NAM Use for Regulatory Application - SARA-ICE

SARA-ICE: Points of Departure for Skin Sensitisation Risk Assessment with OECD GL 497.

Watch the recording or access additional webinar resources, including presenter slides and Q&A report, at www.pcrm.org/SARA-ICEresources.

Wednesday, October 1, 2025

PRESENTER

Emily N. Reinke, Ph.D., D.A.B.T; Principal Investigator, Inotiv

ALSO FEATURING

Joe Reynolds, PhD; Mathematical Modeler, Unilever
Eryn Slankster-Schmierer, PhD; PCRM moderator

Skin sensitisation experts Emily Reinke, PhD, and Georgia Reynolds, MSc, collaborated to develop this NURA training on SARA-ICE: Points of Departure for Skin Sensitisation Risk Assessment with OECD GL 497.

After providing a brief background on the basics of skin sensitisation, Dr. Reinke reviewed the concepts of Adverse Outcome Pathways (AOPs) and how they are used in Defined Approaches to lay the groundwork for understanding OECD Test Guideline 497: Defined Approaches on Skin Sensitisation. She then discussed the Defined Approaches included in the guideline, how the guideline is structured, and what the new updates published in June 2025 entail. Dr. Reinke then presented the new in silico method known as SARA-ICE: Skin Sensitization Risk Assessment - Integrated Chemical Environment Model and gave a live demo along with an overview of how SARA-ICE was designed, the difference between models, and how it could be applied in a case study.

The training concluded with an extended audience-led Q&A session that also featured SARA-ICE developer, Joe Reynolds, PhD, a mathematical modeler at Unilever.

Learning Objectives:

• Understand the basic concepts of skin sensitisation and how it is assessed using a Defined Approach
• Learn about the Adverse Outcome Pathway and how it is used for skin sensitisation assessment
• Understand the contents of OECD Test Guideline 497 and the June 2025 updates
• Learn how and when to use SARA-ICE

Resource Links:

• OECD Guidance Document 497

• NIH-NTP SARA-ICE Model

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