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

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

International Scholarly Research Notices ◽

10.1155/2015/473296 ◽

2015 ◽

Vol 2015 ◽

pp. 1-10 ◽

Cited By ~ 4

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.

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

Drug Metabolism and Personalized Therapy ◽

10.1515/dmpt-2019-0011 ◽

2019 ◽

Vol 34 (3) ◽

Cited By ~ 2

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.

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