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Updated: Jun 4, 2026

An In Vitro Skin Irritation Test (SIT) using the EpiDerm Reconstructed Human Epidermal (RHE) Model
Published on: July 13, 2009
New irritation test method: behind the knee and mucosa
1Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, New York, N.Y., USA.
Abstract:
The epithelium of the lower genital tract, a highly sensitive sensory area where a host of sexual, reproductive and health functions are performed, is a unique anatomical site. It is very responsive to both internal and external stimuli, with a reactive area function of returning to an asymptomatic resting state. Commercial products intended for use in this area must be demonstrated to have minimal inflammatory responses. To determine this, the potential response of the lower genital tract epithelium to such products has to be evaluated. Direct assessment of the vagina is limited, because of its interior location. Behind-the-knee testing offers many advantages. The test products can be compared to commercial products approved by the Food and Drug Administration at the same time, and the use of cross-polarization light permits subsurface evaluation of the extent of inflammation, a more exact measure than surface recording alone.

