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EURL ECVAM Recommendation concerning the Cell Transformation Assays (CTA)

1. EURL ECVAM Recommendation, ESAC Opinion and ESAC WG Report

On 14.03.2012 EURL ECVAM published its recommendation concerning the Cell Transformation Assays (CTA) using Syrian Hamster Embryo Cells (SHE) and the BALB/c 3T3 Mouse Fibroblast Cell Line for In Vitro Carcinogenicity Testing, including the ESAC opinion (Annex 1) based on the ESAC Peer Review of an EURL ECVAM-coordinated validation study of three CTA protocols for in vitro carcinogenicity testing

pdf icon EURL ECVAM Recommendation. Annex 1: ESAC Opinion. Annex 2: EURL ECVAM request for ESAC advice
pdf icon 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


2. Relevant validation study reports

pdf icon Balb/c 3T3 Cell Transformation Assay - Prevalidation study Report                                                   
pdf icon Syrian Hamster Embryonic (SHE) cell pH 7.0 Cell Transformation Assay - Prevalidation study Report
pdf icon Syrian Hamster Embryonic (SHE) cell pH 6.7 Cell Transformation Assay - Prevalidation study Report


3. Summary of the changes made in response to public comments received

The draft EURL ECVAM recommendation concerning three CTAs (Syrian Hamster Embryo (SHE) CTA at pH 6.7, SHE CTA at pH 7.0 and BALB/c 3T3 CTA) for in vitro carcinogenicity testing was developed following the ESAC Opinion Nr. 2011.01. The draft recommendation was published as a Call for Comments on the IHCP Internet Webpage on 7 December 2011 with a deadline for comments of 31 December 2011.

Comments were received from six sources and only one issue was standing out and was addressed by four of the commenters; namely the fact that the SHE CTA uses primary cells from Syrian hamster embryos which is a disadvantage compared with the BALB CTA that apply a cell line. In addition two references have been updated and included in the Recommendation (FDA and SCCS). The recommendation benefited from the Call for Comments and some additional text has been introduced as follows:

  • Executive summary, 3rd bullet: A sentence has been added in the beginning: "The BALB CTA should from a 3R perspective be considered more appropriate than the SHE CTA since it uses a cell line."
  • Section 4, Impact on the 3Rs, paragraph 23: A sentence has been added at the end: ", however, it should be noted that from a 3R perspective the BALB is considerably more appropriate since it uses a cell line and not primary embryonic hamster cells, as is the case for the SHE CTA."