Assessment of an ex vivo irritation test performed on human skin explants and comparison of its results with those of a 24-/48-h human patch test for the evaluation of cosmetics.

Assessment of an ex vivo irritation test performed on human skin explants and comparison of its results with those of a 24-/48-h human patch test for the evaluation of cosmetics.
Toxicol In Vitro. 2020 Oct 12;:105030
Authors: Matarrese P, Beauchef G, Peno-Mazzarino L, Lati E, Fitoussi R, Vié K
Abstract
When developing new cosmetics, it is extremely important to consider the safety of consumers. Absence of potential irritancy is generally assessed using an OECD TG439 compliant Reconstructed Human Epidermis (RHE) systems and MTT assays, resulting in an irritant/not irritant classification. To gain insight into the irritancy of molecules/finished cosmetic products and to predict the outcome of irritation tests performed on subjects whatever their nature, we developed a test that uses skin explants and histological analysis. Results showed that this irritation test is sensitive enough to accurately and repeatably detect known irritants. If the diverse origin of the skin explants used led to variability in the histological alterations scored, the overall grading of irritancy is highly reproducible. Finally, when testing 120 non-alcoholic cosmetics of various galenic forms, comparison of data between the ex vivo irritation tests and of a 24-/48-h human patch test revealed a single false negative, very close to the limit, and a 10% false positive rate. It was not possible to calculate the sensitivity of the ex vivo irritation test; however...

Source: Toxicology in Vitro - October 12, 2020 Category: Toxicology Authors: Matarrese P, Beauchef G, Peno-Mazzarino L, Lati E, Fitoussi R, Vié K Tags: Toxicol In Vitro Source Type: research