Marone Palma Ann, Heimbach James T, Nemzer Boris, Hunter John M
Department of Pharmacology and Toxicology, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA 23298, USA.
JHeimbach LLC, 923 Water Street, Box 66, Port Royal, VA 22535, USA.
Food Chem Toxicol. 2016 Sep;95:75-88. doi: 10.1016/j.fct.2016.06.021. Epub 2016 Jun 25.
A branded calcium fructoborate product, a nature-identical calcium salt of bis (fructose) ester of boric acid found in plants and a natural source of boron in the human diet and sold under the trade name FruiteX-B(®) Brand Calcium Fructoborate ("FrxB"), was evaluated in a 90-day dietary toxicity study and two genotoxicity studies. In the 90-day study, four groups of 10 male and 10 female Crl:SD CD(®) IGS rats were fed diets with FrxB admixtures of 0.56, 1.12, and 1.68% dietary concentration, providing mean overall daily intakes of FrxB in male rats of 385.8, 774.9, and 1161.3 mg/kg bw/day, and 392.1, 784.4, and 1171.1 mg/kg bw/day in female rats. There were no mortalities, no clinical or ophthalmologic signs, body weight, body weight gain, food consumption, food efficiency, Functional Observational Battery (FOB), or Motor Activity (MA) findings associated with the administration of FrxB. There were no adverse changes in hematology, coagulation, clinical chemistry, or urinalysis parameters in male or female rats considered the result of test substance administration. At necropsy, there were no macroscopic, histopathological findings, or organ weight changes deemed related to administration of the test substance. Under the conditions of this study, based on the toxicological endpoints evaluated, the no-observed-adverse-effect level (NOAEL) for FrxB in the diet was 1161.3 and 1171.1 mg/kg bw/day in male and female rats, respectively. Bacterial mutagenicity studies and a micronucleus test using Chinese hamster V79 cells demonstrated no mutagenic or genotoxic potential of the tested brand of calcium fructoborate.
一种名为FruiteX - B（®）品牌果糖硼酸钙（“FrxB”）的品牌产品，它是一种在植物中发现的硼酸双（果糖）酯的天然等同钙盐，也是人类饮食中硼的天然来源。该产品在一项90天的饮食毒性研究和两项遗传毒性研究中进行了评估。在90天的研究中，将四组每组10只雄性和10只雌性Crl:SD CD（®）IGS大鼠分别喂食含有0.56%、1.12%和1.68%饮食浓度的FrxB混合物的饲料，雄性大鼠的FrxB平均每日总摄入量分别为385.8、774.9和1161.3毫克/千克体重/天，雌性大鼠分别为392.1、784.4和1171.1毫克/千克体重/天。未出现死亡情况，未观察到与FrxB给药相关的临床或眼科体征、体重、体重增加、食物消耗、食物效率、功能观察组合（FOB）或运动活动（MA）结果。在雄性或雌性大鼠中，未发现血液学、凝血、临床化学或尿液分析参数的不良变化被认为是受试物质给药的结果。尸检时，未发现与受试物质给药相关的宏观、组织病理学发现或器官重量变化。在本研究条件下，基于所评估的毒理学终点，饮食中FrxB对雄性和雌性大鼠的无观察到有害作用水平（NOAEL）分别为1161.3和1171.1毫克/千克体重/天。细菌诱变性研究和使用中国仓鼠V79细胞的微核试验表明，受试品牌的果糖硼酸钙没有诱变或遗传毒性潜力。
