Safety assessment studies of probiotic Saccharomyces boulardii strain Unique 28 in Sprague-Dawley rats

2011 ◽  
Vol 2 (3) ◽  
pp. 221-227 ◽  
Author(s):  
M. Ratna Sudha
Keyword(s):  
Acute Toxicity ◽  
Safety Assessment ◽  
Clinical Symptoms ◽  
Saccharomyces Boulardii ◽  
Female Rats ◽  
Toxicity Tests ◽  
Human Consumption ◽  
Sprague Dawley ◽  
Toxicity Studies ◽  
Probiotic Yeast

Strains of Saccharomyces boulardii, a probiotic yeast, have been found to be effective in the treatment of diarrhoea, inflammatory bowel disease, irritable bowel syndrome and other conditions. In the present study, Unique 28, a strain of S. boulardii isolated and characterised in our laboratory, was evaluated for its safety assessment. Acute and subacute toxicity tests were performed in rats. The dose of Unique 28 (5×109 cfu/g) fed orally was, up to 6,500 mg per kg of b.w. (body weight) for acute toxicity and up to 1,300 mg per kg of b.w. for sub-acute toxicity studies. This dose was well tolerated and there was no morbidity or any kind of toxic clinical symptoms displayed either in male or female rats. Moreover, the results of sub-acute toxicity studies using Unique 28 administered for 14 weeks indicated that there were no clear unwanted treatment related effects. Overall results of this toxicology assessment indicate that Unique 28 is safe for human consumption.

Acute and subacute toxicity assessment of Madhulai Manappagu (Siddha herbal syrup formulation) in animal model

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Meenakshi Sundaram Malayappan ◽  
Gayathri Natarajan ◽  
Logamanian Mockaiyathevar ◽  
Meenakumari Ramasamy
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Oral Route ◽  
Toxicity Assessment ◽  
Toxicity Study ◽  
Female Rats ◽  
Albino Rats ◽  
Oral Toxicity ◽  
Gross Pathology ◽  
Toxicity Studies

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.

scholarly journals ACUTE AND SUB CHRONIC TOXICITY STUDIES OF PURIFIED WITHANIA SOMNIFERA EXTRACT IN RATS

2018 ◽  
Vol 10 (12) ◽  
pp. 41 ◽  
Author(s):  
Benny Antony ◽  
Merina Benny ◽  
Binu T. Kuruvilla ◽  
Nishant Kumar Gupta ◽  
Anu Sebastian ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Dose Level ◽  
Chronic Toxicity ◽  
Withania Somnifera ◽  
Clinical Signs ◽  
Repeated Administration ◽  
Female Rats ◽  
Toxic Effects ◽  
Toxicity Studies ◽  
Adverse Effect Level

Objective: The objective of the present study was to evaluate the acute and sub-chronic (90 d; repeated dose) toxicity of Withania somnifera (ashwagandha) extract in rats.Methods: The acute toxicity was evaluated as per OECD (Organisation for Economic Co-operation and Development) guidelines 423. Purified ashwagandha extract (PAE) was fed at 2000 mg/kg body weight (bw) to overnight fasted female rats. The animals were observed daily for clinical signs of abnormality/mortality. After 14 d, animals were sacrificed and gross pathological changes were recorded. Sub-chronic toxicity of PAE was studied by feeding the extract at 100, 500 and 1000 mg/kg bw daily to rats as per OECD guidelines 408. After 90 d feeding, heamatological and biochemical parameters of treated rats were compared with control animals. Histopathology of all the major organs was also studied.Results: In the acute toxicity study, no mortality or clinical signs of toxicity were observed in any of the animals at maximum recommended dose level of 2000 mg/kg bw; therefore the LD50 is>2000 mg/kg bw in rats. The repeated administration of PAE for 90 d in rats at the maximum dose level of 1000 mg/kg bw did not induce any observable toxic effects, when compared to its corresponding control animals. The hematology and biochemistry profile of treated rats was similar to control animals and difference was non-significant (p>0.05). The histopathology of major organs of all the control and treated animals was normal. In this study the NOAEL (No Observed Adverse Effect Level) was calculated as 1000 mg/kg bw daily for rats.Conclusion: The present study clearly indicates that PAE does not have any toxic effects in animals at the dose evaluated as evidenced by acute and sub chronic toxicity studies in rats.

