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 (Spanish National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
The principle of this test is based on the application of a dose of the assay product to the skin of several experimental animals, each of which serves as its own control. 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), and non-polar (vegetable oil) are used.
The assay is performed usually with a single dose, but a repeated-exposure test can be ordered after completion of an acute single-exposure test.
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. For repeated-exposure tests, record the reaction 1 hour after each exposure, prior to the next application and for 5 days after the last exposure. 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. 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.