Erythritol: An interpretive summary of biochemical, metabolic, toxicological and clinical data

A critical and comprehensive review of the safety information on erythritol was undertaken. Numerous toxicity and metabolic studies have been conducte d on erythritol in rats, mice and dogs. The toxicity studies consist of lon g-term feeding studies conducted to determine carcinogenic potential, intra venous and oral teratogenicity studies to determine the potential for effec ts on the foetus, oral studies in which erythritol was administered over on e or two generations to determine the potential for reproductive effects, a nd studies in bacterial and mammalian systems to determine mutagenic potent ial. The majority of the safety studies conducted were feeding studies in w hich erythritol was mixed into the diet at concentrations as high as 20%. T he metabolic studies in animals have shown that erythritol is almost comple tely absorbed, not metabolized systemically and is excreted unchanged in th e urine. The safety studies have demonstrated that erythritol is well toler ated and elicits no toxicological effects. The clinical program for erythri tol involved a series of single-dose and repeat-dose, short-duration studie s which have been used to investigate the human correlates to the physiolog ical responses seen in the preclinical studies. The clinical studies showed erythritol to be well tolerated and not to cause any toxicologically relev ant effects, even following high-dose exposure. Erythritol administered ora lly to humans was rapidly absorbed from the gastrointestinal tract and quan titatively excreted in the urine without undergoing metabolic change. At hi gh oral doses, urinary excretion accounted for approximately 90% of the adm inistered dose with minimal amounts appearing in the faeces. A comparison o f the human and animal data indicated a high degree of similarity in the me tabolism of erythritol and this finding supports the use of the animal spec ies used to evaluate the safety of erythritol for human consumption. It can be concluded, based on the available studies that erythritol did not produ ce evidence of toxicity. (C) 1998 Elsevier Science Ltd. All rights reserved .