Case study: Epivaginal 3d tissue model for safer vaginal products

Author: Tina Shahian, PhD | Last updated: July 2026

EpiVaginal Tissue on Application - purple tissue, close view, layers visible

Overview

EpiVaginal is a 3D human vaginal tissue model that offers a human‑relevant alternative to traditional animal irritation tests for feminine products. Built from vaginal‑ectocervical cells, it reproduces key features such as stratified epithelium, barrier function, hormone responsiveness, and immune pathways. Multi‑site studies show strong reproducibility. In tests of nine lubricants, EpiVaginal sensitively detected damage from hyper‑osmolal products through reduced TEER and histological disruption, outperforming standard rabbit vaginal irritation assays. This evidence supports regulatory adoption of New Approach Methodologies (NAMs) and more reliable safety assessments grounded in human biology.

 

Key learnings:

  • Why animal-based vaginal irritation tests are poorly predictive for humans
  • How the EpiVaginal 3D human tissue model more accurately reflects vaginal biology
  • How EpiVaginal improves safety evaluation of lubricants and supports emerging regulatory NAMs

 

Resoruce details:

  • Resource type: Case study
  • Page count: 4
  • Read time: 5 minutes

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