Matsushita Kohei, Toyoda Takeshi, Akane Hirotoshi, Morikawa Tomomi, Ogawa Kumiko
Division of Pathology, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki, Kanagawa, 210-9501, Japan.
Division of Pathology, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki, Kanagawa, 210-9501, Japan.
Food Chem Toxicol. 2023 May;175:113702. doi: 10.1016/j.fct.2023.113702. Epub 2023 Mar 3.
Heme iron (HI) has been widely used as a food additive and supplement to support iron fortification. However, no sufficient toxicological data to evaluate the safety of HI have been reported. In the current study, we performed a 13-week subchronic toxicity study of HI in male and female Crl:CD(SD) rats. Rats were orally administered HI in the diet at concentrations of 0%, 0.8%, 2%, and 5%. Observations of general condition, body weight (bw) and food consumption, urinalysis, hematology, serum biochemistry, and macroscopic and histopathological examination were performed. The results showed that HI had no adverse effects on any of the examined parameters. Therefore, we concluded that the no-observed-adverse-effect level (NOAEL) for HI was estimated to be 5% for both sexes (2,890 mg/kg bw/day for males and 3,840 mg/kg bw/day for females). Since the iron content of HI used in this study was in a range of 2.0-2.6%, iron content at NOAEL for HI was calculated to be 57.8-75.1 mg/kg bw/day for males and 76.8-99.8 mg/kg bw/day for females.
血红素铁（HI）已被广泛用作食品添加剂和补充剂以支持铁强化。然而，尚未有足够的毒理学数据来评估HI的安全性。在本研究中，我们对雄性和雌性Crl:CD(SD)大鼠进行了为期13周的HI亚慢性毒性研究。大鼠通过饮食口服给予浓度为0%、0.8%、2%和5%的HI。进行了一般状况、体重（bw）和食物消耗、尿液分析、血液学、血清生物化学以及大体和组织病理学检查。结果表明，HI对任何检测参数均无不良影响。因此，我们得出结论，HI对两性的无观察到不良作用水平（NOAEL）估计均为5%（雄性为2890毫克/千克体重/天，雌性为3840毫克/千克体重/天）。由于本研究中使用的HI的铁含量在2.0 - 2.6%范围内，HI的NOAEL下的铁含量经计算雄性为57.8 - 75.1毫克/千克体重/天，雌性为76.8 - 99.8毫克/千克体重/天。
