Toxicological risk assessment of bisphenol a released from dialyzers under simulated-use and exaggerated extraction conditions

Badding, Melissa A.; Vargas, Jessica R.; Fortney, Julian L.; Cheng, Qiuqiong J.; Ho, Chih-Hu

doi:10.1016/j.yrtph.2020.104787

Cited by 9 publications

(2 citation statements)

References 8 publications

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“…First, the normal urinary elimination of the conjugated BPA is abolished [ 48 ]. Second, BPA is leached by various types of polysulfone-derived dialyzers from both the membrane and the housing components [ 49 ].…”

Section: Discussionmentioning

confidence: 99%

Toxin Removal and Inflammatory State Modulation during Online Hemodiafiltration Using Two Different Dialyzers (TRIAD2 Study)

Donati

Cappuccilli

Donadei

et al. 2021

MPs

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Uremic toxins play a pathological role in atherosclerosis and represent an important risk factor in dialysis patients. Online hemodiafiltration (HDF) has been introduced to improve the clearance of middle- and large-molecular-weight solutes (>500 Da) and has been associated with reduced cardiovascular mortality compared to standard hemodialysis. This non-randomized, open-label observational study will explore the efficacy of two dialyzers currently used for online HDF, a polysulfone-based high-flux membrane, and a cellulose triacetate membrane, in hemodialysis patients with signs of middle-molecule intoxication or intradialytic hypotension. In particular, the two filters will be evaluated for their ability in uremic toxin removal and modulation of inflammatory status. Sixteen subjects in standard chronic bicarbonate hemodialysis requiring a switch to online HDF in view of their clinical status will be enrolled and divided into two treatment arms, according to the previous history of hypersensitivity to polysulfone/polyethersulfone dialysis filters and hypersensitivity to drugs or other allergens. Group A will consist of 16 patients without a previous history of hypersensitivity and will be treated with a polysulfone filter (Helixone FX100), and group B, also consisting of 16 patients, with a previous history of hypersensitivity and will be treated with asymmetric triacetate (ATA; SOLACEA 21-H) dialyzer. Each patient will be followed for a period of 24 months, with monthly assessments of circulating middle-weight toxins and protein-bound toxins, markers of inflammation and oxidative stress, lymphocyte subsets, activated lymphocytes, and monocytes, cell apoptosis, the accumulation of advanced glycation end-products (AGEs), variations in arterial stiffens measured by pulse wave velocity (PWV), and mortality rate. The in vitro effect on endothelial cells of uremic serum collected from patients treated with the two different dialyzers will also be investigated to examine the changes in angiogenesis, cell migration, differentiation, apoptosis and proliferative potential, and gene and protein expression profile. The expected results will be a better awareness of the different effects of polysulfone gold-standard membrane for online HDF and the new ATA membrane on the removal of uremic toxins removal and inflammation due to blood–membrane interaction.

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Section: Discussionmentioning

confidence: 99%

Toxin Removal and Inflammatory State Modulation during Online Hemodiafiltration Using Two Different Dialyzers (TRIAD2 Study)

Donati

Cappuccilli

Donadei

et al. 2021

MPs

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“…Given the already elevated inflammatory status (reviewed in [11]) in patients with kidney failure, the broad application of BPA in medicinal products, as well as the repetitive nature of hemodialysis therapy, it is important to determine the amounts of BPA and BPS that are leached from dialyzers. Work has been performed previously in assessing the safety use of dialyzers manufactured by Fresenius regarding BPA exposure [12]. In the current project, eight commercial dialyzers manufactured by Fresenius and other companies were included to investigate the extraction and leaching properties of BPA and BPS under simulated and extreme conditions using targeted liquid chromatography-mass spectrometry (LC-MS).…”

Section: Introductionmentioning

confidence: 99%

Bisphenol A and Bisphenol S in Hemodialyzers

Haq,

Wang,

Cheng

et al. 2023

Toxins

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Bisphenol A (BPA)-based materials are used in the manufacturing of hemodialyzers, including their polycarbonate (PC) housings and polysulfone (PS) membranes. As concerns for BPA’s adverse health effects rise, the regulation on BPA exposure is becoming more rigorous. Therefore, BPA alternatives, such as Bisphenol S (BPS), are increasingly used. It is important to understand the patient risk of BPA and BPS exposure through dialyzer use during hemodialysis. Here, we report the bisphenol levels in extractables and leachables obtained from eight dialyzers currently on the market, including high-flux and medium cut-off membranes. A targeted liquid chromatography–mass spectrometry strategy utilizing stable isotope-labeled internal standards provided reliable data for quantitation with the standard addition method. BPA ranging from 0.43 to 32.82 µg/device and BPS ranging from 0.02 to 2.51 µg/device were detected in dialyzers made with BPA- and BPS-containing materials, except for the novel FX CorAL 120 dialyzer. BPA and BPS were also not detected in bloodline controls and cellulose-based membranes. Based on the currently established tolerable intake (6 µg/kg/day), the resulting margin of safety indicates that adverse effects are unlikely to occur in hemodialysis patients exposed to BPA and BPS quantified herein. With increasing availability of new data and information about the toxicity of BPA and BPS, the patient safety limits of BPA and BPS in those dialyzers may need a re-evaluation in the future.

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Applications – Medical Devices

2022

Extractables and Leachables

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Toxicological risk assessment of bisphenol a released from dialyzers under simulated-use and exaggerated extraction conditions

Cited by 9 publications

References 8 publications

Toxin Removal and Inflammatory State Modulation during Online Hemodiafiltration Using Two Different Dialyzers (TRIAD2 Study)

Toxin Removal and Inflammatory State Modulation during Online Hemodiafiltration Using Two Different Dialyzers (TRIAD2 Study)

Bisphenol A and Bisphenol S in Hemodialyzers

Applications – Medical Devices

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