The incidence of chronic progressive nephrosis in young Sprague-Dawley rats from two different breeders

1998 ◽  
Vol 32 (4) ◽  
pp. 477-482 ◽  
Author(s):  
Maud Palm
Keyword(s):  
Kidney Function ◽  
Young Female ◽  
Female Rats ◽  
Common Finding ◽  
Sprague Dawley ◽  
Laboratory Rats ◽  
Toxicity Studies ◽  
Sprague Dawley Rats ◽  
Males And Females

Chronic progressive nephrosis (CPN) in rats may not only become a problem in long-term toxicity studies but also in short-term studies, if the breeding stock is not carefully selected with respect to the kidney function. This paper presents differences in kidney function between young rats of the same strain, Sprague-Dawley, but from two different breeders ('set A' and 'set B' rats). In set A rats, protein in the urine was present in the males, which is a common finding. In set B rats, not only the males but also the females excreted protein in the urine. The method used to detect protein in the urine does not normally show a positive protein result in the young female rats. At the age of 3 months signs of chronic progressive nephrosis were observed in 55% of the males and in 15% of the females in set B. Two months later, the incidence had increased to about 70–80% in males and 50% in females. At 8 months, the incidence was similar, but the severity had increased. These values were compared with those obtained from the set A rats, none of which showed any signs of the disease at the age of 5 months and only 5% of the males and females at the age of 8 months. The results indicated that an increased excretion of protein in the urine may be used as an indicator for chronic progressive nephrosis in the rat and that not only the strain but also the source is important in selecting laboratory rats for toxicity studies.

scholarly journals Acute toxicity assessment for TiO2 photocatalyst (GST) made from wastewater using TiCl4 in rat

2021 ◽  
Vol 36 (3) ◽  
pp. e2021019
Author(s):  
Ja Kyung Seol ◽  
Myeongkyu Park ◽  
Jae Min Im ◽  
Heung Sik Seo ◽  
Hee Ju Park ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
High Efficiency ◽  
Lethal Dose ◽  
Clinical Signs ◽  
Body Weight Loss ◽  
Toxicity Assessment ◽  
Female Rats ◽  
Sprague Dawley ◽  
Weight Changes

TiO2 was a photocatalyst that used to the most common product because of the high efficiency. TiO2 (P-25, commercial nanomaterial product) is the most typical photocatalyst product and TiO2 (GST) was a sludge recycling product. This study was reported to evaluate an acute toxicity of TiO2 (P-25 and GST) according to OECD test guideline 402 and 423 in Sprague-Dawley (SD) female rats via route of oral and dermal. There was investigated the lethal dose (LD50), and mortality, clinical signs, body weight changes and gross findings were continually monitored for 14 days following the single administration. After administration, TiO2 (P-25) was calculated that LD50 was considered to be a dose of over 2000 mg/kg body weight for both different route of exposure, and TiO2 (GST) was the same. Other items were no observed an adverse effect between P-25 and GST; no mortality and clinical signs, accidental body weight loss, no gross findings. On the basis of the above results, the toxicity of the GST was almost equal to that of the commercial product, P-25 and there was no toxicological evidence.

Application of 24-Hour Postexposure Observation to Acute Toxicity Studies with Invertebrates

1976 ◽  
Vol 33 (5) ◽  
pp. 1198-1201 ◽  
Author(s):  
Carl R. Hansen Jr. ◽  
Joseph A. Kawatski
Keyword(s):  
Acute Toxicity ◽  
Free Water ◽  
Toxicity Tests ◽  
Toxicity Studies ◽  
Observation Period

Experimentation with carbaryl, dieldrin, endothal, malathion, and TFM (3-trifluoromethyl-4-nitrophenol) on the ostracod Cypretta kawatai and the midge Chironomus tentons demonstrated that the method of routine toxicity tests with invertebrates can be substantially improved by including a posttreatment (toxicant-free water) observation period. This improvement enables confirmation of death and thereby reveals latent toxicity or recovery.

