Skin Sensitization:
Evaluation and Optimization of Skin Sensitization NGRA for Natural Complex Substances (NCS)
Objective
Establish a solid foundation by substantiating preliminary exposure-based waiving thresholds for NCS. These thresholds would provide a basis for determining when further testing is required based on the level of dermal exposure.
Evaluate and adapt the key components of the skin sensitization NGRA framework, specifically tailored to the unique characteristics of NCS. This adaptation should encompass various aspects, such as conducting a Weight of Evidence (WoE) assessment when dermal exposure exceeds the established thresholds and exploring the suitability of non-animal skin sensitization NAM as a leading option for generating new data.
Develop NGRA case studies that test the proposed thresholds (objective 1) and demonstrate how to apply the adapted framework (objective 2) in real-world risk assessment scenarios.