scholarly journals A 90-Day Oral Toxicological Evaluation of the Methylurate Purine Alkaloid Theacrine

2016 ◽  
Vol 2016 ◽  
pp. 1-17 ◽  
Author(s):  
Amy Clewell ◽  
Gábor Hirka ◽  
Róbert Glávits ◽  
Philip A. Palmer ◽  
John R. Endres ◽  
...  
Keyword(s):  
Body Weight ◽  
Histological Examination ◽  
Food Consumption ◽  
Feed Efficiency ◽  
Wistar Rats ◽  
Toxicological Evaluation ◽  
Hepatocellular Necrosis ◽  
Purine Alkaloid ◽  
Dose Oral ◽  
Mature Spermatozoa

A 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on the methylurate purine alkaloid theacrine, which is found naturally in certain plants. Four groups of Hsd.Brl.Han Wistar rats (ten/sex/group) were administered theacrine by gavage doses of 0 (vehicle only), 180, 300, and 375 mg/kg bw/day. Two females and one male in the 300 and 375 mg/kg bw/day groups, respectively, died during the study. Histological examination revealed centrilobular hepatocellular necrosis as the probable cause of death. In 375 mg/kg bw/day males, slight reductions in body weight development, food consumption, and feed efficiency, decreased weight of the testes and epididymides and decreased intensity of spermatogenesis in the testes, lack or decreased amount of mature spermatozoa in the epididymides, and decreased amount of prostatic secretions were detected at the end of the three months. At 300 mg/kg bw/day, slight decreases in the weights of the testes and epididymides, along with decreased intensity of spermatogenesis in the testes, and lack or decreased amount of mature spermatozoa in the epididymides were detected in male animals. The NOAEL was considered to be 180 mg/kg bw/day, as at this dose there were no toxicologically relevant treatment-related findings in male or female animals.

scholarly journals Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study In Wistar Rats

2019 ◽  
Author(s):  
Appala Naidu. B ◽  
Kamala Kannan ◽  
D. P. Santhosh Kumar ◽  
John W.K. Oliver ◽  
Zachary D. Abbott
Keyword(s):  
Adverse Effect ◽  
Body Weight ◽  
Wistar Rats ◽  
Clinical Signs ◽  
Albumin Level ◽  
Repeat Dose ◽  
Oral Gavage ◽  
Toxicological Evaluation ◽  
Body Weights ◽  
Dose Oral

AbstractA 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on lyophilized spores of the novel genetically modified strain B. subtilis ZB183. Lyophilized spores at doses of 109, 1010, and 1011 CFU/kg body weight/day were administered by oral gavage to Wistar rats for a period of 90 consecutive days. B.Subtilis ZB183 had no effects on clinical signs, mortality, ophthalmological examinations, functional observational battery, body weights, body weight gains and food consumption in both sexes. There were no test item-related changes observed in haematology, coagulation, urinalysis, thyroid hormonal analysis, terminal fasting body weights, organ weights, gross pathology and histopathology. A minimal increase in the plasma albumin level was observed at 1010 and 1011 CFU/kg/day doses without an increase in total protein in males or females and was considered a non-adverse effect. The “No Observed Adverse Effect Level (NOAEL)” is defined at the highest dose of 1011 CFU/kg body weight/day for lyophilized B.Subtilis ZB183 Spores under the test conditions employed.

scholarly journals LyophilizedB. subtilisZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats

2019 ◽  
Vol 2019 ◽  
pp. 1-9
Author(s):  
B. Appala Naidu ◽  
Kamala Kannan ◽  
D. P. Santhosh Kumar ◽  
John W. K. Oliver ◽  
Zachary D. Abbott
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Clinical Signs ◽  
Albumin Level ◽  
Repeat Dose ◽  
Oral Gavage ◽  
Toxicological Evaluation ◽  
Body Weights ◽  
Adverse Effect Level ◽  
Dose Oral

