ICCVAM received no formal test method nominations or submissions in FY 2017. ICCVAM welcomes submissions of innovative test methods that might be acceptable for specific regulatory use and for which adequate validation studies have been completed. To maximize effective implementation of new test methods or approaches, however, ICCVAM evaluates and recommends only those test methods proposed for regulatory uses that align with ICCVAM member agencies’ needs and priorities. More information on ICCVAM test method submissions is available. ICCVAM test method evaluation activities in FY 2017 are summarized below.
Test Method Evaluation Activities in FY 2017
|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. Following publication in FY 2016 of two manuscripts describing strategies to predict animal and human skin sensitization of test results, a third manuscript describing a strategy to predict animal and human skin sensitization potency was published in FY 2017.|
|Electrophilic allergen screening assay||This test method, nominated by the National Institute of Occupational Safety and Health (NIOSH), is an in chemico assay intended to identify potential skin sensitizers. A validation study of the method began in FY 2017 with four ICCVAM agencies participating in the study. The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) coordinates the study, and members of the ICCVAM Skin Sensitization Workgroup serve on the study management team. Current efforts focus on testing a small group of blinded chemicals for a preliminary assessment of accuracy and reproducibility. The study is expected to continue through the end of FY 2018.|
|OptiSafe||NICEATM is coordinating a multilaboratory validation study to determine the reliability and relevance of the OptiSafe test method. In this method, a test substance is applied to a semipermeable membrane to assess the substance’s potential to cause eye irritation. Three participating laboratories completed testing of 30 chemicals in FY 2017. In FY 2018, the nominating laboratory will complete testing on 60 additional coded chemicals to expand the applicability of the method.|
|A cooperative agreement under the NIEHS Phase IIb Small Business Innovation Research is providing funding to MatTek Corporation to validate its EpiAirway™ in vitro human bronchial tissue model to predict the toxicity of inhaled chemicals. Several ICCVAM agency representatives are members of the cooperative agreement steering committee. In FY 2017, the steering committee recommended test chemicals to expand the domain of applicability, making EpiAirway™ more relevant to their respective agencies, and test chemicals are being procured. NICEATM provides scientific oversight of this NIEHS small business program supporting validation of alternative test methods.|
The 16 member agencies of ICCVAM are engaged in additional activities that support replacing, reducing, and refining animal use. Summaries of these activities can be found on the NTP website.