scholarly journals Acute, Subacute, and Genotoxicity Assessments of a Proprietary Blend of Garcinia mangostana Fruit Rind and Cinnamomum tamala Leaf Extracts (CinDura®)

2020 ◽  
Vol 2020 ◽  
pp. 1-15
Author(s):  
Sundararaju Dodda ◽  
Venkata Krishnaraju Alluri ◽  
Trimurtulu Golakoti ◽  
Krishanu Sengupta
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Lethal Dose ◽  
Toxicity Study ◽  
Mouse Bone Marrow ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Garcinia Mangostana ◽  
Cinnamomum Tamala ◽  
Fruit Rind

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.

scholarly journals Acute and 28-Day Subchronic Oral Toxicity of an Ethanol Extract ofZingiber zerumbet(L.) Smith in Rodents

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Chia Ju Chang ◽  
Thing-Fong Tzeng ◽  
Shorong-Shii Liou ◽  
Yuan-Shiun Chang ◽  
I-Min Liu
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Histopathological Examination ◽  
Body Weight Gain ◽  
Lethal Dose ◽  
Ethanol Extract ◽  
Oral Route ◽  
The Body ◽  
Toxicity Study ◽  
Oral Toxicity

The objective of this study was to evaluate the acute and subacute toxicity (28 days) of the ethanol extract ofZ. zerumbetrhizomes (EEZZ) via the oral route in Wistar rats of both sexes. In the acute toxicity study, Wistar rats were administered a single dose of 15 g kg−1of body weight by gavage, and were monitored for 14 days. EEZZ did not produce any toxic signs or deaths; the 50% lethal dose must be higher than 15 g kg−1. In the subchronic toxicity study, EEZZ was administered by gavage at doses of 1000, 2000 and 3000 mg/kg daily for 4 weeks to Wistar rats. The subacute treatment with EEZZ did not alter either the body weight gain or the food and water consumption. The hematological and biochemical analysis did not show significant differences in any of the parameters examined in female or male groups. Necropsy and histopathological examination, did not reveal any remarkable and treatment related changes. A no-observed adverse-effect level for EEZZ is 3000 mg kg−1for rats under the conditions of this study. Hence, consumption of EEZZ for various medicinal purposes is safe.

scholarly journals Delving into the Antiurolithiatic Potential of Tribulus terrestris Extract Through –In Vivo Efficacy and Preclinical Safety Investigations in Wistar Rats

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Jyoti Kaushik ◽  
Simran Tandon ◽  
Rishi Bhardwaj ◽  
Tanzeer Kaur ◽  
Surinder Kumar Singla ◽  
...  
Keyword(s):  
Body Weight ◽  
Aqueous Extract ◽  
Kidney Stones ◽  
Wistar Rats ◽  
Lethal Dose ◽  
Tribulus Terrestris ◽  
Oral Toxicity ◽  
Preclinical Safety

Abstract Modern treatment interventions for kidney stones are wrought with side-effects, hence the need for alternative therapies such as plant-based medicines. We have previously documented through in vitro studies that statistically optimized aqueous extract of Tribulus terrestris (Zygophyllaceae family) possesses antiurolithic and antioxidant potential. This provides strong scientific foundation to conduct in vivo efficacy and preclinical safety studies to corroborate and lend further proof to its ability to prevent and cure kidney stones. The preventive and curative urolithiatic efficacy in experimentally induced nephrolithiatic Wistar rats, along with preclinical toxicity was evaluated following oral administration of statistically optimized aqueous extract of T. terrestris. Treatment showed augmented renal function, restoration of normal renal architecture and increase in body weight. Microscopic analysis of urine revealed excretion of small sized urinary crystals, demonstrating that treatment potentially modulated the morphology of renal stones. Tissue enzymatic estimation affirmed the antioxidant efficacy of treatment with reduced free radical generation. Significant upregulation of p38MAPK at both the gene and protein level was noted in hyperoxaluric group and interestingly treatment reversed it. Acute oral toxicity study established the Median Lethal Dose (LD50) to be greater than 2000 mg/kg body weight (b.wt.) No observed adverse effect level (NOAEL) by repeated oral toxicity for 28 days at 750 mg/kg b.wt. was noted. This study lends scientific evidence to the safe, preventive and curative potential of statistically optimized aqueous extract of T. terrestris at a dose of 750 mg/kg b.wt. and suggests that the extract shows promise as a therapeutic antiurolithic agent.

