scholarly journals A 90-Day Oral Toxicity Study of an Ethanolic Root Extract of Caesalpinia bonduc (L.) Roxb. in Wistar Rats

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Mariette Sindete ◽  
Adam Gbankoto ◽  
Razack Osseni ◽  
Nounagnon Darius Tossavi ◽  
Simon Azonbakin ◽  
...  

Background. Plant medicine is the oldest form of health care known to mankind; hence, studies on their safety for use are essential for the control of adverse drug effects. In Benin, Caesalpinia bonduc is one of many medicinal plants used as aphrodisiac, and for treatment of various ailments including prostatic hyperplasia. Despite its numerous ethnomedicinal benefits, toxicological information associated with its chronic use is currently limited. Objective. The present study therefore assessed the toxicity of an ethanolic root extract of Caesalpinia bonduc in Wistar rats. Methods. Caesalpinia bonduc root extract was administered by oral gavage at doses of 31.25, 125, and 500 mg/kg/day for 90 days to male Wistar rats, after which body weight changes, food consumption, urinary parameters, hematological and blood biochemical parameters, organ weights changes, gross pathology, and histopathology of vital organs were assessed. Results. There were no death or abnormal clinical signs, no significant changes in body weight gain or urinary parameters, and no changes in necropsy and histopathology findings of vital organs associated with extract treatment. However, some indices such as erythrocytes, total cholesterol, and aspartate amino transferase increased in rats treated with high doses of the extract, as well as relative weight of testes, followed by a decrease in food intake and prostate relative weight. Conclusion. The results indicate that an ethanolic root extract of Caesalpinia bonduc does not cause significant adverse effects and suggest its tolerability up to 500 mg/kg for daily administration of 90 days.

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Komlan M. Dossou-Yovo ◽  
Aboudoulatif Diallo ◽  
Povi Lawson-Evi ◽  
Yendubé T. Kantati ◽  
Tchin Darré ◽  
...  

Background. Herbal medication is a worldwide and ancient practice, mostly in developing countries, where a large part of the population is involved in this practice. Hence, studies must be conducted to evaluate their safety and efficiency to avoid or prevent toxicological risks due to their usage. In Togo, Carissa spinarum is a medicinal plant belonging to Apocynaceae family, used as an aphrodisiac or to heal some ailments including malaria, sickle cell anemia, hypertension, pain, and asthma. Notwithstanding its several ethnomedicinal benefits, just a few toxicological data associated with its chronic use are available. Objective. Therefore, this study aims to assess the toxicity of an ethanolic root extract of Carissa spinarum in Wistar rats. Methods. The 90-day oral toxicity process following OECD TG 408 guidelines is used. Male Wistar rats received Carissa spinarum root hydroethanolic extract at 500 and 1000 mg/kg for 90 days by oral gavage. Body weight changes, hematological and blood biochemical parameters, organ weight changes, malondialdehyde as a lipoperoxidation marker expressed according to tissue proteins, and histopathology of vital organs were assessed. Results. No signs of toxicity or mortality were observed during the 90 days experiment. Hematological parameters have not shown any treatment-related abnormalities. According to biochemical parameters, an increase in the chloride ion level was observed at 1000 mg/kg p < 0.01 . There was no significant difference between the treated groups and the control group concerning the malondialdehyde concentration, body weight, and organ relative weight. No changes in necropsy and histopathology of vital organs associated with extract treatment were observed. Conclusion. The results indicated that an ethanolic root extract of Carissa spinarum does not cause adverse effects, which can lead to Wistar rats’ death after 90-day oral administration at 500 and 1000 mg.


2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Sasikumar Murugan ◽  
Himanshu Solanki ◽  
Divya Purusothaman ◽  
Bharathi Bethapudi ◽  
Mital Ravalji ◽  
...  

NR-INF-02 is a standardized extract containing turmerosaccharides from Curcuma longa that has anti-inflammatory, analgesic, and chondroprotective potential. In view of its potential uses, NR-INF-02 was evaluated for its safety in Wistar rats at an oral dose of 250, 500, and 1000 mg/kg in a 90-day repeated dose subchronic toxicity study. NR-INF-02 administered at 250, 500, and 1000 mg/kg for 90 days did not show any mortality or clinical signs of toxicity. Body weight gain, food consumption, ocular and neurological examination, and hematological, blood biochemical, hormone, and urine analysis revealed no evidence of toxicity of NR-INF-02 treatment in rats. Absolute and relative organ weights were comparable to control rats. The study did not reveal any major treatment related gross pathological and histopathological alterations in the tissues or organs examined. Thus, based on study observations, the no-observed adverse effect level (NOAEL) was found to be 1000 mg/kg body weight in albino Wistar rats.


