TABLE 4.
Representative Examples of Adverse Effects Reported in Toxicity Studies of Sucralose and Its Hydrolysis Products at High Dosages
| Reference | Species (and number of animals affected when given) | Adverse effect |
|---|---|---|
| Finn and Lord (2000) | Mouse (1 of 10) | Death during 21 d study: dose (150 mg/kg/d of sucralose hydrolysis products administered by gavage) |
| Mouse (2 of 10) | Deaths during 21 d study: dose (1000 mg/kg/d of sucralose hydrolysis products administered by gavage) | |
| Mouse (increased frequency) | Unkempt coats during 21 d study: dose (500 and 1000 mg/kg/d of sucralose hydrolysis products administered by gavage) | |
| Mouse (1 of 10) | Slow righting reflex (neurological finding) during 21 d study: dose (500 mg/kg/d of sucralose hydrolysis products administered by gavage) | |
| Mann etal. (2000b) | Mouse | Lower erythrocyte counts in females after 104 wk: dose (3% dietary sucralose); chronic nephropathy in females and chronic inflammation of the liver in males: dose (3.0% dietary sucralose); degeneration of the testicular tubular germinal epithelium: dose (0.3–3.0% dietary sucralose) |
| Finn and Lord (2000) | Marmoset | Altered salivary responses during second half of 28 d study: dose (1000 mg/kg/d of sucralose and its hydrolysis products administered by gavage) |
| Marmoset (2 of 3) | Depressed postural reactions at 13 d into a 28 d study: dose (1000 mg/kg/d of sucralose administered by gavage); reactions reportedly remitted by d 27 | |
| Marmoset (2 of 3) | Depressed postural responses on d 27 of 28 d study: dose (1000 mg/kg/d of sucralose hydrolysis products administered by gavage) | |
| Kille et al. (2000) | Rabbit, pregnant | Gastrointestinal tract disturbances, such as peri-anal soiling, scouring and caecal enlargement: dose (750 to 1000 mg/kg/d of sucralose administered by gavage) |
| Rabbit, presumed pregnant (7 of 15) | Mild to severe gastrointestinal distress during d 6 to 19 of gestation: dose (700 mg/kg/d administered by gavage) | |
| Kille et al. (2000); U.S. FDA, 1998 | Rabbit, pregnant (12 of 13 deaths occurred in sucralose-treated animals) | Deaths in four groups of 16 to 18 pregnant rabbits: dose (0, 175, 350, and 700 mg/kg/d administered by gavage during d 6 to 19 of gestation); deaths of 11 rabbits (1 control, 4 receiving 175 mg/kg/d group, 2 receiving 350 mg/kg/d group, and 4 receiving 700 mg/kg/d) were not attributed to sucralose by the experimenters although 10 of these 11 deaths occurred during treatment with sucralose. Only two deaths at 700 mg/kg/d were attributed to sucralose by the experimenters. |
| Rabbit (4 of 9) | Abortions: dose (700 mg/kg/d administered by gavage) | |
| Goldsmith (2000b) | Rat | Decrease in total leukocyte and lymphocyte counts of females after 4 wk: dose (5.0% dietary sucralose) Decrease in alanine aminotransferase (ALT) after 4 wk: dose (5.0% dietary sucralose; also 2.5% in females) Decreased serum phosphorus in all male treatment groups after 4 wk: dose (1 %, 2.5%, and 5% dietary sucralose) Increased urinary excretion of calcium and magnesium in females: dose (5% dietary sucralose) Dose-related increase in cecal weight with and without contents: dose (2.5 and 5.0% dietary sucralose) Decreases in organ weights including spleen, thymus, and heart after 8 wk: dose (5.0% dietary sucralose) |
| Mann et al. (2000a) | Rat | Decrease in alanine aminotransferase (ALT) activity after 11, 38, 51, 77 and 103 wk of treatment; dose (3% dietarysucralose) Thyroxine levels were decreased in male rats at 11 wk in a dose-dependent manner: dose (0.3% to 3.0% dietary sucralose) Higher phosphorus excretion after 77 wk: dose (0.3% to 3.0% dietary sucralose) Non-neoplastic findings in females including renal pelvic epithelial hyperplasia, renal pelvic mineralization, and adrenal cortical haemorrhagic degeneration; cataracts in males: dose (3.0% dietary sucralose) |
| Goldsmith (2000b) | Rat | Increased body weight-relative kidney weights during 28-d study: dose (3000 mg/kg/d by gavage) Increased cecum weights during 28-d study: dose (1500 and 3000 mg/kg/d by gavage) Elongated or distended caecum during 28-d study: dose (1500 and 3000 mg/kg/d by gavage) |
| Goldsmith (2000b) | Dog | Lower lymphocyte counts at 3 mo: dose (1 % dietary sucralose); lower lymphocyte counts at 6 mo; dose (1 % and 3% dietary sucralose); lower lymphocyte counts at 12 mo; dose (0.3% dietary sucralose) |