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Abstract
The purpose of this paper is to provide reference data related to the body weight, food & water consumptions, urinalysis, hematology and serum biochemistry parameters and absolute & relative organ weights obtained from control Sprague-Dawley rats, used in the 4-week and 13-week repeated-dose toxicity studies conducted in our laboratory between 2005 and 2008. The mean, standard deviation, minimum and maximum range values for hematology and serum biochemistry parameters, data of absolute & relative organ weights, and the difference between sexes and study duration of week 4 versus 13 week are presented. The studies were conducted according to “the standards of Toxicity Study for Medicinal Products” (2005) and The KFDA Notification No. 2000-63 ‘Good Laboratory Practice (GLP)’ (2000) issued by KFDA. These data could be used as reference material of Sprague-Dawley rats by conducting the studies to evaluate the toxicological profile of pre-clinical toxicity studies.
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Figure 1.
Reference data of mean body weights from 4- and 13-week toxicity studies in male and female Sprague-Dawley rats
Figure 2.
Reference data of food consumption from 4- and 13-week toxicity studies in male and female Sprague-Dawley rats
Figure 3.
Reference data of water consumption from 4- and 13-week toxicity studies in male and female Sprague-Dawley rats
Table 1.
Parameters, units and methods of analysis used in hematological and serum chemistry examinations
| Parameters (abbreviation) | Units | Methods |
|---|---|---|
| White blood cell count (WBC) | 103/µL | Laser optical flowcytometry or electric resistance method∗ |
| Red blood cell count (RBC) | 106/µL | Laser optical flowcytometry or electric resistance method∗ |
| Hemoglobin concentration (HGB) | g/dL | Cyanmethemoglobin method∗ |
| Hematocrit | % | Calculated from RBC and MCV |
| Mean corpuscular volume (MCV) | fL | Histogram or electric resistance method∗ |
| Mean corpuscular hemoglobin (MCH) | pg | Calculated from HGB and RBC |
| Mean corpuscular hemoglobin concentration (MCHC) | g/dL | Calculated from HGB, RBC and MCV |
| Red cell distribution width (RDW) | % | Histogram∗ |
| Hemoglobin concentration distribution width (HDW) | g/dL | Histogram∗ |
| Platelet | 103/µL | Laser optical flowcytometry or electric resistance method∗ |
| Mean platelet volume (MPV) | fL | Histogram∗ |
| prothrombin time (PT) | sec | Nephelometric analysis# |
| Activated partial thromboplastin time (APTT) | sec | Nephelometric analysis# |
| Neutrophil | % | Peroxidase cytometric flowcytometry or scatter photocoagulation method∗ |
| Lymphocyte | % | Peroxidase cytometric flowcytometry or scatter photocoagulation method∗ |
| Monocyte | % | Peroxidase cytometric flowcytometry or scatter photocoagulation method∗ |
| Eosinophil | % | Peroxidase cytometric flowcytometry or scatter photocoagulation method∗ |
| Basophil | % | Peroxidase cytometric flowcytometry or scatter photocoagulation method∗ |
| Large unstained cells (LUC) | % | Noise-Lymph Histogram∗ |
| Aspartate aminotransferase (AST) | U/L | IFCC method& |
| Alanine aminotransferase (ALT) | U/L | IFCC method& |
| Alkaline phosphatase (ALP) | U/L | P-NPP method& |
| Blood urea nitrogen (BUN) | mg/dL | Urease-UV method& |
| Creatinine | mg/dL | Jaffe method& |
| Glucose | mg/dL | UV method& |
| Total cholesterol (TC) | mg/dL | Enzyme method& |
| Total protein (TP) | g/dL | Biuret method& |
| Creatine phosphokinase (CPK) | U/L | UV-Rate method& |
| Albumin | g/dL | BCG method& |
| Albumin/Globulin (A/G) ratio | ratio | Calculated from PRO, ALB |
| Total bilirubin (TB) | mg/dL | Evelyn-Malloy method& |
| Triglyceride | mg/dL | Enzyme method& |
| Inorganic phosphorus (IP) | mg/dL | UV method& |
| Calcium ion (Ca++) | mg/dL | O-CPC method& |
| Sodium ion (Na+) | mmol/L | Electrode method$ |
| Potassium ion (K+) | mmol/L | Electrode method$ |
| Chloride ion (Cl-) | mmol/L | Electrode method$ |
Table 2.
