Terminology: Dermal Sensitization Test (Mandatory SIAA Test Item)

The objective of this test is to detect delayed allergic reaction (Type IV allergy) by means of a one-time application of the test substance to the skin and allowing it to be absorbed. Immunogenicity is acquired in the body so that T-lymphocytes will recognize it and cause an allergic reaction when they come into contact with the same immunogen again.

[Test Method]
This method is generally called the ‘Maximization Method.’ Using guinea pigs as test animals, the test substance is administered under the skin at three sites in a shaved area on the back. The test substance is administered again one week later to evaluate the presence of eczema or edema.

[Test Results for Zeomic]
There was no eczema or edema of the skin in the tested sites, and thus it was determined that Zeomic has no dermal sensitization qualities (negative).

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