Acute oral systemic toxicity test. EN ISO 10993-11: 2018 - Biological evaluation of medical devices. Oral toxicity assay.
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, whenever possible, the most clinically appropriate route of exposure for use of the device should be chosen for acute systemic toxicity testing. Oral systemic toxicity tests are suitable for devices in direct or indirect contact with the oral mucosa, or for products with different enteral applications.
For the evaluation of acute systemic toxicity by oral route, extracts of the medical device obtained with polar and non-polar solvents are used, and their corresponding controls, the solvents not exposed to the product. The animals used in this assay are young adult rodents (rats or mice). Groups of 5 rodents are used that are inoculated orally, by tube, with each of the extracts of the medical devices and their corresponding controls. Animals receive a single dose of sample or, if necessary, multiple doses over a 24-hour period. The maximum volume of sample to be administered orally in rats and mice is 50 mL of sample per kg of the animal.
The rodents are observed daily for three days and the appearance of secondary 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 extract show a biological reaction significantly greater than that observed in control animals inoculated with the solvents used to prepare the device extract. 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 trial. 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 mice. If in the repeat test with 10 mice 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.
Corrosive or irritating materials should be recorded as such in the documentation and do not need to be tested. The Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) and the European Center for Alternative Methods (ECVAM) have validated the in vitro cytotoxicity test as an alternative to acute oral toxicity tests. The in vitro cytotoxicity test according to the UNE EN ISO 10993-5: 2009 standard is accredited in our laboratory.