Subacute systemic toxicity test by oral route with medical devices (ISO 10993-11: 2017).
Test with the Certificate of Good Laboratory Practices (GLPs).
The animal species chosen for the test are Wistar rats of known origin and with a defined microbiological health status. According to the ISO 10993-11 standard, a total of 10 animals administered with the test product and 10 animals with the control product will be evaluated.
The material must be manufactured, processed, remove contaminants and sterilized by the method provided for the final product, confirmed with adequate documentation to be attached to the material. Due to the duration of the tests, they must be prepared in such a way as to ensure their stability.
The client must indicate the dosage and frequency of application for the test product. Control animals will be dosed with equal volume and frequency with physiological saline solution. Dosing in our laboratory can be done 5 days a week.
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 indicated below:
- 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 the 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 humanitarian sacrifice:
- Complete macroscopic autopsy.
- Extraction of organs for histopathological evaluation. The client must select the study organs. The ISO 10993-11 standard indicates a list for reduced histopathology for tests with medical devices with composition of common use. 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).