Instituto Valenciano de Microbiología

Masía El Romeral
Ctra. de Bétera a San Antonio Km. 0.3
46117 Bétera (Valencia)
Phone. 96 169 17 02
Fax 96 169 16 37
CIF B-96337217


Penile mucosa irritation Test. UNE-EN ISO-10993-10: 2013. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Annex B.

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

This test should only be considered for products directed to contact with penile tissues and whose safety data cannot be obtained by other methods. The test evaluates the potential of the product under test to cause irritation of the tissues with which it is in contact. Products known to be skin or eye irritants that have a pH ≤ 2.0 or ≥11.5 should be excluded from the test, in which case these products should be labeled as potential irritants for penile tissues. When in spite of this, the test is done it must be justified and documented.

This test is performed in 3 rabbits or 3 adult male guinea pigs and must include 3 other animals as negative controls, excluding those animals that show abnormalities in the penis. If equivocal results are obtained, the number of animals must be increased.

The animals are exposed to the product acutely (every hour for 4 hours) or prolonged (depending on the clinical use that the product will have). The results are evaluated 1 hour after the first exposure and immediately before the following exposures, and 1 hour, 24 hours and 48 hours after the last application, in the case of acute exposure.

In the case of prolonged exposure, the evaluation of the results will be 1 hour after the first application and immediately before the next ones.

In addition, in both cases the animals should be humanely sacrificed and a histopathological study should be carried out to detect signs of irritation that are not appreciable macroscopically.

The evaluation of the response must be performed macroscopically and microscopically by histopathological examination of the sacrified animals. With the macroscopic and microscopic findings a numerical index of irritation is obtained that allows cataloging the product as non-irritant, minimal irritant, mild, moderate or intense.