scholarly journals ACUTE ORAL TOXICITY STUDY OF ETHANOLIC EXTRACT OF ACTINOSCIRPUS GROSSUS (L.F.) GOETGH. AND D.A. SIMPSON

2018 ◽  
Vol 11 (7) ◽  
pp. 321
Author(s):  
Savin Chanthala Ganapathi ◽  
Rajendra Holla ◽  
Shivaraja Shankara Ym ◽  
Ravi Mundugaru
Keyword(s):  
Body Weight ◽  
Lethal Dose ◽  
Ethanolic Extract ◽  
Female Rats ◽  
Test Substance ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Healthy Female ◽  
Ld50 Value ◽  
Toxic Potential

Objective: To study the acute oral toxicity of ethanolic extract of Actinoscirpus grossus (L.f.) Goetgh. and D.A. Simpson in Wistar albino rats.Methods: Ethanolic extract of the plant was assessed for single dose acute toxicity by employing Organisation for Economic Co-Operation and Development(OECD) guidelines 425 using Acute Oral Toxicity(AOT) software. The dosed (up or down as per the requirement) rats were observed for 14 days for general appearance, behavior, mortality, and necropsy. A total of 5 healthy female rats of body weight 225±25 g were used.Results: The test substance did not produce any mortality up to the dose of 2000 mg/kg per oral.Conclusion: Test substance is without any toxic potential even at the dose of 2000 mg/kg in animals and the Lethal Dose (LD50) value of A. grossus (L.f.) Goetgh. and D.A. Simpson was found to be more than 2000 mg/kg body weight.

Acute Oral Toxicity Study of Asiasari radix Extract in Mice

2007 ◽  
Vol 26 (3) ◽  
pp. 247-251 ◽  
Author(s):  
T. Ramesh ◽  
K. Lee ◽  
H. W. Lee ◽  
S. J. Kim
Keyword(s):  
Body Weight ◽  
Oral Administration ◽  
Food Consumption ◽  
Methanol Extract ◽  
The Body ◽  
Toxicity Study ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Organ Weights ◽  
Icr Mice

Acute oral toxicity of methanol extract of Asiasari radix was evaluated in ICR mice of both sexes. In this study, mice were administrated orally with dosages of 1000, 3000, and 5000 mg/kg body weight of Asiasari radix extract. Mortality, signs of toxicity, body weight, food consumption, and gross findings were observed for 14 days post treatment of Asiasari radix extract. No mortality, signs of toxicity, and abnormalities in gross findings were observed. In addition, no significant differences were noticed in the body and organ weights between the control and treated groups of both sexes. These results show that the methanol extract of Asiasari radix is toxicologically safe by oral administration.

Oral Toxicity Studies, Histopathology and Anti-Diabetic activity of Polyherbal Extract in STZ induced diabetes in Rats

2021 ◽  
Vol 11 ◽  
Author(s):  
Pranay Wal ◽  
Nikita Saraswat ◽  
Ankita Wal ◽  
Rashmi Saxena Pal ◽  
Deepa Maurya
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Standard Dose ◽  
Ethanolic Extract ◽  
Toxicity Study ◽  
Antidiabetic Activity ◽  
Asparagus Racemosus ◽  
Oral Toxicity ◽  
Saraca Asoca ◽  
Toxicity Studies

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.

Acute oral toxicity study on Wistar rats fed microalgal protein hydrolysates from Bellerochea malleus

2019 ◽  
Vol 27 (16) ◽  
pp. 19087-19094 ◽  
Author(s):  
Ines Barkia ◽  
Hanen Ketata Bouaziz ◽  
Tahiya Sellami Boudawara ◽  
Lotfi Aleya ◽  
Ali Faouzi Gargouri ◽  
...  
Keyword(s):  
Wistar Rats ◽  
Protein Hydrolysates ◽  
Toxicity Study ◽  
Acute Oral Toxicity ◽  
Oral Toxicity

scholarly journals Safety evaluation of fructooligosaccharide (FOSSENCETM): Acute, 14-day, and subchronic oral toxicity study in Wistar rats

