Data Sheet 1
Cytotoxicity, MEM extracts, MTT test system, 24 hrs.
Test article CMC
Confluency of monolayer
| Grade 0: |
100 % |
| Grade 1: |
90 – 100 % |
| Grade 2: |
60 – 90 % |
| Grade 3: |
30 – 60 % |
| Grade 4: |
0 – 30 % |
Change of cell morphology
| Grade 0: |
no changes, normal cells |
| 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 |
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 |
Acceptance Criteria
| Cytotoxic response |
Cytotoxic effect |
Pass / fail |
| 0.0 – 1.0 |
non toxic |
pass |
| 1.1 – 3.0 |
slight toxic |
pass |
| 3.1 – 5.0 |
mild toxic |
retest |
| 5.1 – 7.0 |
moderate toxic |
fail |
| 7.1 – 8.0 |
severe toxic |
fail |
