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DOI10.1016/j.yrtph.2017.09.012
Dermal absorption for pesticide health risk assessment: Harmonization of study design and data reporting for North American Regulatory submissions
Sullivan, Kristie M.1; Aggarwal, Manoj2; Akins, Jonathan M.3; Fabian, Eric4; Heylings, Jon R.5; Raabe, Hans6; Shah, Prakashchandra P. V.7; Wiemann, Christiane8; Peffer, Richard9
发表日期2017-11-01
ISSN0273-2300
卷号90页码:197-205
英文摘要

Although an internationally-adopted in vitro dermal absorption test guideline is available (OECD Test Guideline 428), the replacement of the in vivo approach in North America for pesticide formulations has not occurred due to concern over the reliability and consistency of the in vitro results. A 2012 workshop convened a panel of experts in the conduct of in vitro studies used for pesticide risk assessment, together with North American regulators, to examine techniques for in vitro dermal absorption testing. Discussions led to the recommended "best practices" for the conduct of in vitro dermal absorption studies provided herein. The workshop participants also developed recommendations for reporting study results in order to improve the quality and consistency of the data submitted to regulatory agencies in North America. Finally, a case study is presented that illustrates the use of the "triple-pack" approach; the studies, conducted for the registration of sulfoxaflor, follow the standardized recommendations provided at the workshop. In addressing the concerns of these regulators and of the regulated community, and providing harmonized recommendations to facilitate comparative data analyses, it is anticipated that wider acceptance of in vitro dermal absorption studies alone can be achieved for pesticide risk assessment. (C) 2017 Elsevier Inc. All rights reserved.


英文关键词In vitro;Dermal absorption;Pesticide;Risk assessment;North America;Triple-pack;Human
语种英语
WOS记录号WOS:000413886200021
来源期刊REGULATORY TOXICOLOGY AND PHARMACOLOGY
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/61299
作者单位1.Phys Comm Responsible Med, 5100 Wisconsin Ave NW,Suite 400, Washington, DC 20016 USA;
2.Dow AgroSci Ltd, 3B Pk Sq,Milton Pk, Abingdon OX14 4RN, Oxon, England;
3.Tessenderlo Kerley Inc, 2255 North 44th St,Suite 300, Phoenix, AZ 85008 USA;
4.BASF SE, GB TB-Z470, D-67056 Ludwigshafen, Germany;
5.Keele Univ, Dermal Technol Lab Ltd, Med 1C4, Sci & Business Pk, Keele ST5 5NL, Staffs, England;
6.Inst In Vitro Sci, 30 W Watkins Mill Rd,Suite 100, Gaithersburg, MD 20878 USA;
7.US EPA Headquarters, Ariel Rios Bldg,1200 Penn Ave NW,Mail Code 7505P, Washington, DC 20460 USA;
8.BASF Osterreich GmbH, Millennium Tower,25 OG,Handelskai 94-96, A-1200 Vienna, Austria;
9.Syngenta Crop Protect LLC, POB 18300,410 Swing Rd, Greensboro, NC 27419 USA
推荐引用方式
GB/T 7714
Sullivan, Kristie M.,Aggarwal, Manoj,Akins, Jonathan M.,et al. Dermal absorption for pesticide health risk assessment: Harmonization of study design and data reporting for North American Regulatory submissions[J]. 美国环保署,2017,90:197-205.
APA Sullivan, Kristie M..,Aggarwal, Manoj.,Akins, Jonathan M..,Fabian, Eric.,Heylings, Jon R..,...&Peffer, Richard.(2017).Dermal absorption for pesticide health risk assessment: Harmonization of study design and data reporting for North American Regulatory submissions.REGULATORY TOXICOLOGY AND PHARMACOLOGY,90,197-205.
MLA Sullivan, Kristie M.,et al."Dermal absorption for pesticide health risk assessment: Harmonization of study design and data reporting for North American Regulatory submissions".REGULATORY TOXICOLOGY AND PHARMACOLOGY 90(2017):197-205.
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