Safety evaluation of transgenic low-gliadin wheat in Sprague Dawley rats: An alternative to the gluten free diet with no subchronic adverse effects

2017 ◽  
Vol 107 ◽  
pp. 176-185 ◽  
Author(s):  
Carmen Victoria Ozuna ◽  
Francisco Barro
2007 ◽  
Vol 45 (10) ◽  
pp. 1928-1937 ◽  
Author(s):  
J. Joshua Allan ◽  
A. Damodaran ◽  
N.S. Deshmukh ◽  
K.S. Goudar ◽  
A. Amit

1997 ◽  
Vol 3 (S2) ◽  
pp. 49-50
Author(s):  
B.A. MacDuff ◽  
A. Singh ◽  
I. Chu

Although there are a variety of gasoline ethanol mixtures proposed as neat fuels (ethanol 85% + gasoline 15% = E85; E95) for automobiles, gasohol (gasoline 90% + ethanol 10%) is presently used as a fuel in the United States. The adverse effects, if any, of gasohol ingestion are unknown; effects on the liver of rats administered gasohol are examined in this study.Twenty-four female Sprague-Dawley rats received daily, via gavage, one of the three concentrations of gasohol for 28 days; LD50/20, LD50/100 and LD50/1000, where LD50 = 1.5g ethanol / kg body weight (bw) and 14g gasoline / kg bw. The LD50 was based on that of gasoline, which was obtained from literature value.1 The amount of ethanol added to stock gasohol was only 1/10 its LD50, required to maintain the gasoline ethanol proportion of 9:1. Gasohol was administered in corn oil with total volume 10 ml. Animals that received only corn oil served as controls.


2018 ◽  
Vol 120 ◽  
pp. 544-551
Author(s):  
Maria Bastaki ◽  
Michel Aubanel ◽  
Thierry Cachet ◽  
Jan Demyttenaere ◽  
Maodo Malick Diop ◽  
...  

2020 ◽  
Vol 48 (7) ◽  
pp. 905-908
Author(s):  
Tracy Carlson ◽  
Lily Yee

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.


2014 ◽  
Vol 70 (2) ◽  
pp. 482-491 ◽  
Author(s):  
Sharon S.H. Choi ◽  
Nigel Baldwin ◽  
Valentine O. Wagner ◽  
Shambhu Roy ◽  
Jennifer Rose ◽  
...  

Author(s):  
Min Hong ◽  
Min Lu ◽  
Yimin Qian ◽  
Liping Wei ◽  
Yaqun Zhang ◽  
...  

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.


Andrologia ◽  
2018 ◽  
Vol 51 (3) ◽  
pp. e13196 ◽  
Author(s):  
Amir Hafidz Md Mokhtar ◽  
Ifrah Alam Malik ◽  
Noor Azean Anis Abd Aziz ◽  
Fayez A. Almabhouh ◽  
Damayanthi Durairajanayagam ◽  
...  

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