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Consensus Report on the Future of Animal-Free Systemic Toxicity Testing
Animal Research, Testing, and Experimentation
  • Marcel Leist, University of Konstanz
  • Nina Hasiwa, University of Konstanz
  • Costanza Rovida, University of Konstanz
  • Mardas Daneshian, University of Konstanz
  • David Basketter, DABMEB Consultancy Ltd
  • Ian Kimber, University of Manchester
  • Harvey Clewell, Hamner Institutes for Health Sciences
  • Tilman Gocht, Eberhardt Karls University
  • Alan Goldberg, Johns Hopkins University
  • Francois Busquet, University of Konstanz
  • Anna-Maria Rossi, University of Konstanz
  • Michael Schwarz, Eberhardt Karls University
  • Martin Stephens, Johns Hopkins University
  • Rob Taalman, Cosmetics Europe
  • Thomas B. Knudsen, Environmental Protection Agency
  • James McKim, CeeTox
  • Georgina Harris, Johns Hopkins University
  • David Pamies, Johns Hopkins University
  • Thomas Hartung, University of Konstanz
Document Type
Report
Publication Date
1-1-2014
Abstract

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.

Comments

A report of t4 – the transatlantic think tank for toxicology, a collaboration of the toxicologically oriented chairs in Baltimore, Konstanz and Utrecht, sponsored by the Doerenkamp-Zbinden Foundation.

All authors contributed to this report as individuals, and not as representatives of their organizations. Statements and opinions expressed in this review do not reflect official policies or any other form of positioning of the affiliations of the authors. The text is a consensus document expressing not at each point the exact position of each author. Statements only reflect the majority of the group and not all minority opinions have been included.

Citation Information
Leist, M., Hasiwa, N., Rovida, C., Daneshian, M., Basketter, D., Kimber, I., ... & Rossi, A. M. (2014). Consensus report on the future of animal-free systemic toxicity testing. Alternatives to Animal Experimentation: ALTEX, 31(3), 341-356.