Toxicology decision Tools - Integrated Test Strategies
A new paradigm for evaluating the safety of cosmetic products at L’Oréal
In the cosmetics sector like in other industries, the development of innovative products to meet the expectations of consumers is decisive. In this process of innovation, the first priority of the L’Oréal group remains the safety of consumers.

Historically, risk assessment in toxicology was mainly developed by using safety data generated from studies conducted on laboratory animals. Advances in technology and regulations over the last few years, in particular in the context of implementation of the 7th amendment to the European cosmetics directive, has led to a rethinking of evaluation methods for the safety of cosmetic products.

Considerable scientific challenges need to be met before animal tests can be completely replaced. However, based on L’Oréal’s commitment of over 20 years to the development of alternative tests and methods, and on the progress made over the last few years, partial replacement strategies are now possible for some toxicological endpoints.

By using a “tool kit” of recognized methods and tests, with established reliability and relevance, decision-making trees or “integrated test strategies (ITS)” were drawn up for specific toxicological endpoints such as genotoxicity, skin irritation, eye irritation, sensitivity, etc. Thus, although none of the methods taken separately could generate all the data required, their combination within specific architectures is the new paradigm for the evaluation of the safety of cosmetic products at L’Oréal.

Integrated test strategies combine all the methodological approaches (testing, extrapolation - read across – and/or modeling) with all the existing data. This data concerns the physical-chemical properties of ingredients, as well as the results of in vitro tests (conducted on reconstructed skin such as Episkin, for example), in vivo data (from animal experiments) gathered in the past, in silico data from modeling and the use of expert systems and, of course, existing clinical data. It should be remembered that L’Oréal has built up a heritage of existing data on about the 5 000 substances used in its products.

“This is long-winded work as new tests and new modeling tools are still being developed and validated. Our ITS are therefore constantly being revised to integrate the latest knowledge and create new-generation architectures with the aim of continuous improvement”, explains Pascal Berthe, Director, Worldwide Safety Evaluation, L’Oréal Research & Innovation

ITS are the keystone of safety evaluation at L’Oréal. In this context, it is crucial to maintain strong interaction between the scientists developing and validating in vitro tests and the in silico tools and the regulatory toxicologists to ensure consistency and continuity between science and technology. This approach has led to a rethinking of how safety evaluation information is managed overall. Ultimately, the implementation of ITS has significant consequences for research at L’Oréal. A multi-disciplinary research group is currently rethinking the whole process of R&D, design and methods for selecting raw materials in order to ensure the success of future developments. A revolution is underway.

J. Cotovio, Predictive Models & Methods

Meet our scientists at poster sessions and workshops

Agrostat 2016 is the 14th Symposium on Statistical Methods for the Food Industry (Lausanne, Switzerland 21st-24th March 2016). L’Oréal Research & Innovation was proud to sponsor this congress.

Discover our contributions for Sensometrics, Chemometrics and Risk & Process oral sessions.