scholarly journals ACUTE AND SUB CHRONIC TOXICITY STUDIES OF PURIFIED WITHANIA SOMNIFERA EXTRACT IN RATS

2018 ◽  
Vol 10 (12) ◽  
pp. 41 ◽  
Author(s):  
Benny Antony ◽  
Merina Benny ◽  
Binu T. Kuruvilla ◽  
Nishant Kumar Gupta ◽  
Anu Sebastian ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Dose Level ◽  
Chronic Toxicity ◽  
Withania Somnifera ◽  
Clinical Signs ◽  
Repeated Administration ◽  
Female Rats ◽  
Toxic Effects ◽  
Toxicity Studies ◽  
Adverse Effect Level

Objective: The objective of the present study was to evaluate the acute and sub-chronic (90 d; repeated dose) toxicity of Withania somnifera (ashwagandha) extract in rats.Methods: The acute toxicity was evaluated as per OECD (Organisation for Economic Co-operation and Development) guidelines 423. Purified ashwagandha extract (PAE) was fed at 2000 mg/kg body weight (bw) to overnight fasted female rats. The animals were observed daily for clinical signs of abnormality/mortality. After 14 d, animals were sacrificed and gross pathological changes were recorded. Sub-chronic toxicity of PAE was studied by feeding the extract at 100, 500 and 1000 mg/kg bw daily to rats as per OECD guidelines 408. After 90 d feeding, heamatological and biochemical parameters of treated rats were compared with control animals. Histopathology of all the major organs was also studied.Results: In the acute toxicity study, no mortality or clinical signs of toxicity were observed in any of the animals at maximum recommended dose level of 2000 mg/kg bw; therefore the LD50 is>2000 mg/kg bw in rats. The repeated administration of PAE for 90 d in rats at the maximum dose level of 1000 mg/kg bw did not induce any observable toxic effects, when compared to its corresponding control animals. The hematology and biochemistry profile of treated rats was similar to control animals and difference was non-significant (p>0.05). The histopathology of major organs of all the control and treated animals was normal. In this study the NOAEL (No Observed Adverse Effect Level) was calculated as 1000 mg/kg bw daily for rats.Conclusion: The present study clearly indicates that PAE does not have any toxic effects in animals at the dose evaluated as evidenced by acute and sub chronic toxicity studies in rats.

scholarly journals Toxic Effects of Cannabis and Cannabinoids: Animal Data

2005 ◽  
Vol 10 (suppl a) ◽  
pp. 23A-26A ◽  
Author(s):  
Pierre Beaulieu
Keyword(s):  
Acute Toxicity ◽  
Present Article ◽  
Chronic Toxicity ◽  
Toxic Effects ◽  
Acute Administration ◽  
Toxicity Data ◽  
Toxicity Studies ◽  
Animal Data ◽  
Animal Toxicity

The present article reviews the main toxic effects of cannabis and cannabinoids in animals. Toxic effects can be separated into acute and chronic classifications. Acute toxicity studies show that it is virtually impossible to die from acute administration of marijuana or tetrahydrocannabinol, the main psychoactive component of cannabis. Chronic toxicity involves lesions of airway and lung tissues, as well as problems of neurotoxicity, tolerance and dependence, and dysregulations in the immune and hormonal systems. Animal toxicity data, however, are difficult to extrapolate to humans.

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 Acute toxicity assessment for TiO2 photocatalyst (GST) made from wastewater using TiCl4 in rat

2021 ◽  
Vol 36 (3) ◽  
pp. e2021019
Author(s):  
Ja Kyung Seol ◽  
Myeongkyu Park ◽  
Jae Min Im ◽  
Heung Sik Seo ◽  
Hee Ju Park ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
High Efficiency ◽  
Lethal Dose ◽  
Clinical Signs ◽  
Body Weight Loss ◽  
Toxicity Assessment ◽  
Female Rats ◽  
Sprague Dawley ◽  
Weight Changes

