Single- and Repeated-Dose Oral Toxicity Studies of Citicoline Free-Base (Choline Cytidine 5′-Pyrophosphate) in Sprague-Dawley Rats

The dietary supplement Citicoline free-base (choline cytidine 5′-pyrophosphate) was toxicologically evaluated in Sprague-Dawley rats using oral gavage. In an acute 14-day study, 2000 mg/kg was well tolerated. In a 90-day study, 100, 350, and 1000 mg/kg/day doses resulted in no mortality. In males, slight significant increases in serum creatinine (350 and 1000 mg/kg/day), and decreases in urine volume (all treated groups) were observed. In females, slight significant increases in total white blood cell and absolute lymphocyte counts (1000 mg/kg/day), and blood urea nitrogen (BUN) (100 and 350, but not 1000 mg/kg/day) were noted. A dose-related increase in renal tubular mineralization, without degenerative or inflammatory reaction, was found in females (all treated groups) and two males (1000 mg/kg/day). Renal mineralization in rats (especially females) is influenced by calcium:phosphorus ratios in the diet. A high level of citicoline consumption resulted in increased phosphorus intake in the rats, and likely explains this result.

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4-Week repeated dose oral toxicity study of N-ethyl-2-pyrrolidone in Sprague Dawley rats

Regulatory Toxicology and Pharmacology ◽

10.1016/j.yrtph.2016.09.011 ◽

2016 ◽

Vol 81 ◽

pp. 275-283 ◽

Cited By ~ 4

Author(s):

A.M. Saillenfait ◽

F. Marquet ◽

J.P. Sabaté ◽

D. Ndiaye ◽

A.M. Lambert-Xolin

Keyword(s):

Toxicity Study ◽

Repeated Dose ◽

Sprague Dawley ◽

Oral Toxicity ◽

Sprague Dawley Rats ◽

Dose Oral

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

INQUIRY The Journal of Health Care Organization Provision and Financing ◽

10.1177/00469580211056044 ◽

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.

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A 4-Week Repeated-Dose Oral Toxicity Study of Bojungikgi-Tang in Crl:CD Sprague Dawley Rats

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/4748904 ◽

2017 ◽

Vol 2017 ◽

pp. 1-8 ◽

Cited By ~ 3

Author(s):

Sae-Rom Yoo ◽

Hyekyung Ha ◽

Mee-Young Lee ◽

Hyeun-Kyoo Shin ◽

Su-Cheol Han ◽

...

Keyword(s):

Body Weight ◽

Food Intake ◽

Serum Biochemistry ◽

Toxicity Study ◽

Repeated Dose ◽

Sprague Dawley ◽

Oral Toxicity ◽

Organ Weights ◽

Sprague Dawley Rats ◽

Dose Oral

Traditional herbal medicines have been used for centuries in Asian countries. However, recent studies have led to increasing concerns about the safety and toxicity of herbal prescriptions. Bojungikgi-tang (BJIGT), a herbal decoction, has been used in Korea to improve physical strength. To establish the safety information, BJIGT water extract was evaluated in a 4-week repeated-dose oral toxicity test in Crl:CD Sprague Dawley rats. BJIGT was orally administered in daily doses of 0, 500, 1000, and 2000 mg/kg/day for 4 weeks via oral gavage in male and female rats. We examined the mortality, clinical signs, body weight change, food intake, organ weights, hematology, serum biochemistry, and urinalysis parameters. No significant changes were observed in mortality, clinical sings, body weight, food intake, organ weights, hematology, serum biochemistry, and urinalysis parameters between the control group and the BJIGT-treated groups in the rats of both sexes. The results indicate that BJIGT did not induce toxic effects at a dose level up to 2000 mg/kg in rats. Thus, this concentration is considered the nonobservable effect dose in rats and is appropriate for a 13-week subchronic toxicity study.

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