A series of toxicity trials was conducted to analyze the acute and subchronic oral toxicity of calcium from Jeju Lava Seawater (CJLS) in Sprague-Dawley rats. In the acute toxicity trial, rats were administered 0 or a daily dose of 2,000 mg/kg body weight (BW) of CJLS. General behavior, side effects, and mortality were monitored over 14 days. In the subacute and subchronic trials, daily doses of 0, 250, 500, or 1,000 mg/kg BW were administered to the rats over 28 and 90 days, respectively. Clinical signs were examined daily, and changes in body weight, relative organ weight (ROW), and hematological, biochemical, and pathological parameters were recorded. The acute toxicity trial showed that the maximum tolerated dose of CJLS was >2,000 mg/kg BW, with no adverse effects or mortality observed during the 14-day period. In subacute and subchronic trials, oral administration of CJLS at a dosage of 1,000 mg/kg BW/day did not result in significant changes in BW, ROW, or hematological and biochemical biomarkers. These results indicate that the oral administration of CJLS at doses lower than 1,000 mg/kg BW/day is safe for rats, providing a basis for the clinical use of CJLS.
Pharmacological studies and clinical practices have indicated that Radix Astragali, a dried root of Astragalusmembranaceus possesses a lot of biological activities, including antioxidant, hepatoprotective, anti-diabetic, tonic, diuretic,antimicrobial, antiviral, and immunological activities. These biological activities approved by the modern pharmacologicalstudies are mainly due to the constituents of Astragalus membranaceus including polysaccharides, saponins, flavonoids,amino acids, and trace elements. In resent, the main constituents in the root part showing a lot of biological activities hasbeen isolated also from the aboveground parts such as leaves and sprouts in our laboratory. However, the safety evaluationfor the aboveground parts of Astragalus membranaceus should be checked before expanding their application as one of food.In the study, a 90-day rat oral gavage study has been conducted with the extracts from Astragalus membranaceus-above-ground parts at doses of 1000, 3000, and 5000㎎/㎏/day. The following endpoints were evaluated: clinical observations, bodyweight, gross and microscopic pathology, clinical chemistry, and hematology. Based on the analysis of these endpoints, it wasestimated that NOEL (no observed effect level) for male rats and NOAEL (no observed adverse effect level) for female ratsare 5000㎎/㎏/day of the water-extracts from Astragalus membranaceus-aboveground parts.