IN VITRO SAFETY PROFILE OF PERSONAL CARE PRODUCTS – USE OF AN IN VITRO TESTING PLATFORM BASED ON A RECONSTRUCTED VAGINAL TISSUE MODEL

One of the common goals of industry is to confirm the safety of their products. Ethical concerns have led to the use of alternative testing methods in lieu of traditional testing methods. Several studies have shown good correlation between alternative test methods, traditional testing methods and human exposure. In the current study, the safety profile of three products with potential for vaginal exposure was assessed using the reconstructed human vaginal EpiVaginal™ model (MatTek Corporation, USA); the assay negative control (sterile, deionized water) and positive control (1% Triton® -X-100) were tested alongside. To increase the confidence in the test outcome, histopathology evaluation was conducted to assess the extent of cellular damage. Two liquid products were directly applied to the EpiVaginal™ tissues, while the wet wipe product was placed in direct contact with the tissue. Vaginal irritation expressed at ET50 values (3.32 and 12.71 hours) showed a higher irritation potential for the liquid formulations compared to the wipes (>24 hours). The lower irritation potential of the wipe product may be related to the availability of a rather limited amount of the liquid formulation in the wipes compared to the liquid formulations. Histology evaluations showed good correlation between the ET50 values and change in tissue structure. The results of this in vitro test methodology confirmed the safety profile of the products, should vaginal exposure occur during use. This two-endpoint testing platform (viability and histology) provided not only a correlative interpretation of the data, but also indication of the structural changes of the tissues exposed to the test article that are relevant to human exposure. Future plans include further exploring the capability of this in vitro testing platform for screening products before entering clinical trials.

EpiVaginal (VEC-100), Histology, Personal care products, Tissue viability (ET-50), Vaginal irritation

Triton X-100, wet wipe