Title: Alternative Sweeteners

Trehalose 455
Table 7 Four Acute Toxicological Studies Performed on Mice, Rats, and Beagle
Dogs Using Two Difference Preparations of Trehalose
Study Dose Conclusions
Trehalose crystals: acute Oral gavage 16 g/kg The acute lethal dose is
oral toxicity to the rat greater than 16 g/kg
body weight. Piloerection
in all rats within 5
min of dosing lasting
through day 1. Occurred
at later intervals, but
stopped by day 4.
An acute toxicity study of Intravenous (IV) 1 g/kg No treatment-related mortaltrehalose
in the albino Oral gavage (OG) 5 g/kg ity, body weight
mouse changes, or systemic toxicity
was evident.
An acute toxicity study of Intravenous (IV) 1 g/kg No acute signs of toxicity
trehalose in the albino Oral gavage (OG) 5 g/kg with either IV or OG
rat dose.
An acute toxicity study of Intravenous (IV) 1 g/kg No acute signs of toxicity
trehalose in the beagle 6 day washout with either IV or OG
dog Oral capsules 5 g/kg dose.
C. Acute Eye Irritation Study
Six male New Zealand White rabbits received a single 0.1-ml dose of a 10%
trehalose solution in the right eye (Quadrant Holdings, unpublished data, 1994).
The left eye was used as a control. Eyes were examined at 1, 24, 48, and 72
hours after application. No evidence of irritation was observed.
D. 7-Day Continuous Infusion Study
Three groups of five male Sprague-Dawley rats were dosed by continuous infusion
with a 10% solution of trehalose delivered at a rate of 400 mg/kg/hr, a 5%
solution of dextrose at 200 mg/kg/hr, or a 0.9% NaCl solution at 4 ml/kg/hr
(Quadrant Holdings, unpublished data, 1997). The solutions were administered
for 7 consecutive days through tail vein catheters. No clinical signs, changes in
body weights, or treatment-related findings at necropsy were observed. The only
untoward effect reported was osmotic nephrosis in the animals given trehalose.
This is thought to result from a lack of trehalase in the kidney of rats.