ArticleToxicology2011
Development of an in vitro alternative assay method for vaginal irritation.
Article in Toxicology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 59 citations in OpenAlex.
- Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone.EBioMedicine · 2022Trial
- Comprehensive Evaluation of a Mucoadhesive Self-Emulsifying Anhydrous Base for Vaginal Drug Delivery.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Bioresponsive Hydrogel for On-Demand Nonhormonal Contraception.Gels (Basel, Switzerland) · 2025Article
- Article
- Vaginal irritation testing-prospects of human organotypic vaginal tissue culture models.In vitro cellular & developmental biology. Animal · 2024Review
- Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices.Frontiers in drug safety and regulation · 2024Article
- Chitosan/Solid-Lipid Nanoparticles Hybrid Gels for Vaginal Delivery of Estradiol for Management of Vaginal Menopausal Symptoms.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Characterization of an air-liquid interface primary human vaginal epithelium to study Ebola virus infection and testing of antivirals.Antiviral research · 2023Article
- Toxicity Assessment of Resveratrol Liposomes-in-Hydrogel Delivery System by EpiVaginalPharmaceutics · 2022Article
- A physiologically relevant, estradiol-17β [E2]-responsive in vitro tissue-engineered model of the vaginal epithelium for vaginal tissue research.Neurourology and urodynamics · 2022Article
- The Impact of Over-The-Counter Lactic Acid Containing Vaginal Gels on the Integrity and Inflammatory State of the Vaginal EpitheliumFrontiers in reproductive health · 2022Article
- Serine protease inhibitor disrupts sperm motility leading to reduced fertility in female mice†.Biology of reproduction · 2020Article
- Relating Advanced Electrospun Fiber Architectures to the Temporal Release of Active Agents to Meet the Needs of Next-Generation Intravaginal Delivery Applications.Pharmaceutics · 2019Review
- Multipurpose tenofovir disoproxil fumarate electrospun fibers for the prevention of HIV-1 and HSV-2 infections in vitro.International journal of pharmaceutics · 2017Article
- Ethics of animal research in human disease remediation, its institutional teaching; and alternatives to animal experimentation.Pharmacology research & perspectives · 2017Review
- Stabilization and Sustained Release of HIV Inhibitors by Encapsulation in Silk Fibroin Disks.ACS biomaterials science & engineering · 2017Article
- Engineering and characterization of simplified vaginal and seminal fluid simulants.Contraception · 2016Article
- Impact of Hydroxychloroquine-Loaded Polyurethane Intravaginal Rings on Lactobacilli.Antimicrobial agents and chemotherapy · 2015Article
- Characterization of a Hormone-Responsive Organotypic Human Vaginal Tissue Model: Morphologic and Immunologic Effects.Reproductive sciences (Thousand Oaks, Calif.) · 2015Article
- On the genealogy of tissue engineering and regenerative medicine.Tissue engineering. Part B, Reviews · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
The vaginal mucosa is commonly exposed to chemicals and therapeutic agents that may result in irritation and/or inflammation. In addition to acute effects, vaginal irritation and inflammation can make women more susceptible to infections such as HIV-1 and herpes simplex virus 2 (HSV-2). Hence, the vaginal irritation potential of feminine care formulations and vaginally administered therapeutic agents is a significant public health concern. Traditionally, testing of such materials has been performed using the rabbit vaginal irritation (RVI) assay. In the current study, we investigated whether the organotypic, highly differentiated EpiVaginal™ tissue could be used as a non-animal alternative to the RVI test. The EpiVaginal tissue was exposed to a single application of ingredients commonly found in feminine hygiene products and the effects on tissue viability (MTT assay), barrier disruption (measured by transepithelial electrical resistance, TEER and sodium fluorescein (NaFl) leakage), and inflammatory cytokine release (interleukin (IL)-1α, IL-1β, IL-6, and IL-8) patterns were examined. When compared to untreated controls, two irritating ingredients, nonoxynol 9 and benzalkonium chloride, reduced tissue viability to <40% and TEER to <60% while increasing NaFl leakage by 11-24% and IL-1α and IL-1β release by >100%. Four other non-irritating materials had minimal effects on these parameters. Assay reproducibility was confirmed by testing the chemicals using three different tissue production lots and by using tissues reconstructed from cells obtained from three different donors. Coefficients of variation between tissue lots reconstructed with cells obtained from the same donor or lots reconstructed with cells obtained from different donors were less than 10% and 12%, respectively. In conclusion, decreases in tissue viability and barrier function and increases in IL-1α and IL-1β release appear to be useful endpoints for preclinical screening of topically applied chemicals and formulations for their vaginal irritation potential.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.