Reference data of urinalysis from 4- and 13-week toxicity studies in male and female Sprague-Dawley rats
| Parameters | Result | Grade | 4 weeks-group | 13 weeks-group | ||
|---|---|---|---|---|---|---|
| Males | Females | Males | Females | |||
| Glucose (mg/dL) | Negative | 0 | 56 | 60 | 58 | 63 |
| 100 (Trace) | 1 | 4 | 0 | 7 | 2 | |
| Bilirubin | Negative | 0 | 55 | 59 | 64 | 65 |
| Small | 1 | 5 | 1 | 1 | 0 | |
| Ketone body (mg/dL) | Negative | 0 | 29 | 47 | 43 | 65 |
| 5 (Trace) | 1 | 23 | 12 | 17 | 0 | |
| 15 | 2 | 7 | 1 | 5 | 0 | |
| 40 | 3 | 1 | 0∗ | 0 | 0#$ | |
| Specific gravity | ≤1.005 | 0 | 0 | 3 | 6 | 15 |
| 1.0100 | 1 | 6 | 3 | 9 | 11 | |
| 1.0150 | 2 | 2 | 9 | 18 | 12 | |
| 1.0200 | 3 | 10 | 8 | 15 | 18 | |
| 1.0250 | 4 | 12 | 15 | 11 | 8 | |
| ≥1.030 | 5 | 30 | 22 | 6∗ | 1$ | |
| pH | 5.5 | 0 | 0 | 2 | 0 | 0 |
| 6.0 | 1 | 0 | 8 | 0 | 0 | |
| 6.5 | 2 | 2 | 4 | 0 | 1 | |
| 7.0 | 3 | 9 | 3 | 0 | 7 | |
| 7.5 | 4 | 11 | 13 | 5 | 13 | |
| 8.0 | 5 | 26 | 20 | 43 | 33 | |
| 8.5 | 6 | 12 | 9 | 15 | 11 | |
| ≥9.0 | 7 | 0 | 1 | 2∗ | 0# | |
| Protein (mg/dL) | Negative | 0 | 3 | 26 | 0 | 37 |
| 15 (Trace) | 1 | 4 | 5 | 2 | 8 | |
| 30 | 2 | 10 | 10 | 7 | 9 | |
| 100 | 3 | 25 | 7 | 34 | 9 | |
| ≥300 | 4 | 18 | 12∗ | 22 | 2# | |
| Urobilinogen (Ehrlich unit/dL) | 0.1 | 0 | 60 | 60 | 65 | 65 |
| Nitrite | Negative | 0 | 58 | 60 | 65 | 65 |
| Positive | 1 | 2 | 0 | 0 | 0 | |
| Occult blood | Negative | 0 | 53 | 54 | 29 | 60 |
| Trace | 1 | 2 | 4 | 14 | 3 | |
| Small | 2 | 5 | 1 | 21 | 1 | |
| Moderate | 3 | 0 | 0 | 1 | 0 | |
| Large | 4 | 0 | 1 | 0∗ | 1# | |
| Leukocyte | Negative | 0 | 9 | 41 | 3 | 33 |
| Trace | 1 | 5 | 14 | 3 | 18 | |
| Small | 2 | 22 | 4 | 26 | 10 | |
| Moderate | 3 | 22 | 1 | 29 | 4 | |
| Large | 4 | 2 | 0∗ | 4 | 0# | |
| Number of animals | 60 | 65 | 60 | 65 | ||
Table 3.
