Christian Pellevoisin
Episkin Academy, France
Title: Reconstructed skin models and methods for hazard and risk assessment of chemicals and cosmetics
Biography
Biography: Christian Pellevoisin
Abstract
In 2003, the 7th Amendment to the Cosmetics Directive introduced in Europe the regulatory framework for the phasing out of animal testing for cosmetics purposes. Since 2013, this testing and marketing ban fully entered in force and is now part of the European Cosmetic Regulation. Following this European regulation, we observe outside Europe a strong trend for a progressive shift to non-animal methods for safety of ingredients and cosmetics products. Mechanistic approaches to replace the animal are based on in silico, in chemico and in vitro assays that can inform on one or more key events of adverse outcome pathways (AOP). To be as predictive as possible of human being, such individual in vitro test systems rely more and more on cells of human origin with a 3D organization which better mimic the vivo situation. To this point of view, Reconstructed Human Epidermis (RHE) presents several advantages that make it an alternative method of choice for evaluating some safety endpoints. To date, several alternative methods in toxicology have been developed based upon in vitro skin: Skin penetration, skin corrosion/irritation, phototoxicity and genotoxicity. However, an in vitro alternative method must be validated before being recognized by the concerned regulatory bodies. Today, two alternative methods based on in vitro skin models have been validated as full replacement methods to animal, the OECD-TG 431 for in vitro skin corrosion and the OECD-TG 439 for in vitro skin irritation of chemicals. Moreover, two other methods based on human reconstructed epidermis and full thickness models have been submitted for validation in the field of sensitization and genotoxicity.