Table 5.
6-Week toxicity study |
||||||||
---|---|---|---|---|---|---|---|---|
Males |
Females |
|||||||
Dose (mg/kg) | ||||||||
0 |
30 |
100 |
300 |
0 |
30 |
100 |
300 |
|
No. animals/group | ||||||||
5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | |
Vitamin A (μg/mL) | Pre-study (week 2) | |||||||
0.58 ± 0.090 | 0.60 ± 0.105 | 0.61 ± 0.068 | 0.61 ± 0.087 | 0.69 ± 0.172 | 0.58 ± 0.175 | 0.54 ± 0.175 | 0.58 ± 0.214 | |
Day 6 | ||||||||
0.49 ± 0.085 | 0.20 ± 0.063** | 0.19 ± 0.028** | 0.18 ± 0.036** | 0.49 ± 0.138 | 0.22 ± 0.066*** | 0.20 ± 0.076*** | 0.18 ± 0.044*** | |
Day 37 | ||||||||
0.35 ± 0.080 | 0.07 ± 0.014** | 0.05 ± 0.005*** | 0.04 ± 0.005*** | 0.38 ± 0.086 | 0.07 ± 0.018** | 0.06 ± 0.012*** | 0.04 ± 0.005*** | |
Day 66a | ||||||||
0.60 | 0.24 | 0.32 | 0.14 | 0.67 | 0.31 | 0.29 | 0.16 | |
Thyroxine (μg/dL) | Pre-study (week 2) | |||||||
5.7 ± 1.10 | 5.0 ± 1.16 | 5.3 ± 0.66 | 5.4 ± 1.30 | 5.1 ± 0.43 | 6.9 ± 1.05 | 5.6 ± 0.98 | 5.3 ± 1.22 | |
Day 6 | ||||||||
5.3 ± 0.97 | 3.5 ± 0.77* | 5.0 ± 0.78 | 4.6 ± 1.32 | 5.0 ± 1.10 | 5.0 ± 0.70 | 4.5 ± 0.93 | 5.1 ± 1.63 | |
Day 37 | ||||||||
5.3 ± 0.93 | 2.5 ± 0.78*** | 4.1 ± 0.65* | 4.0 ± 0.50* | 4.6 ± 1.47 | 4.5 ± 1.10 | 3.6 ± 1.13 | 3.9 ± 0.87 | |
Day 66a | ||||||||
5.6 | 4.9 | 5.7 | 4.6 | 4.1 | 5.4 | 5.5 | 5.2 |
39-Week toxicity study |
||||||||
---|---|---|---|---|---|---|---|---|
Males |
Females |
|||||||
Dose (mg/kg) | ||||||||
0 |
15 |
75 |
200 |
0 |
15 |
75 |
200 |
|
No. animals/group | ||||||||
6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | |
Vitamin A (μg/mL) |
Pre-study (week 1) |
|||||||
0.52 ± 0.288 |
0.49 ± 0.215 |
0.51 ± 0.190 |
0.43 ± 0.205 |
0.22 ± 0.096 |
0.26 ± 0.052 |
0.21 ± 0.048 |
0.20 ± 0.016 |
|
Day 92 | ||||||||
0.43 ± 0.127 |
0.09 ± 0.031** |
0.08 ± 0.013*** |
0.07 ± 0.012*** |
0.47 ± 0.184 |
0.19 ± 0.115 |
0.09 ± 0.014*** |
0.08 ± 0.012*** |
|
Day 183 | ||||||||
0.35 ± 0.077 |
0.05 ± 0.014*** |
0.04 ± 0.012*** |
0.02 ± 0.004*** |
0.30 ± 0.067 |
0.05 ± 0.018** |
0.02 ± 0.010*** |
0.02 ± 0.005*** |
|
Day 275 | ||||||||
0.31 ± 0.059 |
0.07 ± 0.016** |
0.05 ± 0.017*** |
0.04 ± 0.009*** |
0.30 ± 0.092 |
0.06 ± 0.021** |
0.03 ± 0.010*** |
0.02 ± 0.005*** |
|
Day 366 | ||||||||
0.42 ± 0.051 |
0.45 ± 0.191 |
0.38 ± 0.058 |
0.52 ± 0.049 |
0.49 ± 0.090 |
0.52 ± 0.085 |
0.41 ± 0.070 |
0.67 ± 0.135 |
|
Thyroxine (μg/dL) | Pre-study (week 2) |
|||||||
5.9 ± 1.23 |
4.8 ± 1.13 |
5.5 ± 2.06 |
4.6 ± 1.46 |
5.3 ± 0.84 |
6.7 ± 1.03 |
6.7 ± 1.43 |
5.8 ± 0.92 |
|
Pre-study (week 1) | ||||||||
6.1 ± 1.10 |
4.9 ± 1.02 |
5.0 ± 1.34 |
4.3 ± 0.90 |
5.7 ± 1.52 |
6.3 ± 1.21 |
5.8 ± 0.82 |
6.1 ± 1.40 |
|
Day 92 | ||||||||
5.8 ± 1.40 |
4.2 ± 1.23 |
3.8 ± 1.25* |
3.4 ± 0.74** |
5.5 ± 1.27 |
4.6 ± 1.05 |
5.3 ± 3.19 |
4.4 ± 0.76 |
|
Day 183 | ||||||||
5.2 ± 0.90 |
3.8 ± 0.88* |
3.2 ± 0.67** |
3.4 ± 0.90** |
4.8 ± 1.07 |
4.2 ± 0.99 |
3.9 ± 0.90 |
4.3 ± 1.16 |
|
Day 275 | ||||||||
5.9 ± 1.01 |
3.7 ± 1.17** |
3.7 ± 0.62** |
4.7 ± 1.22 |
6.0 ± 1.28 |
5.5 ± 1.88 |
4.5 ± 0.82 |
4.7 ± 0.93 |
|
Day 366 | ||||||||
5.1 ± 1.63 | 4.9 ± 0.83 | 5.0 ± 1.05 | 5.2 ± 1.12 | 4.9 ± 1.64 | 5.3 ± 0.34 | 5.1 ± 0.43 | 6.2 ± 0.55 |
Standard deviation not calculated (n = 2/sex/group).
P ≤ 0.05, **P ≤ 0.01, ***P ≤ 0.001.