensang, Andre7; Kleinstreuer, Nicole11; Kroese, E. Dinant12; Lee, Adam C.13,14; Luechtefeld, Thomas7; Maertens, Alexandra7; Marty, Sue1,2; Naciff, Jorge M.5; Palmer, Jessica8; Pamies, David7; Penman, Mike15; Richarz, Andrea-Nicole3; Russo, Daniel P.16,17; Stuard, Sharon B.5; Patlewicz, Grace18; van Ravenzwaay, Bennard12; Wu, Shengde5; Zhu, Hao16,17; Hartung, Thomas7,19
发表日期2016
ISSN1868-596X
卷号33期号:2页码:149-166
英文摘要

Grouping of substances and utilizing read-across of data within those groups represents an important data gap filling technique for chemical safety assessments. Categories/analogue groups are typically developed based on structural similarity and, increasingly often, also on mechanistic (biological) similarity. While read-across can play a key role in complying with legislation such as the European REACH regulation, the lack of consensus regarding the extent and type of evidence necessary to support it often hampers its successful application and acceptance by regulatory authorities. Despite a potentially broad user community, expertise is still concentrated across a handful of organizations and individuals. In order to facilitate the effective use of read-across, this document presents the state of the art, summarizes insights learned from reviewing ECHA published decisions regarding the relative successes/pitfalls surrounding read-across under REACH, and compiles the relevant activities and guidance documents. Special emphasis is given to the available existing tools and approaches, an analysis of ECHA's published final decisions associated with all levels of compliance checks and testing proposals, the consideration and expression of uncertainty, the use of biological support data, and the impact of the ECHA Read-Across Assessment Framework (RAAF) published in 2015.


英文关键词computational toxicology;chemical similarity;read-across;hazard assessment;uncertainty
语种英语
WOS记录号WOS:000385512500007
来源期刊ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61973
作者单位1.Dow Chem Co USA, Midland, MI 48674 USA;
2.Dow AgroSci, Indianapolis, IN USA;
3.Liverpool John Moores Univ, Sch Pharm & Biomol Sci, Liverpool, Merseyside, England;
4.Res Inst Fragrance Mat Inc, Woodcliff Lake, NJ USA;
5.Procter & Gamble Co, Cincinnati, OH USA;
6.Syngenta Ltd, Jealotts Hill Int Res Ctr, Bracknell, Berks, England;
7.Johns Hopkins Bloomberg Sch Publ Hlth, CAAT, Baltimore, MD USA;
8.Stemina Biomarker Discovery Inc, Madison, WI USA;
9.BASF SE, Ludwigshafen, Germany;
10.BASF SE, Res Triangle Pk, NC USA;
11.NIEHS, Natl Toxicol Program, Interagency Ctr Evaluat Alternat Toxicol Methods, POB 12233, Res Triangle Pk, NC 27709 USA;
12.TNO, Risk Anal Prod Dev, Zeist, Netherlands;
13.DuPont Haskell Global Ctr Hlth, Newark, NJ USA;
14.DuPont Haskell Global Ctr Environm Sci, Newark, NJ USA;
15.Penman Consulting, Brussels, Belgium;
16.Rutgers State Univ, Dept Chem, Camden, NJ USA;
17.Rutgers State Univ, Ctr Computat & Integrat Biol, Camden, NJ USA;
18.US EPA, ORD, Natl Ctr Computat Toxicol, Res Triangle Pk, NC USA;
19.Univ Konstanz, CAAT Europe, Constance, Germany
推荐引用方式
GB/T 7714
Ball, Nicholas,Cronin, Mark T. D.,Shen, Jie,et al. Toward Good Read-Across Practice (GRAP) Guidance[J]. 美国环保署,2016,33(2):149-166.
APA Ball, Nicholas.,Cronin, Mark T. D..,Shen, Jie.,Blackburn, Karen.,Booth, Ewan D..,...&Hartung, Thomas.(2016).Toward Good Read-Across Practice (GRAP) Guidance.ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION,33(2),149-166.
MLA Ball, Nicholas,et al."Toward Good Read-Across Practice (GRAP) Guidance".ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION 33.2(2016):149-166.
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