scholarly journals Toxicity Evaluation of Pũrṇa Cantirotaya Centũram, a Siddha Medicine in Wistar Rats

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
B. Chitra ◽  
R. S. Ramaswamy ◽  
V. Suba
Keyword(s):  
Body Weight ◽  
Histopathological Examination ◽  
Toxicity Study ◽  
Repeated Dose ◽  
High Dose ◽  
Oral Toxicity ◽  
High Dose Level ◽  
Show Evidence ◽  
Dose Study ◽  
Acute Study

Pũrṇa Cantirotaya Centũram (PCC), a herbometallic formulation of Siddha medicine, consists of mercury, sulphur, and gold, processed with red cotton flower and plantain stem pith juices. To evaluate its safety, acute and 28-day repeated oral toxicity studies were performed following OECD test guidelines 423 and 407, respectively. In acute study, PCC was administered orally at 5, 50, 300, and 2000 mg/kg body weight. Animals were observed for toxic signs for 14 days. Gross pathology was performed at the end of the study. In repeated dose toxicity study, PCC was administered at 2.5, 25, and 50 mg/kg body weight daily for 28 days. Satellite groups (control and high dose) were also maintained to determine the delayed onset toxicity of PCC. In acute toxicity study, no treatment related death or toxic signs were observed. It revealed that the LD50 cut-off value of PCC is between 2000 and 5000 mg/kg body weight. The repeated dose study did not show evidence of any treatment related changes in all observations up to the high dose level, when compared with the control. Histopathological examination revealed no abnormalities except mild hyperplasia of stomach in high dose group. This study provides scientific validation for the safety of PCC.

scholarly journals 90-Days Repeated Dose Oral Toxicity Study of Sharbat-e-Deenar (A Hepatoprotective Unani Herbal Formulation)

2021 ◽  
Author(s):  
Gulam Mohammed Husain ◽  
Tasleem Ahmad ◽  
Syeda Hajra Fatima ◽  
Ghazala Javed ◽  
Munawwar Husain Kazmi ◽  
...  
Keyword(s):  
Body Weight ◽  
Liver Function ◽  
Clinical Sign ◽  
Equivalent Dose ◽  
Toxicity Study ◽  
Feed Consumption ◽  
Repeated Dose ◽  
High Dose ◽  
Oral Toxicity ◽  
Dose Oral

Sharbat-e-Deenar (SDR) is a compound Unani pharmacopoeial formulation recommended for the treatment of Waram-e-Kabid (hepatitis), Waram-e-Rahem (uterine inflammation/ Pelvic Inflammatory Diseases), Yarqan-e-Suddi (obstructive jaundice), and Istisqa (ascites). The current study was carried out to investigate repeated dose oral toxicity study of SDR for 90 days in Sprague dawley (SD) rats. SDR was orally administered (gavage) at the doses of 4, 10 and 20 mL/kg bw/day. A periodic observation was performed for mortality, morbidity and any clinical sign of toxicity. Changes in body weight and feed consumption were observed weekly throughout study duration. After the treatment duration of three months, animals were anaesthetized and blood samples were subjected to haematological investigation and serum was subjected to different biochemical estimation. Gross necropsy was performed and internal organs/ tissues were processed for histopathological investigation. Treatment with SDR showed no incidence of mortality and no clinical sign of systemic toxicity. Body weight showed pattern of weight gain except significance decrease at mid and high dose at 13th week of study duration. Feed consumption exhibited a significant decrease as compare to control. Haematology and biochemistry profile found normal except certain isolated changes which was considered toxicologically not significant as the values lies in the normal physiological range. There were no changes observed in the gross necropsy and relative organ weight data of control and SDR treated rats. It is reported that few of the animals showed changes in liver at mid (2.5 times of therapeutic equivalent dose) and high dose (5 times of therapeutic equivalent dose) in SDR treated animals that may be attributed to SDR treatment, however, associated liver function parameters like ALT, AST and ALP did not show any alteration of liver function. Based on the results of this study, it may be indicated that liver may be the target organ for toxicity if SDR is used above recommended therapeutic dose for longer duration.

scholarly journals In Vivo Evaluation of the Oral Toxicity of the Chlorobutanol

Toxics ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 24
Author(s):  
Dahye Jeong ◽  
Hyosook Shin ◽  
Jinhee Lee ◽  
Junyoung Yang ◽  
Kikyung Jung ◽  
...  
Keyword(s):  
Body Weight ◽  
Single Dose ◽  
Toxicity Study ◽  
Male Rats ◽  
Repeated Dose ◽  
High Dose ◽  
Oral Toxicity ◽  
Single Dose Study ◽  
Repeated Dose Toxicity ◽  
Liver And Kidney

