In Vitro Irritation
1. Biological Effect: Irritation or Intracutneous reactivity
2. Turnaround time: 8 weeks
3. Sample Requirements:
60 cm² (test item < 0.5 mm thick);
30 cm² (test item ≥ 0.5 mm thick);
at least 2 test items;
The skin irritation study is a test used to evaluate the potential of a product causing skin irritation when used by the consumer. Some medical devices can cause skin irritation by passing through the stratum corneum (the outer layer of the skin) and enter the layers beneath causing toxic effects to these cells. This in turn causes an immediate immune response, which is typically characterized by redness, itching or pain in the area of contact with the product. The In Vitro irritation study utilizes in vitro-cultured skin samples.