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

• Published in: Archives of toxicology Vol. 89; no. 6; pp. 823 - 850
• Main Authors: Tralau, Tewes, Oelgeschläger, Michael, Gürtler, Rainer, Heinemeyer, Gerhard, Herzler, Matthias, Höfer, Thomas, Itter, Heike, Kuhl, Thomas, Lange, Nikola, Lorenz, Nicole, Müller-Graf, Christine, Pabel, Ulrike, Pirow, Ralph, Ritz, Vera, Schafft, Helmut, Schneider, Heiko, Schulz, Thomas, Schumacher, David, Zellmer, Sebastian, Fleur-Böl, Gaby, Greiner, Matthias, Lahrssen-Wiederholt, Monika, Lampen, Alfonso, Luch, Andreas, Schönfelder, Gilbert, Solecki, Roland, Wittkowski, Reiner, Hensel, Andreas
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.06.2015; Springer Nature B.V
• Subjects: Animal Testing Alternatives - legislation & jurisprudence; Animal Testing Alternatives - methods; Animals; Biomedical and Life Sciences; Biomedicine; Environmental Health; Europe; Government Regulation; Humans; Occupational Medicine/Industrial Medicine; Pharmacology/Toxicology; Regulation; Review Article; Species Specificity; Spectrum analysis; Toxicity Tests - methods; Toxicity Tests - standards; Toxicity Tests - trends; Toxicology; Toxicology - legislation & jurisprudence; Toxicology - methods; Toxicology - standards; Toxicology - trends; United States; United States; Europe; REACH; Toxicology future; Food and feed; Consumer products; Contaminants; Plant protection products; Toxicity testing; Regulatory toxicology; Biocides; Alternatives to animal testing; Tox21; BfR
• ISSN: 0340-5761; 1432-0738; 1432-0738
• DOI: 10.1007/s00204-015-1510-0

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.