Terminology: Primary Skin Irritation Test (Mandatory SIAA test item)

This test verifies the presence of dermal reactions from the test substance on the skin of the test animals by making a slight scar on the skin of the test animals, and smearing the test substance onto this site.
The objective of this test is to determine the toxicity upon a single application of the test substance onto the scarred tissue of the test animal from both the qualitative and quantitative (lethal dose) aspects.  

[Test Method]
A test was conducted with rabbits as test animals by applying 0.5g of the test substance over scars made with a syringe needle on healthy skin in the shape of # on the shaved part of the back of a test animal, taking care not to hurt the corium, and left there for 24 hours in accordance with the Pharmaceutical Affairs Bureau Bulletin 313: Standards for Good Laboratory Practices in Pharmaceutical Products Safety Tests.  

[Test Results for Zeomic]
As a result of continuous observation for 72 hours from the time of application, no skin reactions resulting from irritation such as eczema or erythema were observed.
The primary irritation index PII for Zeomic was determined to be 0 (negative).  

Pertaining to Primary Skin Irritation Test (Mandatory SIAA test item)

Contact us

To top