Monitoring of food consumption, gain in body weight and physical observations did not reveal any treatment-related
toxicity in any of the group of rats. Terminal autopsy also did not reveal any signs of
toxicity. Further, no significant alterations in relative organ weight, serum biochemistry and urinalysis were observed up to 1% lactulose supplementation level. The results suggest that supplementation of lactulose in the diet does not produce any toxicity at the doses tested.