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Evaluating the potential of gold, silver, and silica nanoparticles to saturate mononuclear phagocytic system tissues under repeat dosing conditions.
Weaver, James L; Tobin, Grainne A; Ingle, Taylor; Bancos, Simona; Stevens, David; Rouse, Rodney; Howard, Kristina E; Goodwin, David; Knapton, Alan; Li, Xiaohong; Shea, Katherine; Stewart, Sharron; Xu, Lin; Goering, Peter L; Zhang, Qin; Howard, Paul C; Collins, Jessie; Khan, Saeed; Sung, Kidon; Tyner, Katherine M.
Afiliación
  • Weaver JL; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Tobin GA; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Ingle T; National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR, 72079, USA.
  • Bancos S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Stevens D; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Rouse R; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Howard KE; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Goodwin D; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Knapton A; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Li X; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Shea K; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Stewart S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Xu L; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Goering PL; Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Zhang Q; Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Howard PC; National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR, 72079, USA.
  • Collins J; National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR, 72079, USA.
  • Khan S; National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR, 72079, USA.
  • Sung K; National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR, 72079, USA.
  • Tyner KM; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA. Katherine.Tyner@fda.hhs.gov.
Part Fibre Toxicol ; 14(1): 25, 2017 07 17.
Article en En | MEDLINE | ID: mdl-28716104
ABSTRACT

BACKGROUND:

As nanoparticles (NPs) become more prevalent in the pharmaceutical industry, questions have arisen from both industry and regulatory stakeholders about the long term effects of these materials. This study was designed to evaluate whether gold (10 nm), silver (50 nm), or silica (10 nm) nanoparticles administered intravenously to mice for up to 8 weeks at doses known to be sub-toxic (non-toxic at single acute or repeat dosing levels) and clinically relevant could produce significant bioaccumulation in liver and spleen macrophages.

RESULTS:

Repeated dosing with gold, silver, and silica nanoparticles did not saturate bioaccumulation in liver or spleen macrophages. While no toxicity was observed with gold and silver nanoparticles throughout the 8 week experiment, some effects including histopathological and serum chemistry changes were observed with silica nanoparticles starting at week 3. No major changes in the splenocyte population were observed during the study for any of the nanoparticles tested.

CONCLUSIONS:

The clinical impact of these changes is unclear but suggests that the mononuclear phagocytic system is able to handle repeated doses of nanoparticles.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Plata / Bazo / Dióxido de Silicio / Nanopartículas / Oro / Hígado / Macrófagos Tipo de estudio: Etiology_studies Límite: Animals Idioma: En Revista: Part Fibre Toxicol Asunto de la revista: TOXICOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Plata / Bazo / Dióxido de Silicio / Nanopartículas / Oro / Hígado / Macrófagos Tipo de estudio: Etiology_studies Límite: Animals Idioma: En Revista: Part Fibre Toxicol Asunto de la revista: TOXICOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos