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Consensus Report on the Future of Animal-Free Systemic Toxicity Testing
Leist, Marcel1,2; Hasiwa, Nina1; Rovida, Costanza1; Daneshian, Mardas1; Basketter, David3; Kimber, Ian4; Clewell, Harvey5; Gocht, Tilman6; Goldberg, Alan7; Busquet, Francois1; Rossi, Anna-Maria1; Schwarz, Michael6; Stephens, Martin7; Taalman, Rob8; Knudsen, Thomas B.9; McKim, James10; Harris, Georgina7; Pamies, David7; Hartung, Thomas1,7
发表日期2014
ISSN1868-596X
卷号31期号:3页码:341-356
英文摘要

Since March 2013, animal use for cosmetics testing for the European market has been banned. This requires a renewed view on risk assessment in this field. However, in other fields as well, traditional animal experimentation does not always satisfy requirements in safety testing, as the need for human-relevant information is ever increasing. A general strategy for animal-free test approaches was outlined by the US National Research Council's vision document for Toxicity Testing in the 21st Century in 2007. It is now possible to provide a more defined roadmap on how to implement this vision for the four principal areas of systemic toxicity evaluation: repeat dose organ toxicity, carcinogenicity, reproductive toxicity and allergy induction (skin sensitization), as well as for the evaluation of toxicant metabolism (toxicokinetics) (Fig. 1). CAAT-Europe assembled experts from Europe, America and Asia to design a scientific roadmap for future risk assessment approaches and the outcome was then further discussed and refined in two consensus meetings with over 200 stakeholders. The key recommendations include: focusing on improving existing methods rather than favoring de novo design; combining hazard testing with toxicokinetics predictions; developing integrated test strategies; incorporating new high content endpoints to classical assays; evolving test validation procedures; promoting collaboration and data-sharing of different industrial sectors; integrating new disciplines, such as systems biology and high throughput screening; and involving regulators early on in the test development process. A focus on data quality, combined with increased attention to the scientific background of a test method, will be important drivers. Information from each test system should be mapped along adverse outcome pathways. Finally, quantitative information on all factors and key events will be fed into systems biology models that allow a probabilistic risk assessment with flexible adaptation to exposure scenarios and individual risk factors.


英文关键词safety testing;animal-free testing;systemic toxicity;adverse outcome pathways
语种英语
WOS记录号WOS:000339468800010
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/61557
作者单位1.Univ Konstanz, CAAT Europe, Ctr Alternat Anim Testing, D-78457 Constance, Germany;
2.Univ Konstanz, Doerenkamp Zbinden Chair In Vitro Toxicol & Biome, D-78457 Constance, Germany;
3.DABMEB Consultancy Ltd, Sharnbrook, Beds, England;
4.Univ Manchester, Fac Life Sci, Manchester, Lancs, England;
5.Hamner Inst Hlth Sci, Res Triangle Pk, NC USA;
6.Univ Tubingen, Tubingen, Germany;
7.Johns Hopkins Univ, CAAT, Ctr Alternat Anim Testing, Baltimore, MD USA;
8.Cosmet Europe, Brussels, Belgium;
9.US EPA, Res Triangle Pk, NC 27711 USA;
10.CeeTox, Kalamazoo, MI USA
推荐引用方式
GB/T 7714
Leist, Marcel,Hasiwa, Nina,Rovida, Costanza,et al. Consensus Report on the Future of Animal-Free Systemic Toxicity Testing[J]. 美国环保署,2014,31(3):341-356.
APA Leist, Marcel.,Hasiwa, Nina.,Rovida, Costanza.,Daneshian, Mardas.,Basketter, David.,...&Hartung, Thomas.(2014).Consensus Report on the Future of Animal-Free Systemic Toxicity Testing.ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION,31(3),341-356.
MLA Leist, Marcel,et al."Consensus Report on the Future of Animal-Free Systemic Toxicity Testing".ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION 31.3(2014):341-356.
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