Abstract
A new, freely available software for cosmetic products has been designed that considers the regulatory framework for cosmetics. The software allows an overall toxicological evaluation of cosmetic ingredients without the need for additional testing and, depending on the product type, it applies defined exposure scenarios to derive risk for consumers. It takes regulatory thresholds into account and uses either experimental values, if available, or predictions. Based on the experimental or predicted no observed adverse effect level (NOAEL), the software can define a point of departure (POD), which is used to calculate the margin of safety (MoS) of the query chemicals. The software also provides other toxicological properties, such as mutagenicity, skin sensitization, and the threshold of toxicological concern (TTC) to provide an overall evaluation of the potential chemical hazard. Predictions are calculated using in silico models implemented within the VEGA software. The full list of ingredients of a cosmetic product can be processed at the same time, at the effective concentrations in the product as given by the user. SpheraCosmolife is designed as a support tool for safety assessors of cosmetic products and can be used to prioritize the cosmetic ingredients or formulations according to their potential risk to consumers. The major novelty of the tool is that it wraps a series of models (some of them new) into a single, user-friendly software system.
Highlights
The European regulation on cosmetics represented a paradigm shift in Europe for the safety assessment of cosmetics, which transitioned from the classical toxicological approach based on animal testing towards a completely novel strategy, where the use of animals for toxicity testing is banned (EC, 2009)
We developed SpheraCosmolife, a unified software system intended to support risk assessors of cosmetic products and to assist companies to ensure the safety of their products, avoiding ingredients that may be of concern at a given concentration
The assessment of cosmetic ingredients can benefit from the hundreds of in silico models available that predict the properties of interest for many endpoints
Summary
The European regulation on cosmetics represented a paradigm shift in Europe for the safety assessment of cosmetics, which transitioned from the classical toxicological approach based on animal testing towards a completely novel strategy, where the use of animals for toxicity testing is banned (EC, 2009). The European strategy has been followed by an increasing number of countries in the world. Several ambitious projects have addressed sophisticated alternative testing strategies, such as the European initiatives SEURAT-12 (Berggren et al, 2017) and EU-ToxRisk. Using in silico tools is appealing because they can generate safety data for cosmetic ingredients without testing (Gellatly and Sewell, 2019; Taylor and Rego Alvarez, 2020). There are many tens of thousands of cosmetic ingredients, and this number poses an incredible challenge, for in vivo methods, and for other test methods. The possibilities that in silico models offer in this respect were demonstrated by calculating various properties for about 20,000 botanical ingredients of cosmetics (Raitano et al, 2019)
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