Repeated dose study of sucralose tolerance in human subjects

Abstract Two tolerance studies were conducted in healthy human adult volunteers. The first study was an ascending dose study conducted in eight subjects, in which sucralose was administered at doses of 1, 2.5, 5 and 10 mg/kg at 48-hour intervals and followed by daily dosing at 2 mg/kg for 3 days and 5 mg/kg for 4 days. In the second study, subjects consumed either sucralose (n=77) or fructose (50 g/day) (n=31) twice daily in single blind fashion. Sucralose dosage levels were 125 mg/day for weeks 1–3, 250 mg/day during weeks 4–7, and 500 mg/day during weeks 8–12. No adverse experiences or clinically detectable effects were attributable to sucralose in either study. Similarly, haematology, serum biochemistry, urinalysis and EKG tracings were unaffected by sucralose administration. In the 13-week study, serial slit lamp ophthalmologic examination performed in a random subset of the study groups revealed no changes. Fasting and 2-hour post-dosing blood sucralose concentrations obtained daily during week 12 of the study revealed no rising trend for blood sucralose. Sucralose was well tolerated by human volunteers in single doses up to 10 mg/kg/day and repeated doses increasing to 5 mg/kg/day for 13 weeks. Based on these studies and the extensive animal safety database, there is no indication that adverse effects on human health would occur from frequent or long-term exposure to sucralose at the maximum anticipated levels of intake.