title: A 13-week dietary toxicity and toxicokinetic study with l-theanine in rats.
abstract: This study was conducted to evaluate the safety of l-theanine (Suntheanine) when administered as a dietary admixture to male and female Crl:CD (SD)GS BR rats at concentrations providing doses of 0, 1500, 3000 or 4000 mg/kg bw/day for 13 weeks. The study design was consistent with OECD Guideline 408 and USFDA Redbook II (1993) and GLP. There were no consistent, statistically significant treatment-related adverse effects on behavior, morbidity, mortality, body weight, food consumption and efficiency, clinical chemistry, hematology, or urinalysis. There were no consistent treatment-related adverse effects in gross pathology, organ weights or ratios or histopathology. The increased incidence of renal tubular cell adenomas in high-dose females only were not consistent with the characteristics of a renal carcinogen (due to early onset and low number of animals affected) but were more consistent with a genetic predisposition than with direct organ toxicity. The no-observed-adverse-effect-level (NOAEL) was 4000 mg/kg bw/day, the highest dose tested.
authors.affiliation: Department of Pharmacology and Toxicology, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA 23298-0613, USA.
authors.forename: J F
authors.initials: JF
authors.lastname: Borzelleca
authors.forename: D
authors.initials: D
authors.lastname: Peters
authors.forename: W
authors.initials: W
authors.lastname: Hall
mesh_terms: D000818:Animals; D019540:Area Under Curve; D001522:Behavior, Animal / Q000187:drug effects; D001772:Blood Cell Count; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D004032:Diet; D004435:Eating / Q000187:drug effects; D005260:Female; D005971:Glutamates / Q000493:pharmacokinetics / Q000633:toxicity*; D006207:Half-Life; D007107:Immune System / Q000187:drug effects; D007668:Kidney / Q000473:pathology; D008297:Male; D009043:Motor Activity / Q000187:drug effects; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D012727:Sex Characteristics; D016482:Urinalysis
chemical_list: D005971:Glutamates; C026166:theanine