SaferWorldbyDesign: Case studies advancing skin safety assessment according to OECD guidelines

Within the SaferSkin application and collaboration we have established a framework for comparing the results in skin safety assessment from different weight of evidence and defined approaches including those approved under OECD guidance and methods under development and review. In this webinar, we discuss such approaches that combine the use of in silico and in vitro evidence supporting integrated approaches to testing and assessment with a focus on the endpoint of skin sensitisation. Data and models are organised in such an approach as a weight of evidence against the key events of the adverse outcome pathway supporting the risk assessment of product ingredients and preparation of regulatory dossiers.
In our case study approach we work through practical examples considering comparisons between the results of different methods and the defined approach procedures described in the OECD TG 497 guideline. The results include cases which are relatively straightforward and also ones which are more complicated e.g., having conflicting results between assays, differences in conclusions depending on the algorithm, experimental challenges, and cases where additional information is required. Recommendations for overcoming difficulties are provided and including proposals for new experiments for obtaining results with clearer classifications or points of departure for risk assessment. Here, we present the results of two case studies which (a) had inconsistent results from the existing defined approaches and (b) could not produce results because of experimental challenges. We ran the SENS-IS assay on these compounds and evaluated the benefit of running this assay for these cases.
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