Reference data of hematology from 4- and 13 week toxicity studies in male and female Sprague-Dawley rats
| Parameters | 4 weeks-group | 13 weeks-group | ||||
|---|---|---|---|---|---|---|
| N | Mean±SD | Range | N | Mean±SD | Range | |
| Males | ||||||
| RBC (106/µL) | 105 | 7.97±0.43 | 6.7-9.0 | 129 | 8.79±0.39∗ | 7.8-9.9 |
| Hemoglobin (g/dL) | 105 | 15.29±0.82 | 13.6-17.7 | 129 | 15.69±0.65∗ | 13.9-17.3 |
| Hematocrit (%) | 105 | 44.95±3.44 | 37.9-52.2 | 129 | 46.19±3.53∗ | 38.9-55.2 |
| MCV (fL) | 105 | 56.34±2.58 | 51.8-63.6 | 129 | 52.51±2.99∗ | 46.5-60.0 |
| MCH (pg) | 105 | 19.18±0.59 | 17.9-20.9 | 129 | 17.85±0.64∗ | 16.3-20.2 |
| MCHC (g/dL) | 105 | 34.09±1.39 | 30.6-36.8 | 129 | 34.10±2.15 | 29.4-38.3 |
| RDW (%) | 70 | 11.90±2.29 | 9.7-16.5 | 79 | 12.07±0.35 | 11.4-13.0 |
| HDW (g/dL) | 50 | 2.32±0.13 | 2.0-2.6 | 79 | 2.35±0.18 | 1.8-2.8 |
| WBC (103/µL) | 105 | 10.35±2.45 | 4.9-16.3 | 129 | 9.19±2.35∗ | 4.8-20.1 |
| Neutrophil (%) | 105 | 11.48±3.71 | 4.7-23.3 | 129 | 21.85±8.60∗ | 8.1-44.6 |
| Lymphocyte (%) | 105 | 82.69±4.42 | 71.1-89.4 | 129 | 71.57±8.97∗ | 44.8-86.5 |
| Monocyte (%) | 105 | 2.94±1.29 | 0.2-8.0 | 129 | 3.49±1.46∗ | 0.21-10.0 |
| Eosinophil (%) | 105 | 0.82±0.35 | 0.2-2.2 | 129 | 1.33±0.50∗ | 0.30-3.25 |
| Basophil (%) | 105 | 1.59±1.40 | 0.1-5.1 | 129 | 1.16±1.32 | 0.0-5.0 |
| LUC (%) | 50 | 1.01±0.33 | 0.5-1.9 | 79 | 0.96±0.44 | 0.3-2.3 |
| Platelet (103/µL) | 105 | 1050.77±179.18 | 784-1500 | 129 | 971.45±126.77∗ | 735-1418 |
| MPV (fL) | 70 | 6.12±0.98 | 5.2-12.2 | 70 | 6.28±0.86 | 5.0-8.5 |
| PT (sec) | 30 | 10.75±3.04 | 7.6-15.5 | 128 | 13.38±3.63∗ | 8.1-18.3 |
| APTT (sec) | 30 | 16.52±2.20 | 7.9-20.1 | 128 | 18.19±1.27∗ | 15.2-20.9 |
| Females | ||||||
| RBC (106/µL) | 104 | 7.72±0.45∗ | 6.7-9.8 | 129 | 7.79±0.43# | 6.69-8.92 |
| Hemoglobin (g/ dL) | 104 | 14.66±0.83∗ | 12.5-17.8 | 129 | 14.59±0.65# | 13.1-17.0 |
| Hematocrit (%) | 104 | 42.50±2.91∗ | 35.5-54.4 | 129 | 42.60±3.26# | 36.9-51.8 |
| MCV (fL) | 104 | 55.06±2.34∗ | 51.4-63.1 | 129 | 54.66±3.06# | 48.4-63.8 |
| MCH (pg) | 104 | 19.01±0.72 | 17.3-21.3 | 129 | 18.76±0.82# | 16.7-21.8 |
| MCHC (g/dL) | 104 | 34.58±1.22∗ | 30.7-37.1 | 129 | 34.38±2.09 | 30.1-39.7 |
| RDW (%) | 70 | 11.30±2.05 | 9.4-15.2 | 79 | 10.98±0.43# | 10.0-12.2 |
| HDW (g/dL) | 50 | 2.26±0.16 | 1.8-2.6 | 79 | 2.25±0.20# | 1.8-2.7 |
| WBC (103/µL) | 104 | 6.47±1.93∗ | 3.0-12.0 | 129 | 5.55±1.78#$ | 3.0-14.3 |
| Neutrophil (%) | 104 | 12.11±5.96 | 4.9-54.1 | 129 | 14.62±6.69#$ | 4.9-58.1 |
| Lymphocyte (%) | 104 | 81.94±6.74 | 33.3-91.5 | 129 | 79.02±6.85#$ | 37.6-89.7 |
| Monocyte (%) | 104 | 2.84±1.29 | 0.1-7.5 | 129 | 2.94±1.03#$ | 0.8-6.1 |
| Eosinophil (%) | 104 | 1.20±0.49∗ | 0.5-3.5 | 129 | 1.83±1.14#$ | 0.3-10.0 |
| Basophil (%) | 104 | 1.50±1.44 | 0.0-5.2 | 129 | 0.99±1.13$ | 0.0-3.5 |
| LUC (%) | 50 | 0.92±0.34 | 0.4-1.8 | 79 | 0.96±0.49 | 0.4-2.5 |
| Platelet (103/µL) | 104 | 1088.21±137.58 | 815-1397 | 129 | 1015.43±140.67#$ | 674-1373 |
| MPV (fL) | 70 | 6.13±1.01 | 5.1-8.1 | 70 | 6.52±1.13 | 5.2-10.2 |
| PT (sec) | 29 | 10.95±3.79 | 7.3-17.0 | 128 | 13.49±4.12$ | 7.7-19.5 |
| APTT (sec) | 29 | 15.51±2.32 | 10.5-19.5 | 128 | 17.18±1.51#$ | 13.8-21.0 |
WBC: white blood cell count, RBC: red blood cell count, MCV: mean corpuscular volume, MCH: mean corpuscular hemoglobin, MCHC: mean corpuscular hemoglobin concentration. RDW: Red cell distribution width, HDW: Hemoglobin concentration distribution width, LUC: large unstained cells, PT: prothrombin time, APTT: Activated partial thromboplastin time.
