A 13-week dietary toxicity and toxicokinetic study with l-theanine in rats.

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.