SARA-ICE: Skin Sensitization Risk Assessment - Integrated Chemical Environment Model
Access the SARA-ICE Tool
Download SARA-ICE Template File for use in the tool
PCRM will present a webinar on “SARA-ICE: Points of Departure for Skin Sensitisation Risk Assessment with OECD GL 497” on Wednesday, October 1, at 10:00 a.m.-12 noon EDT.
In this webinar, Georgia Reynolds, Unilever, and NICEATM scientist Emily Reinke, Inotiv (contractor supporting NICEATM) will discuss the SARA-ICE tool for prediction of skin sensitization point-of-departure. The webinar will describe the adverse outcome pathways (AOP) concept and how AOPs are used in defined approaches. Presenters will review the defined approaches included in OECD Guideline (GL) 497 issued by the and what the updates published by OECD in June 2025 entail. The training will include a live demo of the SARA-ICE tool along with an overview of how SARA-ICE was designed, the difference between models, and how SARA-ICE could be applied in a case study.
The upcoming webinar is part of PCRM’s New Approach Methodologies (NAMs) Use for Regulatory Application (NURA) program. NURA is a continuing education program to provide toxicology professionals with specialized resources and basic hands-on training in nonanimal NAMs.
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 (Reinke et al. 2025). 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.).