Acute Toxicity of Subcutaneously Administered Vitamin E Isomers Delta- and Gamma-Tocotrienol in Mice

2014 ◽  
Vol 33 (6) ◽  
pp. 450-458 ◽  
Author(s):  
Sibyl N. Swift ◽  
Roli L. Pessu ◽  
Kushal Chakraborty ◽  
Vilmar Villa ◽  
Eric Lombardini ◽  
...  
Keyword(s):  
Vitamin E ◽  
Acute Toxicity ◽  
Injection Site ◽  
Dose Range ◽  
Skin Irritation ◽  
Experimental Period ◽  
Toxicity Study ◽  
Histopathological Analysis ◽  
Toxic Dose ◽  
Gamma Tocotrienol

The toxicity of parenterally administered vitamin E isomers, delta-tocotrienol (DT3) and gamma-tocotrienol (GT3), was evaluated in male and female CD2F1 mice. In an acute toxicity study, a single dose of DT3 or GT3 was administered subcutaneously in a dose range of 200 to 800 mg/kg. A mild to moderately severe dermatitis was observed clinically and microscopically in animals at the injection site at doses above 200 mg/kg. The severity of the reaction was reduced when the drug concentration was lowered. Neither drug produced detectable toxic effects in any other tissue at the doses tested. Based on histopathological analysis for both DT3 and GT3, and macroscopic observations of inflammation at the injection site, a dose of 300 mg/kg was selected as the lowest toxic dose in a 30-day toxicity study performed in male mice. At this dose, a mild skin irritation occurred at the injection site that recovered completely by the end of the experimental period. At a dose of 300 mg/kg of DT3 or GT3, no adverse effects were observed in any tissues or organs.

Safety Evaluation of Eucalyptus globulus Essential Oils through Acute and Sub-acute Toxicity and Skin Irritation in Mice and Rats

2020 ◽  
Vol 14 (3) ◽  
pp. 187-195
Author(s):  
Berhan Mengiste ◽  
Tizazu Zenebe ◽  
Kassahun Dires ◽  
Ermias Lulekal ◽  
Awol Mekonnen ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Essential Oil ◽  
Eucalyptus Globulus ◽  
Biochemical Parameters ◽  
Skin Irritation ◽  
Toxicity Study ◽  
Subacute Toxicity ◽  
Acute Toxicity Study ◽  
Limit Test ◽  
Ointment Formulation

Background: The Eucalyptus globulus extractions have been used by the traditional healers to treat diseases in the study area. Our previous study revealed that the essential oil has antimicrobial and antifungal activity. This study determined phytochemical analysis, skin irritation, acute and subacute toxicity of Eucalyptus globulus essential oil in mice and rats. Methods: The phytochemicals were analyzed using GC-MS mass spectrometry. The acute toxicity study was determined at three dose levels of 1500 mg/kg, 1750mg/kg, and 2000 mg/kg. The essential oil limit test at a dose of 1000 mg/kg was administered to mice for 28 consecutive days for sub-acute toxicity study. The mice mortality, behavioral change, injury and other signs of illness were recorded once daily. Biochemical parameters were evaluated. Liver and kidney were analyzed for histopathological analyses. The 5% ointment formulation was applied to the rat skin to determine skin irritation effects. Results: The Eucalyptus globulus essential oil showed no effect on the mice at a dose of 1500mg/kg and below, but caused signs of toxicity and death at a dose of 1750mg/kg and above compared to the controls (p<0.05). The LD50 value was 1650 mg/kg. There was no significant difference (p > 0.05) in the body weights, gross abnormalities of the organs and biochemical parameters compared to the control at 1000 mg/kg subacute toxicity study. No histopathological changes were detected in the organs tested. The 5% ointment formulation did not show any abnormal skin reaction. Discussion: In the present study, the Eucalyptus globulus essential oil was comparable with other studies in terms of both chemical composition and its effects on sub-acute and topical application. Conclusion: This toxicity study demonstrated that Eucalyptus globulus essential oil is nontoxic at a relatively lower concentration.

