Applying a next generation risk assessment framework for skin sensitisation to inconsistent new approach methodology information

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Nicola Gilmour , Nathalie Alépée, Sebastian Hoffmann, Petra Kern, Erwin Van Vliet, Dagmar Bury, Masaaki Miyazawa, Hayato Nishida, Cosmetics Europe
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Cosmetic products must be safe for their intended use. Regulatory bans on animal testing for new ingredients have resulted in a shift towards the use of new approach methodologies (NAMs) such as in silico predictions and in chemico / in vitro data. Defined approaches (DAs) have been developed to interpret combinations of NAMs to provide information on skin sensitization hazard and potency, three having been adopted within OECD Test Guideline 497. However, the challenge remains as to how DAs can be used to derive a quantitative point of departure for use in next generation risk assessment (NGRA). Here we provide an update to our previously published NGRA framework and present two hypothetical consumer risk assessment scenarios (rinse-off and leave-on) on one case study ingredient. Diethanolamine (DEA) was selected as the case study ingredient based on the existing NAM information demonstrating differences with respect to the outcomes from in silico predictions and in chemico / in vitro data. Seven DAs were applied, and these differences resulted in divergent DA outcomes and reduced confidence with respect to the hazard potential and potency predictions. Risk assessment conclusion for the rinse-off exposure led to an overall decision of safe for all applied DAs. Risk assessment conclusion for the higher leave-on exposure was safe when based on some DAs but unsafe based on others. The reasons for this were evaluated as well as the inherent uncertainty from the use of each NAM and DA in the risk assessment, enabling further refinement of our NGRA framework.

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Gilmour, N. (2023) “Applying a next generation risk assessment framework for skin sensitisation to inconsistent new approach methodology information”, ALTEX - Alternatives to animal experimentation, 40(3), pp. 439–451. doi: 10.14573/altex.2211161.

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