Repeated dose (90 days) oral toxicity study of ursolic acid in Han-Wistar 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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Safety Evaluation of Multiple Strains ofLactobacillus plantarumandPediococcus pentosaceusin Wistar Rats Based on the Ames Test and a 28-Day Feeding Study

The Scientific World JOURNAL ◽

10.1155/2014/928652 ◽

2014 ◽

Vol 2014 ◽

pp. 1-9 ◽

Cited By ~ 4

Author(s):

Cheng-Chih Tsai ◽

Sew-Fen Leu ◽

Quan-Rong Huang ◽

Lan-Chun Chou ◽

Chun-Chih Huang

Keyword(s):

Wistar Rats ◽

Clinical Chemistry ◽

Toxicity Study ◽

Bacterial Strains ◽

Oral Toxicity ◽

Short Term ◽

Mutagenic Potential ◽

Multiple Strains

Three lactic acid bacterial strains,Lactobacillus plantarum, HK006, and HK109, andPediococcus pentosaceusPP31 exhibit probiotic potential as antiallergy agents, both in vitro and in vivo. However, the safety of these new strains requires evaluation when isolated from infant faeces or pickled cabbage. Multiple strains (HK006, HK109, and PP31) were subject to a bacterial reverse mutation assay and a short-term oral toxicity study. The powder product exhibited mutagenic potential inSalmonellaTyphimurium strains TA98 and TA1535 (with or without metabolic activation). In the short-term oral toxicity study, rats received a normal dosage of 390 mg/kg/d (approximately9×109 CFU/kg/d) or a high dosage of 1950 mg/kg/d (approximately4.5×1010 CFU/kg/d) for 28 d. No adverse effects were observed regarding the general condition, behaviour, growth, feed and water consumption, haematology, clinical chemistry indices, organ weights, or histopathologic analysis of the rats. These studies have demonstrated that the consumption of multiple bacterial strains is not associated with any signs of mutagenicity ofS.Typhimurium or toxicity in Wistar rats, even after consuming large quantities of bacteria.

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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 (28 days) oral toxicity study of flutamide in rats, based on the draft protocol for the `Enhanced OECD Test Guideline 407' for screening for endocrine-disrupting chemicals

Archives of Toxicology ◽

10.1007/s002040050664 ◽

2000 ◽

Vol 74 (3) ◽

pp. 127-132 ◽

Cited By ~ 43

Author(s):

Kazuhiro Toyoda ◽

Makoto Shibutani ◽

Toru Tamura ◽

Takatoshi Koujitani ◽

Chikako Uneyama ◽

...

Keyword(s):

Endocrine Disrupting Chemicals ◽

Toxicity Study ◽

Repeated Dose ◽

Oral Toxicity ◽

Endocrine Disrupting ◽

Test Guideline ◽

Oecd Test Guideline ◽

Oecd Test Guideline 407

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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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