Table 3.
Genotoxicity of BCE in the in vitro studies.
| Study 131 |
Study 290 |
Study 332 |
Study 429 |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| In vitro model | TK6 cells | Bacteria | TK6 cells | TK6 cells | HepG2 | Bacteria | ||||
|
| ||||||||||
| BCE concentrations | Up to 1,000 μg/mL | Up to 6,000 μg/plate | Up to 500 μg/mL | Up to 250 μg/mL | Up to 500 μg/mL | Up to 10,000 μg/plate | ||||
| Treatment time | 4 h | 24 h | 20 min | 4 h | 24 h | 4 h | 24 h | 4 h | 24 h | 20 min |
| Mutagenicity: | ||||||||||
| Ames test | Equivocal in TA98 with 10% S9 | Equivocal in TA98 with 10% S9 | ||||||||
| Genotoxicity: | ||||||||||
| MN assay | ↑ | ↑ | NA | ↑ | NA | ↑ | NA | ↑ | ||
| Comet assay | NA | NA | NA | NA | ↑ | ↑* | — | — | ||
| YH2AX | — | — | — | — | ↑ | ↑ | NA | NA | ||
| P53 | — | ↑ | — | ↑ | — | ↑ | NA | NA | ||
| p-Histone 3 | ↑ | ↑ | ↑ | ↑ | NA | NA | NA | NA | ||
MN assay, micronucleus assay; NA, not available; *, not significant; —, no change.