Table 11.
Summary of selected† clinical chemistry findings in the 90-day repeated oral toxicity study.
| Group | ALT | AST | GGT | ALP | TBIL | CREA | CHOL | Pi | ALB | TPROT |
|---|---|---|---|---|---|---|---|---|---|---|
| (mg/kg bw/day) | U/L | U/L | U/L | U/L | μmol/L | μmol/L | mmol/L | mmol/L | g/L | g/L |
| Male (main groups, n = 10 each) | ||||||||||
| Control | 65.11 ± 15.73 | 98.99 ± 17.04 | 1.21 ± 0.23 | 129.10 ± 35.04 | 1.93 ± 0.43 | 28.84 ± 2.54 | 1.90 ± 0.22 | 1.93 ± 0.24 | 34.81 ± 0.60 | 61.99 ± 2.53 |
| 100 | 52.96 ± 9.36 | 95.25 ± 9.39 | 1.27 ± 0.36 | 124.80 ± 40.28 | 1.52 ± 0.25∗ | 27.83 ± 2.98 | 1.86 ± 0.38 | 2.26 ± 0.53 | 35.38 ± 1.15 | 64.65 ± 3.49 |
| 360 | 62.35 ± 16.31 | 83.03 ± 6.33∗ | 2.11 ± 0.67∗∗ | 129.90 ± 43.44 | 1.70 ± 0.24 | 29.01 ± 2.29 | 1.84 ± 0.26 | 2.38 ± 0.34∗ | 36.11 ± 1.41∗ | 66.90 ± 5.38∗ |
| 720 | 51.50 ± 11.56∗ | 88.31 ± 11.96 | 3.44 ± 1.06∗∗ | 161.60 ± 38.08 | 1.87 ± 0.33 | 29.27 ± 3.56 | 1.68 ± 0.42 | 2.10 ± 0.37 | 36.47 ± 1.78∗∗ | 67.29 ± 4.40∗ |
| Historical range♮ | 28.0–86.2 | 67.9–135.7 | 0.0–2.2 | 56–184 | 0.71–2.79 | 18.5 ± 37.2 | 1.27–2.44 | 1.40–2.41 | 33.0–37.4 | 56.8–68.0 |
|
| ||||||||||
| Male (recovery groups, n = 5 each) | ||||||||||
| Control | 57.56 ± 15.48 | 89.22 ± 11.97 | 0.98 ± 0.18 | 104.60 ± 27.83 | 1.61 ± 0.30 | 30.42 ± 2.46 | 2.22 ± 0.29 | 1.95 ± 0.37 | 35.38 ± 0.88 | 66.48 ± 3.33 |
| 720 | 48.70 ± 17.40 | 76.78 ± 11.47 | 1.48 ± 0.16∗∗ | 89.00 ± 16.00 | 1.78 ± 0.41 | 30.56 ± 4.48 | 1.82 ± 0.42 | 2.08 ± 0.28 | 36.00 ± 0.99 | 65.58 ± 3.27 |
|
| ||||||||||
| Female (main groups, n = 10 each) | ||||||||||
| Control | 52.32 ± 7.80 | 85.88 ± 10.45 | 1.54 ± 0.29 | 55.80 ± 16.72 | 1.78 ± 0.22 | 31.81 ± 2.69 | 1.94 ± 0.38 | 1.59 ± 0.23 | 35.35 ± 1.23 | 62.16 ± 2.61 |
| 100 | 51.04 ± 10.64 | 91.17 ± 22.32 | 1.35 ± 0.47 | 64.70 ± 26.19 | 1.91 ± 0.39 | 30.36 ± 2.30 | 1.80 ± 0.27 | 1.96 ± 0.36 | 36.18 ± 1.50 | 64.78 ± 2.63 |
| 360 | 51.40 ± 8.64 | 84.86 ± 12.67 | 3.11 ± 0.74∗∗ | 72.70 ± 22.96 | 1.60 ± 0.25 | 30.85 ± 3.33 | 2.19 ± 0.32 | 1.99 ± 0.35∗∗ | 36.33 ± 1.21 | 64.62 ± 2.83 |
| 720 | 58.11 ± 11.93 | 85.12 ± 15.40 | 7.41 ± 1.72∗∗ | 91.10 ± 23.86∗∗ | 2.13 ± 0.69 | 30.37 ± 2.35 | 2.71 ± 0.41∗∗ | 1.84 ± 0.15∗∗ | 35.90 ± 1.84 | 65.15 ± 4.63 |
| Historical range♮ | 23.4–87.7 | 71.0–141.8 | 0.0–2.9 | 25.0–126 | 1.23–3.30 | 25.6–40.8 | 1.35–3.39 | 0.93–2.01 | 33.2–41.0 | 57.1–74.5 |
|
| ||||||||||
| Female (recovery groups, n = 5 each) | ||||||||||
| Control | 48.12 ± 13.64 | 73.58 ± 11.26 | 1.06 ± 0.15 | 53.60 ± 13.94 | 2.03 ± 0.28 | 34.44 ± 2.50 | 2.37 ± 0.50 | 1.39 ± 0.32 | 37.28 ± 2.70 | 68.94 ± 5.95 |
| 720 | 38.40 ± 4.83 | 70.44 ± 10.04 | 1.96 ± 0.46∗∗ | 49.60 ± 10.36 | 1.78 ± 0.24 | 30.72 ± 2.12∗ | 2.22 ± 0.31 | 1.22 ± 0.28 | 36.76 ± 1.09 | 66.44 ± 1.28 |
Data represent the mean values and the standard deviation.
†: only parameters with statistically significant findings are shown in table.
∗P < 0.05 and ∗∗P < 0.01, statistical significances were 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.