TiO2 was a photocatalyst that used to the most common product because of the high efficiency. TiO2 (P-25, commercial nanomaterial product) is the most typical photocatalyst product and TiO2 (GST) was a sludge recycling product. This study was reported to evaluate an acute toxicity of TiO2 (P-25 and GST) according to OECD test guideline 402 and 423 in Sprague-Dawley (SD) female rats via route of oral and dermal. There was investigated the lethal dose (LD50), and mortality, clinical signs, body weight changes and gross findings were continually monitored for 14 days following the single administration. After administration, TiO2 (P-25) was calculated that LD50 was considered to be a dose of over 2000 mg/kg body weight for both different route of exposure, and TiO2 (GST) was the same. Other items were no observed an adverse effect between P-25 and GST; no mortality and clinical signs, accidental body weight loss, no gross findings. On the basis of the above results, the toxicity of the GST was almost equal to that of the commercial product, P-25 and there was no toxicological evidence.

scholarly journals Clinical and Morphological Aspects in Assessing the Safety of OSPL-502 with Repeated Dose Administration

2018 ◽  
Vol 6 (9) ◽  
pp. 1581-1587
Author(s):  
Sergey A. Zhuchkov ◽  
Alexandr S. Kinzirsky ◽  
Irina V. Koroleva ◽  
Yuriy B. Vicharev
Keyword(s):  
Toxic Effect ◽  
Adrenal Glands ◽  
Clinical Signs ◽  
Clinical Manifestations ◽  
Repeated Administration ◽  
Test Substance ◽  
Sprague Dawley ◽  
Adverse Effect Level ◽  
Pharmacological Substance ◽  
Effect Level

BACKGROUND: OSPL-502 is a new potential medicinal drug which stimulates a cognitive function. It is necessary to reveal clinical manifestations of its general toxic effect and determine organs that are most heavily affected by this pharmacological substance. AIMS: To describe and estimate clinical and histopathological changes in the organism of experimental animals in response to the repeated administration of pharmacological substance OSPL-502. MATERIAL AND METHODS: The study was conducted by the OECD Guidelines (Test No. 407) on Sprague-Dawley rats. The drug was administered at the dose of 20, 60 and 180 mg/kg. RESULTS: The repeated doses of OSPL-502 have not caused any toxic effects on the growth of body weight, food and water consumption of the tested animals, or affected the musculoskeletal system and exploratory behaviour of the rats in the doses of 20 and 60 mg/kg. The dose of 180 mg/kg (1800 times larger than the therapeutic dose) has shown clinical signs of toxicity in females but has not resulted in the death of the animals. Due to morphological methods, we have found histostructural changes in the liver, kidneys and adrenal glands of the rats that were treated with the test substance in the maximum dose. These changes are reversible and reduce within 14 days after the admission of the studied substances is cancelled. CONCLUSION: OSPL-502 at the dose of 180 mg/kg has a weakly pronounced toxic effect, the dose of 60 mg/kg is the threshold, and that of 20 mg/kg is no-observable-adverse-effect-level (NOAEL); the liver, kidneys and adrenal glands can be considered target-organs for the tested substance.

scholarly journals Acute and 30-day oral toxicity studies of a novel coccidiostat – ethanamizuril

2019 ◽  
Vol 8 (5) ◽  
pp. 686-695 ◽  
Author(s):  
Wenlong Xiao ◽  
Xiaoyang Wang ◽  
Chunmei Wang ◽  
Mi Wang ◽  
Chenzhong Fei ◽  
...  
Keyword(s):  
Clinical Signs ◽  
Female Rats ◽  
Male Rats ◽  
Wall Thickening ◽  
High Dose ◽  
Alveolar Wall ◽  
Oral Toxicity ◽  
Male And Female Rats ◽  
Adverse Effect Level ◽  
Ld50 Value

Abstract Ethanamizuril is a novel triazine compound that exhibits remarkable anticoccidial activity. Owing to its pharmacological properties, this study was conducted to evaluate the acute and 30-day oral toxicity of ethanamizuril. In the acute study, ethanamizuril was administered once by oral gavage to mice and rats. The calculated LD50 values for mice and rats were 5776 and 4743 mg per kg b.w, respectively, but the LD50 value for male rats was higher than that of female rats. In the subchronic study, male and female rats were fed with diets supplemented with 0, 20, 60 or 120 mg kg−1 ethanamizuril for 30 days. Treatment related clinical signs of alopecia on the back and neck of the animals were observed in the 60 and 120 mg kg−1 dose groups from the third week of treatment. Significant differences in haematological and biochemical parameters as well as organ-to-body weight ratios were detected between the 60 and 120 mg kg−1 groups. Histopathological observations revealed that 60 and 120 mg kg−1 ethanamizuril could induce focal hepatocellular necrosis and split phase. Slight renal tubule protein casts in the kidneys and alveolar wall thickening in the lungs were also observed in the high dose groups of both genders. The dietary no-observed-adverse-effect level (NOAEL) of ethanamizuril for 30 days was 20 mg kg−1 feed.

