Assessment of Labrasol®/Labrafil®/Transcutol® (4/4/2, v/v/v) as a non-clinical vehicle for poorly water-soluble compounds after 4-week oral toxicity study in Wistar rats

2010 ◽  
Vol 57 (2-3) ◽  
pp. 284-290 ◽  
Author(s):  
J.-L. Delongeas ◽  
G. Vermeil de Conchard ◽  
A. Beamonte ◽  
H. Bertheux ◽  
C. Spire ◽  
...  
2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Cheng-Chih Tsai ◽  
Sew-Fen Leu ◽  
Quan-Rong Huang ◽  
Lan-Chun Chou ◽  
Chun-Chih Huang

Three lactic acid bacterial strains,Lactobacillus plantarum, HK006, and HK109, andPediococcus pentosaceusPP31 exhibit probiotic potential as antiallergy agents, both in vitro and in vivo. However, the safety of these new strains requires evaluation when isolated from infant faeces or pickled cabbage. Multiple strains (HK006, HK109, and PP31) were subject to a bacterial reverse mutation assay and a short-term oral toxicity study. The powder product exhibited mutagenic potential inSalmonellaTyphimurium strains TA98 and TA1535 (with or without metabolic activation). In the short-term oral toxicity study, rats received a normal dosage of 390 mg/kg/d (approximately9×109 CFU/kg/d) or a high dosage of 1950 mg/kg/d (approximately4.5×1010 CFU/kg/d) for 28 d. No adverse effects were observed regarding the general condition, behaviour, growth, feed and water consumption, haematology, clinical chemistry indices, organ weights, or histopathologic analysis of the rats. These studies have demonstrated that the consumption of multiple bacterial strains is not associated with any signs of mutagenicity ofS.Typhimurium or toxicity in Wistar rats, even after consuming large quantities of bacteria.


2020 ◽  
Vol 7 ◽  
pp. 610-623 ◽  
Author(s):  
Lotte Geerlofs ◽  
Zhiyong He ◽  
Sa Xiao ◽  
Zhi-Cheng Xiao

2020 ◽  
Vol 2020 ◽  
pp. 1-15
Author(s):  
Sundararaju Dodda ◽  
Venkata Krishnaraju Alluri ◽  
Trimurtulu Golakoti ◽  
Krishanu Sengupta

The present communication describes a battery of toxicity studies that include an acute oral toxicity, a subacute twenty-eight-day repeated oral dose toxicity, and genotoxicity studies on a herbal formulation CinDura® (GMCT). This proprietary herbal composition contains the extracts of the Garcinia mangostana fruit rind (GM) and the Cinnamomum tamala leaf (CT). The toxicological evaluations were performed following the Organization for Economic Cooperation and Development (OECD) guidelines. The acute oral toxicity study in Wistar rats suggests that the median lethal dose of CinDura® is at least 2000 mg/kg body weight. Acute dermal and eye irritation tests in New Zealand white rabbits indicate that the test item is nonirritant to the skin and eyes. A twenty-eight-day repeated dose oral toxicity study was conducted in male and female Wistar rats using daily doses of 250, 500, and 1000 mg/kg body weight, followed by a fourteen-day reversal period for two satellite groups. The CinDura®-supplemented animals did not show any sign of toxicity on their body weights, organ weights, and on the hematobiochemical parameters. The gross pathology and histopathological examinations indicated no treatment-related changes in the experimental animals. Overall, the no-observed-adverse-effect level (NOAEL) of the herbal blend is 1000 mg/kg body weight, the highest tested dose. Also, the results of the bacterial reverse mutation test and the erythrocyte micronucleus assay in mouse bone marrow suggest that CinDura® (GMCT) is neither mutagenic nor clastogenic.


2016 ◽  
Vol 3 (1) ◽  
pp. 9-12 ◽  
Author(s):  
Acharya Bal Krishna ◽  
Hemanth Kumar Manikyam ◽  
Vinay K Sharma ◽  
Niti Sharma

2019 ◽  
Vol 56 (3) ◽  
pp. 520-534
Author(s):  
Daniela Miricescu ◽  
Alexandra Totan ◽  
Iulia Ioana Stanescu ◽  
Andreea Didilescu ◽  
Ruxandra Sfeatcu ◽  
...  

