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Thirteen-Week Oral Toxicity Study of L-Glutamine in Rats

¹ Health Services Development Department, Ajinomoto Co., Inc., Tokyo, Japan
² The Second Laboratory for Safety Evaluation, Gotemba Laboratory, Bozo Research Center Inc., Tokyo, Japan
³ Amino Acid Department, Ajinomoto Co., Inc., Tokyo, Japan
⁴ Quality Assurance and External Scientific Affairs Department, Ajinomoto Co., Inc., Tokyo, Japan

Correspondence: Address correspondence to Takeshi Kimura, Quality Assurance and External Scientific Affairs Department, Ajinomoto Co., Inc., 1-15-1 Chuoku, Tokyo, Japan. E-mail:takeshi_kimura{at}ajinomoto.com

L-Glutamine (Gln) is a semiessential amino acid used in enteral feeding in critically ill patients, and is contained in numerous dietary supplements available to the general public. This study evaluated toxicological effects of Gln in male and female Sprague-Dawley rats. Gln produced by Ajinomoto Co. (Tokyo, Japan) was incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% (w/w), respectivelly. A control group of rats received only a standard diet. All diets were administered ad libitum for 13 consecutive weeks. To examine recoverability of any potential effects, the administration period was followed by a 5-week recovery period, during which only the standard diet was provided to all animals. Throughout the administration and recovery periods, no deaths were observed, and no changes in diet consumption, ophthalmologic findings, gross pathology, and histopathology were detected. Several changes in urine parameters (total protein, urine pH, and a positive incidence (±) of ketone bodies) were observed in the 2.5% and 5.0% groups at the end of the administration period. Minor increases were found in hematology parameters for the 5.0% group (platelet count, -globulin, lactate dehydrogenase [LDH]), but all changes were within physiological range. No effects of administration were observed in the 1.25% group. The no-observed-adverse-effect level (NOAEL) for Gln was estimated at 1.25% for both genders (males 0.83 ± 0.01 g/kg/day; females, 0.96 ± 0.06 g/kg/day).

Key Words: L-Glutamine • NOAEL • Rat • Safety • Subchronic Toxicity

International Journal of Toxicology, Vol. 23, No. 2, 107-112 (2004)
DOI: 10.1080/10915810490435677


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