scholarly journals A 90-Day Oral Toxicity Study of the Ethanol Extract from Eupatorium japonicum Thunb and Foeniculum vulgare in Rats

2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Guangcheng Dai ◽  
Chenglu Wang ◽  
Wei Tang ◽  
Jiangyun Liu ◽  
Boxin Xue
Keyword(s):  
Body Weight ◽  
Safety Information ◽  
Clinical Signs ◽  
Ethanol Extract ◽  
Male Rats ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Foeniculum Vulgare ◽  
Hematological Indices ◽  
Eupatorium Japonicum

Eupatorium japonicum Thunb and Foeniculum vulgare are two of the most widely used folk herbs and constituents in many traditional Chinese herbal formulas. Nonetheless, little toxicological and safety information associated with following daily repeated exposure is obtained according to previous research. The present study was performed to assess the toxicity of ethanol extract from Eupatorium japonicum Thunb and Foeniculum vulgare (EFE) in male rats administered by dietary oral gavage at target doses of 0.39, 0.78, and 1.56 g/kg body weight/day for 90 days. There were no significant adverse effects on clinical signs, body weight, food conversion efficiency, and vital hematological indices. However, some hematology and biochemical indices such as WCV, MCH, MCHC, LY, MPV, T-CHO, as well as TG revealed significant changes in Sprague–Dawley rats and organ weights in lung and spleen showed diminished in male rats. Necropsy and histopathology findings suggested that no significant differences in absolute weights were found in all organs except lung and spleen, and no treatment-related alteration was identified in any organs. All results obtained in the present study indicated that the proper use of EFE in traditional medicine at oral dosages up to 1.56 g/kg/day body weight may harbor no prolonged toxicity to rats. However, further studies of EFE are still necessary to assess its oral safety in patients.

scholarly journals Safety Evaluation ofYukmijihwang-tang: Assessment of Acute and Subchronic Toxicity in Rats

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Hyekyung Ha ◽  
Jun Kyoung Lee ◽  
Ho Young Lee ◽  
Woo Suk Koh ◽  
Chang Seob Seo ◽  
...  
Keyword(s):  
Body Weight ◽  
Single Dose ◽  
Safety Information ◽  
Clinical Signs ◽  
Safety Evaluation ◽  
Sprague Dawley ◽  
Weight Changes ◽  
Oral Toxicity ◽  
Renal Disorder ◽  
Body Weights

Yukmijihwang-tang(YMJ;Liu wei di huang tang(China),Rokumigan(Japan)) has been used in the treatment of diseases including renal disorder, cognitive vitality, and diabetes mellitus. However, there is very little information regarding the toxicity of YMJ to give an assurance of safety for clinical treatment. To provide safety information for YMJ, we evaluated its acute and sub-chronic toxicity in rats. The single-dose toxicity of YMJ was examined using Sprague-Dawley rats. Rats were treated with YMJ extract orally at 0, 500, 1000, or 2000 mg/kg body weight. After a single administration, clinical signs were observed every day for two weeks, and body weights were measured five times, including an initial measurement on day 1 (the day of administration). In the sub-chronic oral toxicity study, YMJ was administered to rats at 0, 500, 1000, or 2000 mg/kg/day for 13 weeks. Mortalities, clinical signs, body weight changes, food and water consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights, and histological examination were monitored during the study period. We found no mortality and no abnormalities in clinical signs, body weights, and necropsy findings for any of the animals in the acute and sub-chronic studies following oral administration in the rat at up to 2000 mg/kg/day YMJ. YMJ may not have any single-dose toxicity; the LD50of YMJ was over 2000 mg/kg, and it is safe for rats. The no-observed-adverse-effect-level (NOAEL) was considered to be 2000 mg/kg/day.

scholarly journals Subacute Oral Toxicity of Yukmijiwhang-Tang in Crl:CD Sprague-Dawley Rats and Its Cytotoxicity

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Soo-Jin Jeong ◽  
Chang-Seob Seo ◽  
Jung-Im Huh ◽  
Hyeun-Kyoo Shin
Keyword(s):  
Food Intake ◽  
Scientific Evidence ◽  
Safety Information ◽  
Clinical Signs ◽  
Serum Biochemistry ◽  
Female Rats ◽  
Male Rats ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Adverse Effect Level

