Toxicological Assessment of D-Allulose From a Novel One-Step Fermentation Process Using Genetically Modified...

Area of Science:

• Toxicology
• Food Science
• Biotechnology

Background:

• D-Allulose is a rare monosaccharide with low caloric content and high sweetness, similar to D-fructose.
• A novel one-step fermentation process using genetically engineered *Escherichia coli* AS10 strain was developed for D-allulose production.

Purpose of the Study:

• To conduct a 90-day oral toxicity test to evaluate the safety of D-allulose produced via a novel fermentation process.
• To determine the No Observed Adverse Effect Level (NOAEL) of D-allulose.
• To provide scientific evidence for the safety evaluation of this innovative food ingredient for regulatory compliance.

Main Methods:

• Ninety-six Sprague-Dawley (SD) rats were divided into four groups: control and three treatment groups (2.5%, 5.0%, 10.0% D-allulose).
• Oral administration of D-allulose for 90 consecutive days.
• Comprehensive toxicological assessments including body weight, food consumption, hematology, serum biochemistry, organ weights, and histopathology.

Main Results:

• No treatment-related mortality or overt toxic symptoms were observed.
• Statistically significant differences in some parameters (e.g., body weight, kidney weight) were noted but deemed nontoxicologically significant.
• The No Observed Adverse Effect Level (NOAEL) was established at 8000 mg/kg body weight/day.

Conclusions:

• D-Allulose produced via the novel fermentation process is safe for consumption.
• The established NOAEL supports the use of D-allulose as a safe food ingredient.
• The study meets regulatory requirements for novel process-derived food product safety assessment.