Rabbit Vaginal Mucosal Irritation Model
- Duration - 14 days
- Lead time - 30 days
- Standard results - Microbiology, Histology
This model is utilized to evaluate the irritation potential for materials that may come into contact with vaginal tissue. The model is governed by ANSI/AAMI/ISO 10993-10:2010 rules and is highly proscriptive, meaning that variations in the protocol are not allowed when the purpose of the study is for regulatory submission.
For this model, the test material is instilled intravaginally at 24 hour intervals for 5 consecutive days, or longer, if the intended use of the product would necessitate longer exposure in humans. Rabbits are assessed daily (macroscopically) for signs of discharge and erythema or edema. At the conclusion of the study, tissue samples are taken including the cervical, central and caudal parts of the vagina for pathology assessment.
How the Model Works:
The graph below shows the outcome of study where a high dose of test material caused severe vaginal irritation compared to controls. Although the data are not shown, clinical scores of edema and pathology scores for inflammation closely mirrored these results, as is most often the case.
advantages and disadvantages of this model:
This model is required testing for all intravaginal drugs and medical devices.
- Fichorova, RN et al. Interleukin (II) -1, II-6, and II-8 Predict mucosal toxicity of vaginal microbicidal contraceptives, Bio. of Reprod. 71, 761-769.