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SARA-ICE Defined Approach added to OECD Skin Sensitization guideline

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Co-developed by Unilever and NICEATM, the SARA-ICE Defined Approach has been added to OECD GL497 and provides a quantitative prediction of chemical skin sensitization potency in humans.

SARA-ICE diagram

Unilever has over 20 years of experience developing, evaluating and apply non-animal approaches to skin allergy risk assessment, working collaboratively with a wide range of scientific research partners. Find out more here: https://sers.unilever.com/our-science/safety-without-animal-testing/skin-allergy/

In 2021 Unilever and the US NTP Interagency Centre for the Evaluation of Alternative Toxicological Methods, NICEATM began a collaboration to adapt the Unilever-developed Skin Allergy Risk Assessment (SARA) Defined Approach (DA) Bayesian statistical model (Gilmour et al. 2022: https://doi.org/10.1016/j.yrtph.2022.105159 (Opens in a pop-up window )) for regulatory use. This collaboration resulted in the development and evaluation of SARA – Integrated Chemical Environment (SARA-ICE) DA that enables a human point of departure to be predicted for use in skin sensitisation risk assessment.

SARA-ICE estimates the dose with a 1% chance of skin sensitization in a human population (ED01) using NICEATM ICE data on over 400 chemicals from in vivo (human predictive patch test or local lymph node assay) and in vitro (DPRA, kineticDPRA, KeratinoSens™, hCLAT, or U-SENS™) test methods.

SARA-ICE has been accepted by the Organization for Economic Co-operation and Development as one of the defined approaches for skin sensitization described in its Guideline 497.

Detailed information about SARA-ICE was published earlier this year in a peer-reviewed paper (Reinke et al. 2025: https://doi.org/10.1016/j.crtox.2024.100205 (Opens in a pop-up window )) and the tool is available via a web application on the US NTP webpage.

SARA-ICE Web App

The new web tool is an open-access, easy to use, user interface for running the SARA-ICE DA and predicting skin sensitization potency from an uploaded data set. The tool is available on this NTP Website Page (Opens in a pop-up window ).

A screenshot showing the SARA-ICE DA web tool.
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