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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. 2:

Milestones on the road towards a new approach to carcinogenicity testing

Date Event Who was involved
1995 Joint proposal for a new OECD TG for the in vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay (CTA) USA and France
1998 Workshop on “Cell transformation assays as predictors of carcinogenicity” ECVAM
2006 Workshop on “How to reduce false positive results when undertaking in vitro genotoxicity testing and thus avoid unnecessary follow-up animal tests” EURL ECVAM
2006–2011 EU-6 Framework Project CarcinoGENOMICS DG RTD / EU Consortium
2011 ESAC Opinion on prevalidation of in vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay EURL ECVAM
2012 ESAC opinion on validation of in vitro Bhas42 Cell Transformation Assay JaCVAM /EURL ECVAM
2009 Acceptance of transgenic models as alternative to bioassay in second species ICH
2013 ICH Regulatory Notice Document announcing the evaluation of an alternative approach to the 2-year rat carcinogenicity test ICH and Drug Regulatory Authorities
2015 Starting activity on IATA for non-genotoxic carcinogens OECD
2015 Adoption of Guidance Document No. 214 on the in vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay OECD
2016 Adoption of Guidance Document No. 231 on the in vitro Bhas42 Cell Transformation Assay OECD
2016 Inclusion of characteristics of carcinogens in systematic reviews for Monograph program IARC
2017 Initiation of the project on predicting carcinogenicity of agrochemicals EPAA

Abbreviations: DG RTD, EU Directorate General Research and Technological Development; ECVAM, European Centre for the Validation of Alternative Methods; EPAA, European Partnership for Alternative Approaches to Animal Testing; EURL, European Reference Laboratory; IARC, International Agency for Research on Cancer; ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; JaCVAM, Japanese Center for the Validation of Alternative Methods; OECD, Organisation for Economic Co-operation and Development