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Archive - Closed Recommendation

This consultation was open for commenting from 09.12.11 to 31.12.11

Background
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 


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 word icon 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.