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The SEURAT-1 approach towards animal free human safety assessment

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Tilman Gocht1, Elisabet Berggren2, Hans Jürgen Ahr3, Ian Cotgreave4, 5, Mark T. D. Cronin6, George Daston7, Barry Hardy8, Elmar Heinzle9, Jürgen Hescheler10, Derek J. Knight11, Catherine Mahony12, Marc Peschanski13, Michael Schwarz1, Russell S. Thomas14, Catherine Verfaillie15, Andrew White16 and Maurice Whelan2
1 Eberhard Karls University Tübingen, Institute for Experimental and Clinical Pharmacology and Toxicology, Tübingen, Germany;
2 European Commission, Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP) and EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), Ispra, Italy;
3 Department of Molecular and Genetic Toxicology, Bayer AG, Wuppertal, Germany;
4 Swedish Toxicology Sciences Research Center (Swetox), Södertälje, Sweden;
5 Institute of Environmental Medicine, Karolinska Institute, Solna, Sweden ;
6 Liverpool John Moores University, School of Pharmacy and Chemistry, Liverpool, UK;
7 Procter & Gamble, Product Safety and Regulatory Affairs, Cincinnati, OH, USA;
8 Douglas Connect, Zeiningen, Switzerland;
9 Saarland University, Biochemical Engineering, Saarbrücken, Germany;
10 University Hospital Cologne, Institute for Neurophysiology, Cologne, Germany;
11 European Chemicals Agency, Helsinki, Finland;
12 Procter & Gamble, Central Product Safety Department, London, UK;
13 INSERM/UEVE 861, I-STEM/AFM, Evry, France;
14 U.S. Environmental Protection Agency, National Center for Computational Toxicology, Research Triangle Park, NC, USA;
15 Katholieke Universiteit Leuven, Interdepartmental Stem Cell Institute, Leuven, Belgium;
16 Unilever, Safety and Environmental Assurance Centre, Bedford, UK

Summary


SEURAT-1 is a European public-private research consortium that is working towards animal-free testing of chemical compounds and the highest level of consumer protection. A research strategy was formulated based on the guiding principle to adopt a toxicological mode-of-action framework to describe how any substance may adversely affect human health. The proof of the initiative will be in demonstrating the applicability of the concepts on which SEURAT-1 is built on three levels: (i) Theoretical prototypes for adverse outcome pathways are formulated based on knowledge already available in the scientific literature on investigating the toxicological modes-of-action leading to adverse outcomes (addressing mainly liver toxicity); (ii) adverse outcome pathway descriptions are used as a guide for the formulation of case studies to further elucidate the theoretical model and to develop integrated testing strategies for the prediction of certain toxicological effects (i.e., those related to the adverse outcome pathway descriptions); (iii) further case studies target the application of knowledge gained within SEURAT-1 in the context of safety assessment. The ultimate goal would be to perform ab initio predictions based on a complete understanding of toxicological mechanisms. In the near-term, it is more realistic that data from innovative testing methods will support read-across arguments. Both scenarios are addressed with case studies for improved safety assessment. A conceptual framework for a rational integrated assessment strategy emerged from designing the case studies and is discussed in the context of international developments focusing on alternative approaches for evaluating chemicals using the new 21st century tools for toxicity testing.

 

Keywords: alternatives to animal testing, integrated testing strategy, mode-of-action theory, proof-of-concept case studies, safety assessment

 

 

ALTEX (32)1: 9-24

DOI: http://dx.doi.org/10.14573/altex.1408041


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