Acute Skin Irritation test (Draize Skin test). UNE-EN-ISO 10993-10: 2013. Biological Evaluation of Medical Devices. Part 10: Irritation and cutaneous sensibilization.
Test Accredited by ENAC (National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
The principle of this test is based on the application of a single dose to the skin of several experimental animals, each of which serves as its own control (except when intense irritation/corrosion is suspected). The degree of irritation is read and determined at specified intervals and is fully described.
The UNE-EN ISO 10993-10 standard requires the use of three experimental animals (rabbits) to which they will be administered, by dermal route the product directly or the extract of the product in two different points, as well as many control exposures, using the solvents used to prepare the extracts of the product. To prepare the extracts, polar solvents (physiological saline solution, distilled water, 5% hydroalcoholic solution, polyethylene glycol 400), or non-polar (vegetable oil) can be used, according to the product manufacturer´s recommendations, depending on their chemical composition and/or solubility.
The appearance of the places of contact with the product, compared with the contact points of the controls should be observed daily for 3 days, assigning a qualitative and quantitative assessment (0 to 4), to describe and quantify the type of erythema or edema , that could appear. The duration of the study should be sufficient to allow a complete evaluation of the reversibility or irreversibility of the observed effects and does not need to be longer than 14 days. In cases where repeated exposure is requested, the observation period will be a maximum of 21 days. It is not necessary to test strongly acidic or alkaline substances (pH 2 or less, or pH 11.5 or higher) as its corrosive capacity is predicted.