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EURL ECVAM Recommendation on the KeratinoSens™ assay for skin sensitisation testing

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

On 17.02.2014 EURL ECVAM published its Recommendation on the KeratinoSens assay for skin sensitisation 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 a Givaudan-coordinated study transferability and reliability of the KeratinoSens assay for skin sensitisation testing


2. Relevant validation study reports

pdf icon ECVAM Test Submission Template (TST) KeratinoSens assay for the testing of skin sensitizers
pdf icon Attachments
pdf icon Summary sheet of the KeratinoSens assay prepared by EURL ECVAM




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

The recommendation was open for public comments from 15.11.2013 to 29.11.2013. One comment was received which led to following amendment in the document:

  • Considering that there is limited information on the performance of the assay with mixtures including plant extracts, the follow-up recommendations (section 6 of the recommendation) were slightly restructured to improve the proposals towards a better characterisation of potential limitations (including limited data on mixtures), the predictive capacity and  applicability of the assay. A reference to a published study using the KeratinoSens test method to assess plant extracts was included.