Acute vaginal systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Acute systemic toxicity by vaginal exposure.
Test with the Certificate of Good Laboratory Practices (GLPs).
The release of chemical components from a medical device in the body can cause systemic toxicity. The acute systemic toxicity test provides general information on the physiological risks that may arise after acute exposure of a medical device to the relevant clinical route. Medical devices, or their releasable substances, can enter the body through multiple routes of exposure and, according to ISO 10993-11, the most clinically appropriate route of exposure for the drug must be chosen for acute systemic toxicity testing. device use. However, the ISO 10993-11 standard does not indicate the vaginal route of administration as one of the exposure alternatives. To carry out the acute systemic toxicity test by the vaginal route, the administration of the test substance will be followed as indicated in the ISO 10993-23 standard, which describes the vaginal irritation test.
For the evaluation of acute systemic toxicity by the vaginal route, the medical device is used, or extracts of the medical device obtained with polar and non-polar solvents, and their corresponding controls, are used. The animals used in this test are young female rabbits. Groups of 5 rabbits are used that are dosed vaginally with the medical device, or with the extracts of the medical devices, and their corresponding controls. Animals receive a single dose or multiple doses over a 24-hour period, depending on the intended use of the product. The administration dose of the test substance should also be indicated.
The rabbits are observed daily for three days in which the appearance of side effects is studied: adverse clinical signs, change in body mass, serious pathological findings and/or death of the study subjects. The test is considered negative if none of the animals inoculated with the product or product extract show a biological reaction significantly greater than that observed in control animals. If two or more of the five animals inoculated with the test product die, or show signs of toxicity (clinical observation), or three or more of the animals lose more than 10% of their body weight, the test product does not meet the requirements. of the assay. If one of the animals inoculated with the product shows signs of a slight biological reaction, or one of the animals shows significant signs of a biological reaction or dies, the test should be repeated with groups of 10 rabbits. If in the repeat test with 10 rabbits none show signs of significant biological reactivity, compared to the respective controls, the test product fulfills the requirements of the test.
In addition, the client can request the extension of the study through haematological, biochemical, or macroscopic pathology analyses, indicated in the case of testing medical devices whose expected toxicity is based on an existing study or on new materials for which there is no previous experience available. If you are interested in carrying out these analyses, ask us for more information.