{"id":13514,"date":"2026-02-01T23:37:46","date_gmt":"2026-02-01T22:37:49","guid":{"rendered":"https:\/\/www.estiv.org\/congress2026\/programme\/replacing-animals-in-therapeutic-monoclonal-antibody-approvals-4\/"},"modified":"2026-02-10T13:30:25","modified_gmt":"2026-02-10T12:30:25","slug":"evolution-of-an-oecd-test-guideline-and-application-beyond-integrated-nams-for-skin-sensitisation-hazard-and-point-of-departure-for-risk-assessment","status":"publish","type":"page","link":"https:\/\/www.estiv.org\/congress2026\/programme\/evolution-of-an-oecd-test-guideline-and-application-beyond-integrated-nams-for-skin-sensitisation-hazard-and-point-of-departure-for-risk-assessment\/","title":{"rendered":"Evolution of an OECD Test Guideline and Application Beyond; Integrated NAMs for Skin Sensitisation Hazard and Point of Departure for Risk Assessment"},"content":{"rendered":"\n

Chairs: <\/em> Georgia Reynolds & Bambou Tan<\/em><\/p>\n\n\n\n

Developing approaches for assessing skin sensitisation potential and potency of chemicals and ingredients have been an area of active research over many years. This has resulted in a variety of non-animal new approach methods (NAMs) aligned with key events described in the adverse outcome pathway (AOP) and many of which have been validated by the Organisation for Economic Co-operation and Development (OECD) as part of the test guideline programme. For practical application, these methods have been combined in a series of defined approaches (DAs) (OECD TG 497) and in integrated approaches to testing and assessment (IATA) that span use cases for hazard classification, sub-potency classification, and most recently, point of departure (PoD) determination for risk assessment. This session provides an overview of the changes in a recent update to OECD TG 497, including how similar methods can be used in DAs to increase flexibility in their application. In addition, a new computational model, SARA-ICE, is the first approach to be included in the guideline for defining a PoD. The session will showcase how the model can be applied and utilised in integrated frameworks, via use of case studies, to ensure a thorough assessment of skin sensitisation risk for safety assessment, ultimately leading to safer consumer products and improved regulatory compliance.<\/p>\n\n\n\n

Speakers<\/h2>\n\n\n\n
    \n
  1. Emily Reinke<\/a> – Transforming Skin Sensitization: the Evolution of the Defined Approaches for Skin Sensitization (OECD Test Guideline 497)<\/li>\n\n\n\n
  2. Donna Macmillan<\/a> – Best Practice Guidance to advance the acceptance of skin sensitization NAMs and NGRA<\/li>\n\n\n\n
  3. Georgia Reynolds<\/a> – SARA-ICE DA: Defining a PoD for Skin Sensitisation Risk Assessment<\/li>\n\n\n\n
  4. Nathalie Al\u00e9pee <\/a>– Integrated Approaches for Skin Sensitization Assessment: Optimizing Predictive Approaches within Best Guidance Practices<\/li>\n<\/ol>\n\n\n\n




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