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KMID : 1147220220230040131
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Journal of Biomedical and Translational Research
2022 Volume.23 No. 4 p.131 ~ p.149
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Twenty-eight-day oral dose toxicity evaluation of SUNACTIVE Fe-P80 in rats
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Lim Jeong-Hyun
Park Myeong-Kyu
Seo Heung-Sik
Kim Sang-Ho
Kim Woong-Il
Shin In-Sik
Kim Jong-Choon
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Abstract
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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 high-dose 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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KEYWORD
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iron, supplements, SUNACTIVE Fe-P80, subchronic toxicity, no-observed-adverse-effect level
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