J Biomed Transl Res.  2022 Dec;23(4):131-149. 10.12729/jbtr.2022.23.4.131.

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

• Lim JH
• Park MK
• Seo HS
• Kim SH
• Kim WI
• Shin IS
• Kim JC

• KMID: 2538511
• DOI: http://doi.org/10.12729/jbtr.2022.23.4.131

Abstract

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, ophthalmo-scopy, 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.

Keyword

iron; supplements; SUNACTIVE Fe-P80; subchronic toxicity; no-observed-ad- verse-effect level