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Description of key information

In a patch test (15 epicutaneous, occlusive inductions; 1 epicutaneous challenge 14 days later) in 53 human subjects, 0/53 persons showed positive reaction regarding sensitization.

Additional information

One study is available with thirty adults and twenty-three children where the sensitization potential of Irgacet Brown 2GL was investigated in a human patch test. The test material was applied to the upper arms of the subjects and covered by an occlusive patch, being held in place with Blenderm Tape (3 M). After 24-hours the patch was removed and the reactions graded and recorded. A rest period of 24-hours then elapsed after which the patches were reapplied as before. This sequence was repeated until 15 successive patches had been applied. A two-week rest period was then allowed after which a challenge application was applied in a manner similar to the primary patches. In addition a control material consisting of Ivory soap, as a 1% w/v slurry in distilled water, was applied concurrently and in the same manner as the test material.

Irgacet Brown 2GL was neither a primary irritant nor sensitizer to any of the test subjects under the test conditions. The test material is significantly less irritating than a 1% Ivory soap preparation under the same test conditions. Insofar as sensitization is concerned, the significance of extrapolating these results to a general population is statistically limited by the number of the test subjects. From this test in which approximately 50 subjects were used, it may be predicted with a confidence of being correct in 19 out of 20 cases that Irgacet Brown 2GL will be safe to use by 90 out of every 100 people under conditions not exceeding those of this test in severity.