ISO 10993.10 Essays - Intradermal Injection, ISO 10993,

ISO 10993.10 The animal intracutaneous (intradermal) reactivity test was conducted to assess whether the test article (PC) could produce irritation following intradermal injection of the extracts of the test article. This study was conducted based on the requirements for the International Organization for Standardization ISO 10993-10:2009 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. The test article was extracted in 0.9% sodium chloride solution (SC) and cottonseed oil (CO). The extract was injected intradermally to three test rabbits in an attempt to induce irritation. 0.2 ml of the extract obtained with the SC or CO at five sites on one side of each rabbit was injected intradermally. Similarly, 0.2 ml of the SC or CO control was injected on five sites of the contra lateral side of each rabbit. Observations for erythema and edema were conducted after injection and at (24 2) h, (48 2) h and (72 2) h after injection. The final test sample score were obtained by subtracting the score of the blank from the test sample score. Under the conditions of this study, there was no evidence of significant irritation or toxicity from the extracts inject to rabbits.