Subacute systemic toxicity test for vaginally applied products with medical devices (ISO 10993-11: 2017).
Test with Good Laboratory Practice (GLP) certificate.
The animal species chosen for the test will be albino rabbit of the New Zealand breed, of known origin and with a defined microbiological health status. In accordance with ISO 10993-11, a total of 6 females administered with the test product and 6 control females will be evaluated.
The material must be manufactured, processed, contaminant-free and sterilized by the method intended for the final product, confirmed by appropriate documentation that will be attached to the material. Due to the duration of the tests, they must be prepared in a way that ensures their stability.
The client must indicate the dose and frequency of application for the test product. Control animals will be dosed with the same volume and frequency with physiological saline solution. Dosing in our laboratory can be performed on local working days, i.e. 5 days per week excluding local and national holidays.
The duration of the trial will be between 24 hours and 28 days. The selection of treatment time intervals between 14 and 28 days is consistent with most international regulatory guidelines and is considered a reasonable approach.
During the duration of the study, the test animals will be monitored as follows:
- Blood analysis 48 hours before administration of the product.
- Blood and urine analysis before humane slaughter of the animal.
- Measurement of the body weight of the animals 24 hours before application of the product and then every week of observation.
- Observation and clinical signs of the animals (daily or weekly, depending on the duration of the study), including changes in the skin and coat, eyes and mucous membranes, respiratory, circulatory, vegetative and nervous systems, somatomotor and behavioral activity.
- After humane slaughter:
- Complete macroscopic autopsy.
- Organ removal for histopathological evaluation. The client must select the organs for study. ISO 10993-11 indicates a list for reduced histopathology for testing medical devices with commonly used composition. This list includes the following organs: heart, liver, adrenal glands, kidneys, skin, spleen, muscle, brain, ovaries, lungs and bronchial samples, bone (femur or sternum), bone marrow (from femur, rib or sternum).