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Comments on the draft EURL ECVAM Recommendation Concerning Three Cell Transformation Assays (CTAs)

05.03.2012

Summary of the Call for Comments on the draft EURL ECVAM Recommendation Concerning Three Cell Transformation Assays (CTAs)

Alternative tests methods

The draft EURL ECVAM recommendation concerning three Cell Transformation Assays (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 and was open until 31 December 2011.

Comments were received from six sources and only one issue was standing out and was addressed by four of the commenter's; 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 (FDA and SCCS). The recommendation benefitted 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 three Rs, 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."

 

Download the final text of the Recommendation:

pdf icon EURL ECVAM RECOMMENDATION of 5th March 2012 on three Cell Transformation Assays using Syrian Hamster Embryo Cells (SHE) and the BALB/c 3T3 Mouse Fibroblast Cell Line for In Vitro Carcinogenicity Testing