Table 4.
Reference data of blood biochemistry from 4- and 13 week toxicity studies in male and female Sprague-Dawley rats
| Parameters | 4 weeks-group | 13 weeks-group | ||||
|---|---|---|---|---|---|---|
| N | Mean±SD | Range | N | Mean±SD | Range | |
| Males | ||||||
| AST (IU/L) | 105 | 98.25±25.95 | 63.9-228.8 | 129 | 101.09±22.10 | 64.1-168.1 |
| ALT (IU/L) | 105 | 39.81±9.33 | 26.5-101.4 | 129 | 45.50±9.19∗ | 30.8-73.4 |
| ALP (IU/L) | 105 | 149.27±30.47 | 91.0-250.1 | 129 | 91.64±19.92∗ | 58.4-180.4 |
| TB (mg/dL) | 70 | 0.18±0.03 | 0.14-0.28 | 129 | 0.20±0.03 | 0.07-0.29 |
| Glucose (mg/dL) | 105 | 127.94±17.92 | 86.9-209.2 | 129 | 131.02±15.56 | 95.4-188.4 |
| TC (mg/dL) | 105 | 95.55±17.15 | 44.0-139.0 | 129 | 108.65±18.72∗ | 72.0-206.0 |
| Triglyceride (mg/dL) | 105 | 47.40±13.56 | 11.3-85.0 | 129 | 50.20±14.71 | 23.0-110.6 |
| TP (g/dL) | 70 | 6.00±0.24 | 5.22-6.71 | 129 | 6.50±0.52∗ | 5.68-9.25 |
| Albumin (g/dL) | 105 | 3.25±0.23 | 2.69-3.86 | 129 | 3.15±0.21∗ | 2.83-4.05 |
| A/G ratio | 105 | 1.19±0.18 | 0.93-1.72 | 129 | 0.95±0.07∗ | 0.73-1.15 |
| CPK (IU/L) | 50 | 280.93±164.38 | 88.0-909.2 | 129 | 238.28±131.30 | 48.0-715.3 |
| BUN (mg/dL) | 105 | 17.35±2.51 | 11.8-25.4 | 129 | 16.97±2.78 | 12.1-26.1 |
| Creatinine (mg/dL) | 105 | 0.49±0.04 | 0.36-0.60 | 129 | 0.55±0.07∗ | 0.25-0.83 |
| IP (mg/dL) | 105 | 8.78±0.70 | 7.5-10.8 | 129 | 7.36±1.09∗ | 5.6-10.3 |
| Ca++ (mg/dL) | 105 | 10.05±0.45 | 9.0-11.3 | 129 | 9.85±1.26 | 5.8-14.2 |
| Na+ (mmol/L) | 94 | 144.24±1.57 | 141.0-149.0 | 129 | 144.19±3.56 | 129.0-155.0 |
| K+ (mmol/L) | 94 | 4.70±0.36 | 3.81-6.48 | 129 | 4.51±0.38∗ | 3.96-7.87 |
| Cl- (mmol/L) | 94 | 107.51±1.44 | 103.0-110.0 | 129 | 107.57±2.59 | 97.0-116.0 |
| Females | ||||||
| AST (IU/L) | 105 | 96.19±17.98 | 67.3-166.0 | 129 | 100.02±20.65 | 67.5-179.9 |
| ALT (IU/L) | 105 | 31.57±4.94∗ | 19.2-48.7 | 129 | 33.43±5.13#$ | 22.4-47.1 |
| ALP (IU/L) | 105 | 103.43±26.47∗ | 59.0-196.0 | 129 | 63.81±17.71#$ | 30.1-116.0 |
| TB (mg/dL) | 70 | 0.21±0.07∗ | 0.12-0.84 | 129 | 0.22±0.04# | 0.15-0.35 |
| Glucose (mg/dL) | 105 | 110.25±11.26∗ | 84.3-142.4 | 129 | 110.42±12.24# | 80.5-149.4 |
| TC (mg/dL) | 105 | 87.19±16.76∗ | 32.2-126.0 | 129 | 102.82±20.84$ | 51.0-155.0 |
| Triglyceride (mg/dL) | 105 | 33.36±11.36∗ | 4.9-63.0 | 129 | 37.95±7.92#$ | 20.2-58.0 |