Background. The traditional herbal formula Yukmijiwhang-tang (YMJ) consists of six medicinal herbs and has been used to treat dysuria, diabetic mellitus, and neurosis in Korea, China, and Japan. Here we report safety information on its subacute toxicity and the cytotoxicity.Methods. YMJ extract was administered to SD rats at various dosages for 4 weeks. We monitored clinical signs, mortality, body and organ weights, food intake, and hematological and serum biochemistry factors. For cytotoxicity testing, each cell line was treated with various concentrations of YMJ for 24 h.Results. YMJ treatment had no significant effects on changes in clinical signs, body weight, or food intake in male or female rats. In male rats, YMJ treatment decreased the absolute weights of the epididymides and serum Na levels. In female rats, YMJ significantly reduced the prothrombin time (PT) and serum creatine level. However, the changes were not severe and were considered to be in the normal physiological range for rats. The no-observed-adverse-effect-level (NOAEL) was estimated to be 2000 mg/kg/day. YMJ extract did not exert any cytotoxicity against 23 tested cell lines.Conclusions. Our data provide scientific evidence on the safety of YMJ for potential development as a prescription drug.

scholarly journals Thirteen-Week Oral Toxicity Study of HVC1 in Rats

2019 ◽  
Vol 2019 ◽  
pp. 1-10
Author(s):  
Kyungjin Lee ◽  
Ho-Young Choi
Keyword(s):  
Hematological Parameters ◽  
Clinical Signs ◽  
Ethanol Extract ◽  
New Drugs ◽  
Control Group ◽  
High Dose ◽  
Sprague Dawley ◽  
Weight Changes ◽  
Oral Toxicity ◽  
Blood Biochemical

Studies on the safety of herbal medicine are essential for the development of new drugs. The aim of this study was to evaluate the no-observed-adverse-effect-level (NOAEL) of HVC1 (Gamisamhwangsasim-tang, a 30% ethanol extract of a mixture of Pruni Cortex, Scutellariae Radix, Coptidis Rhizoma, and Rhei Rhizoma) and identify its target organs after oral administration to Sprague-Dawley (SD) rats repeatedly for 13 weeks. Three test groups were treated with HVC1 at a dose of either 500 (low-dose), 1,000 (middle-dose), or 2,000 (high-dose) mg/kg/day. Another group received high-dose HVC1 and was observed for 4 weeks following treatment to examine recovery from the effects of the extract. All treatment groups were compared to a vehicle control group. During the study, mortality, clinical signs, body weight changes, food consumption, abnormal lesions in the eye, urinary parameters, hematological parameters, blood coagulation time, blood biochemical parameters, changes in organ weight, gross findings, and histopathological changes were examined. No systemic toxicity related to HVC1 was observed in any group, and it was concluded that the NOAEL of HVC1 was 2,000 mg/kg/day. No target organ was identified.

scholarly journals Nutritional and 13-Week Subchronic Toxicological Evaluation of Lignosus rhinocerotis Mycelium in Sprague-Dawley Rats

2021 ◽  
Vol 18 (3) ◽  
pp. 1271
Author(s):  
I-Chen Li ◽  
Bi-Hua Yang ◽  
Jing-Yi Lin ◽  
Shan Lin ◽  
Chin-Chu Chen
Keyword(s):  
Body Weight ◽  
Histopathological Examination ◽  
Clinical Signs ◽  
Female Rats ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Crude Lipid ◽  
Sprague Dawley Rats ◽  
Freeze Dried ◽  
Lignosus Rhinocerotis

