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

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.

2020 ◽  
Vol 8 (1) ◽  
pp. 1 ◽  
Author(s):  
Nikolay Yakovlevich Golovenko ◽  
Valentina Nikolayevna Kovalenko ◽  
Vitalii Borisovich Larionov ◽  
Аnatoliy Semenovich Reder

Propoxazepam, 7-bromo-5 - (o-chlorophenyl)-3-propoxy - 1,2-dihydro - 3H-1,4-benzodiazepin-2-one, in the models of nociceptive and neuropathic pain showed significant analgesic activity. In order to explore clinical potential of propoxazepam for long term human consumption, toxicology testing in laboratory animals using well-accepted international guidelines is required. Acute toxicity tests were conducted by the oral administration of 2500; 3500; 4000; 4500 and 5000 mg/kg body weight to male and female mice and rats for a period of 3, 7 and 14 day. In subacute study, male rats were administered with various doses of propoxazepam (0.9, 4.5, and 9.0 mg/kg) to evaluate its toxicity for a period of 90 days. The effect of propoxazepam on body weight gain and organ weights, food and water consumptions were analyzed. From the present study, it can be concluded that the acute (3, 7 and 14 days) and subchronic (90 days) oral administrations of propoxazepam did not produce any clinical signs of toxicity or mortality of the male and female mice and rats. These results revealed that the LD50 of propoxazepam is greater than 5000 mg/kg and it therefore, belongs to the category V of relatively non-toxic substances according to the GHS. In the acute toxicity study, neither mortality no significant change in the body weight and the relative organ weights were recorded in all treated mice and rats. Present data set revealed that there wasn`t a strong correlation between body weight with food and water consumptions. The result indicates that the oral administration of propoxazepam did not produce any significant toxic effect in mice and rats and the substance can be safely used for therapeutic use in pharmaceutical formulations.  


2020 ◽  
Vol 99 (11) ◽  
pp. 1276-1279
Author(s):  
Valery N. Rakitskii ◽  
Tatiana M. Epishina ◽  
Elena G. Chkhvirkiya

Introduction. Historically, pesticides are evaluated more strictly from a medical point of view than other chemicals. Since their features, such as deliberate introduction into the environment, the possibility of contact with them by large masses of the population, and the high biological activity determine their potential danger to humans. Purpose of research - study of the biological effect of a technical product derived from triazoles when it is repeatedly ingested orally in mammals (rats), establishment of inactive and active doses, justification of the permissible daily dose (DSD) for humans. Material and methods. In acute experiments, white rats were used, including 6 animals in the group. Tested dose: 500-4000 mg/kg of body weight. A chronic (12 months) experiment was performed on 80 male rats with a bodyweight of 180-190 g at the beginning of the study. Tested doses: 5.0; 16.0 and 55.0 mg/kg of body weight (1 control and 3 experimental animals, 20 individuals each). In the dynamics of the experiment, we observed the condition and behavior of animals, water, and food consumption, recorded the timing of death, changes in body weight, physiological, biochemical, and hematological indices. Results. Indices of the acute oral toxicity on the studied product LD50 male rats were 2250 ± 483 mg/kg body weight. The dose of 5.0 mg / kg of body weight was not found to cause significant changes in all studied indices. The doses of 16.0 and 55.0 mg/kg of body weight had a polytropic effect on the body in experimental animals. Discussion. The studied product for the acute oral toxicity refers to low-hazard compounds, the doses of 16.0 and 55.0 mg/kg of body weight has a polytropic effect on the mammalian body, causing changes in carbohydrate, lipid, and lipoprotein metabolism in the body of rats - was accepted as acting. The dose of 5.0 mg / kg of body weight, when administered in rats, there are no changes in all the studied parameters throughout the experiment, is accepted as invalid. Based on the inactive dose-5.0 mg/kg of body weight and taking into account the reserve factor of 100, we have scientifically justified DSD for a person at the level of 0.05 mg/kg. Summary. The conducted sanitary and Toxicological studies indicate the need to assess the toxicity of new technical products to the mammalian body, to increase the reliability of the developed hygiene standards in environmental objects and food products.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 684-684
Author(s):  
Maria Amelita Estacio ◽  
Liezl Atienza ◽  
Roxanne Gapasin ◽  
Jonna Rose Maniwang ◽  
James Ryan Aranzado ◽  
...  

