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Alternatives to animal testing: EURL ECVAM publishes its Recommendation on a Cell Transformation Assay for carcinogenicity testing based on the Bhas 42 cell line

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Dec 17, 2013

In its Recommendation, EURL ECVAM summarises key performance parameters of this in vitro method and its use within integrated approaches to assessing the carcinogenicity potential of chemicals

On 17 December 2013 the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) of the European Commission's Joint Research Centre published its Recommendation on the Cell Transformation Assay (CTA) for carcinogenicity testing based on the Bhas 42 cell line.

cover page bhas recommendation

Testing the carcinogenic potential of chemicals is a key requirement for their regulatory safety assessment. Currently, only data from animal methods are accepted for this purpose. Among various alternatives developed for carcinogenicity assessment, the CTAs have been shown to recapitulate, in vitro, key stages of carcinogenesis: the transition of normal cells into cancer cells devoid of normal growth control. Bhas 42 cells are a line of immortalised rodent cells that have been selected due to their tendency to spontaneously change their growing behaviour when exposed to chemicals with cancer-causing properties.

Following publication in 2012 of its pdf icon Recommendation on Cell Transformation Assays using primary hamster cells, EURL ECVAM now publishes a Recommendation on a further variant based on the Bhas 42 cell line. The Recommendation is based on the results of a validation study coordinated by Hadano Research Institute (HRI), Food and Drug Safety Center (FDSC) in Japan and follows the study's scientific peer review by EURL ECVAM's Scientific Advisory Committee (ESAC).

In its Recommendation, developed in consultation with EU regulators, stakeholders and international partners, EURL ECVAM concludes that the Bhas 42 CTA can provide important information on the carcinogenicity potential of substances when used within integrated approaches for assessment and testing.

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