Lignosus rhinocerotis (Tiger’s Milk mushroom) is a novel mushroom with sclerotium belonging to the Polyporaceae family and has been reported widely to possess anti-cancer, anti-cough, antioxidant, gastro-protective, immuno-modulating, and neurite-stimulating properties. As numerous studies have proven the tremendous medicinal values of L. rhinocerotis, it is necessary to understand its nutrition as well as its safety for the recipient. Previous research on L. rhinocerotis has mainly focused on the naturally occurring sclerotium and may have overlooked mushroom mycelia from submerged liquid fermentation, which ensures a high uniform quantitative biomass production as well as a high biological value. Hence, this is the first report on the evaluation of nutrition and 13-week repeated oral toxicity of L. rhinocerotis mycelium (LRM). The LRM powder contained 9.0 ± 4.2% moisture, 1.9 ± 1.3% ash, 1.6 ± 2.2% crude lipid, 8.4 ± 5.3% crude protein, 79.3 ± 4.6% carbohydrate, and 364 kcal/100 g energy. The total free amino acid ranged from 349 to 5636 mg/100 g and the umami index of freeze-dried LRM powder was 0.37. For safety assessment, ninety-six rats were divided into four groups, each consisting of twelve male and twelve female rats. Test articles were administered by oral gavage to rats at 850, 1700, and 3400 mg/kg body weight/day for 13 weeks and reverse osmosis water was used as the control. All animals survived to the end of the study. During the experiment period, no abnormal changes were observed in clinical signs, body weight, or ophthalmological examinations. No adverse or test article-related differences were found in urinalysis, hematology, or serum biochemistry parameters between the treatment and control groups. Necropsy and histopathological examination indicated no treatment-related changes. According to the above results, the no-observed-adverse-effect level (NOAEL) of L. rhinocerotis was identified to be greater than 3400 mg/kg body weight (BW)/day in Sprague–Dawley rats.

scholarly journals Acute oral toxicity of squid and cuttlefish ink powder enzyme hydrolysates in Sprague-Dawley rats in accordance with the OECD Test Guideline 425

Food Research ◽  
2021 ◽  
Vol 5 (5) ◽  
pp. 259-264
Author(s):  
Ayu Shazwani Z. ◽  
Husnul Azan T. ◽  
Wan Ezumi M.F. ◽  
Rabeta M.S.
Keyword(s):  
Body Weight ◽  
Clinical Signs ◽  
Normal Structure ◽  
Female Rats ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Sprague Dawley Rats ◽  
Behavioural Patterns ◽  
Ld50 Value ◽  
Enzyme Hydrolysate

The objectives of this study were to determine LD50 and establish the safety of ink squid and cuttlefish hydrolysates. In the acute toxicity study, three groups of female rats were randomly assigned. One group served as the control and two groups orally received a single limiting dose (2000 mg/kg body weight) of ink hydrolysates. There were no signs of adverse toxicity observed in behavioural patterns, clinical signs, and no significant differences (p>0.05) between the control and treated rats regarding their food and water consumption and body weight for up to 14 days. The histopathological evaluation revealed a normal structure and the absence of noticeable lesions in the vital organs of treated animals. It can be concluded that LD50 value is greater than 2000 mg/kg. The results showed that the squid ink powder enzyme hydrolysate (SIPEHs) and cuttlefish ink powder enzyme hydrolysate (CIPEHs) possess low toxicity, as indicated in the rat model. The preliminary results suggested that it should be further evaluated for long-term use and repeated dose effects to support the safe use of these hydrolysates.

scholarly journals Eurycoma longifolia—Infused Coffee—An Oral Toxicity Study

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3125
Author(s):  
Norzahirah Ahmad ◽  
Bee Ping Teh ◽  
Siti Zaleha Halim ◽  
Nor Azlina Zolkifli ◽  
Nurulfariza Ramli ◽  
...  
Keyword(s):  
Body Weight ◽  
Clinical Signs ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Eurycoma Longifolia ◽  
Dependent Relationship ◽  
Adverse Effect Level ◽  
Chronic Study ◽  
Effect Level ◽  
Gender Groups

Coffee infused with the additive Eurycoma longifolia, also known as Tongkat ali (TA), has become widely available in the Malaysian market. Safety evaluations for consumption of the products have been called for due to the herbal addition. This study investigates the acute, subacute and chronic effects of a commercial TA coffee in Sprague Dawley rats when given in a single, repeated and prolonged dosage. The dosages of 0.005, 0.05, 0.30 and 2 g/kg body weight (BW) were used in the acute study and 0.14, 0.29 and 1 g/kg BW were used in the repeated dose studies. The in-life parameters measured were food and water intake, body weight and clinical observations. Blood were collected for hematology and clinical biochemistry analyses. All animals were subjected to full necropsies. Non-toxicity-related changes were observed in the food and water consumption parameters. Body weight showed normal increments and none of the animals had any clinical signs of toxicity. Microscopically assessed organ tissues did not reveal any abnormalities. There was significant decrease of platelet count in all the chronic study male treated groups. Significant elevation of renal profile parameters in both gender groups given 0.29 g/kg BW, along with liver and lipid profile elevation in some female groups of the chronic study were noted. No dose-dependent relationship was apparent in the dosage range tested, though these changes may suggest an initial safety indication to the TA coffee. The study concludes that the no observed adverse effect level (NOAEL) for this commercial TA coffee was 1 g/kg BW.

