Twenty-eight-day oral dose toxicity evaluation of SUNACTIVE Fe-P80 in rats

서지정보

ㆍ발행기관 : 충북대학교 동물의학연구소 ㆍ수록지정보 : Journal of Biomedical and Translational Research / 23권 / 4호
ㆍ저자명 : Jeong-Hyun Lim, Myeong-Kyu Park, Heung-Sik Seo, Sang-Ho Kim, Woong-Il Kim, In-Sik Shin, Jong-Choon Kim

목차

Abstract
INTRODUCTION
MATERIALS AND METHODS
Experimental animals and animal husbandry
Preparation of test substance
Dosage selection and experimental groups
Administration
Clinical signs, body weight, and food consumption
Ophthalmoscopy
Urinalysis
Hematology
Serum biochemistry
Necropsy
Organ weights
Histopathology
Statistical analysis
RESULTS
Clinical signs, body weight, and food consumption
Urinalysis and ophthalmic examination
Hematology
Serum biochemistry
Gross findings and organ weights
Histopathology
DISCUSSION
REFERENCES

영어 초록

Iron deficiency is known to be a common nutritional disorder in many countries, especially among children, women of childbearing age and pregnant women. SUNACTIVE Fe-P80 is a new type of iron supplement that applies nanotechnlateology for the purpose of overcoming the disadvantages of food supplements. This study was conducted to investigate the potential adverse effects of a 28-day repeated oral dose of SUNACTIVE Fe-P80 in rats. SUNACTIVE Fe-P80 was administered once daily by gavage to Sprague-Dawley rats for 28 days at doses of 0, 500, 1,000, and 2,000 mg/kg/day. Additional recovery groups from the control and highdose groups were observed for a 14-day recovery period. At the scheduled termination, the animals were sacrificed, their organs weighed, and blood samples collected. There were no treatment-related effects in the context of clinical signs, body weight, food intake, ophthalmoscopy, urinalysis, necropsy findings, organ weights, and hematologic, serum biochemical and histopathological parameters at any dose tested. Under the present experimental conditions, the no-observed-adverse-effect level of SUNACTIVE Fe-P80 was ≥ 2,000 mg/kg/day in both the sexes, and no target organs were identified. Thus, the results suggest that SUNACTIVE Fe-P80 is relatively safe, as no treatment-related adverse effects were observed following a 28-day repeated oral dose experiment.

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