He Xueying, Tang Juli, Wen Xiantao, Guan Bo, Wang Rui, Wang Hui, Li Hua, Shi Jianfeng, Zeng Yali, Mao Yongjian
Beijing Institute of Medical Device Testing, Beijing, 101111.
Beijing Key Laboratory of Medical Device Testing and Safety Evaluation, Beijing, 101111.
Zhongguo Yi Liao Qi Xie Za Zhi. 2020 Oct 8;44(5):448-452. doi: 10.3969/j.issn.1671-7104.2020.05.016.
The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9, 3.7, 2.5 mg/(kg.d), and the second stage doses of 1.2, 0.25 mg/(kg.d) by the intravenous route. The results showed that the NOAEL of nickel ion is 0.25 mg/(kg.d) for SD rats, and the result was verified by subchronic systemic toxicity test of nickel alloy. The threshold of toxicological concern (TTC) of nickel is 150 μg/d (based on application of 100-fold uncertainty factor and a body weight of 60 kg)deduced by these data.
本研究的目的是探讨镍离子的无观察到有害作用水平（NOAEL），并为含镍医疗器械的生物学评价提供基础数据。将五组SD大鼠通过静脉途径分别在第一阶段以4.9、3.7、2.5mg/（kg·d）的剂量，在第二阶段以1.2、0.25mg/（kg·d）的剂量反复暴露14天。结果表明，SD大鼠镍离子的NOAEL为0.25mg/（kg·d），该结果通过镍合金的亚慢性全身毒性试验得到验证。根据这些数据推导得出镍的毒理学关注阈值（TTC）为150μg/d（基于100倍不确定系数和60kg体重）。
