On June 15, 2026, the National Institutes of Health (NIH) announced that moving forward, NICEATM will continue its important work as a division of the newly created NIH Office of Research Innovation, Validation, and Application (ORIVA). Soon, NICEATM content that you see on this webpage will be transitioned to the NIH ORIVA webpage. In the meantime, you can learn more about the new office and how it is structured.

https://ntp.niehs.nih.gov/go/n465041

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

To broaden the applicability of the Skin Sensitization Risk Assessment – Integrated Chemical Environment (SARA-ICE) defined approach (DA) across a wider range of chemicals, NICEATM and Unilever are seeking additional data to enhance and expand the model. Data should have been generated according to one of these Organisation for Economic Co-operation and Development (OECD) test guidelines:

  • Test No. 442C: In Chemico Skin Sensitisation (e.g., direct peptide reactivity assay or amino acid derivative reactivity assay)
  • Test No. 442D: In Vitro Skin Sensitisation (e.g., KeratinoSens™, EpiSensA, LuSens)
  • Test No. 442E: In Vitro Skin Sensitisation (e.g., human cell line activation test, GARD™skin, IL-8, U-SENS™)

Please contact Emily Reinke to submit your data or ask specific questions about this data request. View general information about submitting data to NICEATM.

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 NIH Integrated Chemical Environment (NICE) 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.

Reinke et al. (2026) compares SARA-ICE's performance in identifying sensitizers and non-sensitizers to that of other skin sensitization tests and defined approaches. Risk calls based on SARA-ICE points-of-departure were as or more protective than those based on human or mouse tests.

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

PCRM presented a webinar on “SARA-ICE: Points of Departure for Skin Sensitisation Risk Assessment with OECD GL 497” in October 2025. In this webinar, Georgia Reynolds, Unilever, and NICEATM scientist Emily Reinke, Inotiv (contractor supporting NICEATM) discussed the SARA-ICE tool for prediction of skin sensitization point-of-departure.

Additional Resources