The 2-year rodent bioassay (OECD Test Guideline 451) remains the “gold standard” for carcinogenicity testing, particularly for the identification of substances with a non-genotoxic mode of action. However, it is a lengthy and expensive process with high animal burden, and sectorial regulatory frameworks increasingly allow the assay to be waived in cases where it may not add value to an assessment of human cancer risk. The report of a workshop held by the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and the European Society of Toxicology In Vitro (ESTIV) is now available. This discusses the current state of the science on alternatives to the 2-year rodent bioassay, and the need to integrate these alternatives into a novel approach for accurate carcinogenicity hazard assessment (both where the 2-year rodent bioassay is still a (regulatory) requirement and in sectors where animal testing is banned or limited). In order to move forward in this area of risk assessment, the workshop noted the need for cross-sectorial sharing of data, experiences and approaches; it concluded that, to reduce reliance on the 2-year rodent bioassay, an integrated approach was required that encompassed epidemiological, traditional and alternative toxicological data.

Corvia R et al. (2017). Report of an EURL ECVAM/ ESTIV workshop: Moving forward in carcinogenicity assessment. Toxicology in Vitro 45, 278-286.


The above items were taken from the March 2018 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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