scholarly journals Antihyperlipidemic Activities and Hematological Properties of Ethanol Extract of Blighia Sapida Koenig Bark in Alloxan-Induced Diabetic Rats

2020 ◽  
Vol 21 (1) ◽  
pp. 11-17
Author(s):  
Oluwafemi Adeleke Ojo ◽  
Adebola Busola Ojo ◽  
Basiru Olaitan Ajiboye ◽  
Oluwatosin Debbie Imiere ◽  
Babatunji Emmanuel Oyinloye
Keyword(s):  
Body Weight ◽  
Blood Cells ◽  
White Blood Cells ◽  
Ethanol Extract ◽  
Stem Bark ◽  
Diabetic Rats ◽  
Male Rats ◽  
Once Daily ◽  
Hematological Indices ◽  
Blighia Sapida

AbstractBlighia sapida (BS) has been shown to be rich sources of antioxidant, thus, we evaluated effects of B. sapida Koenig stem bark ethanol extract (BSE) on lipid metabolism and hematological indices in diabetes rats.Thirty male rats were divided into six groups of five rats each. Diabetes was elicited by intraperitoneal injection of alloxan (65 mg/kg body weight) once and orally administered with glibenclamide (5 mg/kg), B. sapida extract (50, 100 and 150 mg/kg body weight (bw) once daily for 21 days. Serum lipid profile, markers of hepato-renal toxicity and hemato-logical indices were examined using automated analyzer. Data were analyzed using one-way ANOVA and p < 0.05 was considered to be statistically different.Diabetic untreated animals showed considerably elevated total cholesterol p < 0.05, also, significant increase in AST, ALT, ALP, urea and creatinine compared to control. Triglycerides, LDL-c, VLDL-c, AI and CRI decreased with extract administration and HDL-c increased considerable compared to untreated diabetic rats. Furthermore, significant lower hemoglobin (Hb) levels, packed cell volume (PCV), red blood cells (RBCs) levels, white blood cells (WBCs) compared to normal animals was recorded in the untreated group. These changes were returned to normal after the administration of extract 50, 100 and 150 mg/ kg body weight. Hence, these effects were most prominent in the animals treated with 150 mg/kg body weight of B. sapida bark.This indicates that B. sapida stem bark possess anti-hyperlipidemic activity and improved the biochemical parameters within the hematological profile of diabetic rats.

Oral Toxicity Evaluation of Thiodiglycol in Sprague-Dawley Rats

2014 ◽  
Vol 33 (5) ◽  
pp. 393-402 ◽  
Author(s):  
Richard A. Angerhofer ◽  
Mark W. Michie ◽  
Glenn J. Leach ◽  
Mark S. Johnson ◽  
Gunda Reddy
Keyword(s):  
Body Weight ◽  
Food Consumption ◽  
Sulfur Mustard ◽  
Female Rats ◽  
Male Rats ◽  
Control Individual ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Male And Female Rats ◽  
Sprague Dawley Rats