Acute and sub-chronic oral toxicities of DA.AMLODEPON HVD hard capsule in experimental animals

2021 ◽  
Vol 148 (12) ◽  
pp. 58-67
Author(s):  
Pham Thi Van Anh ◽  
Nguyen Van Dam ◽  
Nguyen Van Dat ◽  
Pham Thanh Ky ◽  
Nguyen Trong Thong ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Chronic Toxicity ◽  
The Body ◽  
Toxicity Study ◽  
World Health ◽  
Histopathological Analysis ◽  
Experimental Animals ◽  
Health Organization ◽  
General Conditions

Assessment of toxicities of DA.AMLODEPON HVD hard capsule on experimental animals. The acute toxicity of DA.AMLODEPON HVD was assessed on Swiss mice according to World Health Organization Guidance, and LD50 determination according to the method of Litchfield – Wilcoxon. The sub-chronic toxicity study of DA.AMLODEPON HVD at two doses (0.42 g/kg/day and 1.26g/kg/day) was conducted in rats for four consecutive weeks. After administration, general conditions and the body weight of rats were evaluated. Blood samples were collected for analyzing serum parameters before treatment (T0), second week (T1), and fourth week (T2). Histopathological analysis of livers and kidneys was observed at the end of the experiment. The results revealed that mice were taken up to a maximum dose of 39.15 g/kg with no symptoms of acute toxicity, LD50 of DA.AMLODEPON HVD has not been determined. The sub-chronic toxicity study at two doses did not change the body weight of rats, general conditions. The parameters for structures and functions of livers and kidneys and microscopic of the livers and kidneys are in a normal range during the study period.

scholarly journals Acute and Subchronic (28-day) Oral Toxicity Studies on the Film Formulation of k-Carrageenan and Konjac Glucomannan for Soft Capsule Application

2019 ◽  
Vol 87 (2) ◽  
pp. 9 ◽  
Author(s):  
Ni Sutrisni ◽  
Sundani Soewandhi ◽  
I Adnyana ◽  
Lucy Sasongko
Keyword(s):  
Acute Toxicity ◽  
Experimental Period ◽  
Konjac Glucomannan ◽  
Toxicity Study ◽  
Oral Toxicity ◽  
Subchronic Toxicity ◽  
Acute Toxicity Study ◽  
Relative Organ Weight ◽  
Film Formulation ◽  
Safe Dose

The aim of this study was to investigate the acute and subchronic toxicity of a film formulation that combines κ-Carrageenan and konjac glucomannan for soft capsule application. For the acute toxicity study, a dose of 2000 mg/kg body weight (bw) of the film suspension was administered orally to rats. The animals were observed for toxic symptoms and mortality daily for 14 days. In a subchronic toxicity study, the film suspension, at doses of 10, 30 and 75 mg/kg bw for 28 days, were orally administered to rats. After 28 days, the rats were sacrificed for hematological, biochemical and histological examination. In the acute toxicity study, neither signs of toxicity nor death among the rats were observed for up to 14 days of the experimental period. The results of the subchronic toxicity study show that there were no significant changes observed in the hematology and organ histology. Some alterations to the relative organ weight and blood biochemistry were observed, but they were considered to be temporary effects and not an indication of toxic effects. The overall findings of this study indicate that the film formulation of κ-Carrageenan and konjac glucomannan is non-toxic up to a dose of 75 mg/kg bw, which could be considered a safe dose for soft capsule application.

scholarly journals In Vivo Toxicity Study of Ethanolic Extracts of Evolvulus alsinoides & Centella asiatica in Swiss Albino Mice

2019 ◽  
Vol 7 (7) ◽  
pp. 1071-1076
Author(s):  
Mukesh Kumar Yadav ◽  
Santosh Kumar Singh ◽  
Manish Singh ◽  
Shashank Shekhar Mishra ◽  
Anurag Kumar Singh ◽  
...  
Keyword(s):  
Single Dose ◽  
Acute Toxicity ◽  
Centella Asiatica ◽  
Toxicity Study ◽  
Histopathological Analysis ◽  
Acute Administration ◽  
In Vivo Toxicity ◽  
Evolvulus Alsinoides ◽  
Ethanolic Extracts

