Evaluation of the toxicity and safety of the antioxidant beverage effective microorganisms-X (EM-X) in animal models

Abstract

The acute and chronic toxicity tests and the mutagenic test of the extracts from the fermentation of plants with effective microorganisms (EM-X) were performed in the mouse and the rat. In acute toxicity test, mice were orally treated three times per day with 20-fold of concentrated EM-X for 7 days. For chronic toxicity test, the rats were orally treated with original EM-X once a day for 90 days at the dosages of 180, 120 or 60 ml/kg. At the levels tested EM-X did not lead to significant changes in food consumption, body weight, behaviors and stools. Hematological assays on red blood, white blood cell, hemoglobin, platelets, lymphocyte, granulocyte, middle cell and coagulation time and the biochemical assays on aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, blood urea nitrogen, total protein, albumin, glucose, total bilirubin, creatinine and total cholesterol did not show abnormal changes. The histological inspection of principal organs of the heart, liver, spleen, lung and kidney did not show significant pathological changes. The delaying toxic reactions were detected 2 weeks after administration of EM-X was stopped. The mutagenic test showed that EM-X did not cause mutagenesis and tests of micronucleus of bone marrow cell and sperm shape abnormality upon EM-X were negative. The maximal tolerance dose of EM-X was calculated to be 1800 ml/kg BW in the mouse and rat. Thus, oral administration of EM-X does not present acute and chronic toxicity and mutagenic effects in the animals.