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
en Zh
| WPRIM
| ID: wpr-942760
Biblioteca responsable:
WPRO
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.
Palabras clave
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
Ratas Sprague-Dawley
/
Medición de Riesgo
/
Nivel sin Efectos Adversos Observados
/
Equipos y Suministros
/
Níquel
Tipo de estudio:
Etiology_studies
/
Risk_factors_studies
Límite:
Animals
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Año:
2020
Tipo del documento:
Article