Study of No Observed Adverse Effect Level of Nickel and Its Preliminary Evaluation Biocompatibility.
- Author:
Xueying HE
1
;
Juli TANG
1
;
Xiantao WEN
1
;
Bo GUAN
1
;
Rui WANG
1
;
Hui WANG
1
;
Hua LI
1
;
Jianfeng SHI
1
;
Yali ZENG
1
;
Yongjian MAO
1
Author Information
- Publication Type:Journal Article
- Keywords: No Observed Adverse Effect Level(NOAEL); biocompatibility; medical devices; nickel; threshold of toxicological concern(TTC)
- MeSH: Animals; Equipment and Supplies/adverse effects*; Nickel/toxicity*; No-Observed-Adverse-Effect Level; Rats; Rats, Sprague-Dawley; Risk Assessment
- From: Chinese Journal of Medical Instrumentation 2020;44(5):448-452
- CountryChina
- Language:Chinese
- Abstract: 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.