Chlorobutanol (CB) is used as a preservative in cosmetics and has antibacterial activity. This study investigated the single- and repeated-dose 28-day oral toxicity of a CB solvent in Sprague Dawley (SD) rats. For the single-dose oral toxicity study, a dose of 62.5, 125, or 250 mg per kg of body weight (mg/kg b.w.) of CB was given once orally via gavage. For the repeated-dose 28-day toxicity study, the high dose was set as 100 mg/kg b.w./day, and the middle, middle-low, and low doses were set to 50, 25, and 12.5 mg/kg b.w./day, respectively. Body weight was not significantly changed in the repeated-dose toxicity study. Relative liver and kidney weights were significantly increased in both sexes of the 100 mg/kg b.w./day treatment group. However, there were histopathological changes in liver and kidney for females and males, respectively. These data suggested that the approximate lethal dose (ALD) of CB was over 250 mg/kg b.w./day in the single-dose study, and the no adverse effect level (NOAEL) for CB was over 50 and 12.5 mg/kg b.w./day for female and male rats in the repeated-dose toxicity study.

scholarly journals Acute and Subacute Oral Toxicity Assessment of European Cranberrybush (Viburnum opulus L). Fruit Extract

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 355-355
Author(s):  
Gizem Ozan ◽  
Alev Cumbul ◽  
Engin Sümer ◽  
Dilara Baban ◽  
Ahmet Aydın ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Histopathological Examination ◽  
Clinical Signs ◽  
Toxicity Study ◽  
High Dose ◽  
Oral Toxicity ◽  
Viburnum Opulus ◽  
Fruit Extract ◽  
Subacute Toxicity

Abstract Objectives The intake of the high dose of polyphenols might cause adverse health effects on humans, in such cases, toxicological testing may be required to ensure safe levels of intake. In the present study, acute and subacute oral toxicity studies of polyphenol-rich European cranberrybush (Viburnum opulus L.) (ECB) fruit extract were evaluated to ensure the safe use of this extract. Methods In acute toxicity, freshly prepared ECB extract dissolved in distilled water was administrated to Sprague-Dawley rats by oral gavage at a single dose of 2000 mg/kg and signs of toxicity and mortality was observed. In subacute toxicity, Balb-c mice were administrated orally at 500 (low dose) and 2000 mg/kg (high dose) of ECB extract for 28 days and their mortality, clinical signs and, body weight were recorded on a daily and weekly basis, respectively. At the end of 28 days, while blood samples from each animal were taken for hematological and biochemical analysis, vital organs were taken for histopathological examination. Results In acute toxicity study, ECB extract showed no toxicological signs observed on behavioral change and body weight of rats after 14 days indicating that the lethal dose (LD50) of the ECB fruit extract might be higher than 2000 mg/kg. No death and no abnormal clinical signs were also recorded in subacute toxicity study. However, the increment in body weight of administrated high dose of ECB extract animals were significantly lower than control (P > 0.05). High dose of ECB fruit extract induced the level of in some hematological parameters. Even amylase and lipase values were lower than normal ranges at high dose animals, other biochemical parameters results were not significantly different from the controls. In histopathological examination, the total histopathological scores ECB extract administrated mice at both doses were showed normal histological features in many tissues compared to control. However, administrated with a high dose of ECB extract showed significant changes in kidney, liver, and adipose tissue that were alterations (edema, infiltration, and bleeding) compared to control. Conclusions These findings indicated that polyphenol-rich ECB extract might show a toxic effect at a high dose (2000 mg/kg) and no observed adverse effect level (NOAEL) of ECB extract was 500 mg/kg ECB fruit juice. Funding Sources This study was supported by Yeditepe University.

scholarly journals A 4-Week Repeated-Dose Oral Toxicity Study of Bojungikgi-Tang in Crl:CD Sprague Dawley Rats

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Sae-Rom Yoo ◽  
Hyekyung Ha ◽  
Mee-Young Lee ◽  
Hyeun-Kyoo Shin ◽  
Su-Cheol Han ◽  
...  
Keyword(s):  
Body Weight ◽  
Food Intake ◽  
Serum Biochemistry ◽  
Toxicity Study ◽  
Repeated Dose ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Organ Weights ◽  
Sprague Dawley Rats ◽  
Dose Oral

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.

scholarly journals Safety assessment of essential oils from Xylopia aethiopica (Dunal) fruit from Nigeria

