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A cross-sector review of the demand for in vivo carcinogenicity studies

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Jun 29, 2016
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The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) of the European Commission's Joint Research Centre releases its report reviewing the current demand for in vivo carcinogenicity studies across chemical sectors within the European Union

The approaches for evaluating the carcinogenic potential of substances, including whether carcinogenicity studies should be conducted, differ substantially across sectors. Despite variations in testing schemes, the two-year bioassay study in rodents represents the standard element across all sectors. 

The use of the two-year rodent bioassay though has been questioned in the last decade due to a number of factors including the possible uncertainty associated with the extrapolation of results to humans and the fact that it is very expensive and time consuming. Moreover, the high number of animals used to test a chemical raises obvious ethical concerns. Not surprisingly, there is a strong demand for alternative non-animal assessment strategies and methods in this area.

Exploring opportunities to improve carcinogenicity assessment and reduce the reliance on animal testing, EURL ECVAM's review includes: a systematic review of the different regulatory testing schemes employed for industrial chemicals, biocidal products, human and veterinary medicines, pesticides and cosmetics; an analysis of the number of animals used per sector; and an estimation of the number of carcinogenicity and genotoxicity studies conducted or waived relative to the number of substances authorised per sector per year.

Results from this review will inform initiatives aimed at both reducing animal testing where it is still a requirement and ensuring adequate hazard assessment of substances in sectors where animal use is banned or limited.

The EURL ECVAM report: "Carcinogenicity testing for regulatory purposes in the European Union"

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