Evans1, E., Priston1, R., Inglis2, H., Barnes2, N., Raabe2, H., Costin2, G.-E. 1The Kimberly-Clark Corporation, Roswell, GA, USA. 2Institute for In Vitro Sciences, Inc. (IIVS), Gaithersburg, MD, USA.

Three dimensional (3D) human vaginal-ectocervical tissue constructs may be a relevant in vitro model to rapidly screen for vaginal mucosal irritation potential of raw materials and final formulations. Here we report results from a study with an in vitro vaginal tissue construct (EpiVaginal™ from Mattek Corporation, USA), used to predict irritation responses of a variety of benchmark ingredients (including surfactants and fragrances) and product formulations. Test products were representative body washes, personal care wipes, etc., tested at concentrations relevant to use in final product form. The time-to-toxicity (exposure time to reduce viability of the tissues to 50% of the controls, or ET50) for each test sample was determined. Samples were applied topically to the surface of the tissue constructs for various exposure times. Vaginal irritation expressed as ET50 values showed a close correlation with the expected irritation potential based on previous work, published research results and product market history. In general, our results demonstrated a shortening of the ET50 values with increasing sample concentration; as such, the ET50 values for a dilution series of the positive control (Triton-X-100) ranged from 8.77 to 4.00 h (for a dilution of 0.1%), from 3.83 to 1.53 h (for a dilution of 0.3%) and from 1.69 to 0.64 h for the 1% Triton-X-100. Furthermore, the ET50 of a currently marketed vaginal cream containing 20% benzocaine ranged from 3.03 to 1.50 h. Three categories of personal care wipes were tested and the ET50 values ranged from 4.64 to 6.64 to >24 h, correlating with their expected irritation potential based on other data. In conclusion, our findings suggest that the time-to-toxicity assay using EpiVaginalTM tissues can be used to screen raw ingredients and final products for potential vaginal irritation.


ET50, EpiVaginal™ (VEC-100), Mucosal irritation

Materials Tested

0.1% triton, 0.3% triton, 1% Triton-X-100, 20% benzocaine, Body washes, Deionized water, Fragrance #1, Vaginal cream

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