AIM: We aimed to investigate several parameters after the in vivo acute and sub-acute administration of ethanolic extracts from E. alsinoides & C. asiatica. METHODS: Malignant Ovarian Germ Cell Tumors for in vivo toxicity study guidelines 423 and 407 of Organization for Economic Co-operation and Development (OECD) were followed for acute and sub-acute toxicity assays respectively. For LD50 evaluation, a single dose of ethanolic extracts of Evolvulus alsinoides L. (EEA) and ethanolic extracts of Centella asiatica (ECA) was orally administered to mice at doses of 200, 400, 800, 1600 and 2000 mg/kg. Then the animals were observed for 72 hours. For acute toxicity evaluation, a single dose of both extracts was orally administered to mice at doses of 300, 600, 1200 and 2000 mg/kg and the animals were observed for 14 days. In the sub-acute study, the extracts were orally administered to mice for 28 days at doses of 300, 600, 1200 and 2000 mg/kg. To assess the toxicological effects, animals were closely observed on general behaviour, clinical signs of toxicity, body weight, food and water intake. At the end of the study, it was performed biochemical and hematological evaluations, as well as histopathological analysis from the following organs: brain, heart, liver, and kidney. RESULTS: The oral administration of E. alsinoides and C. asiatica ethanolic extracts, i.e. EEA 300, EEA 600, EEA 1200, EEA 2000, ECA 300, ECA 600, ECA 1200 & ECA 2000 mg/kg doses showed no moral toxicity effect in LD50, acute and sub-acute toxicity parameters. CONCLUSION: In this study, we had found that E. alsinoides & C. asiatica extract at different doses cause no mortality in acute and sub-acute toxicity study. Also, histopathology of kidney, liver, heart, and brain showed no alterations in tissues morphology.

CHEMICAL COMPOSITION OF ESSENTIAL OIL AND EVALUATION OF ACUTE AND SUB-ACUTE TOXICITY OF DOREMA AMMONIACUM D. DON. OLEO-GUM-RESIN IN RATS

2017 ◽  
Vol 15 (1) ◽  
pp. 26
Author(s):  
Azade Raeesdana ◽  
Mohammad Hosein Farzaei ◽  
Mohsen Amini ◽  
Roja Rahimi
Keyword(s):  
Chemical Composition ◽  
Acute Toxicity ◽  
Essential Oil ◽  
Toxicity Study ◽  
Control Group ◽  
Histopathological Analysis ◽  
Medicinal Uses ◽  
Acute Toxicity Study ◽  
Toxicological Studies ◽  
Resin Solution

Background: Dorema Ammoniacum is a perennial herb which has been used in Persian Traditional Medicine for different indications, including gastrointestinal disorders and sciatica. Despite numerous medicinal uses, there is a lack of toxicological studies on Dorema Ammoniacum; therefore, the aim of the present study is to investigate its possible toxic effects as well as the determining chemical composition of its essential oil. Materials and Methods: Acute toxicity study was performed by administration of single increasing geometric doses of oleo-gum-resin solution (1250, 2500, and 5000 mg/kg) to Wistar rats. For sub-acute toxicity study, repeated doses of oleo-gum-resin solution (100, 200 and 500 mg/kg) were administered orally to rats for 4 weeks. At the end of the treatment, histopathological studies, hematological assessments, and biochemical parameters were performed. Results: GC-MS was performed to determine the chemical composition of the essential oil. Acute toxicity results demonstrated no mortality, and the Median Lethal Dose (LD50) was greater than 5000 mg/kg. Sub-acute treatment did not show any significant changes in biochemical and hematological parameters at any doses compared to the control group. Histopathological analysis of the organs revealed varying effects. At the level of the liver, vacuolar degeneration and mild inflammation at 200 and 500 mg/kg doses were observed. At the level of kidney, congestion of glomeruli and a widening of the urinary space at 500mg/kg were observed compared to the control group. The principle components of the essential oil were Cuperene (14.31%) and β-Funebrene (12.74%). Conclusion: The results suggest that the acute administration of the oleo-gum-resin of D. Ammoniacum is not accompanied with signs of toxicity; however, its administration over the long term might associate with renal toxicity and hepatotoxicity.

