title: Safety and mutagenicity evaluation of Vigiis 101 powder made from Lactobacillus paracasei subsp. paracasei NTU 101.
abstract: The aim of the present work was to assess the genotoxic activity and the potential for toxicity upon repeated dosing of "Vigiis 101" powder, a probiotic consisting of dried bacteria Lactobacillus paracasei subsp. paracasei NTU 101. Results of the Ames test in Salmonella typhimurium strains TA1537, TA98, TA100, TA102, and TA1535 showed that Vigiis 101 (⩽5 mg per plate) was not mutagenic. We used experiments on ICR mice to evaluate the genotoxicity of Vigiis 101. Compared to the control, high-dose Vigiis 101 administration (16.72 g per kg of body weight) did not cause significant changes either in the number of reticulocytes or in the percentage (occurrence) of micronucleated reticulocytes. A mammalian chromosomal aberration test showed that the number of Chinese hamster ovary cells with abnormal chromosomes was <4% after Vigiis 101 treatment (maximal concentration was 5 mg/ml). A 28-day oral toxicity assay in Wistar rats was performed to assess the no-observed-adverse-effect level of Vigiis 101. Compared to the control, high-dose Vigiis 101 administration (5000 mg/kg/day) had no effects on mortality and body weight and did not cause toxicopathological lesions. Taken together, these results show that Vigiis 101 has no significant mutagenic or toxic effects.
authors.affiliation: Department of Biochemical Science & Technology, College of Life Sciences, National Taiwan University, Taipei 106, Taiwan.
authors.forename: Wei-Ting
authors.initials: WT
authors.lastname: Tseng
authors.affiliation: SunWay Biotech Co., Taipei 112, Taiwan.
authors.forename: Tsung-Wei
authors.initials: TW
authors.lastname: Shih
authors.affiliation: Graduate Institute of Toxicology, College of Medicine, National Taiwan University, Taipei 106, Taiwan.
authors.forename: Shing-Hwa
authors.initials: SH
authors.lastname: Liu
authors.affiliation: Department of Biochemical Science & Technology, College of Life Sciences, National Taiwan University, Taipei 106, Taiwan. Electronic address: tmpan@ntu.edu.tw.
authors.forename: Tzu-Ming
authors.initials: TM
authors.lastname: Pan
mesh_terms: D000818:Animals; D016466:CHO Cells; D006224:Cricetinae; D003412:Cricetulus; D005260:Female; D007778:Lactobacillus; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D015162:Micronucleus Tests / Q000379:methods; D009152:Mutagenicity Tests / Q000379:methods*; D011208:Powders; D019936:Probiotics / Q000008:administration & dosage* / Q000633:toxicity; D051381:Rats; D017208:Rats, Wistar
chemical_list: D011208:Powders
keywords: Lactobacillus paracasei subsp. paracasei NTU 101; No observed adverse effect level; Probiotic