Data Sheet 1

Cytotoxicity, MEM extracts, MTT test system, 24 hrs.

Test article CMC

Table 1 : Confluency of monolayer
Grade 0 : 100%
Grade 1 : 90-100%
Grade 2 : 60-90%
Grade 3 : 30-60%
Grade 4 : 0-30%



Table 2 : Change of cell morphology
Grade 0 : no changes, normal cel
Grade 1 : slight changes, few cells affected
Grade 2 : mild changes, some cells rounded and/or spindle shaped
Grade 3 : moderate changes, many cells rounded and/or spindle shaped
Grade 4 : severe changes, about all cells show morphologic change.



Table 3 : Inhibition of cell metabolism
Grade 0 : 0-10% compared to the negative control
Grade 1 : 10-30% compared to the negative control
Grade 2 : 30-50% compared to the negative control
Grade 3 : 50-70% compared to the negative control
Grade 4 : 70-100% compared to the negative control



Table 4 : Acceptance Criteria
cytotoxic response reactivity pass/fail
0.0 - 1.0 none pass
1.1 - 3.0 slight pass
3.1 - 5.0 mild retest
5.1 - 7.0 moderate fail
7.1 - 8.0 severe fail



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