Registration Dossier

Administrative data

specific investigations: other studies
Adequacy of study:
supporting study

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Principles of method if other than guideline:
Test procedure:
Approximately 0.2 ml of each test material was applied to
the gauze portion of an adhesive dressing. The dressing was
allowed to air dry for between 30 and 90 minutes before
application. These dressings formed occlusive patches when
applied to the treament sites. The patches were removed
twenty-four hours after application.

Results and discussion

Details on results:
With one exception , observations of both treated sites
remained negative throughout the test interval. At the 48
hour challenge observation, one subject exhibited a mild
erythema, but this was normal at 72 hours.

Applicant's summary and conclusion