PDF(Pubmed)
Abstract：
Steady-calcium formula (SCF), a functional food mixture with potential of joint care, contains five major ingredients. However, the uncertain cross-reactivity among these included ingredients cannot be excluded. Hence, it is important to ensure the safety of this mixture. In this study, the safety of SCF was evaluated through in vitro genotoxicity assessment and 28-day oral toxicity study in rats. The bacterial reverse mutation test and mammalian chromosome aberration test displayed that SCF did not induce mutagenicity and clastogenicity. The 28-day repeated dose assessment of SCF in rats revealed no mortality and adverse effects in clinical signs, body weight, urinalysis, hematology, organ weight, and histopathology at all treated groups. Although some significant changes were observed in food intake and parameters of serum biochemistry at the highest dose in males, they were not dose-related and considered to be within normal range. These findings indicate that SCF does not possess genotoxic potential and no obvious evidence of subacute toxicity. These results demonstrate for the first time that the genotoxicity and subacute toxicity for SCF are negative under our experimental conditions and the no observed adverse effect level (NOAEL) of SCF may be defined as at least 5470 mg/kg/day.
摘要：
稳定钙配方(SCF)，具有关节护理潜力的功能性食物混合物，包含五个主要成分。然而,不能排除这些包含的成分之间不确定的交叉反应性。因此，重要的是要确保这种混合物的安全。在这项研究中,通过体外遗传毒性评估和大鼠28日口服毒性研究评估了SCF的安全性.细菌回复突变试验和哺乳动物染色体畸变试验表明，SCF没有诱导致突变性和致突变性。在大鼠中对SCF的28天重复剂量评估显示，在临床体征中没有死亡和不良反应。体重,尿液分析,血液学,器官重量,所有治疗组的组织病理学。尽管男性在最高剂量下观察到食物摄入量和血清生化参数的一些显着变化，它们与剂量无关,被认为在正常范围内.这些发现表明SCF不具有遗传毒性潜力，也没有亚急性毒性的明显证据。这些结果首次表明，在我们的实验条件下，SCF的遗传毒性和亚急性毒性是阴性的，并且SCF的未观察到的不良反应水平（NOAEL）可以定义为至少5470mg/kg/天。
