Evaluation of 28-day repeated oral dose toxicity of SUNACTIVE Zn–P240 in rats

• Published in: Regulatory toxicology and pharmacology Vol. 125; p. 105001
• Main Authors: Lim, Jeong-Hyun, Park, Myeong-Kyu, Baek, Hyung-Seon, Lim, Je-Oh, Moon, Changjong, Shin, In-Sik, Kim, Jong-Choon
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.10.2021
• Subjects: Animals; Dietary Supplements - toxicity; Dose-Response Relationship, Drug; Erythrocytes - drug effects; Female; Liver - drug effects; Male; Nanotechnology; No-Observed-Adverse-Effect Level; NOAEL; Pancreas - drug effects; Rats; Rats, Sprague-Dawley; Repeated oral dose toxicity; Stomach - drug effects; SUNACTIVE Zn–P240; Target organ; Zinc - pharmacology; Zinc supplement; Repeated oral dose toxicity; Zinc supplement; SUNACTIVE Zn–P240; NOAEL; Target organ
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2021.105001

This study was conducted to investigate the potential toxicity of repeated oral dose of SUNACTIVE Zn–P240, a new type of zinc supplement, in Sprague-Dawley rats. SUNACTIVE Zn–P240 was administered once daily by gavage at doses of 0, 500, 1000, and 2000 mg/kg/day for each group over a 28-day period. At 2000 mg/kg/day, there were increases in serum alkaline phosphatase (ALP) and alanine aminotransferase, liver weight, histopathological changes in stomach, liver, and pancreas and decreases in body weight, food consumption, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration, total protein (TP), and albumin. At 1000 mg/kg/day, there was an increase in the serum ALP level and there were decreases in the MCV, MCH, and TP. There were no treatment-related adverse effects in the 500 mg/kg/day group. Under the present experimental conditions, the target organs in rats were determined to be the stomach, pancreas, liver, and erythrocyte and the no-observed-adverse-effect level (NOAEL) in rats was considered to be 500 mg/kg/day. •SUNACTIVE Zn–P240 is a new type of zinc supplement that applies nanotechnology.•Twenty eight-day repeated oral dose toxicity of SUNACTIVE Zn–P240 was evaluated in rats.•The target organs of SUNACTIVE Zn–P240 were the stomach, pancreas, liver, and erythrocyte.•The NOAEL for both male and female rats was 500 mg/kg/day.