2020 ◽  
Vol 7 (7) ◽  
pp. 3865-3876
Author(s):  
Raphael Chukwuma Ekeanyanwu ◽  
Nnaemeka Emmanuel Mgbedo ◽  
Alvan Tochukwu Njoku
Keyword(s):  
Essential Oils ◽  
Histopathological Examination ◽  
Initial Period ◽  
Safety Evaluation ◽  
Toxicity Tests ◽  
High Dose ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
High Dose Level ◽  
Xylopia Aethiopica

Introduction: The essential oils of Xylopia aethiopica fruits have been reported to possess numerous biochemical effects. However, no toxicological data is available regarding the safety evaluation of the essential oils from the plant spice. The present study was performed to evaluate the safety of essential oils from X. aethiopica (XAEO) fruit by acute and sub-acute oral toxicity studies in experimental rodents. Methods: In assessing the safety of XAEO, acute and sub-acute oral toxicity tests were performed following OECD guidelines 425 and 407, respectively, with slight modifications. At the end of each test, hematological and biochemical analysis of the collected blood was performed. Histopathological examination of vital organs of the animals was conducted for gross findings and for comparison to controls. Results: In acute oral toxicity, signs of toxicity were observed in the initial period of the experiment which culminated in the death of the mice before the end of the experiment. The sub-acute test observations indicated that generally, there were no significant differences (p<0.05) up to the high dose level compared to the controls. Conclusion: This study demonstrated the tolerability of XAEO administered daily for 28 days up to 450 mg/kg dose.

scholarly journals Oral toxicity study of sports nutritional powder in Wistar rats: A 90 day repeated dose study

2018 ◽  
Vol 5 ◽  
pp. 497-503 ◽  
Author(s):  
Joby Jacob ◽  
Augustine Amalraj ◽  
Chandradhara Divya ◽  
Suresh Janadri ◽  
P.M. Manjunatha ◽  
...  
Keyword(s):  
Wistar Rats ◽  
Toxicity Study ◽  
Repeated Dose ◽  
Oral Toxicity ◽  
Dose Study

scholarly journals Acute and 28-Day Subchronic Oral Toxicity of an Ethanol Extract ofZingiber zerumbet(L.) Smith in Rodents

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Chia Ju Chang ◽  
Thing-Fong Tzeng ◽  
Shorong-Shii Liou ◽  
Yuan-Shiun Chang ◽  
I-Min Liu
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Histopathological Examination ◽  
Body Weight Gain ◽  
Lethal Dose ◽  
Ethanol Extract ◽  
Oral Route ◽  
The Body ◽  
Toxicity Study ◽  
Oral Toxicity

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.

Acute and 28-day repeated dose oral toxicity study of caraway oil in rats

2019 ◽  
Vol 34 (3) ◽  
Author(s):  
Sandip T. Auti ◽  
Yogesh A. Kulkarni
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Toxicity Study ◽  
Repeated Dose ◽  
Oral Toxicity ◽  
Repeated Dose Toxicity ◽  
Relative Organ Weight ◽  
Dose Oral ◽  
Food And Water Intake ◽  
Dose Levels

Abstract Background Caraway oil (CO) obtained from the fruits of Carum carvi L. (Apiaceae) is used in traditional systems of medicine for various diseases. The present study was designed to evaluate the safety profile of CO by acute and repeated dose oral toxicity as per the Organisation for Economic Co-operation and Development guidelines 423 and 407, respectively. Methods In an acute toxicity study, a single dose of CO (300 and 2000 mg/kg) was given to female Wistar rats, and the animals were observed for signs of behavioral alterations, morbidity and mortality for 14 days. Repeated dose toxicity was performed at doses of 50, 100 and 200 mg/kg for 28 days in Wistar rats. The effects of CO on food and water intake, body weight, relative organ weight, clinical biochemistry, hematological parameters and urine parameters were studied. Gross necropsy and histopathology of vital organs were carried out. Results A single oral dose at 300 mg/kg CO did not show any signs of toxicity and mortality, while a dose of 2000 mg/kg showed signs of mortality in one animal and some signs of toxicity in another two animals. In the repeated dose toxicity study, CO at selected dose levels did not show any significant alterations in food and water intake, body weight and relative organ weight. Administration of CO did not show any significant changes in hematological, biochemical and urine parameters and histopathology study when compared with normal control animals. Conclusions The CO was found to be safe at all selected dose levels in the repeated dose toxicity study in rats.

scholarly journals Toxicological Assessment of Bromochlorophene: Single and Repeated-Dose 28-Day Oral Toxicity, Genotoxicity, and Dermal Application in Sprague–Dawley Rats

