Acute and Subchronic Oral Toxicity Study of Polyherbal Formulation Containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol. ex. Maton in Rats

The polyherbal formulation containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol ex. Maton has been used for hypertension treatment empirically. Our previous study showed its blood pressure-lowering effect on a rat model of hypertension. However, toxicity data were not available for this polyherbal formulation. This study is aimed at evaluating the acute and subchronic oral toxicity of the polyherbal formulation in rats. The acute toxicity study was conducted on 6 female Wistar rats using the fixed-dose method for the treatment group and 5 female Wistar rats for the control. The single dose of 2,000 mg/kg of the polyherbal formulation was given orally. There were no significant toxic effects and no death observed until the end of the study, and it was showed that the lethal dose 50% (LD50) of the polyherbal formulation was estimated to be more than 2,000 mg/kg. The macroscopic and microscopic examination of vital organs showed no symptoms of toxicity. At the subchronic toxicity study, the polyherbal formulation with 3 dose variations of 252 mg/kg, 1,008 mg/kg, and 4,032 mg/kg was administered for 91 days orally. The lowest dose of 252 mg/kg is equivalent to the daily recommended dose for a human. There were no significant toxic effects observed at all doses on physical sign and symptoms, weight gain, food intake, hematological parameters, biochemical parameters, and macroscopic and microscopic examination of organs. These findings showed that the short- and long-term oral administration of the polyherbal formulation is safe to use within its dose recommendation.

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Acute oral toxicity study of “Polyherbal formulation (Rosmarinus officinals, Ashwaghandha and Amla) in Wistar rats”

International Journal of Mosquito Research ◽

10.22271/23487941.2021.v8.i3a.535 ◽

2021 ◽

Vol 8 (3) ◽

pp. 35-46

Author(s):

Dr. Shivaraj Y ◽

Kaveri KR ◽

Dr. Asiya Nuzhat FB ◽

Rajesh R

Keyword(s):

Wistar Rats ◽

Toxicity Study ◽

Acute Oral Toxicity ◽

Oral Toxicity ◽

Polyherbal Formulation

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Acute oral toxicity study of “Polyherbal formulation (Rosmarinus officinals, Ashwaghandha and Amla) in Wistar rats”

Journal of Entomology and Zoology Studies ◽

10.22271/j.ento.2021.v9.i4a.8752 ◽

2021 ◽

Vol 9 (4) ◽

pp. 16-27

Author(s):

Dr. Shivaraj Y ◽

Kaveri KR ◽

Dr. Asiya Nuzhat FB ◽

Rajesh R

Keyword(s):

Wistar Rats ◽

Toxicity Study ◽

Acute Oral Toxicity ◽

Oral Toxicity ◽

Polyherbal Formulation

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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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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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Acute and Subacute Toxicity Studies of the Ethyl Acetate Soluble Proanthocyanidins of the Immature Inflorescence of Cocos nucifera L. in Female Wistar Rats

BioMed Research International ◽

10.1155/2019/8428304 ◽

2019 ◽

Vol 2019 ◽

pp. 1-12

Author(s):

C. P. Ekanayake ◽

M. G. Thammitiyagodage ◽

S. Padumadasa ◽

B. Seneviratne ◽

C. Padumadasa ◽

...

Keyword(s):

Body Weight ◽

Acute Toxicity ◽

Ethyl Acetate ◽

Wistar Rats ◽

Cocos Nucifera ◽

Toxicity Study ◽

Immature Inflorescence ◽

Subacute Toxicity ◽

Toxicity Studies ◽

Female Wistar Rats

Ayurvedic and traditional medical practitioners of Sri Lanka use the decoction of the immature inflorescence of Cocos nucifera L. (IC) variety aurantiaca for the treatment of menorrhagia. The progestogenic effect of the ethyl acetate soluble proanthocyanidins (EASPA) of the IC in female rats at a dose of 3.5 mg/kg body weight has been reported. Acute and subacute toxicity studies of EASPA of the IC carried out using female Wistar rats according to Organization for Economic Co-operation and Development (OECD) guidelines 423 and 407, respectively, are reported herein. In the acute toxicity study, a single dose of EASPA (2000 mg/kg body weight) was orally administered to rats, which were monitored for 14 days. In the subacute toxicity study, rats were orally administered with EASPA daily for 28 days at doses of 1.75, 3.5, 7, and 14 mg/kg body weight. No rat in either the acute or subacute toxicity study exhibited mortality or clinical signs of toxicity. Further, these rats did not show any significant change in their mean body weight, food, and water intake, haematological and biochemical parameters as well as in the results of their histopathological examinations compared to those of control group rats. According to results of the acute toxicity, the LD50 of EASPA is estimated to be greater than 2000 mg/kg body weight. Considering the results of the subacute toxicity study, the oral administration of EASPA daily for 28 days was well tolerated up to the dose, 14 mg/kg by rats. These results will be useful in the development of a novel therapeutic agent from EASPA of the IC for the treatment of menorrhagia, which incapacitates a considerable proportion of women worldwide.

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