Presentation: Next generation risk assessment (NGRA) case study: use of 0.1% coumarin in face cream

Several theoretical frameworks describing a tiered approach for NGRA have been published over the past few years (Berggren et al. 2017; Dent et al. 2018), but concrete next generation risk assessment (NGRA) examples of how to analyse, integrate and interpret all the data obtained from new approach methodologies (NAMs) in order to inform a safety decision are still lacking. Confidence in applying NAMs in a decision-making context will only come with learning by doing and sharing more case studies. Therefore, this session aims to share our recent NGRA case study work (Baltazar et al. 2020; Hatherell S. et al. 2020; Moxon et al. 2020) where we integrated currently available NAMs in a hypothetical safety assessment of 0.1% coumarin in a face cream to make a safety decision without using any animal data. The objective of this session is to explore the different elements that form the basis of a NGRA approach, including an overview of the NAMs used (e.g. PBK modelling, Eurofins Safety44™ screen, BioMap® Diversity 8 Panel, high-throughput transcriptomics etc.,) followed by an in-depth discussion of the different elements of this case study: 1) exposure information and collation of existing information; 2) In vitro biological activity characterisation; 3) refinement steps; 4) margin of safety calculation and 5) risk assessment conclusion. Each section will include a short presentation followed by an interactive session (e.g. Q&A and/or polls). At the end of session participants will have the opportunity to share their confidence in the NGRA decision-making approach, any remaining uncertainties and suggest additional work to address identified data/knowledge gaps.

View the presentation here.


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