Table 5.
Summary of selected† hematological findings in the 14-day repeated oral toxicity study.
| Group | WBC | NEU | LYM | MONO | EOS | RBC | HCT | MCV | MCH | MCHC | PLT | RET |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (mg/kg bw/day) | ×109/L | % | % | % | % | ×1012/L | L/L | fL | pg | g/L | ×109/L | % |
| Male (main groups, n = 5 each unless otherwise noted) | ||||||||||||
| Control | 7.56 ± 1.03 | 14.90 ± 1.96 | 82.56 ± 2.13 | 1.78 ± 0.78 | 0.74 ± 0.34 | 8.17 ± 0.71 | 0.44 ± 0.04 | 53.70 ± 2.47 | 19.06 ± 0.78 | 355.20 ± 5.93 | 773.40 ± 66.89 | 4.74 ± 0.58 |
| 1000 | 8.20 ± 1.54 | 15.60 ± 3.16 | 82.20 ± 3.09 | 1.66 ± 0.51 | 0.46 ± 0.15 | 8.59 ± 0.54 | 0.45 ± 0.02 | 52.98 ± 2.12 | 19.02 ± 0.74 | 360.20 ± 2.59 | 868.00 ± 47.65 | 2.96 ± 0.39∗∗ |
| 2000 | 7.03 ± 1.40 | 9.92 ± 4.69∗ | 88.90 ± 5.21∗ | 1.06 ± 0.39 | 0.12 ± 0.16∗∗ | 8.92 ± 0.72 | 0.45 ± 0.01 | 50.62 ± 3.30 | 18.28 ± 0.87 | 361.80 ± 7.60 | 901.80 ± 93.29∗ | 2.51 ± 1.30∗∗ |
| 3000†† (n = 2) | 14.44 ± 2.59∗∗ | 13.35 ± 1.91 | 82.90 ± 2.97 | 3.35 ± 1.20∗ | 0.30 ± 0.14∗ | 9.17 ± 0.06 | 0.44 ± 0.02 | 48.30 ± 1.84∗ | 18.40 ± 0.28 | 380.50 ± 9.19∗∗ | 1009.50 ± 44.55∗∗ | 1.49 ± 1.22∗∗ |
| Historical range♮ | 6.23–13.73 | 6.8–28.2 | 68.5–91.6 | 0.8–3.7 | 0.1–2.2 | 6.6–9.5 | 0.37–0.50 | 48.7–60.8 | 17.9–21.1 | 348–377 | 631–1185 | 3.35–6.73 |
|
| ||||||||||||
| Female (main groups, n = 5 each unless otherwise noted) | ||||||||||||
| Control | 6.21 ± 1.16 | 10.46 ± 2.87 | 88.02 ± 3.06 | 1.02 ± 0.33 | 0.50 ± 0.22 | 8.10 ± 0.22 | 0.44 ± 0.01 | 54.14 ± 0.90 | 19.40 ± 0.33 | 358.60 ± 3.21 | 913.40 ± 37.32 | 4.62 ± 0.82 |
| 1000 | 7.24 ± 3.22 | 10.36 ± 3.69 | 88.06 ± 4.01 | 0.94 ± 0.30 | 0.62 ± 0.22 | 8.61 ± 0.34∗ | 0.46 ± 0.01 | 52.98 ± 2.57 | 18.90 ± 0.75 | 356.80 ± 5.22 | 887.00 ± 109.73 | 3.59 ± 0.53 |
| 2000 | 7.31 ± 2.77 | 13.26 ± 8.36 | 85.28 ± 8.22 | 1.12 ± 0.41 | 0.30 ± 0.10 | 8.76 ± 0.28∗ | 0.45 ± 0.01 | 51.10 ± 1.08∗ | 18.38 ± 0.36∗∗ | 359.60 ± 7.16 | 914.60 ± 87.37 | 3.44 ± 0.92 |
| 3000†† (n = 2) | 4.13 ± 1.49 | 26.35 ± 20.86 | 72.20 ± 21.78 | 1.45 ± 0.92 | 0.00 ± 0.00∗∗ | 8.26 ± 0.63 | 0.42 ± 0.02∗ | 50.35 ± 1.20∗ | 17.95 ± 0.07∗∗ | 357.00 ± 9.90 | 1551.00 ± 599.63 | 5.58 ± 5.82 |
| Historical range♮ | 4.07–10.67 | 5.5–24.2 | 71.7–92.5 | 0.7–3.5 | 0.2–2.7 | 7.8–9.1 | 0.41–0.47 | 48.1–57.8 | 17.7–20.5 | 353–374 | 635–1118 | 2.56–6.97 |
Data represents the mean values and the standard deviation.
Dose was reduced from 4000 to 3000 mg/kg bw/d on day 2.
†: only parameters with statistically significant findings are shown in table.
††: dose was reduced from 4000 to 3000 mg/kg bw/d on day 2.
∗P < 0.05 and ∗∗P < 0.01, significance determined with Duncan's multiple range test or with Mann–Whitney U test versus control.
♮: minimum and maximum levels reported as the range of historical control values.