2017 ◽  
Vol 17 (1) ◽  
pp. 85-92
Author(s):  
Sun Yanru ◽  
Shen Zhenhuang ◽  
Jia Zhe ◽  
Miao Xiaoqing

Bao-Yuan-Ling (BYL) is an apitherapy formulation which is composed of royal jelly, propolis and bee venom. Cardioprotective effects of BYL has been demonstrated, while the toxicity of BYL was not clear. In this study, acute and sub-acute toxicity test of BYL was processed following Organization for Economic Co-operation and Development (OECD) 423 and OECD 407, respectively, in Wistar rats. In acute toxicity test, rats were orally treated with BYL at the single dose of 2000 mg/kg and 5000 mg/kg. No death occurred in the acute toxicity test for 7 days, which indicated the lethal dose 50% value exceeded 5000 mg/kg. In sub-acute toxicity study, rats were treated with BYL at the dose of 250 mg/kg, 500 mg/kg and 1000 mg/kg in a daily base for continuous 28 days. Results showed that female rats were more likely to be affected by BYL in body weight changes, while biochemical indicators of blood serum in male rats were more susceptible to drug effects. However, neither female nor male rats were affected by BYL administration significantly on the organs via hematoxylin-eosin staining analysis. Results suggested that BYL was slightly toxic and clinical use was safe and reliable.


2018 ◽  
Vol 5 (2) ◽  
Author(s):  
Ragesh R Nair

The aim of the study was to evaluate the acute oral and sub-acute toxicity of ethanolic root extract of Tetracera akara in Swiss albino mice and Wistar rats. Tetracera akara (Burm. f.) Merr. has been used as traditional medicine by the Kani tribe of Kerala to cure liver diseases. In acute toxicity studies, four groups of mice (n = 5/group/sex) were orally treated with doses of 0.625 g, 1.25 g, 2.5 g and 5.0 g/kg and mortality were recorded. In the sub-acute toxicity study, animals received T. akara extract at the doses of 0.1 g, 0.5 g and 2.5 g/kg/day (n = 5/group/sex) for 28 days, biochemical, hematological, morphological and histopathological parameters were determined. T. akara did not produce any mortality in the acute toxicity studies, showing LD50 higher than 5 g/kg. Sub-acute treatment with T. akara didn’t cause any changes in body weight gain, hematological, biochemical profiles when compared to normal control. In addition, no changes in morphological and histopathological aspect of organs were observed in the animals. Taking all factors into consideration, administration of Tetracera akara does not produce acute toxicity in Swiss albino mice or sub-acute toxicity in Wistar rats, suggesting it’s safe use by humans.


2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Aldeíde de Oliveira Batista Rocha ◽  
Liliane de Queirós Sousa ◽  
Clélia de Alencar Xavier Mota ◽  
Elane Cristina S. Santos ◽  
Margareth de Fátima Formiga Melo Diniz ◽  
...  

The treatment during the embryonic preimplantation phase of Wistar rats with thePradosia huberiextract did not interfere with the water and feed consumption, as well as upon the body-weight gain. However, it has expressed a decrease of the uterine implant number, followed by the preimplantation losses at all applied doses (1.22, 6.1, and 30.5 mg/kg), and the number of embryonic resorptions in the two highest doses (6.1 and 30.5 mg/kg). After the organ weighing (hypophysis, ovaries, and uterus), only the relative weight of the hypophysis was raised at the different doses (1.22, 6.1, and 30.5 mg/kg). It was concluded that the hydroalcoholic extract ofPradosia hubericompromises the reproductive ability during the embryonic preimplantation phase, suggesting a possible toxic effect upon the reproductive system of Wistar rats.


1989 ◽  
Vol 8 (3) ◽  
pp. 525-538 ◽  
Author(s):  
G. M. Mesfin ◽  
D. F. Morris ◽  
W. J. Seaman ◽  
T. A. Marks

Groups of 25 male Sprague-Dawley rats were treated orally with losulazine at 0 (vehicle control), 4, 8, 16, or 32 mg/kg/day for 1 year. Daily clinical signs, weekly food consumption and body weight changes, and terminal hematologic and blood chemistry values were evaluated. Terminal urinalysis in 10 randomly selected rats from all groups and levels of serum luetinizing hormone, prolactin, and testosterone from control, low-, and high-dose groups were also evaluated. Fertility was determined in eight randomly selected rats from each group at 35–49 weeks. Reversibility of breeding performance was evaluated in 10 rats treated for 30 weeks and allowed to recover for 17 weeks. Selected organs were weighed and the testes and epididymides were microscopically evaluated in all rats that survived through the 1 year treatment period. Rats treated with losulazine showed dosage-dependent ptosis, somnolence, fecal softening, and decreased food consumption with a corresponding retarded body weight gain. There were no biologically significant changes in hematologic, blood chemistry, or urinalysis values between treated and control rats. Relative spleen, heart, adrenal, and brain weights were increased in treated rats. There was a reversible dosage and time-dependent decreased fertility in rats treated with losulazine for 6–12 months. The incidence of testicular tubular atrophy/degeneration, usually confined to the subcapsular areas of the testes, and concentration of degenerate ge.minal cells in the epididymides, were increased in treated compared to vehicle control rats. Testicular lesions were not dosage related, were minimal to mild after 1 year of treatment, and were not attended by a decrease in relative testicular weights. Decreased fertility was not correlated with the apparently treatment-related testicular lesions. It could not be determined whether the minor testicular lesions seen in rats treated with losulazine were related to stressful conditions the rats were apparently under or to the effects of the drug on the hypothalamus-pituitary-gonadal axis or the sympathetic nervous system.


