Chairs: Emily Reinke & Bambou Tan
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.
Speakers
- Emily Reinke – Transforming skin sensitization: the evolution of the defined approaches for skin sensitization (OECD Test Guideline 497)
- Donna Macmillan – Best practice guidance to advance the acceptance of skin sensitization NAMs and NGRA
- Predrag Kukic – SARA-ICE DA: defining a PoD for skin sensitisation risk assessment
- Nathalie Alépee – Integrated approaches for skin sensitization assessment: optimizing predictive approaches within best guidance practices