A 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on lyophilized spores of the novel genetically modified strainB. subtilisZB183. Lyophilized spores at doses of 109, 1010, and 1011 CFU/kg body weight/day were administered by oral gavage to Wistar rats for a period of 90 consecutive days.B. subtilisZB183 had no effects on clinical signs, mortality, ophthalmological examinations, functional observational battery, body weights, body weight gains and food consumption in both sexes. There were no test item-related changes observed in haematology, coagulation, urinalysis, thyroid hormonal analysis, terminal fasting body weights, organ weights, gross pathology and histopathology. A minimal increase in the plasma albumin level was observed at 1010and 1011 CFU/kg/day doses without an increase in total protein in males or females and was considered a nonadverse effect. The “No Observed Adverse Effect Level (NOAEL)” is defined at the highest dose of 1011 CFU/kg body weight/day for lyophilizedB. subtilisZB183 Spores under the test conditions employed.

scholarly journals Acute and Subchronic Toxicological Evaluation of the Herbal Product HAD-B1 in Rats

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
So-Jung Park ◽  
Soo-Dam Kim ◽  
Eun-Bin Kwag ◽  
Ji Hye Park ◽  
Hwa-Seung Yoo
Keyword(s):  
Body Weight ◽  
Food Consumption ◽  
Dose Range ◽  
Clinical Signs ◽  
Toxicity Study ◽  
Toxicological Evaluation ◽  
Male And Female ◽  
Range Finding ◽  
Sd Rats ◽  
Finding Study

This study evaluates acute and subchronic toxicity of a Korean herbal formula HAD-B1 in rat to investigate whether HAD-B1 has potential toxicity to humans. First, the study to assess the acute oral toxicity at dose levels of 0, 500, 1000, and 2000 mg/kg body weight (BW) was performed in male and female SD rats (Crl: CD, specific pathogen-free) (n = 5/group). Based on the result of the acute oral study, 4 weeks’ dose range finding study and 13 weeks’ subchronic study were performed (dose range finding study, DRF; n = 5/group) and 13 weeks (subchronic study; n = 10/group) in male and female SD rats. The control group was administered with distilled water (DW). Clinical signs, body weight, food consumption, ophthalmic examination, urinalysis, hematological/biochemical parameters, gross finding at necropsy, and histopathological examination were investigated and recorded. In the oral acute toxicity study of SD rats, no clinical signs, mortality, body weight changes, and gross findings were observed. Also, there were no treatment-related changes in the 4-week DRF study. Based on these results, a 13-week repeated-dose toxicity study (subchronic) in SD rats was performed. HAD-B1 showed temporal hypersalivation in clinical signs and an increased tendency in body weight at 2000 mg/kg BW. However, there were no treatment-related changes in mortality, food consumption, ophthalmology, urinalysis, hematology, biochemistry, gross finding at necropsy, organ weights, and histopathology in either sex of any group. Based on this toxicological evaluation of HAD-B1, we concluded that no target organ was determined, and the no observed adverse effect level (NOAEL) of HAD-B1 was determined to be > 2000 mg/kg B W. Therefore, we decided that consuming HAD-B1 is relatively nontoxic.

ACUTE AND SUBACUTE ORAL TOXICITY TESTS OF SINTERED DICALCIUM PYROPHOSPHATE ON OVARIECTOMIZED RATS FOR OSTEOPOROSIS TREATMENT

2010 ◽  
Vol 22 (03) ◽  
pp. 169-176 ◽  
Author(s):  
Kai-Chiang Yang ◽  
Chen-Chie Wang ◽  
Chang-Chin Wu ◽  
Tsai-Yi Hung ◽  
Hsiu-Chi Chang ◽  
...  
Keyword(s):  
Body Weight ◽  
Bone Mass ◽  
Histological Examination ◽  
Food Consumption ◽  
Toxicity Test ◽  
Recovery Period ◽  
Clinical Signs ◽  
Ovariectomized Rats ◽  
Oral Toxicity ◽  
Mineral Contents

