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ICCVAM Biennial Report 2020-2021

Biennial Progress Report 2020-2021 Interagency Coordinating Committee on the Validation of Alternative Methods

Compilation of Human Skin Sensitization Data

Appropriate evaluation of NAMs requires reference data for assessing a NAM's ability to predict an outcome of interest. Human data provide the most relevant basis for such comparisons, but they are rarely available due to obvious ethical issues associated with toxicology testing in humans. One exception is data from skin sensitization tests that are routinely conducted using a wide range of materials. For this project, CPSC, FDA, and NICEATM scientists and collaborators collected data from 2,277 human predictive patch tests conducted under two protocols: the human repeat insult patch test and the human maximization test. Data were collected from more than 1,500 publications. The data collection process also captured protocol elements and positive or negative outcomes, calculated traditional and non-traditional dose metrics, and developed a scoring system to evaluate each test for reliability. The resulting database, which contains information for 1,366 unique substances, was characterized for physicochemical properties, chemical structure categories, and protein binding mechanisms. A description of the database (Strickland et al.) was presented at the 2021 ASCCT annual meeting, and a publication is being drafted for submission in 2022. The data are publicly available via ICE to serve as a resource for the development and evaluation of NAMs for skin sensitization testing.