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.
Artigo
em Chinês
| 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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Ratos Sprague-Dawley
/
Medição de Risco
/
Nível de Efeito Adverso não Observado
/
Equipamentos e Provisões
/
Níquel
Tipo de estudo:
Estudo de etiologia
/
Fatores de risco
Limite:
Animais
Idioma:
Chinês
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2020
Tipo de documento:
Artigo
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