TABLE 7.
90‐Day subchronic oral toxicity study organ—hematology analysis (mean ± SD).
| Group a | C | S‐L | S‐M | S‐H | Re‐C | Re‐H |
|---|---|---|---|---|---|---|
| Dose (mL/kg) | 0 | 1.5 | 5 | 15 | 0 | 15 |
| Male rats | ||||||
| Test parameter | ||||||
| WBC (/μL) | 11,432.0 ± 1818.0 | 9952.0 ± 1520.1 | 9841.0 ± 1328.0 | 10,908.0 ± 1775.4 | 9814.0 ± 919.2 | 9064.0 ± 1676.5 |
| RBC (106/μL) | 9.236 ± 0.694 | 9.261 ± 0.412 | 9.34 ± 0.400 | 9.340 ± 0.538 | 8.722 ± 0.306 | 8.906 ± 0.337 |
| HGB (g/dL) | 16.41 ± 0.74 | 15.78 ± 0.66 | 16.22 ± 0.49 | 16.33 ± 0.56 | 15.26 ± 0.35 | 15.70 ± 0.78 |
| HCT (%) | 47.80 ± 1.80 | 45.50 ± 1.92 | 46.40 ± 1.49 | 46.86 ± 2.42 | 44.16 ± 1.05 | 45.02 ± 2.77 |
| MCV (fL) | 51.97 ± 3.56 | 49.18 ± 2.07 | 49.74 ± 1.94 | 50.29 ± 3.35 | 50.40 ± 1.87 | 50.60 ± 3.32 |
| MCH (pg) | 17.81 ± 0.76 | 17.05 ± 0.65 | 17.39 ± 0.52 | 17.50 ± 0.82 | 17.40 ± 0.64 | 17.64 ± 0.92 |
| MCHC (%) | 34.32 ± 0.89 | 34.69 ± 0.39 | 34.95 ± 0.45 | 34.87 ± 0.84 | 34.56 ± 0.18 | 34.92 ± 0.54 |
| PLT (103/μL) | 1069.4 ± 173.3 | 1175.5 ± 135.5 | 1161.9 ± 116.9 | 1088.4 ± 57.3 | 1022.4 ± 80.1 | 1034.8 ± 80.8 |
| MPV (fL) | 6.71 ± 0.21 | 6.77 ± 0.18 | 6.68 ± 0.19 | 6.75 ± 0.24 | 6.76 ± 0.23 | 7.02 ± 0.25 |
| NEUT (%) | 13.62 ± 2.69 | 14.98 ± 2.09 | 16.45 ± 2.94 | 15.54 ± 3.05 | 13.76 ± 2.96 | 15.6 ± 2.93 |
| LYMPH (%) | 81.32 ± 3.09 | 79.03 ± 2.41 | 77.81 ± 3.55 | 79.29 ± 2.88 | 81.10 ± 3.00 | 78.42 ± 2.46 |
| MONO (%) | 3.46 ± 0.60 | 4.20 ± 0.73 | 3.82 ± 0.65 | 3.69 ± 0.66 | 3.92 ± 0.69 | 4.14 ± 1.17 |
| EOS (%) | 1.47 ± 0.60 | 1.66 ± 0.60 | 1.81 ± 0.52 | 1.38 ± 0.45 | 1.08 ± 0.33 | 1.76 ± 0.61 |
| BAŞO (%) | 0.13 ± 0.05 | 0.13 ± 0.08 | 0.11 ± 0.06 | 0.10 ± 0.07 | 0.14 ± 0.05 | 0.08 ± 0.08 |
| RET (%) | 2.83 ± 0.29 | 3.02 ± 0.28 | 2.96 ± 0.42 | 2.91 ± 0.32 | 2.96 ± 0.47 | 2.88 ± 0.25 |
| Female rats | ||||||
| Test parameter | ||||||
| WBC (/μL) | 8155.0 ± 845.6 | 8158.0 ± 829.9 | 8427.0 ± 956.5 | 8251.0 ± 859.6 | 8450.0 ± 1328.3 | 8874.0 ± 1253.3 |