2018 ◽  
Vol 2 ◽  
pp. 239784731878775 ◽  
Author(s):  
Manish Jain ◽  
Manoj Gote ◽  
Ashok Kumar Dubey ◽  
S Narayanan ◽  
H. Krishnappa ◽  
...  

Fructooligosaccharide (FOS) has been used in infant formula and conventional foods as prebiotics. Short chain FOS (FOSSENCETM) is produced by a patented process of biotransformation of sucrose by the action of enzyme from live microbial cells, hence toxicology studies were initiated to assess its safety. The objective of the present study was to determine safety of FOSSENCETM in acute, 14-day, and subchronic (90-day) toxicity studies. In acute and 14-day studies, administration of the FOSSENCETM to Wistar rats did not cause any mortality or clinical signs and changes in body weights, feed consumption, and gross pathology at the doses of 2000, 5000, and 9000 mg/kg body weight. In the subchronic (90-day) toxicity study, FOSSENCETM was administered by oral gavage to Wistar rats at the doses of 0, 2000, 5000, and 9000 mg/kg/day for 90 days. No treatment-related clinical signs or mortalities were observed. Similarly, no treatment-related toxicologically or biologically significant changes in body weight, feed consumption, ophthalmological findings, neurological effects, hematology, clinical chemistry, urinalysis, and gross pathological findings were noticed. However, statistically significant increase in weight of cecum (without correlative microscopic change) was noted at all the test item-treated groups in males and females and was considered to be a trophic effect and not a toxic effect in rats.


2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Hyekyung Ha ◽  
Jun Kyoung Lee ◽  
Ho Young Lee ◽  
Woo Suk Koh ◽  
Chang Seob Seo ◽  
...  

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.


2013 ◽  
Vol 76 (7) ◽  
pp. 1226-1239 ◽  
Author(s):  
ARTURO ANADÓN ◽  
MARÍA A. MARTÍNEZ ◽  
IRMA ARES ◽  
VICTOR CASTELLANO ◽  
MARIA R. MARTÍNEZ-LARRAÑAGA ◽  
...  

ALIBIRD, a test substance composed of oligosaccharides derived from lactulose, a hydrolysate of a whey protein concentrate, and a supercritical extract of rosemary (1:0.5:0.05), was prepared in the laboratory and evaluated for its safety as a multifunctional food additive. In oral toxicity studies (acute and 28 days repeated dose) using Wistar rats, ALIBIRD was administered in a single oral gavage dose of 2,000 mg/kg of body weight and resulted in no adverse events or mortality; a daily dose of 2,000 mg/kg of body weight for 28 days by gavage also resulted in no adverse effects or mortality. No abnormal clinical signs, behavioral changes, body weight changes, or changes in food and water consumption occurred in either study. There were no changes in hematological and serum chemistry values, organ weights, or gross or histological characteristics. Based on test results, it is concluded that ALIBIRD is well tolerated in rats at an acute and subchronic (28 days) dose of 2,000 mg/kg of body weight.


2016 ◽  
Vol 36 (6) ◽  
pp. 603-615 ◽  
Author(s):  
AT Gotardo ◽  
VV Dipe ◽  
IM Hueza ◽  
SL Górniak

Studies have revealed that impairment of the pregnant body weight reduces the fetal body weight and causes minor changes in skeletal development. The aim of the present study was to assess the effects of maternal feed restriction during pregnancy in offspring immune system development. Pregnant Wistar rats were distributed into 5 groups: 1 control in which dams received food ad libitum and 4 experimental groups in which dams were fed restricted amounts of rodent ration (16, 12, 9, or 6 g/rat/day) from the 6th to 17th gestation day. Teratogenicity was assessed using classical teratological evaluation and developmental immunotoxicology protocols. Maternal body weight gain, fetus weight, and placenta weight were reduced for feed-restricted females from the groups fed 12, 9, and 6 g/rat/day ( p < 0.05). No pup mortality was observed immediately after cesarean sections among the groups, and no visceral or skeletal malformations were detected. An immunoteratological study revealed an increase in the relative weight of the thymus and an increase in the phorbol myristate-acetate solution-induced hydrogen peroxide release by inflammatory cells in 21-day-old pups. Alterations in the delayed-type hypersensitivity response and the humoral immune response against sheep red blood cells were observed in pups from feed-restricted mothers. Feed restriction in Wistar rats during organogenesis did not promote structural malformations but resulted in offspring with lower birth weights and promoted significant changes in the immune responses of the rat pups.


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