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International Journal of Toxicology
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Articles

Thirteen-Week Oral Toxicity Study of L-Lysine Hydrochloride in Rats

Shoji Tsubuku1
Masahiro Mochizuki2
Kazunori Mawatari3
Miro Smriga4
Takeshi Kimura4

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 Chou-ku, Tokyo, Japan. E-mail:takeshi_kimura{at}ajinomoto.com

L-Lysine hydrochloride (Lys) is an essential amino acid in humans and animals, and it is used in animal feeds, in prevention of herpes simplex recurrence, and cereal fortification in some developing countries. This study evaluated toxicological and behavioral effects of Lys during a dosing study with male and female Sprague-Dawley rats. The amino acid was incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% (w/w). A control group of rats received a standard diet. All diets were administered ad libitum for 13 consecutive weeks. To examine stability 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. In male and female rats in each concentration group, treatment-related changes were not observed in the clinical signs, body weights, diet consumption, water intake, ophthalmology, gross pathology, organ weights, or histology. A Lys-related drop in serum concentration and an increase in urine excretion of chlorides was a compensatory reaction to the ingested hydrochloride. No functional, biochemical, or histological changes in renal function were found. The no-observed-adverse-effect level (NOAEL) for Lys was estimated at 5.0% for both genders (male, 3.36 ± 0.12 g/kg/day; female, 3.99 ± 0.28 g/kg/day).

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

International Journal of Toxicology, Vol. 23, No. 2, 113-118 (2004)
DOI: 10.1080/10915810490444415


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