Terminology: Cytotoxicity Test

The objective of this test is to confirm whether a test substance acting on cultured cells can cause the degradation of normal cell functions, morphological changes, the suppression of propagation or the death of cells.

[Test Method]
A test using Chinese hamster lung fibroblast V79 cells was conducted and cytotoxicity was evaluated with the colony formation method in compliance with the ‘Guidelines for Biological Testing Required for the Certification of the Manufacturing (Export) of Medical Devices’ per Bulletin No. 99 of the Medical Devices Division of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare.

[Test Results for Zeomic]
As a result, colony formation 50% inhibitory concentration (LC50) was measured at 25 μg/ml, confirming that Zeomic has very low cytotoxicity.

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