Development of a next generation risk assessment framework for the evaluation of skin sensitisation of cosmetic ingredients.

Development of a next generation risk assessment framework for the evaluation of skin sensitisation of cosmetic ingredients. Regul Toxicol Pharmacol. 2020 Jul 06;:104721 Authors: Gilmour N, Kern PS, Alépée N, Boislève F, Bury D, Clouet E, Hirota M, Hoffmann S, Kühnl J, Lalko JF, Mewes K, Miyazawa M, Nishida H, Osmani A, Petersohn D, Sekine S, van Vliet E, Klaric M Abstract All cosmetic products placed onto the market must undergo a risk assessment for human health to ensure they are safe for consumers, including an assessment of skin sensitisation risk. Historically, in vivo animal test methods were used to identify and characterise skin sensitisation hazard, however non-animal and other new approach methodologies (NAMs) are now the preferred and mandated choice for use in risk assessment for cosmetic ingredients. The experience gained over the last three decades on how to conduct risk assessments based upon NAMs has allowed us to develop a non-animal, next generation risk assessment (NGRA) framework for the assessment of skin sensitisers. The framework presented here is based upon the principles published by the International Cooperation on Cosmetic Regulation (ICCR) and is human relevant, exposure led, hypothesis driven and designed to prevent harm. It is structured in three tiers and integrates all relevant information using a weight of evidence (WoE) approach that can be iterated when new information becomes available. The in...
Source: Regulatory Toxicology and Pharmacology : RTP - Category: Toxicology Authors: Tags: Regul Toxicol Pharmacol Source Type: research