Study of No Observed Adverse Effect Level of Nickel and Its Preliminary Evaluation Biocompatibility / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 448-452, 2020.
Article
in Chinese
| WPRIM
| ID: wpr-942760
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Rats, Sprague-Dawley
/
Risk Assessment
/
No-Observed-Adverse-Effect Level
/
Equipment and Supplies
/
Nickel
Type of study:
Etiology study
/
Risk factors
Limits:
Animals
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2020
Type:
Article
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