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The oral LD 50 of sodium cyclamate in mice and rats is 10–12 g/kg bw (Richards et al., 1951); the oral LD 50 in male and female hamsters—based on eight days’ administration in drinking-water and calculated on the basis of mortality up to day 16—was 9.8 and 12 g/kg bw, respectively; for calcium cyclamate, the respective values were 4.5 ...
1 sty 2000 · The overall conclusion is that the testicular abnormalities and the sporadic cases of different malignancies found after more than 20 years of dosing do not provide clear evidence of a toxic or carcinogenic effect of sodium cyclamate in monkeys.
In Canada, the odds ratio for use of cyclamate was 1.09 (0.60–1.97) in males and 0.92 (0.63–1.36) in females 16. In neither study were the increased risks seen in subgroups in other studies replicated.
Sodium cyclamate is a potent sweetening agent. It has been subjected to numerous safety and carcinogenicity studies. Animal data led to warning against excessive and indiscriminate use a long time ago, causing the World Health Organization in 1967 to adopt a safety limit of 50 mg/kg.
Between 5 and 10 tablets represent from 200 to 400 mg of cyclamate and from 20 to 40 mg of saccharin. Above 10 tablets represent more than 400 mg of cyclamate and more than 40 mg of saccharin. All sweetener-consuming participants used doses within the ADI for cyclamate and saccharin.
Chemistry. Cyclamate is the sodium or calcium salt of cyclamic acid (cyclohexanesulfamic acid), which itself is prepared by reacting freebase cyclohexylamine with either sulfamic acid or sulfur trioxide. [2]
A dose of 500 mg/kg corresponds to ∼30 calorie-reduced drinks. In 1994, after 24 years, the remaining 14 cyclamate and 16 control monkeys were killed and autopsied. In the cyclamate group, three animals showed malignancies, whereas none were found in the controls.
