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Annual Report for Fiscal Year 2015

Annual Report for Fiscal Year 2015

ICCVAM Test Method Evaluation Activities

ICCVAM received no formal test method nominations or submissions in FY 2015. ICCVAM welcomes submissions of innovative test methods, which may be acceptable for specific regulatory use and for which adequate validation studies have been completed. However, to maximize the potential for effective implementation of new test methods or approaches, ICCVAM only conducts evaluations and prepares recommendations on test method submissions proposed for regulatory uses that align with ICCVAM member agencies needs and priorities. More information on ICCVAM test method submissions is available. NICEATM and ICCVAM test method evaluation activities in FY 2015 are summarized in the table below.

Test Method Evaluation Activities in FY 2015

Test Method ICCVAM Recommendations/Agency Status
ICCVAM integrated decision strategy for skin sensitization ICCVAM developed integrated decision strategies using in vitro, in chemico, and in silico information based on an established skin sensitization adverse outcome pathway. Three manuscripts describing different strategies and targets are in preparation.
Electrophilic allergen screening assay This test method, nominated by NIOSH, is an in chemico assay intended to identify potential skin sensitizers. NICEATM worked with the sponsor to address technical issues with the assay.
OptiSafe ocular irritation test NICEATM is coordinating the validation of the in vitro Optisafe ocular irritation test method. In this method, a test substance is applied to a semipermeable membrane and damage to macromolecules in the membrane is measured to assess the substance’s potential of the substance to cause eye irritation. NICEATM staff and ICCVAM Ocular Toxicity Working Group members will serve on a validation management team to provide oversight and direction for a multilaboratory validation study. Testing should be completed in FY 2016, along with a study report detailing the results.


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