Acute toxicity test of triple fermented barley extracts (fbe) in mice after oral administration

Abstract

The objective of this study was to obtain information on acute (single) oral dose toxicity of triple fermented (using saccharification, Saccharomyces cerevisiae, and Weissella cibaria) barley extracts (Hordeum vulgare L., FBe) in female and male ICR mice, to facilitate the development of natural products as medicinal ingredients and functional food. To investigate toxicity and identify target organs, FBe was orally administered once to female and male ICR mice at doses of 2000, 1000, 500, and 0 mg/kg (of body weight) in a volume of 20 mL/kg, dissolved in distilled water. The mortality, change in body weight, and clinical signs were monitored for 14 days following treatment. Additionally, gross observations of the organs, changes in organ weights, and histopathological measurements of principle organs were compared between treatment and control groups of the same sex. The results showed that a single oral dose of FBe was not associated with mortality in any of the treatment groups over the 14-day experimental period. No FBe treatment-related changes in body and organ weights, clinical signs, or necropsy and histopathological findings were detected in this experiment. The results obtained in this study suggest that FBe is non-toxic in mice and is therefore likely to be safe for clinical use. The LD50 (lethal dose in 50% of animals) and approximate LD in mice following a single oral dose of FBe were determined to be greater than 2000 mg/kg, the recommended dose limit for both female and male rodents. In addition, no specific organ targets or clinical signs were detected.