Chronic Toxicity and Carcinogenicity Study of Lactitol in Mice

Abstract

Lactitol is a sweet-tasting disaccharide sugar alcohol with potential applications as a reduced calorie sugar substitute. In a chronic toxicity/carcinogenicity study, groups of 50 male and 50 female Cpb:Swiss random (SPF) mice received diets containing 0, 2, 5, and 10% lactitol for 104 weeks. The test compound was added to the diet at the expense of sucrose. The treatment started after a 5-day period during which the weanling mice were adapted to the basal diet. In the highest dosage group, the mean daily intake of lactitol was about 11 g/kg b.w. and 7.5 g/kg b.w. for adult male and female mice, respectively. Lactitol was generally well tolerated. Mean body weights and mortality were not affected by the treatment. Semiquantitative urine analysis and examination of urinary sediment revealed no abnormalities. With the exception of the filled or empty cecum which exhibited a significantly higher weight in the 10% lactitol group and, to a lesser extent, also in the 5% lactitol group, the weight of all other organs was not affected by the treatment. Nonneoplastic and preneoplastic changes were about equally distributed amongst the controls and top-dose group. Neoplastic lesions were in no instance related to the feeding of lactitol. Contrary to observations made with other polyols, nephrocalcinosis did not occur more frequently in lactitol-fed mice. It is concluded that the feeding of lactitol at dietary levels of up to 10% to mice throughout their lifetime failed to show carcinogenic effects or any other sign of toxicity. The only observed treatment-related effect was an enlargement of the cecum which lacks toxicological relevance for humans and which is a well-known consequence of the feeding of slowly digestible compounds in mice and rats.

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