Deriving a provisional tolerable intake for intravenous exposure to silver nanoparticles released from medical devices.

Autor: Savery LC; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Viñas R; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Nagy AM; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Pradeep P; Department of Mathematics, Statistics, and Computer Science, Marquette University, P.O. Box 1881, Milwaukee, WI 53201, USA., Merrill SJ; Department of Mathematics, Statistics, and Computer Science, Marquette University, P.O. Box 1881, Milwaukee, WI 53201, USA., Hood AM; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Malghan SG; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Goering PL; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: Peter.Goering@fda.hhs.gov., Brown RP; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2017 Apr; Vol. 85, pp. 108-118. Date of Electronic Publication: 2017 Jan 27.
DOI: 10.1016/j.yrtph.2017.01.007
Abstrakt: Silver nanoparticles (AgNP) are incorporated into medical devices for their anti-microbial characteristics. The potential exposure and toxicity of AgNPs is unknown due to varying physicochemical particle properties and lack of toxicological data. The aim of this safety assessment is to derive a provisional tolerable intake (pTI) value for AgNPs released from blood-contacting medical devices. A literature review of in vivo studies investigating critical health effects induced from intravenous (i. v.) exposure to AgNPs was evaluated by the Annapolis Accords principles and Toxicological Data Reliability Assessment Tool (ToxRTool). The point of departure (POD) was based on an i. v. 28-day repeated AgNP (20 nm) dose toxicity study reporting an increase in relative spleen weight in rats with a 5% lower confidence bound of the benchmark dose (BMDL 05 ) of 0.14 mg/kg bw/day. The POD was extrapolated to humans by a modifying factor of 1,000 to account for intraspecies variability, interspecies differences and lack of long-term toxicity data. The pTI for long-term i. v. exposure to 20 nm AgNPs released from blood-contacting medical devices was 0.14 μg/kg bw/day. This pTI may not be appropriate for nanoparticles of other physicochemical properties or routes of administration. The methodology is appropriate for deriving pTIs for nanoparticles in general.
(Published by Elsevier Inc.)
Databáze: MEDLINE
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