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IRRITATION TESTING OF CONTRACEPTIVE AND FEMININE-CARE PRODUCTS USING EPIVAGINAL™, AN IN VITRO HUMAN VAGINAL-ECTOCERVICAL TISSUE MODEL.
Ayehunie, S., Hayden, P., Cannon, C., Lamore, S., Klausner, M., Sheasgreen, J.
MatTek Corporation, Ashland, MA.
Presented at EUROTOX 2006, Cavtat and Dubrovnik, Croatia, September 20-24, (2006).
Keywords: Anti-fungal creams, Contraceptives, Cytokines, DNA-PCR, Douches, EpiVaginal, Estrogen receptor, HIV-1, IL-1α, IL-1β, IL-8, Irritation, MTT, Microbicides, VEC DNA-PCR, Vaginal care products
Endpoints: ET-50, HIV infection, Histology (H & E staining), MTT viability
Materials Tested: Ammonium lauryl sulfate, Benzocaine, Clotrimazole, Glycerin, Miconazole nitrate, Nonoxynol-9 (N9), Povidene-iodine, Pramoxine HCl, Resorcinol, Tioconazole, Triton X-100, Vinegar
Summary:
This study by scientists at MatTek Corp. demonstrated that MatTek’s EpiVaginal human cervico-vaginal tissue equivalent is a useful, highly reproducible non-animal tool that can be used to assess the irritation potential of feminine hygiene products, as well enabling HIV infection, microbicides and drug absorption studies.
Normal human vaginal-ectocervical (VEC) cells were cultured to reconstruct VEC tissues in vitro (designated as EpiVaginal VEC-100). In some cultures, normal human dendritic cells were also incorporated (designated as EpiVaginal VLC-100-FT).
Both EpiVaginal tissues mimic native in vivo tissue in that they have basal, parabasal, glycogenated intermediate, and the superficial cell layers.
To test the utility of EpiVaginal VEC tissues, contraceptives, microbicides, anti-itch agents, and other vaginal care products were topically applied.
To mimic heterosexual HIV infection, the EpiVaginal VLC tissues were topically exposed to HIV-1 viruses.
Quality control (QC) testing on each batch of EpiVaginal tissue utilized Triton X-100 (1%) and water as positive and negative controls, respectively. The MTT assay was used to determine the exposure time necessary to decrease the EpiVaginal tissue viability to 50% (ET-50) for the positive control and 18 vaginal care products.
QC testing showed the EpiVaginal tissues to be highly reproducible; the average intra-lot coefficient of variation was <10% and ET-50s averaged 1.34 hr ± 0.21 (n=41 lots).
The EpiVaginal VEC tissue model discriminated between the mildness of vaginal care products. The ET-50 values ranged between 1.7-2.7 hr for feminine washes, 3.5-7.0 hr for contraceptives, 6.9->18 hr for anti-itch creams, and were > 18 hr for douches, lubricants, and anti-fungal creams. Released cytokines and gene expression levels showed that IL-1α, IL-1β, and IL-8 were associated with toxicity of vaginal care products.
Finally, EpiVaginal VLC tissues were infectible with macrophage-tropic and T-cell tropic HIV-1 strains as evidenced by DNA-PCR.
Based on these results, it is likely that the EpiVaginal VEC tissue model will serve as a useful, highly reproducible, non-animal tool to assess the irritation of vaginal care products. In addition, the EpiVaginal VLC tissue will enable studies pertaining to HIV infection, microbicides and drug absorption.
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