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Journal of Long-Term Effects of Medical Implants

年間 4 号発行

ISSN 印刷: 1050-6934

ISSN オンライン: 1940-4379

SJR: 0.184 SNIP: 0.485 CiteScore™:: 1.1 H-Index: 39

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Physiologically Based Pharmacokinetic Modeling of the Disposition of Octamethylcyclotetrasiloxane (D4) Migration from Implants in Humans

巻 18, 発行 2, 2008, pp. 133-144
DOI: 10.1615/JLongTermEffMedImplants.v18.i2.20
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要約

A physiologically based pharmacokinetic model was developed to describe the silicone constituent octamethylcyclotetrasiloxane (D4) and its migration from intact or ruptured silicone gel-filled breast implants into surrounding tissues. D4 is a representative low-molecular weight constituent of silicone gel that is soluble enough in biological fluids to migrate from the implant and into surrounding tissues. The simulations were based on a representative young adult (premenopausal) woman and a mature (postmenopausal) woman using worst-case exposure conditions (i.e., complete rupture of the largest implant available, maximum levels of D4 in silicone, equal solubility of D4 in breast tissue and gel, and a range of breast tissue fat contents). The results indicate that D4 is cleared primarily by exhalation with highest concentrations achieved briefly in breast tissues of a representative postmenopausal woman. Maximum D4 levels in breast tissues for this scenario were estimated to be approximately 750 ppb with over 90% cleared in about 20 days. Thus, it is unlikely that D4 would be detected in any tissue within a few weeks of receiving an implant, even if immediately ruptured, under the assumptions used in this model.

キーワード: D4, implants, PBPK, migration, silicone.
によって引用された
  1. McMullin Tami S., Yang Yuching, Campbell Jerry, Clewell Harvey J., Plotzke Kathy, Andersen Melvin E., Development of an integrated multi-species and multi-dose route PBPK model for volatile methyl siloxanes – D4 and D5, Regulatory Toxicology and Pharmacology, 74, 2016. Crossref

  2. Xu Shihe, Kozerski Gary, Mackay Donald, Critical Review and Interpretation of Environmental Data for Volatile Methylsiloxanes: Partition Properties, Environmental Science & Technology, 48, 20, 2014. Crossref

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