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

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.

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

Traditional and Integrative Medicine ◽

10.18502/tim.v6i1.5924 ◽

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.

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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/4748904 ◽

2017 ◽

Vol 2017 ◽

pp. 1-8 ◽

Cited By ~ 3

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.

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Ninety days repeated dose oral toxicity study of Makaradhwaja in Wistar rats

AYU (An International Quarterly Journal of Research in Ayurveda) ◽

10.4103/ayu.ayu_33_17 ◽

2017 ◽

Vol 38 (2) ◽

pp. 171

Author(s):

Shrirang Jamadagni ◽

PallaviShrirang Jamadagni ◽

RajendraKumar Singh ◽

Sachchidanand Upadhyay ◽

SudeshN Gaidhani ◽

...

Keyword(s):

Wistar Rats ◽

Toxicity Study ◽

Repeated Dose ◽

Oral Toxicity ◽

Dose Oral

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Single dose oral toxicity study of ethanolic extract from inflorescence of Casuarina equisetifolia in Wistar rats

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v8i6-s.2075 ◽

2018 ◽

Vol 8 (6-s) ◽

pp. 44-47

Author(s):

O. Umamaheswar Rao ◽

M. Chinna Eswaraiah

Keyword(s):

Body Weight ◽

Single Dose ◽

Wistar Rats ◽

Ethanolic Extract ◽

Toxicity Study ◽

Casuarina Equisetifolia ◽

Oral Toxicity ◽

Dose Oral ◽

Test Guideline ◽

Oecd Test Guideline

The purpose of the study was to evaluate the single dose oral toxicity of the ethanolic extract from inflorescence of Casuarina equisetifolia, Family: Casuarinaceae in female Wistar Rats. The acute toxicity study was carried out based on Organization for Economic Co-operation and Development (OECD) Test Guideline 423. However, this plant safety evaluation data was not available so, selected the starting dose from 300 mg/kg body weight. The animals were orally administered a single dose of 300 mg/kg body weight and followed by 2000 mg/kg body weight in next step. Signs of toxicity and mortality were observed after 30 min, 1, 2, 4 and 24h of administration of the extract and once daily for 14 days. There was no mortality in the tested animals and no abnormal clinical signs were observed related to test item. No abnormalities were detected in gross pathology observations in all the rats at both the dose levels. Based on observations of the present study, it can be concluded that the LD50 of ethanolic extract from inflorescence of Casuarina equisetifolia is greater than 2000mg/kg body weight and can be classified as Category 5; however, further studies are needed to confirm long term toxicities. Keywords: Acute oral toxicity, ethanolic extract from inflorescence of Casuarina equisetifolia, LD50, OECD Test Guideline, Wistar Rat.

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In Vivo Evaluation of the Oral Toxicity of the Chlorobutanol

Toxics ◽

10.3390/toxics10010024 ◽

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.

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4-Week repeated dose oral toxicity study of N-ethyl-2-pyrrolidone in Sprague Dawley rats

Regulatory Toxicology and Pharmacology ◽

10.1016/j.yrtph.2016.09.011 ◽

2016 ◽

Vol 81 ◽

pp. 275-283 ◽

Cited By ~ 4

Author(s):

A.M. Saillenfait ◽

F. Marquet ◽

J.P. Sabaté ◽

D. Ndiaye ◽

A.M. Lambert-Xolin

Keyword(s):

Toxicity Study ◽

Repeated Dose ◽

Sprague Dawley ◽

Oral Toxicity ◽

Sprague Dawley Rats ◽

Dose Oral

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Repeated dose (90 days) oral toxicity study of ursolic acid in Han-Wistar rats

Toxicology Reports ◽

10.1016/j.toxrep.2020.04.005 ◽

2020 ◽

Vol 7 ◽

pp. 610-623 ◽

Cited By ~ 1

Author(s):

Lotte Geerlofs ◽

Zhiyong He ◽

Sa Xiao ◽

Zhi-Cheng Xiao

Keyword(s):

Ursolic Acid ◽

Wistar Rats ◽

Toxicity Study ◽

Repeated Dose ◽

Oral Toxicity

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Acute, Subacute, and Genotoxicity Assessments of a Proprietary Blend of Garcinia mangostana Fruit Rind and Cinnamomum tamala Leaf Extracts (CinDura®)

Journal of Toxicology ◽

10.1155/2020/1435891 ◽

2020 ◽

Vol 2020 ◽

pp. 1-15

Author(s):

Sundararaju Dodda ◽

Venkata Krishnaraju Alluri ◽

Trimurtulu Golakoti ◽

Krishanu Sengupta

Keyword(s):

Body Weight ◽

Wistar Rats ◽

Lethal Dose ◽

Toxicity Study ◽

Mouse Bone Marrow ◽

Acute Oral Toxicity ◽

Oral Toxicity ◽

Garcinia Mangostana ◽

Cinnamomum Tamala ◽

Fruit Rind

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.

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