Worldwide reproducibility of a highly differentiated 3-dimensional vaginal tissue model for testing of feminine hygiene products
When making risk and hazard assessments of new ingredients or finished products, reproducibility of the toxicology test system is of extreme importance to regulators, in-house toxicologists, and formulation scientists. One of the advantages of in vitro test systems vis-Ă -vis animal-based systems is that the in vitro systems can be highly reproducible while in vivo models typically exhibit high variability. The commercially available, in vitro vaginal tissue model, EpiVaginal (MatTek Corporation) has been proposed as an in vitro replacement for the rabbit vaginal irritation test for assessing the safety of spermicides and other feminine care products. The EpiVaginal model is cultured using normal human vaginal ectocervical epithelial cells, is highly differentiated, and develops a 3-dimensional structure that mirrors in vivo vaginal tissue. The model has been used to screen products for vaginal irritancy and inflammation, vaginal drug delivery, and to develop HIV-1 microbicides. In the current study, reproducibility of the quality control data and testing results for feminine care products were each compared in 3 labs.
EpiVaginal, VEC-100, Vaginal irritation, historical QC database, PAS staining, glycogen, feminine hygiene products, TEER, Nonoxynol-9 N9, bio-lubricant, lactic acid, Povidone iodide, Polydimethylsiloxane, interlab reproducibility, intralot reproducibility
feminine hygiene products, TEER, Nonoxynol-9 N9, bio-lubricant, lactic acid, Povidone iodide, Polydimethylsiloxane
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