Skin Sensitization Tests

Evaluates the potential for sensitizing effects and allergic reactions of medical devices,cosmetic products or drug formulations over long exposure. Various methods can be used for this test, and sensitization tests including guinea pig tests are the tests that take the longest among the tests described within the scope of ISO 10993 standards. These methods are:

• Buehler Test Method (Repeated Sensitization):. In this method, the material is applied topically to the shaved skin of the guinea pigs repeatedly in order to observe the allergic response. Materials such as drapes and clothes are preferred to be tested by this method due to the ability of mimicking the clinical use.
• Guinea Pig Maximization Test (Magnuson-Kligman Method): This method is a more invasive test method performed in guinea pigs. Initially the substance is injected to the guinea pig, then this application is followed by a topical application. Post topical application, the allergic response is measured.
• Local Lymph Node Method: In this method, the amount of thymidine produced in lymphocytes and used as an allergic response is checked to see if an allergic response has occurred.