Safety and mutagenicity evaluation of Vigiis 101 powder made from Lactobacillus paracasei subsp. paracasei NTU 101.
Regul Toxicol Pharmacol
; 71(2): 148-57, 2015 Mar.
Article
em En
| MEDLINE
| ID: mdl-25481278
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Probióticos
/
Lactobacillus
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Testes de Mutagenicidade
Limite:
Animals
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article