Genotoxicity and Repeat-Dose 28-day Oral Toxicological Evaluation of Sukré™, a Purified l-Arabinose From Acacia Hydrolysate.

Abstract

Sukré™, a highly purified l-arabinose produced from hydrolyzed acacia, has potential uses as a natural sweetener. To evaluate the safety of l-arabinose, a battery of GLP-compliant in vitro and in vivo studies were conducted with Sukré™ (Compound Solutions, Inc, USA). No mortality, morbidity, or adverse effects were observed in a 28-day subchronic toxicity study conducted in rats administered doses up to 7200 mg/kg bw/day Sukré™ by gavage. Thus, the 28-day oral subchronic NOAEL for Sukré™ in male and female Wistar rats was 7200 mg/kg bw/day, the highest dose tested. Furthermore, results of in vitro studies (a bacterial reverse mutation assay, a mammalian chromosomal aberration study, and a mammalian micronucleus study) demonstrate that Sukré™ was non-mutagenic and non-clastogenic. Collectively, these observations indicate that oral consumption of Sukré™ is not of toxicological concern and provide supportive evidence for the safe oral consumption of Sukré™ as an ingredient in foods.