Sintered dicalcium pyrophosphate (SDCP) is a synthetic pyrophosphate analog that could be utilized in the treatment for osteoporosis. In this study, an ovariectomized rat model is used to evaluate the systematic toxicity of orally administered SDCP relative to its effects on bone mass. Ovariectomized Wistar rats were treated with experimental medication with different dosing strategies (0.5 mg/kg five days weekly, and 2.5 mg/kg once weekly) for once (acute oral toxicity test) and four weeks (subacute oral toxicity test) followed by recovery period. Clinical signs of toxicity, body weight, and food consumption of rats were recorded. Blood samples were collected for hematological and blood biochemical analyses. Rats were sacrificed for necropsy and major visceral organs were harvested for histological examination after the recovery period. Long bones of four limbs were harvested to evaluate the effects of SDCP on bone mass. Results showed that there was no change in clinical signs, body weight, food consumption, hematology, blood biochemistry, necropsy, and histological examination attributable to the oral administration with SDCP to rats during the dosing period and the recovery period. Analysis of bone ashes revealed that the ovariectomized rats ingested with 0.5 mg/kg SDCP five days weekly continually for four weeks increased bone mineral contents significantly. In the ovariectomized rats ingested with 2.5 mg/kg SDCP once weekly continually for four weeks, the bone mineral contents were increased to normal bone quality. This study indicates that the SDCP can increase bone mass in the ovariectomized rat with no deleterious effects.

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.

scholarly journals Toxicological evaluation of Hydrocotyle bonariensis Comm. ex Lamm (Araliaceae) leaves extract

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Komla Kaboua ◽  
Tcha Pakoussi ◽  
Aklesso Mouzou ◽  
Mindede Assih ◽  
Balakiyém Kadissoli ◽  
...  
Keyword(s):  
Body Weight ◽  
Hematological Parameters ◽  
Oral Route ◽  
Phytochemical Screening ◽  
Oral Toxicity ◽  
Toxicological Evaluation ◽  
Toxicity Studies ◽  
Significant Difference ◽  
Dose Oral ◽  
Phytochemical Compounds

Abstract Background The present study was designed to determine the cytotoxic, acute and sub-chronic oral toxicity profile of the hydroethanol extract of Hydrocotyle bonariensis leaves. The toxicity studies are preceded by a phytochemical screening to characterize the phytochemical compounds contained in this extract. Results The phytochemical screening allowed to identify the presence of alkaloids, tannins, flavonoids and saponosids. The cytotoxicity study allowed retaining that this extract does not present cellular toxicity. The acute oral toxicity study was performed at a limit dose of 5000 mg/kg body weight by the oral route. The extract showed no signs of toxicity or mortality during the 14-day daily observation period. Repeated-dose oral toxicity studies were conducted by administering 500 mg/kg and 1000 mg/kg body weight of the extract orally daily to the treated batches for 28 days. The extract did not reveal any toxicity either on the weights of the animals or on the relative weights of the organs taken. The analysis of biochemical and hematological parameters revealed no significant difference between the indicators of the batches treated with 500 mg/kg and 1000 mg/kg, compared to the control batch during the 28 days of treatment. Conclusion These results show that the hydroethanol extract of Hdrocotyle bonariensis leaves is relatively safe toxicologically when administered orally.

scholarly journals Single dose oral toxicity study of ethanolic extract from inflorescence of Casuarina equisetifolia in Wistar rats

2018 ◽  
Vol 8 (6-s) ◽  
pp. 44-47
Author(s):  
O. Umamaheswar Rao ◽  
M. Chinna Eswaraiah
Keyword(s):  
Body Weight ◽  
Single Dose ◽  
Wistar Rats ◽  
Ethanolic Extract ◽  
Toxicity Study ◽  
Casuarina Equisetifolia ◽  
Oral Toxicity ◽  
Dose Oral ◽  
Test Guideline ◽  
Oecd Test Guideline

The purpose of the study was to evaluate the single dose oral toxicity of the ethanolic extract from inflorescence of Casuarina equisetifolia, Family: Casuarinaceae in female Wistar Rats. The acute toxicity study was carried out based on Organization for Economic Co-operation and Development (OECD) Test Guideline 423. However, this plant safety evaluation data was not available so, selected the starting dose from 300 mg/kg body weight. The animals were orally administered a single dose of 300 mg/kg body weight and followed by 2000 mg/kg body weight in next step. Signs of toxicity and mortality were observed after 30 min, 1, 2, 4 and 24h of administration of the extract and once daily for 14 days. There was no mortality in the tested animals and no abnormal clinical signs were observed related to test item. No abnormalities were detected in gross pathology observations in all the rats at both the dose levels. Based on observations of the present study, it can be concluded that the LD50 of ethanolic extract from inflorescence of Casuarina equisetifolia is greater than 2000mg/kg body weight and can be classified as Category 5; however, further studies are needed to confirm long term toxicities. Keywords: Acute oral toxicity, ethanolic extract from inflorescence of Casuarina equisetifolia, LD50, OECD Test Guideline, Wistar Rat.

