In Vitro Method Can Assess the Irritation Potential of Personal Lubricants

A new paper in Toxicology In Vitro demonstrates how an in vitro reconstructed human vaginal epithelium (RHVE) test method can be used in regulatory safety testing requirements for personal lubricant products. The paper, “Using a reconstructed human vaginal epithelium to assess irritation: a proof-of-concept study supporting regulatory qualification of the method for use with personal lubricants,” was co-authored by PETA Science Consortium International e.V., the Institute for In Vitro Sciences, MatTek (Now Part of Sartorius), and the Slovak Academy of Sciences.

In the study, the EpiVaginal^TM model was used to evaluate five water-based products for vaginal irritation potential, which included three personal lubricants and two vaginal contraceptives containing a known vaginal irritant. The study found that the RHVE test method can rank vaginal products according to their vaginal irritation potential and therefore has the potential to serve as a replacement to the rabbit vaginal irritation (RVI) test method for assessing water-based personal lubricants. Scientific confidence in the test method’s ability to predict human vaginal irritation was evaluated using a framework co-authored by the Science Consortium that was previously used to evaluate confidence in in vitro eye irritation testing approaches for agrochemical formulations.