Diligent profiling of preclinical safety of the silk protein sericin

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Farogh Ahsan ◽  
Tarique Mahmood ◽  
Mohammed Haris Siddiqui ◽  
Shazia Usmani ◽  
Paramdeep Bagga ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Silk Protein ◽  
Toxicity Study ◽  
Histopathological Analysis ◽  
Toxicological Effects ◽  
Acute Toxicity Study ◽  
Significant Difference ◽  
Adverse Effect Level ◽  
Effect Level ◽  
Water Administration

AbstractBackgroundSericin is a widely used protein in the pharmaceutical industry derived from the silkworm, Bombyx mori, and used for the treatment of various diseases and pathological conditions. It is the main ingredient of the Unani preparation khameera abresham. The study was conducted to evaluate the preclinical toxicity of the silk protein sericin in mice.MethodsIn the acute toxicity study, sericin was administered once orally to different groups of animals at doses of 500, 1000, and 2000 mg/kg. Animals were observed for 14 days. In the sub-acute toxicity study, sericin was administered in mice for 4 weeks in the toxic group at doses of 500, 1000, and 2000 mg/kg, while in the recovery group it was administered for 4 weeks at doses of 500 and 2000 mg/kg followed by 2 weeks of distilled water administration.ResultsIn the acute toxicity study, the observed parameters showed no significant difference, and no mortality was reported. In the sub-acute toxicity study, there were no toxicological effects in any of the estimated parameters, while histopathological analysis showed inflammation in vital organs at the dose of 2000 mg/kg.ConclusionsResults of our acute toxicity study suggest that sericin is safe at all administered doses, while the sub-acute study suggests that the NOAEL (no-observed-adverse-effect level) of sericin is below 2000 mg/kg, at which it can be considered safe.

PHARMACOGNOSTIC, ANTIOXIDANT AND ACUTE TOXICITY STUDY OF Ficus sycomorus (Linn) (Moraceae) ROOT AND STEM BARK

2020 ◽  
Vol 4 (2) ◽  
pp. 605-614
Author(s):  
Murtala M. Namadina ◽  
H. Haruna ◽  
U. Sanusi
Keyword(s):  
Acute Toxicity ◽  
Radical Scavenging ◽  
Stem Bark ◽  
The Body ◽  
Toxicity Study ◽  
Bark Extract ◽  
Root Extract ◽  
Acute Toxicity Study ◽  
Radical Scavenging Ability ◽  
Phytochemical Components

Most of biochemical reactions in the body generates Reactive Oxygen Species (ROS), which are involved in the pathogenesis of oxidative stress-related disorders like diabetes, nephrotoxicity, cancer, cardiovascular disorders, inflammation and neurological disorders when they attack biochemical molecules like proteins, lipids and nucleic acid. Antioxidants are used to protect the cells or tissues against potential attack by ROS. Most medicinal plants possess a rich source of antioxidants such as flavonoids, phenols, tannins, alkaloids among others. These phytochemicals are currently pursued as an alternative and complimentary drug. In this study, phytochemical components, antioxidant and acute toxicity study of the methanol extract of stem bark and root of F. sycomorus were carried out using standard methods. Findings from this study revealed the presence of some diagnostic microscopical features such as calcium oxalate, starch, gum/mucilage, lignin, Aleurone grain, suberized/Cuticular cell wall and inulin but calcium carbonate was absent in stem bark but present in the powdered root. Quantitative physical constants include moisture contents (6.40% and 7.82%), ash value (7.20% and 9.30 %) in stem bark and root respectively. Carbohydrates, alkaloid, flavonoids, saponins, tannins, glycoside, steroid, triterpenes and phenols were present in all the extracts. They were found to exhibit potent 1,1,-diphenyl 2-picryl hydrazyl (DPPH) free scavenging activity. The DPPH radical scavenging ability of the extracts showed the following trend Ascorbic acid < stem bark extract˃ root extract. The LD50 of the methanolic stem bark and root extracts were found to be greater than 5000 mg /kg and is considered safe for use. Nonetheless, further

In-vitro and in-vivo evaluation of antidiabetic activity of Withania coagulans extract

2019 ◽  
Vol 09 ◽  
Author(s):  
Tejas Patel ◽  
B.N. Suhagia
Keyword(s):  
Blood Glucose ◽  
Acute Toxicity ◽  
Aqueous Extract ◽  
Pancreatic Beta Cell ◽  
Toxicity Study ◽  
Acute Toxicity Study ◽  
Withania Coagulans ◽  
Study Results

