ECVAM-Coordinated Prevalidation Study of Three Cell Transformation Assays for Chemical Carcinogenicity Testing

A formal prevalidation study of the Syrian hamster embryo (SHE) Cell Transformation Assays (CTAs) performed at pH 6.7 and pH 7.0 and the BALB/c 3T3 CTA was coordinated by ECVAM. The study was designed to complement the findings of the OECD detailed review paper (DRP) on CTAs and aimed at refining and standardising existing protocols, and assessing their reliability. The study results were peer-reviewed by the ECVAM Scientific Advisory Committee, which concluded that the study succeeded in generating standardised, transferable and reproducible SHE protocols. Further evaluation and use of the BALB/c 3T3 protocol was recommended to expand reproducibility data. The study results, together with the OECD DRP extensive database, support the utility of the SHE assays for carcinogenicity potential assessment. Based on available data and a formal ECVAM Recommendation on CTA status, the OECD will discuss and decide the necessary follow-up work, possibly in view of test guideline development.

PHRAKONKHAM Pascal;  GRIESINGER Claudius;  HALDER Maria;  CORVI Raffaella; 

2013-11-28

SPEKTRUM AKAD VERLAG

JRC68293

1868-596X,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC68293,