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. Author manuscript; available in PMC: 2019 Aug 16.
Published in final edited form as: ALTEX. 2018;35(2):139–162. doi: 10.14573/altex.1804051

Tab. 3:

Milestones on the road towards a new approach to DART

Date Event Who was involved
2002 Validation of three embryotoxicity tests ECVAM, ZEBET, RIVM
unclear Zebrafish for DART Many groups, currently validated by EBTC
2005–2010 ReProTect ECVAM, University Tübingen (Coordinator Michael Schwarz), 35 partners
2009 Stemina DevTox assay commercially available Stemina
2012 Acceptance of extended one-generation reproductive toxicity study ECVAM, ECHA
2008–2017 Definition of TTC BASF SE, CAAT
2017 Draft Guidance “Detection of toxicity to reproduction for human pharmaceuticals” including suggested reference chemicals for characterizing alternative DART assays ICH

Abbreviations: BASF SE, German chemical company; CAAT, Center for Alternatives to Animal Testing at Johns Hopkins University; EBTC, Evidence-based Toxicology Collaboration; ECHA, European Chemicals Agency; ECVAM, European Centre for the Validation of Alternative Methods; ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; RIVM, Netherlands National Institute for Public Health and the Environment; ZEBET – Center for Documentation and Evaluation of Alternative Methods to Animal Experiments at the German Federal Institute for Risk Assessment