| Study title | GLP 90‐day oral toxicity study on 6′‐SL sodium salt in SD rats (Unpublished study report, 2021) | ||||
|---|---|---|---|---|---|
| Key results | |||||
| Parameters | Sex | Dose groups (expressed in mg 6′‐SL sodium salt/kg bw per day) | |||
|
0 (control, G1); mean ± SD |
542 (low dose, G2); mean ± SD |
1084 (intermediate dose, G3); mean ± SD |
2168 (high dose, G4); mean ± SD |
||
| Haematology | |||||
| Platelets (104/μL) | M | 113.1 ± 11.9 | 133.5 ± 12.8** | 117.0 ± 18.7 | 114.6 ± 7.8 |
| F | 116.5 ± 10.5 | 114.5 ± 10.4 | 109.6 ± 14.5 | 122.6 ± 19.3 | |
| Clinical chemistry | |||||
| Alanine aminotransferase (ALT) IU/L | M | 27 ± 4 | 31 ± 4 | 34 ± 9 | 33 ± 4## |
| F | 28 ± 6 | 28 ± 6 | 32 ± 18 | 30 ± 5 | |
| Sodium (mmol/L) | M | 145 ± 2 | 146 ± 1 | 145 ± 1 | 146 ± 1 |
| F | 143 ± 1 | 144 ± 1 | 144 ± 2 | 145 ± 1** | |
| Urinalysis | |||||
| Sodium (mmol/L) | M | 78 ± 21 | 86 ± 22 | 133 ± 37## | 160 ± 80## |
| F | 99 ± 45 | 110 ± 40 | 158 ± 62* | 153 ± 52 | |
| Sodium (mmol/24 h) | M | 1.4 ± 0.9 | 1.5 ± 0.4 | 2.2 ± 0.6* | 2.4 ± 0.8** |
| F | 1.3 ± 0.5 | 1.6 ± 0.4 | 1.5 ± 0.4 | 1.7 ± 0.4 | |
| Potassium (mmol/24 h) | M | 4.3 ± 2.3 | 3.4 ± 0.3 | 3.4 ± 0.5 | 2.6 ± 0.6# |
| F | 3.3 ± 0.7 | 3.3 ± 0.9 | 2.7 ± 0.8 | 2.4 ± 0.7* | |
| Chloride (mmol/L) | M | 88 ± 21 | 64 ± 15 | 70 ± 31 | 52 ± 32* |
| F | 118 ± 46 | 109 ± 46 | 122 ± 54 | 90 ± 34 | |
| Chloride (mmol/24 h) | M | 1.6 ± 0.9 | 1.1 ± 0.2 | 1.2 ± 0.4 | 0.8 ± 0.3# |
| F | 1.5 ± 0.5 | 1.6 ± 0.5 | 1.2 ± 0.4 | 1.0 ± 0.4* | |
| Organ weight values – absolute | |||||
| Pituitary (mg) | M | 17.8 ± 1.8 | 18.8 ± 2.5 | 19.8 ± 2.8 | 16.5 ± 2.0 |
| F | 25.3 ± 4.6 | 18.2 ± 4.7** | 17.6 ± 3.2** | 23.8 ± 3.3 | |
| Thyroid (mg) | M | 44.2 ± 6.8 | 53.6 ± 11.2* | 43.8 ± 6.8 | 37.9 ± 4.5 |
| F | 40.1 ± 4.0 | 25.4 ± 3.1** | 29.26 ± 4.7** | 36.9 ± 3.7 | |
| Ovaries (mg) | M | – | – | – | – |
| F | 112.7 ± 20.0 | 95.3 ± 18.2 | 85.5 ± 17.5* | 94.5 ± 27.2 | |
| Organ weight values – relative to bw | |||||
| Pituitary (mg/g bw) | M | 0.0317 ± 0.0034 | 0.0329 ± 0.0029 | 0.0337 ± 0.0032 | 0.0292 ± 0.0035 |
| F | 0.0840 ± 0.0128 | 0.0611 ± 0.0133** | 0.0584 ± 0.0066** | 0.0790 ± 0.0129 | |
| Thyroid (mg) | M | 0.0782 ± 0.0104 | 0.0937 ± 0.0198* | 0.0750 ± 0.0130 | 0.0674 ± 0.0103 |
| F | 0.1343 ± 0.0171 | 0.0860 ± 0.0132** | 0.0972 ± 0.0113** | 0.1221 ± 0.0138 | |
*p < 0.05; **p < 0.01 significant difference in the parametric procedure; #p < 0.05; ##p < 0.01 significant difference in the non‐parametric procedure.