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Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions

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Abstract

The advent of new testing systems and “omics”-technologies has left regulatory toxicology facing one of the biggest challenges for decades. That is the question whether and how these methods can be used for regulatory purposes. The new methods undoubtedly enable regulators to address important open questions of toxicology such as species-specific toxicity, mixture toxicity, low-dose effects, endocrine effects or nanotoxicology, while promising faster and more efficient toxicity testing with the use of less animals. Consequently, the respective assays, methods and testing strategies are subject of several research programs worldwide. On the other hand, the practical application of such tests for regulatory purposes is a matter of ongoing debate. This document summarizes key aspects of this debate in the light of the European “regulatory status quo”, while elucidating new perspectives for regulatory toxicity testing.

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The authors gratefully acknowledge the input gained from numerous critical discussions with colleagues at the BfR.

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  1. German Federal Institute for Risk Assessment (BfR), Max-Dohrn-Strasse 8-10, 10589, Berlin, Germany

    Tewes Tralau, Michael Oelgeschläger, Rainer Gürtler, Gerhard Heinemeyer, Matthias Herzler, Thomas Höfer, Heike Itter, Thomas Kuhl, Nikola Lange, Nicole Lorenz, Christine Müller-Graf, Ulrike Pabel, Ralph Pirow, Vera Ritz, Helmut Schafft, Heiko Schneider, Thomas Schulz, David Schumacher, Sebastian Zellmer, Gaby Fleur-Böl, Matthias Greiner, Monika Lahrssen-Wiederholt, Alfonso Lampen, Andreas Luch, Gilbert Schönfelder, Roland Solecki, Reiner Wittkowski & Andreas Hensel

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Tewes Tralau and Michael Oelgeschläger are first authors.

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Tralau, T., Oelgeschläger, M., Gürtler, R. et al. Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions. Arch Toxicol 89, 823–850 (2015). https://doi.org/10.1007/s00204-015-1510-0

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