Background: Diabetes mellitus is major issue to public health as its prevalence is rising day by day. Synthetic agents available for the diabetic treatment are expensive or produce undesirable side effect on chronic use and some of them are not suitable during pregnancy. Herbal medicines accepted widely due to side effects and low cost. Objective: The aim of present study was to evaluate the activity of Withania coagulans extract using In-vitro and In-vivo model. Methods: Different three types of Withania coagulans extract were prepared using aqueous (W1), Alcohol (W2) and hydro-alcoholic (50:50) mixture (W3). In-vitro Anti-diabetic activity of the all three extracts evaluated using RINm5F Pancreatic beta cells.Further, n-vivo anti-diabetic evaluation performed by administering 50 mg/kg (p.o) aqueous extract for 7 days in Streptozotocin (STZ)-induced mice. Body weight of the animals was also determined to perform acute toxicity study. Results: The results of in –vitro cell based study indicated that among all three extract, aqueous extract (W1) of Withania coagulans showed potential increase in inulin release. The EC50 of the W1 (249.6 µg/L) which is compared with standard (Glibenclamide) EC50. From the results of In-vitro study, W1 subjected for acute toxicity study and the acute toxicity study results indicated LD50 of 50mg/kg. Diabetic rats treated with W1 extract at oral dose of 50 mg/kg for 7 days showed 34.17% reduction in blood glucose in comparison to untreated diabetic (STZ-induced) rats. Blood glucose levels of Standard treated (Glibenclamide) and control untreated. Conclusion: In conclusion, results of pancreatic beta cell based study showed increase in insulin release by administration of extract. Further aqueous extract (W1) was potentially reduced blood glucose level in STZ induced diabetic mice.

Acute and subacute toxicity assessment of Madhulai Manappagu (Siddha herbal syrup formulation) in animal model

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Meenakshi Sundaram Malayappan ◽  
Gayathri Natarajan ◽  
Logamanian Mockaiyathevar ◽  
Meenakumari Ramasamy
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Oral Route ◽  
Toxicity Assessment ◽  
Toxicity Study ◽  
Female Rats ◽  
Albino Rats ◽  
Oral Toxicity ◽  
Gross Pathology ◽  
Toxicity Studies

Abstract Objectives Madhulai Manappagu – a well-known sastric and widely prescribed Siddha herbal syrup formulation indicated for treating Veluppu Noi (Anaemia especially Iron deficiency Anaemia) has been in day today practice in Tamil Nadu for a quite longer decades. The syrup is a herbal preparation which has a sweet pleasant odour and a palatable taste, contain the juice of pomegranate (Punica granatum L.) as the main ingredient. Though the formulation is a fruit juice, the safety profile of the syrup is not established and is being marketed without toxicological evaluation. The study is aimed at ascertaining the acute and sub-acute toxicity assessment of Madhulai Manappagu in Wistar Albino rats. Methods The acute and sub-acute (28day repeated oral) toxicity studies were performed as per the guidelines mentioned in the Organization for Economic Cooperation and Development (OECD) 423 (adopted on December 2001) and TG 407 (adopted on October 2008) with slight modifications respectively. For acute toxicity study, three female rats were randomly selected as control; three female rats were randomly selected and were administered a single dose of 5,000 mg/kg body weight per oral route. For sub-acute (28day repeated oral) toxicity studies, three doses of test drug MM of 500 mg/kg/day (low dose), 750 mg/kg/day (intermittent dose) and 1,000 mg/kg/day (high dose) were selected for administration. Both sexes of Wistar Albino rats were randomized into four groups of 10 animals each (five males, five females). Group I was kept as control group. Group II, III and IV served as low, intermittent and high doses of MM respectively. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed. Results In the acute toxicity study, rats showed no toxicological signs on behavior, gross pathology and body weight of rats when treated with a single dose of 5,000 mg/kg body weight per oral route. In the subacute (28 days repeated oral) toxicity study, rats have showed no significant changes on behavior, gross pathology, body weight, and hematological and biochemical parameters when treated with Madhulai Manappagu in three different doses. Conclusions The toxicity studies which include both acute and 28 days repeated (subacute) oral toxicity studies, revealed no observed adverse effect level (NOAEL) of Madhulai Manappagu in animals. Thus the safety of the drug in human usage was ensured.

scholarly journals EVALUATION OF ACUTE TOXICITY STUDY AND DIURETIC ACTIVITY OF URAL SYRUP

2013 ◽  
Vol 4 (4) ◽  
pp. 522-525
Author(s):  
Tejas Thakkar ◽  
Rakesh Patel ◽  
Hardik Soni ◽  
Ghanshyam Patel
Keyword(s):  
Acute Toxicity ◽  
Toxicity Study ◽  
Diuretic Activity ◽  
Acute Toxicity Study
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