The hypercaloric diet leads to obesity which is a risk factor for developing many systemic diseases such as diabetes, cardiovascular diseases and cancer. The purpose of our study was to observe the antioxidants effects of entrapped alfa-tocopherol (vitamin E) and lutein in Poly Lactic-CO-Glycolic acid (PLGA) in Wistar rats that received 3 weeks hypercaloric diet. Hepatic and splenic lysates have been used to detect changes in total antioxidant capacity (TAC) and advanced oxidative protein products (AOPP). The AOPP liver levels were statistically decreased in the case of rats groups that received a daily dose of PLGA-lutein or PLGA-vitamin E versus the control group. The AOPP level was decreased but statistically insignificant in Wistar rats spleen who received a daily dose of PLGA-lutein. At hepatic level, TAC was statistically increased in rats groups that received a daily dose of vitamin E or lutein. An increased statistical level of TAC was observed in the spleen cell lysing in Wistar rats who received the daily dose of PLGA-vitamin E. Entrapment of vitamin E and lutein in PLGA structure has diminished the effects of hypercaloric diet and can be considered a attractive and promising approach to enhance the bioavailability and activity of poorly water soluble compounds.


2021 ◽  
Vol 11 ◽  
Author(s):  
Pranay Wal ◽  
Nikita Saraswat ◽  
Ankita Wal ◽  
Rashmi Saxena Pal ◽  
Deepa Maurya

Background: Diabetes mellitus is a disease and endocrine disorder and it's a growing health problem in various countries. The prevalence of diabetes rises worldwide including South Africa 5.4% in 2025 increases as expected. The World Health Organization (WHO) estimated the diabetes mellitus problem in adults 173 million in developing counties. In this research observation of glucose levels indicated the diabetic state in Wistar rats by resulting from Streptozotocin administration and using a Metformin as a standard dose. This study demonstrated the acute oral toxicity and subacute oral toxicity of ethanolic extract of Saraca asoca leaves and Asparagus racemosus roots and showed the antidiabetic activity. Objective: To perform acute toxicity studies and sub-acute toxicity of the polyherbal ethanolic extract on the vital organ and isolated organ and record and noticed the visible changes on organs of each group of Wistar rats. Explore the hypoglycaemic action of the polyherbal extract of Saraca asoca and Asparagus racemosus. Methods: Wistar rats were divided into required groups for toxicity study first is acute oral toxicity 5,50, 300,2000 mg/kg body weight. Subacute oral toxicity studies were performed by administering a 250, 500, 1000mg/kg body weight. For demonstrating the antidiabetic activity the animals divided into 5 groups 1 normal control given saline group 2 standard dose Metformin compulsory dose groups 3 Streptozotocin-Induced diabetic 150mg/kg body weight body weight, groups 4 ethanolic extracts at a 100mg/kg groups 5 ethanolic extract 200mg/kg. On the last day of all the dosing period examined the Blood glucose levels and body weights of rat and histopathology studied were done by animal sacrifice and cut organs such as tissue pancreas, spleen, heart, lungs, liver, and kidney, placed on the slide and done a microscopic examination. Data selection has been complete by research papers from many databases such as NCBI, Web of science and Science direct and PubMed from year 1989 to 2020 by utilize research. skeywords such as “Antidiabetic”, “Saraca indica”, “Asparagus racemosus”, “ethanolic polyherbal extract”, “oral toxicity study”, “histopathology”, “Streptozotocin. Results : The polyherbal ethanolic extract of Saraca asoca and Asparagus racemosus at a dose of 100mg/kg and 200mg/kg was showed better effects against Streptozotocin-Induced diabetic 150mg/kg body weight body weight. All the extracts showed significantly (P <0.05) and it is safe and non-toxic nature by performed a toxicity study acute and subacute oral toxicity and the bodyweight are also improved, no inflammation and erosion are seen on any organs of Wistar rat by demonstrated a histopathology analysis. Conclusions: The polyherbal ethanolic extract of Saraca asoca and Asparagus racemosus showed hypoglycaemic activity against STZ-induced diabetes in experimental Wistar rats in Wistar rats. The results are shown beneficial effects of these ethanolic extract it helps in improving the changes in lipid metabolism, and protect the organs of Wistar rat liver, kidney, spleen, pancreas, lungs, heart against due to impairment of blood glucose and also in body weight. All organs were weighted and cut the tissue of organs and stained from eosin dye and changes observed by microscopy photos. no signs of inflammation and erosion.


2019 ◽  
Vol 27 (16) ◽  
pp. 19087-19094 ◽  
Author(s):  
Ines Barkia ◽  
Hanen Ketata Bouaziz ◽  
Tahiya Sellami Boudawara ◽  
Lotfi Aleya ◽  
Ali Faouzi Gargouri ◽  
...  

2018 ◽  
Vol 5 ◽  
pp. 497-503 ◽  
Author(s):  
Joby Jacob ◽  
Augustine Amalraj ◽  
Chandradhara Divya ◽  
Suresh Janadri ◽  
P.M. Manjunatha ◽  
...  

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