During the study period, no clinical signs, ophthalmological abnormalities, or deaths were observed in either the control or the treatment groups (data not shown). The animals showed no significant
differences in body weight and food consumption between the control and treatment groups. Body weight increased gradually throughout the study period in males and females of all groups (Fig. 1). At the end of the study, all animals were euthanized selleck chemicals llc and subjected to a necropsy. Data in Table 4 indicate that there were no significant differences in hematological parameters between the control and Vigiis 101-treated groups. Data in Table 5 show some statistically significant differences (p < 0.05) in clinical chemistry Selleckchem CX 5461 parameters between the control and Vigiis 101-treated groups. In male rats, blood chemistry parameters, including potassium (K), aspartate aminotransferase (AST), and triglyceride (TG) were significantly different but were within the physiologically acceptable range (K: 3.82∼5.55 mg/dl; AST: 74∼143 U/l; TG: 20∼114 mg/dl) in the treatment groups. In Vigiis 101-treated female rats, statistically significant changes in AST also resulted in the values that was within
the acceptable range (AST: 65∼203 U/l). The data in Table 6 and Table 7 indicate that no significant organ weight and relative organ weight changes were noted in either the male or female rats. Fig. 2 and Fig. 3 demonstrate the results of histopathological examination
of the rats. The results showed that no significant lesions were present in Baricitinib the liver, kidneys, heart, spleen, adrenal glands, epididymis, testes, uterus, and ovaries of the control or high-dose Vigiis 101 groups. Probiotic products fermented by L. paracasei subsp. paracasei NTU 101 have been shown to have various beneficial effects on humans and animals, such as hypolipidemic, immunomodulatory, osteoprotective, and antiobesity effects. In the literature, there are no available classical toxicology data on Vigiis 101. To our knowledge, there are no published studies on traditional genotoxicity or mutagenicity of L. paracasei subsp. paracasei NTU 101 or L. paracasei subsp. paracasei strains in general. Hence, we decided to evaluate the safety of Vigiis 101 powder made from L. paracasei subsp. paracasei NTU 101 provided by SunWay Biotech Co., Ltd. (fermentation by means of typical industrial equipment). We used two in vitro genotoxicity tests of Vigiis 101, one in vivo genotoxicity test, and a 28-day oral toxicity assay in Wistar rats. The Ames test in Salmonella strains TA98, TA100, TA102, TA1535, and TA1537 showed that Vigiis 101 does not induce a greater than two-fold increase in the number of reverse mutations at the doses 0.3–5.0 mg/plate. Nor does metabolically activated Vigiis 101 (with an S9 mix) exhibit mutagenicity.