Abstract Objectives “Bignay” (Antidesma bunius), “lipote” (Syzygium polycephaloides) and “duhat” (Syzgium cumini) are indigenous berries in the Philippines that are known to contain high antioxidant properties and other health-promoting and disease-preventing compounds. However, oral toxicity studies on these berries are not yet explored. Hence, this study evaluated the acute oral toxicity of these berries in freeze-dried forms using 6-week old ICR mice following the OECD guidelines 425 (up and down method). Methods Treatment groups were administered with freeze-dried powders of “bignay”, “lipote” and “duhat” reconstituted in distilled water at various doses: 55 mg/kg body weight (BW), 175 mg/kg BW, 550 mg/kg BW, 2000 mg/kg BW and 5000 mg/kg BW while control group was administered with distilled water. Body weight, feed and water intake were obtained daily. Biochemical profiles were measured prior to administration of reconstituted berries at day 1 and prior to euthanasia. Toxicity, morbidity and mortality cases were observed daily. Euthanasia and necropsy were performed to check for gross organ abnormalities. Results Mice that received the different concentrations of “bignay”, “lipote” and “duhat” had normal feed and water consumption and gained weight during the test period. No clinical and behavioral signs of toxicity were observed and there was zero morbidity and mortality. Post-mortem evaluation showed no lesions on various organs examined. Blood ALT, BUN and creatinine levels were within normal published values. Conclusions These results show that different concentrations of freeze-dried “bignay”, “lipote” and “duhat” are non-toxic using ICR mice and therefore have high potential to be developed into food supplements and nutraceuticals. Funding Sources Philippine Council for Health Research and Development - Department of Food Science and Technology Enhanced Creative Work and Research Grant - Office of Vice Chancellor for Academic Affairs, University of the Philippines.


2020 ◽  
Vol 2020 ◽  
pp. 1-15
Author(s):  
Sundararaju Dodda ◽  
Venkata Krishnaraju Alluri ◽  
Trimurtulu Golakoti ◽  
Krishanu Sengupta

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.


2021 ◽  
Vol 10 (5) ◽  
pp. 282-285
Author(s):  
Sunil Hajare ◽  
◽  
Ranjit Suresh Ingole ◽  
Maheshkumar Vitthal Ingawale ◽  
Vivek Borekar ◽  
...  

Maintaining optimum digestive functions is crucial for achieving health and profitability in livestock enterprises. However, the efficiency of these functions is upset by common problems such as indigestion, anorexia, flatulence, ruminal stasis and impaction. Pachoplus™ (M/s Ayurvet Limited, India) is a polyherbal rumenotoric, carminative and stomachic that helps to achieve and restore optimum digestive functions in livestock. A study was undertaken to evaluate the potential of Pachoplus™ to elicit acute oral toxicity as per OECD 423 guidelines. Nine non-pregnant, nulliparous, adult female Swiss albino mice were used for the study. The animals were observed for the manifestation of toxic effects and mortality after the oral administration of the test substance. Toxicity was evaluated on the basis of changes in body weight, overt signs of toxicity, gross and histological appearances of vital organs, and blood biochemistry. Pachoplus™ was found safe for oral use as no toxic effects or mortalities were observed till day 14


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Sae-Rom Yoo ◽  
Hyekyung Ha ◽  
Mee-Young Lee ◽  
Hyeun-Kyoo Shin ◽  
Su-Cheol Han ◽  
...  

Traditional herbal medicines have been used for centuries in Asian countries. However, recent studies have led to increasing concerns about the safety and toxicity of herbal prescriptions. Bojungikgi-tang (BJIGT), a herbal decoction, has been used in Korea to improve physical strength. To establish the safety information, BJIGT water extract was evaluated in a 4-week repeated-dose oral toxicity test in Crl:CD Sprague Dawley rats. BJIGT was orally administered in daily doses of 0, 500, 1000, and 2000 mg/kg/day for 4 weeks via oral gavage in male and female rats. We examined the mortality, clinical signs, body weight change, food intake, organ weights, hematology, serum biochemistry, and urinalysis parameters. No significant changes were observed in mortality, clinical sings, body weight, food intake, organ weights, hematology, serum biochemistry, and urinalysis parameters between the control group and the BJIGT-treated groups in the rats of both sexes. The results indicate that BJIGT did not induce toxic effects at a dose level up to 2000 mg/kg in rats. Thus, this concentration is considered the nonobservable effect dose in rats and is appropriate for a 13-week subchronic toxicity study.


