title: Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions.
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.
authors.affiliation: German Federal Institute for Risk Assessment (BfR), Max-Dohrn-Strasse 8-10, 10589, Berlin, Germany.
authors.forename: Tewes
authors.initials: T
authors.lastname: Tralau
authors.forename: Michael
authors.initials: M
authors.lastname: Oelgeschläger
authors.forename: Rainer
authors.initials: R
authors.lastname: Gürtler
authors.forename: Gerhard
authors.initials: G
authors.lastname: Heinemeyer
authors.forename: Matthias
authors.initials: M
authors.lastname: Herzler
authors.forename: Thomas
authors.initials: T
authors.lastname: Höfer
authors.forename: Heike
authors.initials: H
authors.lastname: Itter
authors.forename: Thomas
authors.initials: T
authors.lastname: Kuhl
authors.forename: Nikola
authors.initials: N
authors.lastname: Lange
authors.forename: Nicole
authors.initials: N
authors.lastname: Lorenz
authors.forename: Christine
authors.initials: C
authors.lastname: Müller-Graf
authors.forename: Ulrike
authors.initials: U
authors.lastname: Pabel
authors.forename: Ralph
authors.initials: R
authors.lastname: Pirow
authors.forename: Vera
authors.initials: V
authors.lastname: Ritz
authors.forename: Helmut
authors.initials: H
authors.lastname: Schafft
authors.forename: Heiko
authors.initials: H
authors.lastname: Schneider
authors.forename: Thomas
authors.initials: T
authors.lastname: Schulz
authors.forename: David
authors.initials: D
authors.lastname: Schumacher
authors.forename: Sebastian
authors.initials: S
authors.lastname: Zellmer
authors.forename: Gaby
authors.initials: G
authors.lastname: Fleur-Böl
authors.forename: Matthias
authors.initials: M
authors.lastname: Greiner
authors.forename: Monika
authors.initials: M
authors.lastname: Lahrssen-Wiederholt
authors.forename: Alfonso
authors.initials: A
authors.lastname: Lampen
authors.forename: Andreas
authors.initials: A
authors.lastname: Luch
authors.forename: Gilbert
authors.initials: G
authors.lastname: Schönfelder
authors.forename: Roland
authors.initials: R
authors.lastname: Solecki
authors.forename: Reiner
authors.initials: R
authors.lastname: Wittkowski
authors.forename: Andreas
authors.initials: A
authors.lastname: Hensel
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence / Q000379:methods*; D000818:Animals; D005060:Europe; D033161:Government Regulation; D006801:Humans; D013045:Species Specificity; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards / Q000639:trends; D014116:Toxicology / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards / Q000639:trends; D014481:United States