Acute intracutaneous irritation test. UNE-EN-ISO 10993-10: 2013 - Biological evaluation of medical devices - Part 10: Irritation and skin sensitization tests.

Test accredited by ENAC (National Accreditation Entity).

Test with the Certificate of Good Laboratory Practices (GLPs).

The possibility that a product may cause irritation when introduced into a patient / individual can be evaluated from the response observed when an extract of the product is injected intracutaneously into experimental animals. This is a generic test, and does not exclude the need to perform other more specific tests depending on the type of use of the product, since the tissues differ in vascularization, composition, and response. Therefore, the irritation capacity may need to be tested using the same contact conditions in which the product is to be used (e.g., ocular irritation tests for ocular application products).

The standard UNE-EN ISO 10993-10, requires the use of three experimental animals (rabbits) that will be administered intracutaneously, the product or an extract of it in five different points, as well as as many control inoculations, 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.

General comments: The appearance of the inoculation sites, compared to the inoculation sites 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.