scholarly journals Acute Toxicity Evaluation of a Crude Sap Isolated from Nypa fruticants Wurmb. in Sprague Dawley Rats

2021 ◽  
Vol 50 (3) ◽  
pp. 711-721
Author(s):  
SITI FATIMAH ROQIAH YAHAYA ◽  
NIZA SAMSUDDIN ◽  
SUHANA MAMAT ◽  
ROZITA HOD ◽  
NOR ZAMZILA ABDULLAH ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Histopathological Examination ◽  
Vital Signs ◽  
Treated Group ◽  
Female Rats ◽  
Full Blood Count ◽  
Control Group ◽  
Sprague Dawley ◽  
Sprague Dawley Rats ◽  
Significant Difference

Nypa fruticans Wurmb. (nipa palm) sap, locally known as air nira or tuak, is a sweet natural beverage in Malaysia with antioxidant potency beneficial for human health. However, nypa sap lacks scientific attention with no toxicity study has been established. Therefore, this study was performed to evaluate the acute toxicity of nypa sap in the female Sprague Dawley rats. Twenty-five female rats were randomly divided into one control group and four treated groups. Treated groups were orally administered with doses of 5, 50, 300, and 2000 mg/kg of nypa sap, while the control group had received normal saline solution. The animals’ vital signs and mortality were recorded daily at an interval of 30 min and continued up to 14 days. Their blood samples and organs were harvested for toxicity analysis to assess liver and kidney function, lipid profile, and full blood count. The acute toxicity test via measurement of the biochemical and haematological parameters had shown that there was no significant difference between the treated and control groups. However, the blood glucose level in the treated groups (at higher doses of 300 and 2000 mg/kg, respectively) was significantly decreased. A similar trend was recorded for mean corpuscular volume (MCV) albeit in the treated group of 50 mg/kg doses. Histopathological examination of the organs showed no signs of abnormality in both treated and untreated groups. Overall, the results showed that consumption of nypa sap is potentially safe with no acute toxic effect on the laboratory rat models.

scholarly journals Acute and Subacute Toxicity Assessment of Ethyl Acetate Extracts from Aerial Parts of Clerodendrum thomsoniae Balf.f in Rodents

2021 ◽  
Vol 11 (6) ◽  
pp. 13952-13961
Keyword(s):  
Acute Toxicity ◽  
Ethyl Acetate ◽  
Human Subjects ◽  
Female Rats ◽  
Laboratory Animals ◽  
Oral Toxicity ◽  
Subacute Toxicity ◽  
Toxicity Studies ◽  
Male And Female Rats

Clerodendrum is a genus of about 500 species belongs to the family Lamiaceae. Several species of this genus have been proved for the treatment of various diseases. Clerodendrum thomsoniae Balf.f were selected in this study; according to the literature available, there is no systematic toxicity studies for this plant were described. The current study was therefore carried out to evaluate the acute and sub-acute toxicity in mice and rats. The acute oral toxicity study was performed in mice following OECD guidelines 425, and the sub-acute toxicity was performed in male and female rats following OECD guidelines 407. The results showed that mice given a single dose of up to 2000 mg/kg orally did not show any toxicity signs or mortality. In the sub-acute toxicity analysis in rats, 3 specific daily doses of 150, 300, and 600 mg/kg for 28 days did not induce any major changes to the hematological and biochemical parameters. Histopathological studies revealed normal architecture that did not indicate any morphological disturbances. In our study, no deaths or any signs of toxicity were found in acute and subacute toxicity studies after oral administration according to OECD guidelines, which concluded that ethyl acetate extract of Clerodendrum thomsoniae Balf (EACT) could use for in vivo biological activity studies in laboratory animals to explore its various medicinal activity before study in human subjects.

scholarly journals Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials

2021 ◽  
Vol 12 ◽  
Author(s):  
Jin-Sung Park ◽  
Euna Kwon ◽  
Yun-Soon Kim ◽  
Sang-Moo Kim ◽  
Dae-Sun Kim ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Clinical Signs ◽  
Water Extract ◽  
Deciduous Tree ◽  
Human Consumption ◽  
Beagle Dogs ◽  
Sprague Dawley ◽  
Oral Toxicity