2021 ◽  
Vol 12 ◽  
Author(s):  
Hansol Won ◽  
Da Hye Jeong ◽  
Hyo-Sook Shin ◽  
Jin Hee Lee ◽  
Jeong Pyo Lee ◽  
...  
Keyword(s):  
Single Dose ◽  
Toxicity Study ◽  
Female Rats ◽  
Male Rats ◽  
Repeated Dose ◽  
High Dose ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Sd Rats ◽  
Dermal Application

Bromochlorophene (BCP) has shown good properties in sterilization and antibacterial activity and is widely used as a household chemical. We evaluated the genotoxicity, single and repeated-dose 28-day oral toxicity, and dermal application of a BCP suspension in Sprague–Dawley (SD) rats. For the single-dose toxicity study, a dose of 25–1,000 mg per kg of bodyweight (mg/kg b.w.) of BCP was given once orally to SD rats. Mortality and clinical signs were observed and recorded for the first 30 min after treatment, at 4 h post-administration, and then at least once daily for 14 days after administration. For the repeated-dose 28-day toxicity study, the high dose was set at 1,000 mg/kg b.w. and the middle, middle-low, and low dose were set to 500, 250, and 125 mg/kg, respectively. Hematology and biochemistry parameters were examined. Gross pathologic and histopathologic examinations were performed on selected tissues from all animals. A bacterial reverse mutation assay, in vitro chromosomal aberration assay, and in vivo micronucleus assay were performed to assess genotoxicity-dermal application exposure assessment of BCP in rats. A high oral approximate lethal dose (ALD) of 1,000 mg/kg was observed in the single-dose toxicity test. During the repeated-dose 28-day time period, most animal deaths after administration occurred during the first 3 weeks. The 1,000 mg/kg b.w. oral dose caused the death of six male rats (6/7) and four female rats (4/7). At 500 mg/kg b.w., the female rats showed mortality (1/7). For the biochemistry assays, cholesterol was increased significantly compared to vehicle in both sexes in the 250 and 500 mg/kg groups. Histopathological changes with treatment-related findings were observed in the pancreas in female rats treated with a high dose of BCP compared with the vehicle group. BCP showed no genotoxic effect. These data suggested that the ALD of BCP, estimated as a non-genotoxic substance, was over 1,000 mg/kg b.w. in the single-dose toxicity study, and the NOAEL of BCP was considered to be 250 mg/kg b.w. for male and female rats after repeated oral administration for 28 days under the present study conditions.

scholarly journals Palmitoylethanolamide: Prenatal Developmental Toxicity Study in Rats

2021 ◽  
pp. 109158182098607
Author(s):  
Narendra S. Deshmukh ◽  
Shailesh Gumaste ◽  
Silma Subah ◽  
Nathasha Omal Bogoda
Keyword(s):  
Body Weight ◽  
Developmental Toxicity ◽  
Reproductive Toxicity ◽  
Toxicity Study ◽  
High Dose ◽  
Pregnant Rats ◽  
Human Dose ◽  
Adverse Effect Level ◽  
Female Wistar Rats ◽  
Effect Level

Palmitoylethanolamide (PEA) is an endogenous ethanolamine playing a protective and homeodynamic role in animals and plants. Prenatal developmental toxicity of PEA was tested following oral administration to pregnant female Wistar rats, from days 0 to 19 of gestation, at dosage of 250, 500, or 1,000 mg/kg body weight, according to Organisation for Economic Co-operation and Development Test Guideline No. 414. On gestation day 20, cesarean sections were performed on the dams, followed by examination of their ovaries and uterine contents. The fetuses were further examined for external, visceral, and skeletal abnormalities. Palmitoylethanolamide did not cause any alterations at any of the given dosages in the measured maternal parameters of systemic toxicity (body weight, food consumption, survival, thyroid functions, organ weight, histopathology), reproductive toxicity (preimplantation and postimplantation losses, uterus weight, number of live/dead implants and early/late resorptions, litter size and weights, number of fetuses, their sex ratio), and fetal external, visceral, or skeletal observations. Any alterations that were recorded were “normal variations” or “minor anomalies,” which were unrelated to treatment with PEA. Under the condition of this prenatal study, the no-observed-adverse-effect level of PEA for maternal toxicity, embryotoxicity, fetotoxicity, and teratogenicity in rats was found to be >1,000 mg/kg body weight/d. It indicates that PEA is well tolerated by and is safe to pregnant rats even at a high dose of 1,000 mg/kg body weight/d, equivalent to a human dose of greater than 9.7 g/d. This prenatal developmental toxicity study contributes greatly in building a robust safety profile for PEA.

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