Table 12 Mutagenicity data, 4 h exposure, without metabolic activation
From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®
Sample | Number of large colonies | Number of small colonies | Mutant frequency (*10^-6) | Small colonies [%] | Small colonies mutant frequency (*10^-6) | Mutagenicity |
|---|---|---|---|---|---|---|
NC1 | 78 | 2 | 128.82 | 2.50 | 3.22 | N/A |
NC2 | 64 | 2 | 97.72 | 3.03 | 2.96 | N/A |
PC | 130 | 60 | 518.83 | 31.58 | 163.84 | Mutagenic |
4SEAL® 1 | 64 | 2 | 102.40 | 3.03 | 3.10 | Not Mutagenic |
4SEAL® 2 | 58 | 3 | 98.34 | 4.92 | 4.84 | Not Mutagenic |