Table 3.
Results of the in vitro mammalian chromosomal aberration test.
| Experiment A | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Groups | S9-mix | Treatment time | Sampling time | Cytotoxicity | Mean number of aberrant cells /150 cells | % of aberrant cells | Mean number of aberrations/150 cells | Mean aberrations | |||||||||
| Chromosome | Chromatid | Others | |||||||||||||||
| Gap+ | Gap− | Gap- | Gap+ | Gap− | Gap | Del | Exchange | Gap | Del | Exchange | |||||||
| Test item | |||||||||||||||||
| 250 µg/mL | − | 3 h | 20 h | 5 | 7 | 4 | 2.333 | 7 | 4 | 0 | 0 | 0 | 4 | 4 | 0 | — | |
| 500 µg/mL | − | 3 h | 20 h | 16 | 7 | 4 | 2.667 | 7 | 4 | 2 | 1 | 1 | 1 | 2 | 1 | — | |
| 1000 µg/mL | − | 3 h | 20 h | 27 | 9 | 5 | 3.000 | 9 | 5 | 1 | 1 | 1 | 4 | 3 | 0 | — | |
| 2000 µg/mL | − | 3 h | 20 h | 32 | 8 | 3 | 2.000 | 8 | 3 | 3 | 0 | 1 | 3 | 2 | 0 | — | |
| Vehicle control | − | 3 h | 20 h | 0 | 8 | 4 | 2.667 | 8 | 4 | 1 | 0 | 2 | 3 | 2 | 0 | — | |
| Positive control | − | 3 h | 20 h | 50 | 39∗∗ | 33∗∗ | 22.000 | 57∗∗ | 38∗∗ | 7 | 8 | 6 | 12 | 13 | 12 | — | |
| Test item | |||||||||||||||||
| 250 µg/mL | + | 3 h | 20 h | 6 | 8 | 5 | 3.000 | 9 | 6 | 2 | 1 | 2 | 2 | 1 | 3 | — | |
| 500 µg/mL | + | 3 h | 20 h | 17 | 10 | 4 | 2.667 | 10 | 4 | 3 | 1 | 1 | 4 | 2 | 1 | — | |
| 1000 µg/mL | + | 3 h | 20 h | 20 | 9 | 5 | 3.000 | 9 | 5 | 1 | 1 | 1 | 4 | 1 | 2 | — | |
| 2000 µg/mL | + | 3 h | 20 h | 32 | 8 | 4 | 2.667 | 8 | 4 | 1 | 1 | 1 | 4 | 3 | 0 | — | |
| Vehicle control | + | 3 h | 20 h | 0 | 8 | 6 | 3.667 | 9 | 6 | 1 | 1 | 3 | 3 | 2 | 1 | — | |
| Positive control | + | 3 h | 20 h | 52 | 44∗∗ | 38∗∗ | 25.333 | 88∗∗ | 59∗∗ | 10 | 8 | 7 | 19 | 11 | 34 | — | |
| Experiment B | |||||||||||||||||
| Test item | |||||||||||||||||
| 125 µg/mL | − | 20 h | 20 h | 6 | 7 | 4 | 2.333 | 8 | 4 | 1 | 1 | 1 | 3 | 2 | 1 | — | |
| 250 µg/mL | − | 20 h | 20 h | 20 | 9 | 4 | 2.667 | 9 | 4 | 1 | 1 | 1 | 4 | 2 | 1 | — | |
| 500 µg/mL | − | 20 h | 20 h | 56 | 8 | 3 | 2.000 | 8 | 3 | 2 | 1 | 1 | 3 | 1 | 0 | — | |
| Vehicle control | − | 20 h | 20 h | 0 | 6 | 3 | 2.000 | 6 | 3 | 1 | 0 | 1 | 2 | 2 | 0 | — | |
| Positive control | − | 20 h | 20 h | 52 | 41∗∗ | 34∗∗ | 22.667 | 67∗∗ | 46∗∗ | 8 | 7 | 7 | 13 | 13 | 20 | — | |
| Test item | |||||||||||||||||
| 125 µg/mL | − | 20 h | 28 h | 6 | 6 | 3 | 2.000 | 6 | 3 | 1 | 0 | 2 | 2 | 2 | 0 | — | |
| 250 µg/mL | − | 20 h | 28 h | 22 | 7 | 3 | 2.667 | 8 | 3 | 2 | 1 | 0 | 3 | 2 | 1 | — | |
| 500 µg/mL | − | 20 h | 28 h | 56 | 8 | 4 | 2.667 | 9 | 4 | 1 | 0 | 2 | 4 | 3 | 0 | — | |
| Vehicle control | − | 20 h | 28 h | 0 | 7 | 4 | 2.333 | 7 | 4 | 1 | 0 | 2 | 3 | 2 | 1 | — | |
| Positive control | − | 20 h | 28 h | 49 | 46∗∗ | 41∗∗ | 27.000 | 73∗∗ | 48∗∗ | 7 | 7 | 7 | 18 | 16 | 20 | — | |
| Test item | |||||||||||||||||
| 250 µg/mL | + | 3 h | 28 h | 4 | 7 | 3 | 2.000 | 7 | 3 | 0 | 1 | 1 | 4 | 2 | 0 | — | |
| 500 µg/mL | + | 3 h | 28 h | 23 | 8 | 4 | 2.333 | 8 | 4 | 2 | 0 | 1 | 3 | 2 | 1 | — | |
| 1000 µg/mL | + | 3 h | 28 h | 26 | 8 | 3 | 2.000 | 8 | 3 | 2 | 0 | 1 | 4 | 2 | 1 | — | |
| 2000 µg/mL | + | 3 h | 28 h | 33 | 9 | 4 | 2.333 | 10 | 4 | 2 | 1 | 2 | 4 | 1 | 0 | — | |
| Vehicle control | + | 3 h | 28 h | 0 | 7 | 3 | 2.000 | 7 | 3 | 1 | 0 | 2 | 4 | 2 | 0 | — | |
| Positive control | + | 3 h | 28 h | 53 | 45∗∗ | 42∗∗ | 27.667 | 89∗∗ | 62∗∗ | 8 | 9 | 9 | 20 | 17 | 28 | — | |
Abbreviations: −, without S9-mix; +, with S9=mix; del deletion; gap−, excluding gaps; gap+, including gaps. Vehicle control, DME medium; positive control with S9-mix, cyclophasphamide (5.0 µg/mL); positive control without S9-mix (experiment A), EMS (1.0 µg/mL); positive control without S9-mix (experiment B), EMS (0,4 µg/mL). Cytotoxicity=100-RICC (relative increase in cell counts). ∗∗p < 0.01.