Safety Evaluation of Lactulose Syrup in Rats
The safety of lactulose to be used in infant milk food formula as a bifIdogenic factor was assessed. Lactulose syrup (50%) was administered intragastrically to groups of male and female rats (Wistar - CFT strain, 50g), at doses of 2, 4, 8, 12, 24 and 36 g/kg body weight/day in split doses for 20 days. A control group of rats received lactose solution at similar levels. The general condition of animals, their behaviour, food consumption and mortality if any, were recorded. The LD50 values and maximum tolerated dose were calculated. The computed LD50 values for male and female rats were >31g and >21g/kg body weight and the maximum tolerated doses were 18 g and 10 g/kg body weight, respectively. Concentration greater than these caused transient diarrhoea, which disappeared within 5 h of feeding of lactulose. Treatment had no effect on food consumption, growth rate or behaviour and no mortality was observed in any of the groups. The study indicated that incorporation of lactulose at 0.5% in infant formula, as a bifidogenic factor, did not induce any adverse effects on rats.
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