Human data set for skin sensitization methods evaluation
Appropriate evaluation of new approach methodologies (NAMs) requires reference data for assessing the method’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, which that are routinely conducted using a wide range of materials. For this project, CPSC, FDA, and NICEATM scientists and collaborators in the German Federal Institute of Risk Assessment collected data from 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 (Strickland et al. 2023), which represents the largest set of human data ever assembled for the purpose of evaluating non-animal approaches for chemical safety testing, was characterized for physicochemical properties, chemical structure categories, and protein binding mechanisms. The data are publicly available via the Integrated Chemical Environment to serve as a resource for the development and evaluation of NAMs for skin sensitization testing.