Thiodiglycol (TDG) is the main product of sulfur mustard hydrolysis and is an environmental contaminant. Subacute and subchronic oral toxicity studies with TDG were conducted in Sprague-Dawley rats. Neat TDG was administered by gavage at doses of 157, 313, 625, 1250, 2500, 5000, and 9999 mg/kg/d, 5 days per week, for 14 days. In the 14-day study, decreased body weight and food consumption were observed at 5000 mg/kg/d. In the 90-day study, rats received neat TDG at doses of 50, 500, or 5000 mg/kg/d for 5 days per week. A fourth group served as a sham control. Individual body weight and food consumption were measured weekly. At termination of the experiment, urine, blood, and tissue samples were collected. Rats displayed significant decreased body weight with no effect on food consumption following administration of TDG at 5000 mg/kg/d. Both male and female rats showed significant increased kidney weights at 5000 mg/kg/d. The organ to body weight ratios increased significantly for liver, kidneys, testes, and brain in males and adrenals in females for 5000 mg/kg/d. At all doses of TDG, hematological and clinical parameters and tissue histopathology remained unaltered. The no observed adverse effect level (NOAEL) for oral subchronic toxicity was 500 mg/kg/d. Benchmark dose (BMD) was derived from the decreased gain in body weight that was seen in male rats. A BMD based on a 10% decrease in body weight was 1704 mg/kg/d, and the lower confidence limit on the dose BMD, the BMDL, was 372 mg/kg/d.

Subacute and Subchronic Oral Toxicity of p-Chlorotoluene in the Rat

1990 ◽  
Vol 9 (5) ◽  
pp. 487-495
Author(s):  
James B. Terrill ◽  
Merrel Robinson ◽  
Gary W. Wolfe ◽  
Leonard H. Billups
Keyword(s):  
Adverse Effect ◽  
Body Weight ◽  
Dose Group ◽  
Corn Oil ◽  
Clinical Laboratory ◽  
Clinical Signs ◽  
High Dose Group ◽  
High Dose ◽  
Sprague Dawley ◽  
Oral Toxicity

p-Chlorotoluene was administered by corn oil gavage for 14 and 90 days to male and female Sprague-Dawley-derived rats at dosages of 200, 600, and 1800 mg/kg per day and 50, 200, and 800 mg/kg per day, respectively. In the 14-day study, 8 of 10 animals of each sex in the high-dose group died due to treatment. Other treatment-related signs for these animals included an adverse effect upon body weight and clinical signs of salivation, tremors, and prostration. In the 200 and 600 mg/kg per day groups there were no apparent treatment-related effects. In the 90-day study, 4 of 10 males and 2 of 10 females in the high-dose group died due to treatment. Other signs for this treatment group included an adverse effect upon body weight and clinical signs of languid behavior, prostration, tremors, sensitivity to touch, epistaxis, and respiratory distress. Increases in alkaline phosphatase and creatinine (males only), and increases in adrenal (absolute and relative, females), kidney (relative, both sexes), and liver (relative, both sexes) weights were also noted. Histopathologic findings of centrilobular hepatocellular hypertrophy, adrenal cortical hyperplasia, and exacerbation of chronic progressive nephropathy confirmed the clinical laboratory and organ weight results as being treatment related for the animals receiving 800 mg/kg per day for 90 days. Animals receiving 50 or 200 mg/kg per day (90 days) did not exhibit treatment-related findings.

Mesotheliomas and Proliferative Lesions of the Testicular Mesothelium Produced in Fischer, Sprague-Dawley and Buffalo Rats by Methyl(acetoxymethyl)nitrosamine (DMN-OAc)

1979 ◽  
Vol 16 (5) ◽  
pp. 574-582 ◽  
Author(s):  
J. J. Berman ◽  
J. M. Rice
Keyword(s):  
Body Weight ◽  
Tumor Cells ◽  
Mesothelial Cells ◽  
Male Rats ◽  
Sprague Dawley ◽  
Colloidal Iron ◽  
Microscopic Appearance ◽  
Intraperitoneal Dose ◽  
Single Focus

A single intraperitoneal dose of methyl(acetoxymethyl)nitrosamine (13 mg/kg body weight) given to 78 5-week-old male rats induced 25 mesotheliomas; two mesotheliomas were found in 67 control rats. All mesotheliomas arose from the peritesticular mesothelium and had a typical microscopic appearance of branching papillary fronds with a collagenous core covered by one or many layers of plump tumor cells. Cytoplasm of tumor cells contained material that reacted positively to a colloidal iron stain and was labile to hyaluronidase. In addition to frank mesotheliomas, 16 lesions, which we called atypical mesothelial proliferations. were found. These consisted of a single focus of plump mesothelial cells overlying an area of thick stroma. Often these foci included short, non-branched papillary projections above the surface of adjacent normal mesothelium. Twelve of the 16 lesions occurred in methyl(acetoxymethyl)nitrosamine-treated rats.

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