Archive - Closed Recommendation
Different variants of the Cell Transformation Assay (CTA) have been in use since the 1970's and a rather consistent picture of the CTAs capacity to predict the carcinogenic potential of substances has been established. To further promote the use of CTAs for regulatory purposes ECVAM coordinated a study aiming at the standardisation and subsequent evaluation of three CTA protocols in terms of their transferability and reproducibility. The protocol variants addressed were the Syrian Hamster Embryo (SHE) CTA performed at pH 6.7 and at pH 7.0, and the BALB/c 3T3 mouse fibroblast cell line CTA. ECVAM requested the ECVAM Scientific Advisory Committee (ESAC) to review in detail the three validation reports and develop an ESAC Opinion on the performance of the three CTAs.
Based on the above, ECVAM developed the present recommendation. The aim of any ECVAM recommendation is to provide ECVAM's views on the validity of the test method(s) in question in addition to advice on possible regulatory applicability, limitations and proper scientific use of the test methods, and to suggest possible follow-up activities.
Documents open for commenting
The documents that are open for public commenting are divided into two separate parts:
Part 1: The ECVAM Recommendation with supportive background information and the ESAC Opinion
Part 2: The three validation reports and the ESAC Working Group peer review consensus report
- Syrian Hamster Embryonic (SHE) cell pH 6.7 Cell Transformation Assay - Prevalidation study Report
- Syrian Hamster Embryonic (SHE) cell pH 7.0 Cell Transformation Assay - Prevalidation study Report
- Balb/c 3T3 Cell Transformation Assay - Prevalidation study Report
- ESAC Working Group Peer Review Consensus Report on an ECVAM-coordinated prevalidation study concerning three protocols of the Cell Transformation Assay (CTA) for in vitro carcinogenicity testing
Please note that the ESAC Opinion (Annex 1 of Part 1) and the documents in Part 2 are finalised and will not be revised or changed following this open commenting round.
The dedicated ECVAM mailbox JRC-ECVAM-Recom@ec.europa.eu is the only procedure for submitting comments and comments received by other means will not be considered. Please use the designated template for comments.
Follow-up of comments
ECVAM reserves the rights to make any changes to the ECVAM Recommendation and the supportive background document following the commenting round, in addition to publishing the received comments on the ECVAM Website.