Evaluation of genotoxicity and subchronic toxicity of standardized rose hip extract

2017 ◽  
Vol 37 (7) ◽  
pp. 725-741 ◽  
Author(s):  
A Nagatomo ◽  
M Oguri ◽  
N Nishida ◽  
M Ogawa ◽  
A Ichikawa ◽  
...  
Keyword(s):  
Oral Dose ◽  
Chinese Hamster ◽  
Gene Mutations ◽  
Ethanol Extract ◽  
Female Rats ◽  
Toxicity Studies ◽  
Male And Female Rats ◽  
Adverse Effect Level ◽  
Effect Level ◽  
Rose Hip

Rose hip is the fruit of the rose plant, which is widely used in food, cosmetics and as a traditional medicine. Therefore, rose hip is considered safe and has a sufficient history of consumption as food. However, few studies have reported on the safety of rose hip extracts in toxicological analyses. Thus, to evaluate the safety of rosehip polyphenol MJ (RHPMJ), an aqueous ethanol extract standardized with the trans-tiliroside content, we performed genotoxicity and 90-day repeated oral dose toxicity studies in compliance with the Organisation for Economic Co-operation and Development-Good Laboratory Practice. RHPMJ did not induce gene mutations in reverse mutation tests of Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA strains and did not induce chromosomal aberrations in cultured Chinese hamster lung (CHL/IU) cells. Moreover, micronucleus tests using rat bone marrow showed RHPMJ had no micronucleus-inducing potential. Finally, 90-day repeated oral dose toxicity studies (100–1000 mg/kg) in male and female rats showed no treatment-related toxicity in rats. These data indicate that the RHPMJ had no genotoxicity and a no-observed-adverse-effect level greater than 1000 mg/kg in rats.

Comparative Evaluation of the Acute Toxic Effects in Monkeys, Pigs and Mice of a Genetically Engineered Salmonella Strain (VNP20009) Being Developed as an Antitumor Agent

2000 ◽  
Vol 19 (1) ◽  
pp. 19-25 ◽  
Author(s):  
King C. Lee ◽  
Li-Mou Zheng ◽  
Xiang Luo ◽  
Caroline Clairmont ◽  
Jessica Fischer ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Comparative Evaluation ◽  
Clinical Signs ◽  
Clinical Pathology ◽  
Genetically Engineered ◽  
The Body ◽  
Toxic Effects ◽  
Weight Increase ◽  
High Dose ◽  
Physical Damage

The objective of these studies was to perform a comparative evaluation of the acute toxicity of VNP20009, a genetically engineered Salmonella strain, in monkeys, pigs, and mice. It is hypothesized that mice would be more susceptible than other animal species to the toxic effects of VNP20009, because mice are the most sensitive natural host for the parental wild-type Salmonella typhimurium strain. These studies also compared the virulence of VNP20009 and the parental Salmonella in mice. In Cynomolgus monkeys and Yorkshire pigs ( n = 2/dose), various doses (expressed as colony forming units [cfu] per animal) of VNP20009, or vehicle, were administered as a single IV injection (∼ 1 ml/min). The body weight, body temperature, clinical signs, clinical pathology (serum chemistry and hematology), and ophthalmic examinations (only in monkeys) were evaluated at various times. Necropsy was performed on day 15 in the pigs, and necropsy and histopathology on days 8 or 15 in the monkeys. In C57BL/6 mice ( n = 10/dose), various doses of VNP20009, or the parental Salmonella, were administered as a single IV bolus injection. The mice were observed daily over 3 weeks. The results from monkeys showed that VNP20009-related changes in clinical pathology were primarily confined to fiver enzymes and fiver function tests (i.e., cholesterol, triglyceride, alanine aminotransferase, and aspartate aminotransferase levels). Significant toxicological changes occurred only at the dose of 1 × 1010 cfu/monkey, but not at the doses of 1 × 108 or 3 × 109 cfu/monkey. Gross necropsy and histology findings were primarily confined to the spleen (enlargement, weight increase, and reticuloendothelial hyperplasia), thymus (size and weight reduction and lymphoid depletion), mesenteric lymph node (enlargement), and lung (weight increase). Most of these necropsy and microscopic findings, which occurred mostly in the high-dose group, may be related to the physiological responses to infection, rather than related to the intrinsic toxicity of VNP20009. The results from pigs showed that VNP20009 induced toxicological effects only at the dose of 3 × 109 cfu/pig, but not at the doses of 3 × 108 or 3 × 1010 cfu/pig. Both pigs treated with 3 × 1010 cfu/pig died within the first 2 days post-treatment. Necropsy showed the presence of abdominal transudate fluid, skin blotching, and pulmonary-and gall bladder-associated edema. Therefore, the pig mortality may have been related to the physical damage induced by the sudden systemic presence of large amounts of suspension. The results from mice showed that VNP20009, at doses as high as 1 × 106 cfu/mouse, did not induce any mortality. A 30% mortality rate was induced by 3 × 106 cfu/mouse, and 100% mortality by 1 × 107 cfu/mouse. The parental Salmonella, at a dose of 1 × 102 or 3 × 102 cfu/mouse, induced a 100% mortality. In conclusion, the doses of VNP20009 that induced acute toxicity are very high, suggesting that VNP20009 may be a safe agent. The virulence is 50,000 × less in VNP20009 than the parental Salmonella.

