Skin Allergy Risk Assessment Model Development

This document is a technical report detailing the development of the Skin Allergy Risk Assessment (SARA) model by Unilever's Safety, Environmental & Regulatory Science team. The SARA model aims to estimate the point of departure (PoD) for skin sensitization and assess the risk associated with chemical exposure in consumer products. It incorporates a weight of evidence approach, utilizing various data sources including historical clinical data, in vitro studies, and in silico predictions. The report outlines the evolution of the SARA model from its initial prototype to its current version, highlighting key advancements such as the inclusion of new inputs and the establishment of a comprehensive database for reactivity classifications. Additionally, it discusses the model's performance in cross-validation exercises compared to traditional quantitative risk assessment methods, demonstrating improved discriminatory power for risk classification. The document also references relevant studies and methodologies that inform the SARA model's framework.