2005 ◽  
Vol 24 (4_suppl) ◽  
pp. 41-59 ◽  
Author(s):  
Seiichi Mizuno ◽  
John H. Mennear ◽  
Keiichi Matsuura ◽  
Bruce K. Bernard

The objective of this multiple-dose toxicity study was to assess the toxicological potential of two tripeptides, L-valyl-L-prolyl-L-proline (VPP) and L-isoleucyl-L-prolyl-L-proline (IPP), when administered once daily for 91 consecutive days to rats. The test article, powdered casein hydrolysate (CH) known to contain 0.6% VPP plus IPP, was prepared using Aspergillus oryzae protease. Prior to administration to the rats by oral gavage, the test article was suspended in sterile water. Groups of 12 male and 12 female Charles River rats were administered once daily doses of 0, 40, 200, or 1000 mg of CH (0, 0.2,1.2, or 6 mg VPP plus IPP/kg body weight [BW]). Antemortem evaluative parameters included gross observations of behavior and clinical signs; food consumption and body weight gains; ophthalmologic examinations; clinical pathology (hematology, clinical chemistry); and urinalysis. Postmortem parameters included determination of absolute and relative (to fasting body weight) organ weights and histopathological evaluation of approximately 50 organs and tissues from each animal. All rats survived until the scheduled termination of the study and no treatment-related clinical signs were observed. Food consumption was unaffected by administration of CH. All animals gained weight and there were no statistical differences between groups with respect to weight gains. There were no meaningful changes in hematological or coagulation parameters. Mid- and high-dose males (but not females) had slightly (<2%) increased mean serum chloride concentrations, but because the difference was so small and it was observed in only one sex, the authors considered its association with CH administration to be doubtful. Urinalysis revealed the occasional presence of crystals, leukocytes, and epithelial cells in animals from all experimental groups. Similarly, ophthalmic changes (lenticular clouding) were observed in both control and dosed animals. Mean relative (to body weight) kidney weight was decreased by 8 % in low-dose males and mean relative uterus weight was elevated 46 % in low-dose females. Absolute organ weights were not affected. Only naturally occurring microscopic changes were observed in all groups and none could be attributed to CH administration. It was concluded that, under the conditions of these experiments, the maximally tolerated dose (MTD) and the no-observable-effect level (NOEL) for powdered CH administered once daily for 13 weeks was greater than 1000 mg/kg BW/day or greater than 6 mg of VPP plus IPP/kg BW/day. There was no evidence of target organ toxicity associated with administration of the tripeptides. This corresponds to an margin of safety (MOS) of 60 based upon current thinking regarding incorporation in food.


2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Chia Ju Chang ◽  
Thing-Fong Tzeng ◽  
Shorong-Shii Liou ◽  
Yuan-Shiun Chang ◽  
I-Min Liu

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.


Author(s):  
MANOHAR REDDY ◽  
RAJA SUNDARARAJAN

Objective: The fundamental reason for this examination was to look at the acute and subchronic toxicity studies of chloroform and methanol extracts of Barleria buxifolia Linn. (Acanthaceae) on creature models according to the OECD rules 407 and 425, respectively. Methods: In acute oral toxicity, study a single oral dosages of 5000 mg/kg body weight of chloroform and methanol extracts was given individually to rats and watched them for 2 weeks for the discovery of acute changes and for its mortality any. During acute oral toxicity study period, no mortality was seen without any signs of intense changes. Further, it was executed the subchronic toxicity of extracts. Barleria buxifolia extracts (chloroform and methanol) were independently given every day at dosages of 250 and 500 mg/kg body weight for 90 days to recognize the progressions any at subchronic poisonousness levels. Towards the finish of the experimentation the serum tests of trail creatures were gathered and watched for any progressions in haematological, biochemical and histopathological boundaries Results: All parameters of treated group were shown unaltered changes throughout the study period when compared with that of normal group. The outcomes propose that the oral organization of chloroform and methanol extracts of Barleria buxifolia did not raise any huge poisonous impacts when contrasted with that of control animals. Conclusion: Hence, the extracts may be safe for therapeutic use and as an alternative system of medicine.


2021 ◽  
pp. 29-45
Author(s):  
Uzuazokaro Mark-Maria Agatemor ◽  
Okwesili Fred Chiligue Nwodo

Background and Objective: Data from researches have shown a rise in disease, ill health and death linked with the utilization of herbal products, thereby raising global awareness in the last few years. On that account, the safety and toxicity evaluations of herbal products and preparations was essential. This study evaluated the toxicological profile of Yagari – a herbal mixture. Materials and Methods: Acute oral toxicity (LD50) was carried out in Swiss mice according to Lorke’s method while sub-chronic toxicity study was carried out with 20 adult albino rats which were divided into 4 groups of 5 animals each. Group one served as control and received normal saline while Groups 2 to 4 received 250, 500 and 1000 mg/kg yagari respectively for 28 days. The body weights of the rats were monitored while on day 29, the rats were sacrificed and blood samples and organs were collected for biochemical/hematological analysis and histopathological examination respectively. Results: Results showed that Yagari is not noxious up to 5000 mg/kg following acute oral toxicity study. The sub-chronic toxicity test divulged that Yagari had no serious end results on the biochemical, hematological and histopathological parameters, although the body weight of the animals significantly increased. Conclusion: It was concluded that Yagari is not toxic, still further investigations on a large number of animals are essentially needed to denote safety and efficacy of the herbal formulation.


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