| TP (g/dL) | 70 | 5.83±0.30∗ | 4.97-7.30 | 129 | 6.20±0.33#$ | 5.35-7.06 |
| Albumin (g/dL) | 105 | 3.28±0.28 | 2.69-4.27 | 129 | 3.21±0.18 | 2.73-3.68 |
| A/G ratio | 105 | 1.31±0.24∗ | 0.96-1.97 | 129 | 1.08±0.08#$ | 0.92-1.32 |
| CPK (IU/L) | 50 | 259.48±156.59 | 49.0-782.0 | 129 | 264.90±185.99 | 44.0-1316.6 |
| BUN (mg/dL) | 105 | 18.99±3.08∗ | 11.7-28.4 | 129 | 17.99±2.59#$ | 11.7-26.4 |
| Creatinine (mg/dL) | 105 | 0.51±0.07 | 0.29-0.63 | 129 | 0.61±0.07#$ | 0.35-0.79 |
| IP (mg/dL) | 105 | 7.95±0.78∗ | 6.2-10.0 | 129 | 6.67±1.27#$ | 4.1-10.4 |
| Ca++ (mg/dL) | 105 | 9.68±0.51∗ | 7.8-11.1 | 129 | 9.52±1.00 | 4.6-11.0 |
| Na+ (mmol/L) | 95 | 143.26±1.83∗ | 139.0-148.0 | 128 | 144.08±2.66$ | 134.0-154.0 |
| K+ (mmol/L) | 95 | 4.53±0.31∗ | 3.97-5.70 | 128 | 4.27±0.46#$ | 3.59-7.89 |
| Cl- (mmol/L) | 95 | 108.29±1.85∗ | 104.0-113.0 | 128 | 109.09±2.39#$ | 101.0-116.0 |
Table 5.
Reference data of absolute and relative organ weights from 4- and 13 week toxicity studies in male Sprague-Dawley rats
| Organs | Males | |||||
|---|---|---|---|---|---|---|
| 4 weeks-group | 13 weeks-group | |||||
| N | Mean±SD | Range | N | Mean±SD | Range | |
| Body weights (g)a) | 105 | 312.21±23.740 | 267.13-399.36 | 129 | 435.09±30.590 | 326.71-508.72 |
| Brain (g) | 75 | 1.8405±0.0854 | 1.6717-2.0621 | 129 | 1.9855±0.1440 | 1.7500-3.3610 |
| (%) | 75 | 0.5854±0.0393 | 0.5118-0.6829 | 129 | 0.4582±0.0443 | 0.3979-0.8360 |
| Pituitary gland (g) | 70 | 0.0119±0.0117 | 0.0082-0.1080 | 129 | 0.0122±0.0017 | 0.0084-0.0212 |
| (%) | 70 | 0.0038±0.0038 | 0.0021-0.0345 | 129 | 0.0028±0.0004 | 0.0018-0.0049 |
| Thyroid gland-left+right (g) | 40 | 0.0164±0.0032 | 0.0092-0.0224 | 50 | 0.0191±0.0066 | 0.0121-0.0497 |
| (%) | 40 | 0.0052±0.0009 | 0.0034-0.0074 | 50 | 0.0045±0.0015 | 0.0028-0.0083 |
| Thyroid gland-left (g) | 40 | 0.0081±0.0020 | 0.0051-0.0131 | 50 | 0.0098±0.0059 | 0.0050-0.0379 |
| (%) | 40 | 0.0026±0.0006 | 0.0018-0.0042 | 50 | 0.0023±0.0013 | 0.0012-0.0083 |
| Thyroid gland-right (g) | 40 | 0.0083±0.0020 | 0.0035-0.0128 | 50 | 0.0093±0.0019 | 0.0061-0.0149 |
| (%) | 40 | 0.0026±0.0005 | 0.0013-0.0041 | 50 | 0.0022±0.0005 | 0.0014-0.0034 |
| Heart (g) | 105 | 1.1035±0.1144 | 0.9046-1.8449 | 129 | 1.3930±0.1128 | 1.0750-1.6520 |
| (%) | 105 | 0.3537±0.0278 | 0.2976-0.5414 | 129 | 0.3206±0.0210 | 0.2739-0.3729 |
| Lung (g) | 105 | 1.4373±0.1210 | 1.1755-1.7220 | 129 | 1.7809±0.1970 | 1.4345-3.1306 |
