Curation of Eye and Skin Irritation Reference Data

Establishing confidence in alternatives to animal use for eye and skin irritation hazard assessment requires high-quality reference data for evaluation of new approaches. NICEATM works to identify high-quality data from scientific publications and public databases, extract the data and associated metadata, and characterize the usefulness of the resulting data sets for evaluation of new testing approaches.

Analysis of Variability in In Vivo Rabbit Skin Irritation Assay Data

Skin irritation testing is required for registration of many types of products. Characterizing the inherent variability in the historically used in vivo rabbit skin irritation test is critical to setting appropriate expectations for performance of new approach methodologies. NICEATM established a curated data set of in vivo skin irritation test results from substances that were tested multiple times (Rooney et al. 2021). With this data set, we assessed the reproducibility of the resulting hazard classifications using conditional probabilities. The results showed that, regardless of the classification system used, the extremes of the classification scales (corrosive or non-irritant) are the most reproducible, while substances classified as mild or moderate irritants are more likely to be classified in a different category when tested again. These analyses help provide much needed context not only to assess the reference in vivo test method but also to aid in setting expectations for performance of new approach methodologies.