scholarly journals Safety Evaluation of Two Probiotic Bifidobacterial Strains, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63, by Oral Toxicity Tests Using Rats

2009 ◽  
Vol 28 (1) ◽  
pp. 7-15 ◽  
Author(s):  
Fumiaki Abe ◽  
Tomoko Yaeshima ◽  
Keiji Iwatsuki
2021 ◽  
Vol 12 ◽  
Author(s):  
Hongyun Lu ◽  
Wen Zhao ◽  
Wei-Hsien Liu ◽  
Ting Sun ◽  
Hanghang Lou ◽  
...  

Probiotics have been reported to play a major role in maintaining the balance of microbiota in host. Consumption of food with probiotics has increased with consumer concerns regarding healthy diets and wellness. Correspondingly, safety evaluation of probiotics for human consumption has become increasingly important in food industry. Herein, we aimed to test the safety of Bifidobacterium lactis BL-99 and Lacticaseibacillus paracasei K56 and ET-22 strains in vitro and in vivo. In results, these strains were found to be negative for mucin degradation and platelet aggregation test. Additionally, the three strains were susceptible to eight antibiotics. In accordance with bacterial reversion mutation (Ames) assay, the tested strains had no genetic mutagenicity. Finally, it was confirmed that there were no dose-dependent mortality and toxicity throughout multidose oral toxicity tests in rats. Our findings demonstrated that B. lactis BL-99 and L. paracasei K56 and ET-22 can achieve the generally recognized as safe (GRAS) status as probiotics in the future.


2018 ◽  
Vol 2 ◽  
pp. 239784731880737
Author(s):  
Satoshi Arai ◽  
Jun-ichi Minami ◽  
Masamichi Muto ◽  
Noriyuki Iwabuchi ◽  
Koji Yamauchi ◽  
...  

In this study, the safety of Bifidobacterium breve MCC1274, a probiotic bifidobacterial strain, was assessed by single-dose and 90-day repeated-dose oral toxicity studies. In the single-dose oral toxicity assay using 6000 mg/kg of B. breve MCC1274 corresponding to 8.4 × 1011 colony-forming unit (CFU)/kg, mortality and adverse effects were not observed. Furthermore, the administration of 1000 mg/kg of B. breve MCC1274 by oral gavage in saline for 90 days did not induce any signs of toxicity, such as changes in clinical signs, body weight (BW), food consumption, ophthalmoscopy, urinalysis, hematology, blood chemistry, organ weight, gross pathology, and histopathology compared to the control group given cornstarch in saline (10/sex/group). The no-observed-adverse-effect-level of B. breve MCC1274 in the 90-day repeated-dose toxicity study was greater than 1000 mg/kg corresponding to 1.3 × 1011 CFU/kg. Based on the findings of this study, the acceptable daily intake of B. breve MCC1274 was calculated to be 1.3 × 109 CFU/kg BW/day.


2020 ◽  
Vol 7 (7) ◽  
pp. 3865-3876
Author(s):  
Raphael Chukwuma Ekeanyanwu ◽  
Nnaemeka Emmanuel Mgbedo ◽  
Alvan Tochukwu Njoku

Introduction: The essential oils of Xylopia aethiopica fruits have been reported to possess numerous biochemical effects. However, no toxicological data is available regarding the safety evaluation of the essential oils from the plant spice. The present study was performed to evaluate the safety of essential oils from X. aethiopica (XAEO) fruit by acute and sub-acute oral toxicity studies in experimental rodents. Methods: In assessing the safety of XAEO, acute and sub-acute oral toxicity tests were performed following OECD guidelines 425 and 407, respectively, with slight modifications. At the end of each test, hematological and biochemical analysis of the collected blood was performed. Histopathological examination of vital organs of the animals was conducted for gross findings and for comparison to controls. Results: In acute oral toxicity, signs of toxicity were observed in the initial period of the experiment which culminated in the death of the mice before the end of the experiment. The sub-acute test observations indicated that generally, there were no significant differences (p<0.05) up to the high dose level compared to the controls. Conclusion: This study demonstrated the tolerability of XAEO administered daily for 28 days up to 450 mg/kg dose.


