Abstract
Cosmetic products need to have a proven efficacy combined with a comprehensive toxicological assessment. Before the current Cosmetic regulation N°1223/2009, the 7th Amendment to the European Cosmetics Directive has banned animal testing for cosmetic products and for cosmetic ingredients in 2004 and 2009, respectively. An increasing number of alternatives to animal testing has been developed and validated for safety and efficacy testing of cosmetic products and cosmetic ingredients. For example, 2D cell culture models derived from human skin can be used to evaluate anti-inflammatory properties, or to predict skin sensitization potential; 3D human skin equivalent models are used to evaluate skin irritation potential; and excised human skin is used as the gold standard for the evaluation of dermal absorption. The aim of this manuscript is to give an overview of the main in vitro and ex vivo alternative models used in the safety testing of cosmetic products with a focus on regulatory requirements, genotoxicity potential, skin sensitization potential, skin and eye irritation, endocrine properties, and dermal absorption. Advantages and limitations of each model in safety testing of cosmetic products are discussed and novel technologies capable of addressing these limitations are presented.
Highlights
Cosmetic products need to have a proven efficacy combined with a comprehensive toxicological assessment
This review discusses the main in vitro alternative models used in safety testing of cosmetic products and cosmetic ingredients with a focus on regulatory requirements, genotoxicity potential, skin sensitization potential, skin and eye irritation, endocrine properties, and dermal absorption
For chemicals of hitherto unknown sensitization potential, the preclinical evaluation of cosmetic ingredients using the New Approach Methods (NAMs) strategies described above is an essential and important first step to ensure the safety profile of cosmetics, and as described in [71], post-market surveillance, often referred to as cosmetovigilance, will remain an important part to ensure that the use of cosmetic ingredients, as well as their concentration in formulated products remain safe to the consumers
Summary
Manon Barthe 1 , Clarisse Bavoux 2 , Francis Finot 3 , Isabelle Mouche 3 , Corina Cuceu-Petrenci 3 , Andy Forreryd 4 , Anna Chérouvrier Hansson 4 , Henrik Johansson 4 , Gregory F. Lemkine 5 , Jean-Paul Thénot 1 and Hanan Osman-Ponchet 1, *. A.; Johansson, H.; Lemkine, G.F.; Thénot, J.-P.; et al Safety Testing of Cosmetic Products: Overview of Established Methods and New
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