| (%) | 105 | 0.4614±0.0352 | 0.3701-0.5612 | 129 | 0.4099±0.0401 | 0.3341-0.6859 |
| Thymus (g) | 105 | 0.4884±0.0961 | 0.3430-1.0030 | 129 | 0.2908±0.0582 | 0.0330-0.4990 |
| (%) | 105 | 0.1564±0.0265 | 0.1021-0.2512 | 129 | 0.0670±0.0137 | 0.0088-0.1110 |
| Spleen (g) | 105 | 0.7227±0.0906 | 0.4866-1.0124 | 129 | 0.8068±0.1238 | 0.5252-1.4780 |
| (%) | 105 | 0.2317±0.0249 | 0.1822-0.3250 | 129 | 0.1856±0.0271 | 0.1239-0.3536 |
| Liver (g) | 105 | 9.2262±0.9352 | 7.1168-12.2383 | 129 | 10.8939±1.0637 | 8.1270-13.433 |
| (%) | 105 | 2.9542±0.1853 | 2.5341-3.4428 | 129 | 2.5025±0.1520 | 2.1591-2.9796 |
| Kidney-left+right (g) | 105 | 2.1533±0.2037 | 1.6745-2.6934 | 129 | 2.5850±0.2403 | 1.9486-3.1480 |
| (%) | 105 | 0.6899±0.0441 | 0.6137-0.8163 | 129 | 0.5946±0.0429 | 0.4971-0.7199 |
| Kidney-left (g) | 105 | 1.0696±0.1025 | 0.8109-1.3637 | 129 | 1.2844±0.1189 | 0.9572-1.5370 |
| (%) | 105 | 0.3427±0.0223 | 0.3036-0.4035 | 129 | 0.2955±0.0220 | 0.2464-0.3553 |
| Kidney-right (g) | 105 | 1.0837±0.1065 | 0.8476-1.3865 | 129 | 1.3006±0.1289 | 0.9590-1.6320 |
| (%) | 105 | 0.3472±0.0242 | 0.3001-0.4128 | 129 | 0.2991±0.0231 | 0.2102-0.3646 |
| Adrenal gland-left+right (g) | 105 | 0.0501±0.0063 | 0.0296-0.0703 | 129 | 0.0534±0.0074 | 0.0383-0.0825 |
| (%) | 105 | 0.0161±0.0020 | 0.0107-0.0223 | 129 | 0.0123±0.0017 | 0.0094-0.0186 |
| Adrenal gland-left (g) | 105 | 0.0255±0.0033 | 0.0174-0.0360 | 129 | 0.0271±0.0040 | 0.0183-0.0400 |
| (%) | 105 | 0.0082±0.0011 | 0.0060-0.0114 | 129 | 0.0063±0.0009 | 0.0041-0.0090 |
| Adrenal gland-right (g) | 105 | 0.0246±0.0034 | 0.0218-0.0255 | 129 | 0.0262±0.0039 | 0.0187-0.0425 |
| (%) | 105 | 0.0079±0.0011 | 0.0044-0.0109 | 129 | 0.0060±0.0009 | 0.0045-0.0096 |
| Testis-left+right (g) | 55 | 3.6020±0.2814 | 2.7044-4.2000 | 129 | 4.0187±0.2417 | 3.5420-4.6611 |
| (%) | 55 | 1.1596±0.1198 | 0.7640-1.3940 | 129 | 0.9266±0.0666 | 0.7710-1.1236 |
| Testis-left (g) | 55 | 1.8053±0.1509 | 1.0359-2.1050 | 129 | 2.0051±0.1173 | 1.7740-2.3020 |
| (%) | 55 | 0.5814±0.0641 | 0.3200-0.7025 | 129 | 0.4624±0.0328 | 0.3871-0.5669 |
| Testis-right (g) | 55 | 1.7966±0.1600 | 0.8609-2.1010 | 129 | 2.0136±0.1316 | 1.7440-2.3652 |
| (%) | 55 | 0.5782±0.0637 | 0.3009-0.6915 | 129 | 0.4643±0.0352 | 0.3809-0.5678 |
