A laboratory test called the in-vitro skin irritation test is used to assess if a product has the potential to irritate skin when used by the end user. Certain products possess the ability to cause skin irritation by penetrating the skin’s outer layer and causing harm and damage to the cells beneath. The area that comes into contact with the drug then experiences an acute immunological reaction, which is frequently accompanied by redness, itching, or pain.
When evaluating a product’s or medical device’s biological safety, skin irritation is a crucial factor. An approved lab will conduct an in-vitro skin irritation test to identify substances, blends, and combinations that may elicit mild to moderate skin irritation.
Traditionally, in vivo models have been used to assess medical devices and products for irritation. To reduce the need for animal testing in vivo, other methods for assessing the risk of skin irritation have been developed.
The process for evaluating medical devices and the materials that make them for their potential to cause skin irritation and sensitization is outlined in ISO 10993.
pretest considerations for irritation, including in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.
Three-dimensional skin models are used in the in-vitro skin irritation test to assess skin irritation. This in vitro model is a great substitute for animal research, as many in vivo studies for cosmetic components are currently prohibited from use in many areas. For the testing of chemicals, pharmaceuticals, and skincare products, we employ the EpiDerm kit, a validated in vitro model system.
You can determine whether a material in your product can pierce the skin’s outer layer and cause cytotoxicity in the cells underneath it by using the in-vitro skin irritation test model. The skin model releases a quantifiable amount of inflammatory mediators, which can be used to increase the test’s sensitivity if the effect is minimal or undetectable. Both solids and liquids can be tested with the device.
