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Annual Report for Fiscal Year 2016

Annual Report for Fiscal Year 2016

ICCVAM Test Method Evaluation Activities

ICCVAM received no formal test method nominations or submissions in FY 2016. 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 2016 are summarized in the table below.

Test Method Evaluation Activities in FY 2016

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. A manuscript describing strategies to predict animal and human skin sensitization of test results was published in FY 2016. Another manuscript describing a strategy to predict human skin sensitization potency is in preparation.
Electrophilic allergen screening assay This test method, nominated by NIOSH, is an in chemico assay intended to identify potential skin sensitizers. A validation study of the method is planned for FY 2017. Laboratories from three ICCVAM agencies will conduct the testing. NICEATM will coordinate the study and members of the ICCVAM Skin Sensitization Working Group will serve on the study management team.
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 to cause eye irritation. Training of participating labs is underway, with the first phase of chemical testing to begin in FY 2017.


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