Safety assessment studies of probiotic Saccharomyces boulardii strain Unique 28 in Sprague-Dawley rats

2011 ◽  
Vol 2 (3) ◽  
pp. 221-227 ◽  
Author(s):  
M. Ratna Sudha
Keyword(s):  
Acute Toxicity ◽  
Safety Assessment ◽  
Clinical Symptoms ◽  
Saccharomyces Boulardii ◽  
Female Rats ◽  
Toxicity Tests ◽  
Human Consumption ◽  
Sprague Dawley ◽  
Toxicity Studies ◽  
Probiotic Yeast

Strains of Saccharomyces boulardii, a probiotic yeast, have been found to be effective in the treatment of diarrhoea, inflammatory bowel disease, irritable bowel syndrome and other conditions. In the present study, Unique 28, a strain of S. boulardii isolated and characterised in our laboratory, was evaluated for its safety assessment. Acute and subacute toxicity tests were performed in rats. The dose of Unique 28 (5×109 cfu/g) fed orally was, up to 6,500 mg per kg of b.w. (body weight) for acute toxicity and up to 1,300 mg per kg of b.w. for sub-acute toxicity studies. This dose was well tolerated and there was no morbidity or any kind of toxic clinical symptoms displayed either in male or female rats. Moreover, the results of sub-acute toxicity studies using Unique 28 administered for 14 weeks indicated that there were no clear unwanted treatment related effects. Overall results of this toxicology assessment indicate that Unique 28 is safe for human consumption.

scholarly journals Acute and Subacute Toxicity Assessment of Ethyl Acetate Extracts from Aerial Parts of Clerodendrum thomsoniae Balf.f in Rodents

2021 ◽  
Vol 11 (6) ◽  
pp. 13952-13961
Keyword(s):  
Acute Toxicity ◽  
Ethyl Acetate ◽  
Human Subjects ◽  
Female Rats ◽  
Laboratory Animals ◽  
Oral Toxicity ◽  
Subacute Toxicity ◽  
Toxicity Studies ◽  
Male And Female Rats

Clerodendrum is a genus of about 500 species belongs to the family Lamiaceae. Several species of this genus have been proved for the treatment of various diseases. Clerodendrum thomsoniae Balf.f were selected in this study; according to the literature available, there is no systematic toxicity studies for this plant were described. The current study was therefore carried out to evaluate the acute and sub-acute toxicity in mice and rats. The acute oral toxicity study was performed in mice following OECD guidelines 425, and the sub-acute toxicity was performed in male and female rats following OECD guidelines 407. The results showed that mice given a single dose of up to 2000 mg/kg orally did not show any toxicity signs or mortality. In the sub-acute toxicity analysis in rats, 3 specific daily doses of 150, 300, and 600 mg/kg for 28 days did not induce any major changes to the hematological and biochemical parameters. Histopathological studies revealed normal architecture that did not indicate any morphological disturbances. In our study, no deaths or any signs of toxicity were found in acute and subacute toxicity studies after oral administration according to OECD guidelines, which concluded that ethyl acetate extract of Clerodendrum thomsoniae Balf (EACT) could use for in vivo biological activity studies in laboratory animals to explore its various medicinal activity before study in human subjects.

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