Safety assessment of astaxanthin from Haematococcus pluvialis: Acute toxicity, genotoxicity, distribution and repeat-dose toxicity studies in gestation mice

2020 ◽  
Vol 115 ◽  
pp. 104695 ◽  
Author(s):  
Tingting Niu ◽  
Jiawei Zhou ◽  
Feng Wang ◽  
Rongrong Xuan ◽  
Juanjuan Chen ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Safety Assessment ◽  
Haematococcus Pluvialis ◽  
Repeat Dose ◽  
Repeat Dose Toxicity ◽  
Toxicity Studies

scholarly journals Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats

2020 ◽  
Vol 7 ◽  
pp. 376-385 ◽  
Author(s):  
Margitta Dziwenka ◽  
Robert Coppock ◽  
McCorkle Alexander ◽  
Eddie Palumbo ◽  
Carlos Ramirez ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Repeat Dose ◽  
Sprague Dawley ◽  
Repeat Dose Toxicity ◽  
Toxicity Studies ◽  
Sprague Dawley Rats

Rodent big brother: Development and validation of a home cage automated behavioural monitoring system for use in repeat-dose toxicity studies in rats

2014 ◽  
Vol 229 ◽  
pp. S47-S48 ◽  
Author(s):  
Will S. Redfern ◽  
J. Douglas Armstrong ◽  
James Heward ◽  
Ben Allison ◽  
Tim Lukins ◽  
...  
Keyword(s):  
Monitoring System ◽  
Home Cage ◽  
Repeat Dose ◽  
Repeat Dose Toxicity ◽  
Toxicity Studies ◽  
Big Brother ◽  
Development And Validation

Nonclinical Safety Assessment of a Synthetic Peptide Thrombopoietin Agonist

2011 ◽  
Vol 30 (4) ◽  
pp. 385-404 ◽  
Author(s):  
Elaine Knight ◽  
Gary Eichenbaum ◽  
Verna Hillsamer ◽  
Tony Greway ◽  
Alfred Tonelli ◽  
...  
Keyword(s):  
Antibody Formation ◽  
Safety Assessment ◽  
Chemical Nature ◽  
Osseous Metaplasia ◽  
Repeat Dose ◽  
Stopping Criterion ◽  
Platelet Volume ◽  
Repeat Dose Toxicity ◽  
Pharmacologic Effect ◽  
Pharmacologic Activity

RWJ-800088 is a novel, potent polyethylene glycol (PEG)-conjugated thrombopoietin (TPO) mimetic that increases platelet levels and protects against thrombocytopenia. A nonclinical safety program was customized for this peptide that takes into account its protein-like structure, synthetic chemical nature, agonist pharmacologic activity, and mode of administration. In repeat-dose toxicity studies, the salient findings were dose-related increases in circulating platelet counts, mean platelet volume, and megakaryocytes in the bone marrow with no antibody formation. Reversible myelofibrosis and hyperostosis were observed in rats, but not dogs, when the circulating platelet levels exceeded 3× those of vehicle controls. The bone effects were due to the exaggerated pharmacologic effect and excessive stimulation and elevation of megakaryocytes by TPO, which results in intramedullary proliferation of fibroblasts and mesenchymal cells followed by osseous metaplasia. These findings support the use of platelet elevations of >3× as a stopping criterion to prevent potential adverse bone-related effects in humans.

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.

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