Penile mucosa irritation Test. ISO 10993-23: 2021: Biological evaluation of medical devices. Part 23 - Tests for irritation. Annex D.4. Penile Irritation Test.
Test with the Certificate of Good Laboratory Practices (GLPs).
This test should only be considered for products intended for contact with penile tissue and if safety data cannot be obtained by other methods. The test evaluates the potential of the product under test to cause irritation of the penile. Products shown to be skin or eye irritant or materials with a pH ≤ 2.0 or ≥11.5 should be excluded from the test and should be labeled as potential penile irritant.
This test is performed in 3 albino 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 or not clear results are obtained, additional testing shall be considered.
For acute exposure test, the animals are exposed to the product every hour for 4 hours. Other treatment schedules based on the clinical use shall be justified and documented. The appearance of the penis is evaluated 1 hour after the first exposure, immediately before the subsequent treatments, and at 1 hour, 24 hours and 48 hours after the last application.
For prolonged repeated-exposure tests, base the number of applications, their duration and their interval on the exposure time anticipated in the clinical situation. The appearance of the penis should be evaluated 1 hour after the first application, immediately before the subsequent treatments, and at 1 hour, 24 hours and 48 hours after the last application.
After the 48 hours observation, the animals should be humanely sacrificed, and a histopathological study should be carried out to detect signs of irritation in the distal penis and sheath of the animals that are not appreciable macroscopically.
The evaluation of the response must be performed macroscopically and microscopically by histopathological examination. With the microscopic findings, subtracting the control group average from the test group average the irritation index is obtained. The irritation index allows cataloging the product as non-irritant, minimal, mild, moderate or severe irritant.