2018 ◽  
Vol 2 ◽  
pp. 239784731878775 ◽  
Author(s):  
Manish Jain ◽  
Manoj Gote ◽  
Ashok Kumar Dubey ◽  
S Narayanan ◽  
H. Krishnappa ◽  
...  
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Clinical Chemistry ◽  
Clinical Signs ◽  
Safety Evaluation ◽  
Toxicity Study ◽  
Feed Consumption ◽  
Oral Toxicity ◽  
Trophic Effect ◽  
Neurological Effects

Fructooligosaccharide (FOS) has been used in infant formula and conventional foods as prebiotics. Short chain FOS (FOSSENCETM) is produced by a patented process of biotransformation of sucrose by the action of enzyme from live microbial cells, hence toxicology studies were initiated to assess its safety. The objective of the present study was to determine safety of FOSSENCETM in acute, 14-day, and subchronic (90-day) toxicity studies. In acute and 14-day studies, administration of the FOSSENCETM to Wistar rats did not cause any mortality or clinical signs and changes in body weights, feed consumption, and gross pathology at the doses of 2000, 5000, and 9000 mg/kg body weight. In the subchronic (90-day) toxicity study, FOSSENCETM was administered by oral gavage to Wistar rats at the doses of 0, 2000, 5000, and 9000 mg/kg/day for 90 days. No treatment-related clinical signs or mortalities were observed. Similarly, no treatment-related toxicologically or biologically significant changes in body weight, feed consumption, ophthalmological findings, neurological effects, hematology, clinical chemistry, urinalysis, and gross pathological findings were noticed. However, statistically significant increase in weight of cecum (without correlative microscopic change) was noted at all the test item-treated groups in males and females and was considered to be a trophic effect and not a toxic effect in rats.

scholarly journals Safety and toxicological evaluation of NXT15906F6 (TamaFlex®)

2018 ◽  
Vol 2 ◽  
pp. 239784731774924
Author(s):  
Vladimir Badmaev ◽  
Hogne Vik ◽  
Sidney J Stohs ◽  
Frank Galluzzo
Keyword(s):  
Body Weight ◽  
Broad Spectrum ◽  
Wistar Rats ◽  
Micronucleus Test ◽  
Curcuma Longa ◽  
Lethal Dose ◽  
Female Rats ◽  
Mouse Bone Marrow ◽  
Toxicological Evaluation ◽  
Male And Female Rats

NXT15906F6 (TamaFlex®) is a food-derived herbal composition with synergistic anti-inflammatory properties and the potential to improve muscle–skeletal function in healthy populations. NXT15906F6 contains standardized ethanol/aqueous extracts of Tamarindus indica seeds and an ethanol extract of Curcuma longa rhizome in a 2:1 ratio. The present study was conducted to evaluate the broad-spectrum safety of NXT15906F6. All studies were conducted in compliance with good laboratory practice requirements and followed Organization for Economic Cooperation and Development Guidelines for Testing of Chemicals. The acute oral and acute dermal lethal dose of NXT15906F6 was greater than 2000 mg/kg body weight in Wistar rats. NXT15906F6 was classified as nonirritating to the skin and as a mild irritant to the eyes of New Zealand white rabbits. A repeated-dose 90-day subchronic study in Wistar rats was conducted. Groups of animals ( n = 20, 10 male and 10 female) were orally supplemented with 0, 250, 500, and 1000 mg/kg/day of NXT15906F6 for 90 days. In parallel, two separate groups of animals ( n = 10, five male and five female) were gavaged with 0 and 1000 mg/kg body weight of NXT15906F6 for 90 days and observed for another 28 days. No morbidity, mortality, or significant adverse events were observed during the study or the follow-up phase. The no observed adverse effect level for NXT15906F6 was 1000 mg/kg/day in both male and female rats. A bacterial reverse mutation test and an in vivo mouse bone marrow erythrocyte micronucleus test showed that the NXT15906F6 herbal blend is nonmutagenic and nongenotoxic. In summary, the safety studies conducted in various models demonstrate the broad-spectrum safety of NXT15906F6.

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