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Meeting of the ECVAM Scientific Advisory Committee (ESAC)

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Mar 28, 2011
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ESAC opinion discussed (prevalidation of three protocols of an in vitro cell transformation assay)

 

On 22-23 March 2011 the European Centre for Validation of Alternative Methods (ECVAM) Scientific Advisory Committee (ESAC) met at the Joint Research Centre in Ispra, Italy.

The ESAC discussed how its opinion, on the prevalidation of three protocols of an in vitro cell transformation assay (CTA) could support further steps towards the use of this assay in the assessment of the carcinogenic potential of substances. This opinion, adopted by ESAC in February 2011, had been transmitted to OECD. It will support discussions, among other topics, on the development of a test guideline for cell transformation assays at key OECD meetings coming in April 2011. ECVAM is preparing, on the basis of ESAC's advice, a recommendation on the status of the CTA assay.

The ESAC also started the preparation for the peer review of three validation studies and agreed on setting up dedicated ESAC Working Groups for this purpose. Two of the three studies concern test methods for skin sensitisation testing. These are:

  • an ECVAM-coordinated prevalidation study on the Direct Peptide Reactivity Assay (DPRA) and
  • an external prevalidation study on a cell-based reactivity assay.

The third one concerns an ECVAM-coordinated follow-up study with the 3T3 NRU cytotoxicity assay that was validated by NICEATM/ECVAM in 2004 for acute oral toxicity testing. The current follow-up study aimed to establish if that test could be used for identifying substances that do not require classification as acute oral toxicants under the EU Classification, Labelling and Packaging Regulation (EC) 1272/2008.

One session of the ESAC meeting was dedicated to detailed discussions on Performance Standards (PS), including the emerging OECD-concept of PS-based test guidelines ("PBTGs"), scientific and technical aspects of validation studies based on PS and ECVAM's approach to peer review of such studies. The ESAC furthermore addressed a request from ECVAM concerning the definition of performance standards for two in vitro eye irritation assays, the Cytosensor Microphysiometer and the Fluorescein Leakage test methods. Both were validated by ECVAM in 2009 and draft test guidelines are on the table of a forthcoming OECD meeting (April 2011). However, for the Cytosensor Microphysiometer method, performance standards are an essential pre-condition for adoption of the draft Test Guideline. It was agreed that ECVAM would prepare the performance standards and ESAC would then peer-review this work.

In a brief exchange of views concerning the recent Society of Toxicology conference the committee agreed with ECVAM that future developments in toxicology may require a re-examination of current approaches to validation and expressed interest to support ECVAM in such developments.

Finally, ESAC was informed about ongoing and planned activities at ECVAM and of the other validation bodies with whom ECVAM cooperates in the context of the International Cooperation on Alternative Testing Methods (ICATM). The OECD observer provided the committee with an update on developments in the OECD test guidelines programme and the responsible Commission services summarised briefly the revised Directive (2010/63/EU) on the protection of animals used for scientific purposes. It was highlighted that the Directive firmly embeds the 3Rs principle into European legislation and that ECVAM has now been legally mandated to act as the European Union Reference Laboratory for the promotion of alternative methods.

The next meeting of ESAC is planned for the 4-5th October 2011.

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