THE ACUTE TOXICITY AND SEMI-CHRONIC TOXICITY OF BACIMIX PRODUCT CONTAINING TWO STRAINS OF BACILLUS SUBTILIS BS 304.04 AND BACILLUS COAGULANS BC 304.06 ON EXPERIMENTAL ANIMAL MODEL

Objectives: To examine the safety of a BaciMix product, containing two strains of Bacillus subtilis BS 304.04 and Bacillus coagulans BC 304.06 on mice and rats. Materials and methods: The acute toxicity using the Litchfield-Wilcoxon method on Swiss mice and semi-chronic toxicity of the BaciMix product on Wistar rats was performed. Results: LD50 of the mice which were administered orally with the highest dose of 4 x 1011 CFU/kg of the product was not determined. The BaciMix product was well-tolerated and did not show any effects on the growth or food intake in animals. The differences in the number of red blood cells, white blood cells, hemoglobins, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activities, cholesterol, protein, bilirubin and creatinine were not statistically significant in rats serum dosed continuously for 28 days with of 1.68 x 109 CFU/kg and 8.4 x 109 CFU/kg of the product. In addition, no histopathological abnormalities or changes were observed in all the groups of animals. Conclusion: These results suggested that the BaciMix product could be safe for human use.