Moving forward in carcinogenicity assessment: Report of an EURL ECVAM/ESTIV workshop

Abstract

There is an increased need to develop novel alternative approaches to the two-year rodent bioassay for the carcinogenicity assessment of substances where the rodent bioassay is still a basic requirement, as well as for those substances where animal use is banned or limited or where information gaps are identified within legislation. The current progress in this area was addressed in a EURL ECVAM- ESTIV workshop held in October 2016, in Juan les Pins. A number of initiatives were presented and discussed, including data-driven, technology-driven and pathway-driven approaches. Despite a seemingly diverse range of strategic developments, commonalities are emerging. For example, providing insight into carcinogenicity mechanisms is becoming an increasingly appreciated aspect of hazard assessment and is suggested to be the best strategy to drive new developments. Thus, now more than ever, there is a need to combine and focus efforts towards the integration of available information between sectors. Such cross-sectorial harmonisation will aid in building confidence in new approach methods leading to increased implementation and thus a decreased necessity for the two-year rodent bioassay.

Keywords: Alternative methods; CTA; Cancer hallmarks; Carcinogenicity; Mechanisms; Rodent bioassay; Toxicogenomics.

Fig. 1

Identifying breast carcinogens using direct and indirect evidence. Outputs include chemicals of concern as well as biological processes to be included in toxicity screening. The steps in the blue box are the focus of the indirect evidences discussed within the text. (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.)

Fig. 2

Moving forward in carcinogenicity assessment. Integration of data, application of new technologies and approaches, regulatory relevance and acceptance across sectors can warrant a better carcinogenicity safety assessment.