scholarly journals Acute toxicity and repeated dose 28-day oral toxicity study of metriviv syrup in female rats

Author(s):  
AmitG Patel ◽  
MukeshkumarB Nariya ◽  
Subrata De
Author(s):  
Meenakshi Sundaram Malayappan ◽  
Gayathri Natarajan ◽  
Logamanian Mockaiyathevar ◽  
Meenakumari Ramasamy

Abstract Objectives Madhulai Manappagu – a well-known sastric and widely prescribed Siddha herbal syrup formulation indicated for treating Veluppu Noi (Anaemia especially Iron deficiency Anaemia) has been in day today practice in Tamil Nadu for a quite longer decades. The syrup is a herbal preparation which has a sweet pleasant odour and a palatable taste, contain the juice of pomegranate (Punica granatum L.) as the main ingredient. Though the formulation is a fruit juice, the safety profile of the syrup is not established and is being marketed without toxicological evaluation. The study is aimed at ascertaining the acute and sub-acute toxicity assessment of Madhulai Manappagu in Wistar Albino rats. Methods The acute and sub-acute (28day repeated oral) toxicity studies were performed as per the guidelines mentioned in the Organization for Economic Cooperation and Development (OECD) 423 (adopted on December 2001) and TG 407 (adopted on October 2008) with slight modifications respectively. For acute toxicity study, three female rats were randomly selected as control; three female rats were randomly selected and were administered a single dose of 5,000 mg/kg body weight per oral route. For sub-acute (28day repeated oral) toxicity studies, three doses of test drug MM of 500 mg/kg/day (low dose), 750 mg/kg/day (intermittent dose) and 1,000 mg/kg/day (high dose) were selected for administration. Both sexes of Wistar Albino rats were randomized into four groups of 10 animals each (five males, five females). Group I was kept as control group. Group II, III and IV served as low, intermittent and high doses of MM respectively. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed. Results In the acute toxicity study, rats showed no toxicological signs on behavior, gross pathology and body weight of rats when treated with a single dose of 5,000 mg/kg body weight per oral route. In the subacute (28 days repeated oral) toxicity study, rats have showed no significant changes on behavior, gross pathology, body weight, and hematological and biochemical parameters when treated with Madhulai Manappagu in three different doses. Conclusions The toxicity studies which include both acute and 28 days repeated (subacute) oral toxicity studies, revealed no observed adverse effect level (NOAEL) of Madhulai Manappagu in animals. Thus the safety of the drug in human usage was ensured.


2007 ◽  
Vol 39 (2) ◽  
pp. 97 ◽  
Author(s):  
K Jayakumar ◽  
M Narayanaswamy ◽  
NB Shridhar ◽  
Jagadish Sanganal ◽  
Suguna Rao ◽  
...  

2020 ◽  
Vol 10 (3) ◽  
pp. 142-147
Author(s):  
DP Pradeep ◽  
K Murugan ◽  
G S Manoj

The use of crude herbal decoctions in the traditional treatment of diseases is a common practice.  Pogostemon benghalensis and P. cablin are commonly used for treatment of diverse categories of diseases such as infectious and non-infectious disease. Native people use the crude decoctions as bactericidal, antimalarial, anti-leshimania, anti-diarrheal and insecticidal activities. Its safety profile is not yet elucidated and therefore, this study was to analyze the acute toxicity of essential oils (Eos) from P. benghalensis and P. cablin as medicinal. Methods include acute toxicity study using male and female Wistar albino rats with single oral dose and followed up to 14 days as per the guidelines of OECD. Visual observations were carried regularly during the experimental period while body weight was measured weekly. Organ weight, clinical chemistry and hematology data were collected on the 7th and 14th days. Results were presented as mean ± standard deviation. One-way analysis of variance (ANOVA) was carried. Oral administration of Eos from P. benghalensis and P. cablin revealed no treatment-related mortality in female rats up to the dose of 5000 mg/kg. In acute toxicity studies, no remarkable treatment related anomalies were observed compared to negative controls. Food consumption, body weight, organ weight, hematology did not showed sound variation between controls and treatment groups. However, creatinine, triglycerides, and monocytes were lower in the treated groups in 7th day as compared to control groups. No significant variations between male and female groups in relative organ weight, hematology were noticed. In conclusion, the Eos from P. benghalensis and P. cablin showed LD50 > 3000 mg/kg in acute toxicity studies. Keywords: Pogostemon benghalensis, P. cablin, traditional medicine, safety, plant medicine, adverse effect, acute oral toxicity


2021 ◽  
Vol 12 ◽  
Author(s):  
Hansol Won ◽  
Da Hye Jeong ◽  
Hyo-Sook Shin ◽  
Jin Hee Lee ◽  
Jeong Pyo Lee ◽  
...  