| Epididymis-left+right (g) | 54 | 0.9270±0.0556 | 0.7855-1.0796 | 109 | 1.3653±0.0998 | 1.1470 -1.8270 |
| (%) | 54 | 0.2987±0.0252 | 0.2428-0.3587 | 109 | 0.3136±0.0263 | 0.2628-0.4154 |
| Epididymis-left (g) | 54 | 0.4613±0.0312 | 0.3825-0.5567 | 109 | 0.6790±0.0509 | 0.5767-0.9000 |
| (%) | 54 | 0.1487±0.0140 | 0.1182-0.1850 | 109 | 0.1559±0.0135 | 0.1300-0.2046 |
| Epididymis-right (g) | 55 | 0.4665±0.0303 | 0.3990-0.5401 | 109 | 0.6863±0.0574 | 0.5530-0.9270 |
| (%) | 55 | 0.1503±0.0126 | 0.1211-0.1745 | 109 | 0.1576±0.0145 | 0.1276-0.2108 |
| Prostate (g) | 95 | 0.4094±0.0959 | 0.1946-0.6760 | 129 | 0.5704±0.1438 | 0.1380-0.9310 |
| (%) | 95 | 0.1313±0.0316 | 0.0639-0.2131 | 129 | 0.1312±0.0320 | 0.0285-0.2087 |
Table 6.
Reference data of absolute and relative organ weights from 4- and 13 week toxicity studies in female Sprague-Dawley rats
| Organs | Females | |||||
|---|---|---|---|---|---|---|
| 4 weeks-group | 13 weeks-group | |||||
| N | Mean±SD | Range | N | Mean±SD | Range | |
| Body weights (g)a) | 105 | 198.33±17.060 | 155.16-246.76 | 130 | 249.12±19.920 | 199.47-330.00 |
| Brain (g) | 75 | 1.6986±0.0915 | 1.3810-1.9511 | 130 | 1.7976±0.0804 | 1.4667-2.1750 |
| (%) | 75 | 0.8553±0.0661 | 0.7077-1.0348 | 130 | 0.7254±0.0576 | 0.5433-0.8858 |
| Pituitary gland (g) | 70 | 0.0117±0.0019 | 0.0077-0.0167 | 130 | 0.0132±0.0021 | 0.0092-0.0291 |
| (%) | 70 | 0.0059±0.0009 | 0.0042-0.0082 | 130 | 0.0053±0.0007 | 0.0037-0.0100 |
| Thyroid gland-left+right (g) | 40 | 0.0146±0.0037 | 0.0086-0.0261 | 50 | 0.0156±0.0024 | 0.0101-0.0242 |
| (%) | 40 | 0.0073±0.0022 | 0.0045-0.0155 | 50 | 0.0063±0.0011 | 0.0045-0.0102 |
| Thyroid gland-left (g) | 40 | 0.0072±0.0020 | 0.0038-0.0127 | 50 | 0.0078±0.0015 | 0.0041-0.0122 |
| (%) | 40 | 0.0036±0.0012 | 0.0020-0.0073 | 50 | 0.0032±0.0007 | 0.0018-0.0051 |
| Thyroid gland-right (g) | 40 | 0.0074±0.0021 | 0.0044-0.0138 | 50 | 0.0078±0.0016 | 0.0038-0.0120 |
| (%) | 40 | 0.0037±0.0011 | 0.0021-0.0082 | 50 | 0.0032±0.0006 | 0.0015-0.0051 |
| Heart (g) | 105 | 0.7762±0.0831 | 0.6176-1.1928 | 130 | 0.8823±0.0732 | 0.7267-1.1060 |
| (%) | 105 | 0.3919±0.0314 | 0.3310-0.5352 | 130 | 0.3550±0.0257 | 0.2747-0.4444 |
| Lung (g) | 105 | 1.1598±0.1130 | 0.8950-1.7510 | 130 | 1.3569±0.1121 | 1.1050-1.6790 |
| (%) | 105 | 0.5866±0.0520 | 0.4514-0.7679 | 130 | 0.5459±0.0390 | 0.4587-0.6645 |
| Thymus (g) | 105 | 0.3362±0.0718 | 0.1870-0.6166 | 130 | 0.2277±0.1187 | 0.1330-1.4640 |
