Wind of Change Challenges Toxicological Regulators

Tewes Tralau, Christian Riebeling, Ralph Pirow, Michael Oelgeschläger, Andrea Seiler, Manfred Liebsch, and Andreas Luch


German Federal Institute for Risk Assessment (BfR), Center for Alternative Methods to Animal Experiments (ZEBET), Berlin, Germany


Abstract

Background: In biomedical research, the past two decades have seen the advent of in vitro model systems based on stem cells, humanized cell lines, and engineered organotypic tissues, as well as numerous cellular assays based on primarily established tumor-derived cell lines and their genetically modified derivatives.


Objective: There are high hopes that these systems might replace the need for animal testing in regulatory toxicology. However, despite increasing pressure in recent years to reduce animal testing, regulators are still reluctant to adopt in vitro approaches on a large scale. It thus seems appropriate to consider how we could realistically perform regulatory toxicity testing using in vitro assays only.


Discussion and Conclusion: Here, we suggest an in vitro–only approach for regulatory testing that will benefit consumers, industry, and regulators alike.


Key words: alternative testing approach, chemical safety testing, in vitro testing strategy, in vivo testing, regulatory acceptance, stem cells, Tox-Test Dummy. 


Environ Health Perspect 120:1489–1494 (2012). http://dx.doi.org/10.1289/ehp.1104782 [Online 7 August 2012]


Address correspondence to A. Luch, German Federal Institute for Risk Assessment (BfR), Max-Dohrn Strasse 8–10, 10589 Berlin, Germany. Telephone: 49 30 18412 4538. E-mail: Andreas.Luch@bfr.bund.de


The authors declare they have no actual or potential competing financial interests.


Received 24 November 2011; Accepted 7 August 2012; Online 7 August 2012.