Protective Effects of Fagonia cretica L. Extract in Cafeteria Diet Induced Obesity in Wistar Rats

2020 ◽  
Vol 20 (3) ◽  
pp. 185
Author(s):  
Divyang Patel ◽  
Vimal Kumar
Keyword(s):  
Body Weight ◽  
Food Consumption ◽  
Wistar Rats ◽  
Cafeteria Diet ◽  
Control Group ◽  
Protective Effects ◽  
Methanolic Extracts ◽  
Diet Induced Obesity ◽  
Daily Food ◽  
Obese Control

Obesity is one of the major life style disorders which may lead to undesirable effects on cholesterol, triglycerides, blood pressure and insulin resistance and eventually increases the risk of various adverse conditions like ischemic heart disease, stroke, coronary artery disease &amp; type 2 diabetes. The present investigation was undertaken to explore protective effects of aerial parts of <em>Fagonia cretica</em> L. extract in cafeteria diet induced obesity in Wistar rats. Female Wistar rats were provided with cafeteria diet (CD) for the period of 10 weeks to induce obesity. <em>Fagonia cretica</em> L. methanolic extracts (200 &amp; 400 mg/kg) &amp; standard drug orlistat (30 mg/kg) were administered for last 6 weeks along with the continuation of CD. Various primary metabolic indicators of obesity like daily food consumption, body weight, lipid profile, fecal fat content &amp; fat pads were studied. Administration of methanolic extract of <em>Fagonia cretica</em> L. significantly stopped increase in daily food consumption &amp; body weight gain as compared to obese control group. Improvement in lipid profile was also observed in the all treatment groups rats as compared to obese control group rats. Obtained results validate that supplementation of <em>Fagonia cretica</em> L. methanolic extracts in obese rats resulted in significant protection against various indicators of obesity.

Acute and 28-day repeated dose oral toxicity study of caraway oil in rats

2019 ◽  
Vol 34 (3) ◽  
Author(s):  
Sandip T. Auti ◽  
Yogesh A. Kulkarni
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Toxicity Study ◽  
Repeated Dose ◽  
Oral Toxicity ◽  
Repeated Dose Toxicity ◽  
Relative Organ Weight ◽  
Dose Oral ◽  
Food And Water Intake ◽  
Dose Levels

Abstract Background Caraway oil (CO) obtained from the fruits of Carum carvi L. (Apiaceae) is used in traditional systems of medicine for various diseases. The present study was designed to evaluate the safety profile of CO by acute and repeated dose oral toxicity as per the Organisation for Economic Co-operation and Development guidelines 423 and 407, respectively. Methods In an acute toxicity study, a single dose of CO (300 and 2000 mg/kg) was given to female Wistar rats, and the animals were observed for signs of behavioral alterations, morbidity and mortality for 14 days. Repeated dose toxicity was performed at doses of 50, 100 and 200 mg/kg for 28 days in Wistar rats. The effects of CO on food and water intake, body weight, relative organ weight, clinical biochemistry, hematological parameters and urine parameters were studied. Gross necropsy and histopathology of vital organs were carried out. Results A single oral dose at 300 mg/kg CO did not show any signs of toxicity and mortality, while a dose of 2000 mg/kg showed signs of mortality in one animal and some signs of toxicity in another two animals. In the repeated dose toxicity study, CO at selected dose levels did not show any significant alterations in food and water intake, body weight and relative organ weight. Administration of CO did not show any significant changes in hematological, biochemical and urine parameters and histopathology study when compared with normal control animals. Conclusions The CO was found to be safe at all selected dose levels in the repeated dose toxicity study in rats.

Toxicological evaluation of xanthan gum based hydrogel formulation in Wistar rats using single dose study

2020 ◽  
Vol 77 (2) ◽  
pp. 353-360
Author(s):  
Nadia Malik ◽  
Mahmood Ahmad ◽  
Muhammad Minhas ◽  
Ruqia Tulain ◽  
Ikrima Khalid ◽  
...  
Keyword(s):  
Single Dose ◽  
Xanthan Gum ◽  
Wistar Rats ◽  
Toxicological Evaluation ◽  
Single Dose Study ◽  
Dose Study ◽  
Hydrogel Formulation
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