| RBC (106/μL) | 8.188 ± 0.280 | 8.272 ± 0.294 | 8.583 ± 0.313 | 8.465 ± 0.530 | 8.086 ± 0.292 | 8.014 ± 0.397 |
| HGB (g/dL) | 15.08 ± 0.40 | 15.32 ± 0.72 | 15.84 ± 0.44 | 15.50 ± 0.81 | 15.08 ± 0.42 | 14.74 ± 0.38 |
| HCT (%) | 43.34 ± 1.02 | 44.41 ± 2.18 | 45.49 ± 0.92 | 44.62 ± 2.10 | 43.80 ± 1.19 | 42.46 ± 1.28 |
| MCV (fL) | 52.96 ± 1.64 | 53.67 ± 1.24 | 53.06 ± 1.86 | 52.75 ± 1.24 | 54.22 ± 2.17 | 53.02 ± 1.01 |
| MCH (pg) | 18.41 ± 0.57 | 18.53 ± 0.42 | 18.48 ± 0.57 | 18.34 ± 0.44 | 18.64 ± 0.7 | 18.40 ± 048 |
| MCHC (%) | 34.80 ± 0.36 | 34.50 ± 0.36 | 34.82 ± 0.56 | 34.74 ± 0.54 | 34.42 ± 0.45 | 34.72 ± 0.30 |
| PLT (103/μL) | 1120.7 ± 159.5 | 1075.7 ± 112.6 | 1131.4 ± 148.0 | 1057.6 ± 89.2 | 1073.4 ± 98.4 | 1035.4 ± 102.2 |
| MPV (fL) | 6.88 ± 0.29 | 6.99 ± 0.25 | 7.02 ± 0.26 | 6.93 ± 0.14 | 7.08 ± 0.28 | 7.06 ± 0.19 |
| NEUT (%) | 10.79 ± 3.52 | 10.81 ± 2.47 | 10.11 ± 2.81 | 12.22 ± 1.73 | 11.14 ± 2.68 | 12.44 ± 2.24 |
| LYMPH (%) | 84.01 ± 4.05 | 84.30 ± 2.67 | 85.28 ± 3.07 | 83.29 ± 1.85 | 84.60 ± 2.96 | 82.40 ± 2.42 |
| MONO (%) | 3.54 ± 0.91 | 3.33 ± 0.72 | 3.02 ± 0.51 | 3.08 ± 0.85 | 3.26 ± 0.63 | 3.72 ± 0.47 |
| EOS (%) | 1.54 ± 0.26 | 1.41 ± 0.40 | 1.50 ± 0.48 | 1.33 ± 0.51 | 0.94 ± 0.24 | 1.30 ± 0.46 |
| BAŞO (%) | 0.12 ± 0.09 | 0.15 ± 0.12 | 0.09 ± 0.07 | 0.08 ± 0.10 | 0.06 ± 0.09 | 0.14 ± 0.13 |
| RET (%) | 3.64 ± 0.39 | 3.48 ± 0.39 | 3.57 ± 0.35 | 3.74 ± 0.36 | 3.42 ± 0.33 | 3.20 ± 0.37 |
Note: Data were presented as mean ± SD of 10 animals per group in main study; five animals per group in recovery study.
Abbreviations: BASO, Basophil; EOS, Eosinophil; HCT, Hematocrit; HGB, Hemoglobin; LYMPH, Lymphocyte; MCH, Mean corpuscular hemoglobin; MCHC, Mean corpuscular hemoglobin concentration; MCV, Mean corpuscular volume; MONO, Monocyte; MPV, Mean platelet volume; NEUT, Neutrophil; PLT, Platelet; RBC, Red blood cell; RET, Reticulocyte; WBC, White blood cell.
a
C: control; S‐L: Symbiota® low dose group; S‐M: Symbiota® middle dose group; S‐H: Symbiota® high dose group; Re‐C: recovery control group; Re‐H: recovery high dose group.