Mouse Single Oral Dose Toxicity Test of Lactobacillus-fermented Araliae Continentalis Radix Aqueous Extracts (fACR)

Abstract

The objective of this study was to obtain acute (single) oral dose toxicity information on Lactobacillusfermented Araliae Continentalis Radix aqueous extracts (fACR) in female and male ICR mice, as compared with Araliae Continentalis Radix aqueous extracts (ACR). After administering a single oral dose of fACR, no treatment-related mortalities were observed within 14 days after the end of treatment up to 2,000 mg/kg, the maximum dosage for rodents of both sexes; moreover, no fACR treatment-related changes in the body and organ weights, clinical signs, necropsy, and histopathological findings were detected in this experiment. In addition, no ACR 2,000 mg/kg treatment-related mortalities, clinical signs, body and organ weights, or gross and histopathological findings were observed, as compared with equal genders of vehicle control. The results obtained in this study suggest that fACR is non-toxic in mice and is, therefore, likely to be safe for clinical use. The LD50 and approximate LD in female mice and male mice, respectively, were considered after a single oral dose of fACR over 2,000 mg/kg, the maximum dosage for rodents. In addition, no specific targets or clinical signs were detected in the present study. ACR 2,000 mg/kg-treated mice also did not show any treatment-related mortalities, clinical signs, changes to body and organ weights, or gross and histopathological findings, as compared with equal genders of vehicle control.