Bromochlorophene (BCP) has shown good properties in sterilization and antibacterial activity and is widely used as a household chemical. We evaluated the genotoxicity, single and repeated-dose 28-day oral toxicity, and dermal application of a BCP suspension in Sprague–Dawley (SD) rats. For the single-dose toxicity study, a dose of 25–1,000 mg per kg of bodyweight (mg/kg b.w.) of BCP was given once orally to SD rats. Mortality and clinical signs were observed and recorded for the first 30 min after treatment, at 4 h post-administration, and then at least once daily for 14 days after administration. For the repeated-dose 28-day toxicity study, the high dose was set at 1,000 mg/kg b.w. and the middle, middle-low, and low dose were set to 500, 250, and 125 mg/kg, respectively. Hematology and biochemistry parameters were examined. Gross pathologic and histopathologic examinations were performed on selected tissues from all animals. A bacterial reverse mutation assay, in vitro chromosomal aberration assay, and in vivo micronucleus assay were performed to assess genotoxicity-dermal application exposure assessment of BCP in rats. A high oral approximate lethal dose (ALD) of 1,000 mg/kg was observed in the single-dose toxicity test. During the repeated-dose 28-day time period, most animal deaths after administration occurred during the first 3 weeks. The 1,000 mg/kg b.w. oral dose caused the death of six male rats (6/7) and four female rats (4/7). At 500 mg/kg b.w., the female rats showed mortality (1/7). For the biochemistry assays, cholesterol was increased significantly compared to vehicle in both sexes in the 250 and 500 mg/kg groups. Histopathological changes with treatment-related findings were observed in the pancreas in female rats treated with a high dose of BCP compared with the vehicle group. BCP showed no genotoxic effect. These data suggested that the ALD of BCP, estimated as a non-genotoxic substance, was over 1,000 mg/kg b.w. in the single-dose toxicity study, and the NOAEL of BCP was considered to be 250 mg/kg b.w. for male and female rats after repeated oral administration for 28 days under the present study conditions.


2021 ◽  
Vol 9 (A) ◽  
pp. 976-981
Author(s):  
Rizka Qurrota A’yun ◽  
Uswatun Hasanah ◽  
Hamam Hadi ◽  
Mustofa Mustofa ◽  
Eva Nurinda ◽  
...  

BACKGROUND: Porang (Amorphophallus oncophyllus) is a local tuber food that high in bioactive compound glucomannan. It uses are limited due to oxalate acid content which poses health risks. Strobilanthes crispus leaves could reduce the level of calcium oxalate in porang. However, there is still no study to prove its safety. AIM: This study aimed to investigate the acute oral toxicity study of porang (A. oncophyllus) macerated with S. crispus based on observation of mortality rate (LD50), the changes in behavior during 72 h, renal and hepatic function such as urinary protein, serum glutamic oxaloacetic transaminase (SGOT), and serum glutamic pyruvic transaminase (SGPT) levels of Wistar rat (Rattus norvegicus) METHODS: An acute toxicity test was conducted based on the Organization of Economic Co-Operation and Development 420 Fixed-Dose Procedure Guideline that consists of preliminary and main studies. For the preliminary study, rats were divided into control and five treatment groups with the dosage of 50, 300, 2000, and 5000 mg/kg body weight (BW) for each natural porang flour (NPF) and S. crispus-macerated porang flour (SPF). For the main study, rats were divided into four groups, those were NPF and SPF with the dosage of 2000 and 5000 mg/kg BW. Levels of urinary protein and blood serum SGOT and SGPT levels were measured at 0, 24, and 72 after treatment. RESULTS: The acute toxicity study showed that porang and porang macerated with S. crispus were not toxic until the highest dose of 5000 mg/kg BW. It was proved by the absence of LD50, no change in behavior, no weight losses, and also the results of biochemical tests, such as urinary protein, SGOT, and SGPT which were still in the normal range. CONCLUSIONS: Porang flour and SPF were concluded as non-toxic food based on acute toxicity study.


2016 ◽  
Vol 81 ◽  
pp. 275-283 ◽  
Author(s):  
A.M. Saillenfait ◽  
F. Marquet ◽  
J.P. Sabaté ◽  
D. Ndiaye ◽  
A.M. Lambert-Xolin

2020 ◽  
Vol 7 ◽  
pp. 610-623 ◽  
Author(s):  
Lotte Geerlofs ◽  
Zhiyong He ◽  
Sa Xiao ◽  
Zhi-Cheng Xiao

Toxins ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 87 ◽  
Author(s):  
Silvio Sosa ◽  
Marco Pelin ◽  
Federica Cavion ◽  
Fabienne Hervé ◽  
Philipp Hess ◽  
...  

Pinnatoxin G (PnTx-G) is a marine cyclic imine toxin produced by the dinoflagellate Vulcanodinium rugosum, frequently detected in edible shellfish from Ingril Lagoon (France). As other pinnatoxins, to date, no human poisonings ascribed to consumption of PnTx-G contaminated seafood have been reported, despite its potent antagonism at nicotinic acetylcholine receptors and its high and fast-acting toxicity after intraperitoneal or oral administration in mice. The hazard characterization of PnTx-G by oral exposure is limited to a single acute toxicity study recording lethality and clinical signs in non-fasted mice treated by gavage or through voluntary food ingestion, which showed differences in PnTx-G toxic potency. Thus, an acute toxicity study was carried out using 3 h-fasted CD-1 female mice, administered by gavage with PnTx-G (8–450 µg kg−1). At the dose of 220 µg kg−1 and above, the toxin induced a rapid onset of clinical signs (piloerection, prostration, hypothermia, abdominal breathing, paralysis of the hind limbs, and cyanosis), leading to the death of mice within 30 min. Except for moderate mucosal degeneration in the small intestine recorded at doses of 300 µg kg−1, the toxin did not induce significant morphological changes in the other main organs and tissues, or alterations in blood chemistry parameters. This acute oral toxicity study allowed to calculate an oral LD50 for PnTx-G equal to 208 μg kg−1 (95% confidence limits: 155–281 µg kg−1) and to estimate a provisional NOEL of 120 µg kg−1.


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