Acer tegmentosum Maxim., commonly known as Manchurian stripe maple, is a deciduous tree belonging to the family of Aceraceae and has been traditionally used in folk medicine for its remedial effects in liver diseases and traumatic bleedings. With a growing body of experimental evidence for its pharmacological efficacies, such as neuroprotective, hepatoprotective, antioxidant, and anti-inflammatory activities, A. tegmentosum has gradually gained popularity as a health supplement and functional food. However, the large part of essential toxicity information still remained lacking despite the possibility of mutagenic potentials as previously suggested, posing safety concerns for human consumption. In this study, we evaluated 90-day repeated oral toxicity of A. tegmentosum Maxim. water extract (ATWE) in SD rats with acute toxicity assessment in beagle dogs, and reevaluated genotoxicity using a combination of in vitro and in vivo assays. During the oral study period, ATWE did not cause toxicity-related clinical signs and mortality in rodents without adverse effects observed in the analysis of hematology, serum biochemistry, and histopathology, establishing >5,000 mg/kg BW as the NOAEL. In addition, doses up to 5,000 mg/kg BW did not cause acute toxicity in beagle dogs. When assessed for genotoxicity using bacterial reverse mutation, chromosome aberration, and micronucleus formation, ATWE showed lack of mutagenicity and clastogenicity. These results demonstrated that AWTE was safe in the present preclinical study for systemic toxicity and genotoxicity at the tested doses, providing a guideline for safe use in humans.

scholarly journals Acute toxicity studies of aqueous leaf extract of Phyllanthus niruri

2011 ◽  
Vol 4 (4) ◽  
pp. 206-210 ◽  
Author(s):  
George Asare ◽  
Phyllis Addo ◽  
Kwasi Bugyei ◽  
Ben Gyan ◽  
Samuel Adjei ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Leaf Extract ◽  
Female Rats ◽  
Full Blood Count ◽  
Control Group ◽  
High Dose ◽  
Oral Gavage ◽  
Phyllanthus Niruri ◽  
Toxicity Studies ◽  
Aqueous Leaf Extract

Acute toxicity studies of aqueous leaf extract ofPhyllanthus niruriPhyllanthus niruriis a plant with medicinal properties. It is often used to treat mild malaria and the elimination of renal stones. However, studies on its toxicity are scarce. The study was carried out to determine if the aqueous leaf extract ofP. niruriadministered to female Sprague-Dawley rats would illicit evidence of toxicity. Fifteen female rats weighing 150-200 g were divided into 3 groups. Rats in Group 1 were given a single low dose (LD) of 2 000 mg/kg b.w. of the extract by oral gavage within 24 hrs. Rats in Group 2 were given a single high dose (HD) of 5 000 mg/kg b.w. of the extract by oral gavage within 24 hrs. Rats in Group 3 were not given any extract but drinking water and served as the control group (C). All the rats were observed for signs of toxidromes for 14 days. On the 15thday, all the rats were sacrificed. Body organs were harvested for macroscopic examination. Urine and blood samples were drawn and analyzed. Hematological tests performed included full blood count and hemoglobin. Biochemical examinations included bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, globulin, alkaline phosphatse (ALP), γ-glutamyltranspeptidase (GGT), urea, and creatinine. The results of the three groups were not significantly different. Examination of the various body organs did not show any abnormality. Thus no toxicity was observed at the levels administered. The LD50of the aqueous extract is > 5 000 mg/kg. b.w.

Acute and sub-acute toxicity studies using Shemamruthaa, a modified indigenous Siddha preparation, in Sprague-Dawley rats

2013 ◽  
Vol 23 (1) ◽  
pp. 299-306 ◽  
Author(s):  
Elumalai Nandhakumar ◽  
Ayyakkannu Purushothaman ◽  
Panchanadham Sachdanandam
Keyword(s):  
Acute Toxicity ◽  
Sprague Dawley ◽  
Toxicity Studies ◽  
Sprague Dawley Rats
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