Abnormal toxicity. European Pharmacopoeia (2.6.9. Abnormal Toxicity). Biological Evaluation of Medical Devices.
Test with the Certificate of Good Laboratory Practices (GLPs).
In this test the product under study must be inoculated intravenously to groups of mice, dissolved in injectable water or in physiological saline solution, observing the mice to know those that die in the following 24 hours, not fulfilling the requirements if it dies more than a mouse. In case of dying one of the mice the test must be repeated.
For preparations of immune sera or vaccines for human use, a human dose should be inoculated, not exceeding 1 mL in groups of mice, and observed following the same criteria previously indicated, but in addition groups of guinea pigs should be inoculated intraperitoneally with a human dose, without exceeding 5 mL, observing the animals for 7 days. In the same way as with mice, if one of the animals dies, the test should be repeated.