| (%) | 105 | 0.1691±0.0296 | 0.0932-0.2569 | 130 | 0.0915±0.0467 | 0.0530-0.5810 |
| Spleen (g) | 105 | 0.5453±0.0798 | 0.3912-0.8468 | 130 | 0.5871±0.0755 | 0.3990-0.8500 |
| (%) | 105 | 0.2750±0.0318 | 0.1971-0.3799 | 130 | 0.2357±0.0243 | 0.1797-0.3049 |
| Liver (g) | 105 | 5.5126±0.6933 | 4.1260-7.6414 | 130 | 5.9782±0.6327 | 4.6418-7.6460 |
| (%) | 105 | 2.7742±0.1762 | 2.4255-3.4580 | 130 | 2.4016±0.1924 | 2.0235-3.0236 |
| Kidney-left+right (g) | 105 | 1.3841±0.1490 | 1.1390-1.9965 | 130 | 1.4808±0.1226 | 1.1870-1.8560 |
| (%) | 105 | 0.6983±0.0467 | 0.5854-0.8488 | 130 | 0.5953±0.0357 | 0.4919-0.6853 |
| Kidney-left (g) | 105 | 0.6844±0.0726 | 0.5610-0.9770 | 130 | 0.7396±0.0694 | 0.5900-1.0760 |
| (%) | 105 | 0.3453±0.0234 | 0.2844-0.4096 | 130 | 0.2972±0.0202 | 0.2335-0.3493 |
| Kidney-right (g) | 105 | 0.6997±0.0802 | 0.5700-1.0195 | 130 | 0.7413±0.0618 | 0.5880-0.9040 |
| (%) | 105 | 0.3530±0.0263 | 0.2991-0.4392 | 130 | 0.2981±0.0197 | 0.2532-0.3446 |
| Adrenal gland-left+rigt (g) | 105 | 0.0623±0.0068 | 0.0490-0.0866 | 130 | 0.0600±0.0077 | 0.0418-0.0881 |
| (%) | 105 | 0.0316±0.0036 | 0.0117-0.0216 | 130 | 0.0241±0.0028 | 0.0165-0.0308 |
| Adrenal gland-left (g) | 105 | 0.0316±0.0037 | 0.0230-0.0465 | 130 | 0.0309±0.0048 | 0.0202-0.0511 |
| (%) | 105 | 0.0160±0.0019 | 0.0117-0.0216 | 130 | 0.0124±0.0017 | 0.0080-0.0176 |
| Adrenal gland-right (g) | 105 | 0.0307±0.0035 | 0.0232-0.0401 | 130 | 0.0291±0.0036 | 0.0208-0.0372 |
| (%) | 105 | 0.0155±0.0018 | 0.0107-0.0204 | 130 | 0.0117±0.0014 | 0.0085-0.0146 |
| Ovary-left+right (g) | 105 | 0.0895±0.0147 | 0.0578-0.1278 | 130 | 0.0888±0.0172 | 0.0526-0.1511 |
| (%) | 105 | 0.0452±0.0068 | 0.0305-0.0655 | 130 | 0.0356±0.0061 | 0.0208-0.0556 |
| Ovary-left (g) | 105 | 0.0451±0.0090 | 0.0262-0.0693 | 130 | 0.0443±0.0099 | 0.0214-0.0725 |
| (%) | 105 | 0.0228±0.0044 | 0.0139-0.0335 | 130 | 0.0178±0.0036 | 0.0080-0.0305 |
| Ovary-right (g) | 105 | 0.0444±0.0078 | 0.0284-0.0661 | 130 | 0.0444±0.0095 | 0.0259-0.0820 |
| (%) | 105 | 0.0224±0.0035 | 0.0143-0.0320 | 130 | 0.0178±0.0035 | 0.0102-0.0266 |
| Uterus (g) | 80 | 0.5025±0.2344 | 0.2140-1.4945 | 90 | 0.6348±0.3087 | 0.3250-1.6083 |
| (%) | 80 | 0.2524±0.1166 | 0.1135-0.7970 | 90 | 0.2573±0.1308 | 0.1226-0.6888 |
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