Safety evaluation of a standardized phytochemical composition extracted from Bacopa monnieri in Sprague–Dawley rats

2007 ◽  
Vol 45 (10) ◽  
pp. 1928-1937 ◽  
Author(s):  
J. Joshua Allan ◽  
A. Damodaran ◽  
N.S. Deshmukh ◽  
K.S. Goudar ◽  
A. Amit
Keyword(s):  
Safety Evaluation ◽  
Bacopa Monnieri ◽  
Sprague Dawley ◽  
Phytochemical Composition ◽  
Sprague Dawley Rats

Spontaneous Necrotizing Hepatic Arteriopathy in Male Sprague-Dawley Rats

2020 ◽  
Vol 48 (7) ◽  
pp. 905-908
Author(s):  
Tracy Carlson ◽  
Lily Yee
Keyword(s):  
Hepatic Artery ◽  
Evaluation Studies ◽  
Safety Evaluation ◽  
Vascular Wall ◽  
Sprague Dawley ◽  
Control Male ◽  
Perivascular Edema ◽  
Sprague Dawley Rats ◽  
Safety Studies ◽  
Microscopic Features

Differentiating test article–related vascular changes from spontaneous findings is important for microscopic interpretation in drug safety evaluation studies intended for regulatory submission. Here, we report background spontaneous hepatic artery degeneration and necrosis in up to 20% of 3- to 9-month-old control male Sprague-Dawley rats in 23 individual safety studies. The vascular degeneration occurred in one cross section of a medium-sized hepatic artery near the hilus and ranged from acute intramural hemorrhage and fibrinoid necrosis to chronic fibrosis of the vascular wall with perivascular edema, hemorrhage, and inflammatory cell infiltrates. The cause was uncertain. Many microscopic features were consistent with systemic necrotizing arteriopathy (SNA) or polyarteritis; however, there was no change in arteries commonly affected in SNA/polyarteritis (mesenteric, pancreatic, or testicular arteries) and hepatic artery degeneration/necrosis occurred in younger rats which is unusual for SNA/polyarteritis. Spontaneous hepatic artery degeneration/necrosis represents a sporadic background finding that may be confused with a test article’s toxicologic effect.

Safety evaluation of the human-identical milk monosaccharide sialic acid (N-acetyl-d-neuraminic acid) in Sprague-Dawley rats

2014 ◽  
Vol 70 (2) ◽  
pp. 482-491 ◽  
Author(s):  
Sharon S.H. Choi ◽  
Nigel Baldwin ◽  
Valentine O. Wagner ◽  
Shambhu Roy ◽  
Jennifer Rose ◽  
...  
Keyword(s):  
Sialic Acid ◽  
Safety Evaluation ◽  
Neuraminic Acid ◽  
Sprague Dawley ◽  
Sprague Dawley Rats

scholarly journals A 90-day Sub-chronic Oral Toxicity Assessment of Mulberry Extract in Sprague Dawley Rats

2021 ◽  
Vol 58 ◽  
pp. 004695802110560
Author(s):  
Min Hong ◽  
Min Lu ◽  
Yimin Qian ◽  
Liping Wei ◽  
Yaqun Zhang ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Recovery Period ◽  
Safety Evaluation ◽  
Toxicity Assessment ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Renal Tubular Cells ◽  
Sprague Dawley Rats ◽  
Adverse Effect Level ◽  
Renal Tubular

Mulberry extract from Fructus Mori contains an anthocyanin pigment and has been widely used as a food additive in China and other Eastern Asian countries. Only few research has been done on toxicological profiling of mulberry extract for its safety evaluation; however, the data is inconclusive. In the current study, mulberry extract of 4200, 1400, or 466 mg/kg were orally administrated to Sprague Dawley rats for 90 consecutive days followed by a recovery period of 28 days. No abnormalities were detected in body weights, food intake, ophthalmological, hematological, coagulation, clinical chemistry, and organ weights parameters. Discoloration of urine (red, purple, and brown) and feces (black), along with bedding material (purple) were observed in the 4200 mg/kg group. Further, microscopic examination revealed brown granules in the renal tubular cells for rats in 4200 and 1400 mg/kg groups. Since these changes were associated with excretory effect of the extract, the No Observed Adverse Effect Level was determined to be 4200 mg/kg, which was equivalent to the 1058.5 mg/kg of anthocyanin.

scholarly journals Safety evaluation of cricket(Gryllus bimaculatus) extract in Sprague-Dawley rats

2016 ◽  
Vol 32 (1) ◽  
pp. 12-25 ◽  
Author(s):  
Somin Lee ◽  
Kyu Sup Ahn ◽  
Hyeon Yeol Ryu ◽  
Hye Jin Kim ◽  
Jin Kyu Lee ◽  
...  
Keyword(s):  
Safety Evaluation ◽  
Sprague Dawley ◽  
Gryllus Bimaculatus ◽  
Sprague Dawley Rats

scholarly journals Safety Evaluation of Wood–Based Activated Carbon Fibers in a 28–day Feeding Study in Sprague–Dawley Rats

2015 ◽  
Vol 60 (2) ◽  
pp. 427-434
Author(s):  
Han Chien Lin ◽  
Ji Cheng Hsueh ◽  
Wen-Ru Li ◽  
Ying-Jang Lai ◽  
She–Ching Wu ◽  
...  
Keyword(s):  
Activated Carbon ◽  
Carbon Fibers ◽  
Safety Evaluation ◽  
Activated Carbon Fibers ◽  
Sprague Dawley ◽  
Feeding Study ◽  
Sprague Dawley Rats

scholarly journals Safety evaluation for multispecies probiotics in a 28-day feeding study in Sprague-Dawley rats

2014 ◽  
Vol 8 (7) ◽  
pp. 127-136 ◽  
Author(s):  
Huang Chun-Chih ◽  
Nam Mun-Kit ◽  
Tsai Yueh-Ting ◽  
Tsai Cheng-Chih
Keyword(s):  
Safety Evaluation ◽  
Sprague Dawley ◽  
Feeding Study ◽  
Sprague Dawley Rats
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