When this test applies
Required where the device contacts vaginal mucosa, under ISO 10993-1:2025 and ISO 10993-23:2021. The route matters: mucosal tissue responds differently from skin, so an intracutaneous or dermal irritation result does not stand in for it. This is the study for intravaginal devices, applicators and any product with mucosal contact in that site.
When to run it
After cytotoxicity, and once the material and its manufacturing process are locked. Because it includes histology it takes longer and costs more than a macroscopic-only irritation study, so it is worth confirming the contact category first — your biological evaluation plan should establish whether the mucosal route is genuinely in scope.
What a pass tells you
That the difference in mean score between test and control sites did not exceed the non-irritant threshold ISO 10993-23 sets — assessed both macroscopically and on histology. The histology is the part that distinguishes this from a simpler irritation study: a site can look unremarkable and still show a tissue response under the microscope.
What it does not tell you
It speaks to local mucosal response at this site only. It says nothing about sensitization, systemic effects, or irritation by any other route, and it is not a substitute for the intracutaneous reactivity study where skin or subcutaneous contact is also in scope.
Method
Testing per ISO 10993-23:2021 in the rabbit. Two extracts are prepared, one polar and one non-polar, and applied to the vaginal mucosa; test and control sites are scored macroscopically and then processed for histological evaluation. Extraction ratio follows ISO 10993-12: 6 cm²/mL for material under 0.5 mm thick, 3 cm²/mL at 0.5 mm or thicker, or 0.1 to 0.2 g/mL where surface area is indeterminate.
Where it runs
This method is domestically sourced. The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker cover, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Cytotoxicity and sensitization as the baseline battery, and intracutaneous reactivity where the device also has skin or subcutaneous contact.
