Improving risk assessment of color additives in medical device polymers

Vaishnavi Chandrasekar, Dustin W. Janes, Christopher Forrey, David M. Saylor, Akhil Bajaj, Timothy V. Duncan, Jiwen Zheng, Kausar B. Riaz Ahmed, Brendan J. Casey

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

Many polymeric medical device materials contain color additives which could lead to adverse health effects. The potential health risk of color additives may be assessed by comparing the amount of color additive released over time to levels deemed to be safe based on available toxicity data. We propose a conservative model for exposure that requires only the diffusion coefficient of the additive in the polymer matrix, D, to be specified. The model is applied here using a model polymer (poly(ether-block-amide), PEBAX 2533) and color additive (quinizarin blue) system. Sorption experiments performed in an aqueous dispersion of quinizarin blue (QB) into neat PEBAX yielded a diffusivity D = 4.8 × 10−10 cm2s−1, and solubility S = 0.32 wt %. On the basis of these measurements, we validated the model by comparing predictions to the leaching profile of QB from a PEBAX matrix into physiologically representative media. Toxicity data are not available to estimate a safe level of exposure to QB, as a result, we used a Threshold of Toxicological Concern (TTC) value for QB of 90 µg/adult/day. Because only 30% of the QB is released in the first day of leaching for our film thickness and calculated D, we demonstrate that a device may contain significantly more color additive than the TTC value without giving rise to a toxicological concern. The findings suggest that an initial screening-level risk assessment of color additives and other potentially toxic compounds found in device polymers can be improved.

Original languageEnglish (US)
Pages (from-to)310-319
Number of pages10
JournalJournal of Biomedical Materials Research - Part B Applied Biomaterials
Volume106
Issue number1
DOIs
StatePublished - Jan 2018

Bibliographical note

Funding Information:
The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration, are the views of the authors, and should not be construed to represent any agency determination or policy. The mention of commercial products, the sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by Department of Health and Human Services. Cryogenic ultramicrotoming and TEM imaging were performed at the FDA White Oak Nanotechnology Core Facility. This research was partially administered by the Oak Ridge Institute for Science and Education through an agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The authors thank Jennifer Goode, Ronald Brown, Alan Hood, Irada Isayeva, and Michael Ibrahim for helpful discussions.

Funding Information:
The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration, are the views of the authors, and should not be construed to represent any agency determination or policy. The mention of commercial products, the sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by Department of Health and Human Services. Cryogenic ultramicrotom-ing and TEM imaging were performed at the FDA White Oak Nanotechnology Core Facility. This research was partially administered by the Oak Ridge Institute for Science and Education through an agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The authors thank Jennifer Goode, Ronald Brown, Alan Hood, Irada Isayeva, and Michael Ibrahim for helpful discussions.

Publisher Copyright:
© 2017 Wiley Periodicals, Inc.

Keywords

  • color additive
  • diffusion
  • leaching
  • medical device
  • molecular dynamics
  • polymer

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