Skin Allergy Risk Assessment Model Overview

This document is a technical report detailing the Skin Allergy Risk Assessment (SARA) Model developed by Unilever. The SARA Model operates within a Next Generation Risk Assessment (NGRA) framework to estimate the point of departure for sensitizing doses of chemicals based on specific data. It provides a risk metric that assesses the probability of consumer exposure being classified as low risk. The report outlines the development of a Bayesian statistical model that estimates a no-effect dose from human repeat insult patch test (HRIPT) data. The SARA Model utilizes a database of 428 chemicals and incorporates various assay inputs to benchmark risk. The document also discusses the GARDskin Dose-Response assay as a potential input for the SARA Model, examining its correlation with the estimated threshold concentration for skin sensitization. Additionally, it addresses the performance of the model with various chemicals and highlights the need for further reproducibility data to enhance its accuracy.