New Presentation: Next generation risk assessment for consumer safety of cosmetics: A case study approach

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The principles for the use of non-animal approaches in consumer safety risk assessments were recently outlined by the International Cooperation on Cosmetics Regulation (ICCR). A key principle is that modern risk assessments should be exposure led. This means that novel methods that are used to make decisions about human safety must be quantitative, so that and any predictions relating to dose must be interpretable in the context of actual levels of consumer exposure. Interpreting dose-response data from in vitro toxicity assays requires an understanding of both cellular exposure in in vitro assays and how these relate to in vivo internal concentrations. Understanding both dosimetry and physiologically-based kinetic (PBK) modelling have been identified as essential components for robust decision-making in Next Generation Risk Assessments (NGRA). An NGRA approach for skin allergy risk assessment (SARA) has been evaluated using six case study ingredients in two different product exposure scenarios will be described. This is a tiered model-based approach that integrates predictive chemistry expertise, historical in vivo data, in silico predictions and in vitro data to predict the probability of human skin sensitisation occurring following a given product exposure with explicit uncertainty. For evaluation of systemic toxicity using NGRA approaches, a series of case study chemicals (including caffeine, curcumin, bisdemethoxycurcumin, tetrahydrocurcumin, 6-gingerol and coumarin) are being evaluated in a joint research programme between Unilever and the US Environmental Protection agency (EPA). This uses selected ToxCast assays and high throughput transcriptomics together with in silico chemistry tools and PBK modelling. A key challenge with respect to the application of these tools for safety decision-making is a reliance on quantification of in vitro-to-in vivo extrapolation e.g. the concentration-dependent transition from adaptation to injury relies on an understanding of in vitro concentrations that relate to this `tipping point’. These case study examples are providing increasing confidence in the application of the ICCR principles for “Integrated Strategies for Safety Assessments of Cosmetic Ingredients” for robust decision-making in consumer safety.

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