Repeated-Dose Oral Toxicity Study of Lactobacillus Plantarum AF1 Isolated from Kimchi in Rats

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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Preclinical safety assessment ofAngelica acutilobausing a 13-week repeated dose oral toxicity study in rats

Laboratory Animal Research ◽

10.5625/lar.2017.33.3.223 ◽

2017 ◽

Vol 33 (3) ◽

pp. 223 ◽

Cited By ~ 2

Author(s):

Jun-Won Yun ◽

Euna Kwon ◽

Seung-Hyun Kim ◽

Ji-Ran You ◽

Yun-Soon Kim ◽

...

Keyword(s):

Safety Assessment ◽

Toxicity Study ◽

Repeated Dose ◽

Oral Toxicity ◽

Dose Oral ◽

Preclinical Safety

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Four-week repeated dose oral toxicity study of gum ghatti in rats

Fundamental Toxicological Sciences ◽

10.2131/fts.7.227 ◽

2020 ◽

Vol 7 (5) ◽

pp. 227-232

Author(s):

Ryo Kawahara ◽

Kenichiro Watanabe ◽

Rina Yamane ◽

Hideki Yasui ◽

Nao Kikugawa ◽

...

Keyword(s):

Toxicity Study ◽

Repeated Dose ◽

Oral Toxicity ◽

Gum Ghatti ◽

Dose Oral

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Twenty-Eight-Day Repeated-Dose Oral Toxicity Study of Water-Miscible Coenzyme Q10 Preparation (Q10EP40) in Rats

JOURNAL OF HEALTH SCIENCE ◽

10.1248/jhs.51.346 ◽

2005 ◽

Vol 51 (3) ◽

pp. 346-356 ◽

Cited By ~ 1

Author(s):

Hozumi Tanaka ◽

Kumiko Nagata ◽

Shigeto Oda ◽

Hiroshi Edamoto ◽

Mitsuaki Kitano ◽

...

Keyword(s):

Coenzyme Q10 ◽

Toxicity Study ◽

Repeated Dose ◽

Oral Toxicity ◽

Dose Oral

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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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