2012 ◽  
Vol 9 (2) ◽  
pp. 75-82
Author(s):  
Hiromu OHNOGI ◽  
Shoko HAYAMI ◽  
Yoko KUDO ◽  
Shigetoshi MIZUTANI ◽  
Tatsuji ENOKI

2019 ◽  
Vol 9 (3) ◽  
pp. 207-216
Author(s):  
Lalit Sharma ◽  
Aditi Sharma ◽  
Girdhari L. Gupta ◽  
Gopal Singh Bisht

Background: A standardized polyherbal preparation (POL-6) containing six plant extracts Hypericum perforatum, Bacopa monnieri, Centella asiatica, Withania somnifera, Ocimum sanctum and Camellia sinesis have good antioxidant, anti-inflammatory, and immunomodulatory activities. The present study was carried out to evaluate the safety profile of POL-6 through acute and subacute oral toxicity models in Wistar rats. Methods: In acute safety evaluation, a single dose of 2000mg/kg of POL-6 was given orally to five rats and was observed for 14 days. In subacute safety evaluation POL-6 at the doses of 250, 500 and 1000 mg/kg was given orally to the rats once a day for 28 days. The animals were observed for the signs of toxicity and mortality during the study period. Results: In acute toxicity evaluation, POL-6 treatment did not show any toxic signs and mortality in animals during the observation period. In subacute toxicity studies, no changes were seen in any of the dose levels of POL-6 treatment during the total body weights, organ weights and hematobiochemical parameters examination of the rats. No lesions were seen during the gross/histopathological examination. Conclusion: The study revealed that administration of POL-6 for 28 days showed no significant treatment generated toxic effects in the animals, hence it can be considered as non-toxic if it is ingested in a time not greater than a month.


Heliyon ◽  
2019 ◽  
Vol 5 (8) ◽  
pp. e02129 ◽  
Author(s):  
Anwarbaig C. Mirza ◽  
Shital S. Panchal

1988 ◽  
Vol 7 (6) ◽  
pp. 721-739 ◽  

Glyceryl Ricinoleate is the monoester of glycerol and ricinoleic acid. Castor oil contains 87–90% Glycerol Ricinoleate. Ricinoleic acid is metabolized by both β-oxidation and α-oxidation. Acute oral toxicity tests in mice indicated that Glyceryl Ricinoleate has an LD50 greater than 25.0 ml/kg and is, at most, mildly irritating to unrinsed rabbit eyes. This ingredient was not a primary skin irritant. Castor oil was nonmutagenic by the Ames test. Ricinoleic acid was not a carcinogen when tested in mice. In human single-insult occlusive patch tests, no indication of skin irritation potential was observed in the two products containing 5.6% Glyceryl Ricinoleate. The available data on Glyceryl Ricinoleate were insufficient to determine whether this ingredient, under each relevant condition of use, was either safe or not safe. The types of data required before a decision can be made include: (1) 28 day chronic dermal toxicity in guinea pigs, and (2) clinical sensitization and photosensitization studies (or an appropriate ultraviolet spectrum instead of the photosensitization data).


2020 ◽  
Vol 10 (18) ◽  
pp. 6301 ◽  
Author(s):  
Eun Song Lee ◽  
Chan-Ick Cheigh ◽  
Joo Hyun Kang ◽  
Seung Young Lee ◽  
Sea C. Min

This article evaluates the effects of in-package atmospheric dielectric barrier discharge cold plasma (ADCP) treatment on microbial inactivation, nitrate and nitrite contents, oral toxicity, and storage quality of protein-coated boiled chicken breast cubes (CBCs). ADCP treatment at 24 kV for 3 min inactivated natural mesophilic aerobic bacteria, Salmonella, and Tulane virus in CBCs by 0.7 ± 0.2, 1.4 ± 0.1 log CFU/cube, and 1.1 ± 0.2 log PFU/cube, respectively. ADCP treatment did not affect the nitrite content of CBCs (p > 0.05). Furthermore, the hematological and blood biochemical parameters from toxicity tests indicated the toxicological safety of ADCP-treated CBCs. Microbial counts of natural bacteria and Salmonella in ADCP-treated CBCs were lower than the ADCP-untreated CBCs by 0.7–0.9 and 1.4–1.7 log CFU/cube, respectively, throughout post-treatment storage at 4 °C for 21 d. ADCP treatment did not alter the pH, color, total volatile basic nitrogen, lipid oxidation, and tenderness of CBCs during storage at 4 and 24 °C, and did not change the sensory properties of CBCs following a 3 d storage period at 4 °C (p > 0.05). Thus, ADCP treatment has the potential to be applied as a method to increase the microbiological safety of packaged ready-to-eat chicken products, leading to overall toxicological safety.


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