SARA-ICE: Skin Sensitization Risk Assessment - Integrated Chemical Environment Model

There is an international need for non-animal approaches to identify potential skin sensitizers. While defined approaches (DAs) are accepted for making a binary prediction of whether or not a substance might be a skin sensitizer (as described in OECD Guideline 497), there remains a need for non-animal approaches for quantitative prediction of skin sensitizer potency. 

The Skin Sensitization Risk Assessment – Integrated Chemical Environment (SARA-ICE) DA is a Bayesian statistical model developed in a collaboration between NICEATM and the consumer products company Unilever. SARA-ICE estimates a human-relevant metric of skin sensitizer potency. This metric, termed ED01, is the dose with a 1% chance of human skin sensitization. SARA-ICE uses data on over 400 chemicals from the NICEATM Integrated Chemical Environment (ICE) to predict a point-of-departure using any combination of in vivo (human predictive patch test or local lymph node assay) and in vitro (direct peptide reactivity assay [DPRA], kinetic DPRA, KeratinoSens™, human cell line activation test, or U-SENS™) data.

Download the SARA-ICE database (May 2023 - read-only Excel file)

The SARA-ICE model was described in presentations at the 2024 Society of Toxicology meeting (Maxwell et al., "New Approach Methods: Computational" poster session and Reinke et al. "New Approach Methods: Computational" poster session) and the 2024 annual meeting of the American Society for Cellular and Computational Toxicology (Reinke et al.). 

Resources to enable broad application of the SARA-ICE model will be available on this page soon, including a SARA-ICE web application, user guide, and training video.