Title: Analysis of carcinogenicity testing for regulatory purposes in the European Union
Authors: MADIA FEDERICAWORTH AndrewCORVI Raffaella
Publisher: Publications Office of the European Union
Publication Year: 2016
JRC N°: JRC100609
ISBN: 978-92-79-56876-3
ISSN: 1831-9424
Other Identifiers: EUR 27765
OP LB-NA-27765-EN-N
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC100609
DOI: 10.2788/547846
Type: EUR - Scientific and Technical Research Reports
Abstract: 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 validity of the two-year bioassay though has been questioned in the last decade. Uncertainty is associated with the extrapolation of data from rodents to humans. Furthermore, these studies are extremely time and resource-consuming; the high animal burden has raised ethical concerns. For all these reasons, there is a strong demand for alternative strategies and methods. The development of new in vitro methods for carcinogenicity testing, however, has progressed slowly and those available are far from being accepted for regulatory decision making, especially when evaluating the carcinogenicity of non-genotoxic chemicals or specific classes of compounds such as biologicals, microorganisms and nanomaterials. The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) has carried out an analysis of carcinogenicity testing requirements and assessment approaches across different sectors. This consisted of: a systematic review of the different testing requirements; a review of the number of animals used per sector; an estimation of the number of carcinogenicity and genotoxicity studies conducted or waived in respect of the number of substances authorized per sector per year; a review of the type of justifications for waiving the two-year bioassay and how opportunities for waiving are being used. Results from this analysis will provide context for initiatives aimed at: 1) reducing the need for animal use where animal testing is still a requirement; 2) ensuring an adequate carcinogenicity assessment in sectors where animal use is banned or limited; and 3) improving the process of cancer hazard identification where existing methods are not suitable.
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