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ICCVAM Evaluation of In Vitro Assays to Identify Potential Sensitizers

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NICEATM and ICCVAM are evaluating the application of in vitro methods and integrated decision strategies for the regulatory safety assessment of allergic contact dermatitis hazards. This includes validation of two in vitro cell culture-based methods and one in chemico direct peptide reactivity assay. A European Centre for the Validation of Alternative Methods (ECVAM) study management team with liaisons from NICEATM, ICCVAM, and the Japanese Center for the Validation of Alternative Methods is leading the validation studies.

In September 2009, ECVAM launched an open call to invite laboratories to participate in the initial phase (phase III prevalidation) of the evaluation of three test methods designed for the assessment of the skin sensitization potential of substances. The three methods are: 1) the direct peptide reactivity assay, 2) the myeloid U937 skin sensitization test (MUSST) and 3) the human cell line activation test (h-CLAT). Within this project the selected laboratories will work in close contact with multinational companies as well as the European Commission Joint Research Centre.

View information about the Open Call for Tender (expired October 2009), including technical specifications, on ECVAM website

NICEATM is evaluating the integration of various types of physical-chemical properties and in vitro data with uncertain in vivo test results to determine decision algorithms that can be used for regulatory safety decisions. NICEATM and ICCVAM will also propose in vitro assays that can be used with high-throughput screening (HTS) platforms in order to increase the accuracy of in vitro predictions of allergic contact dermatitis. NICEATM will evaluate the HTS results to identify the most useful assays.

























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