Analysis of bisphenol-propane in dialyzer and its effect on human body

Author:

Yun Chen1,He Xiaofan2,Xie Ting3,Chi-Wa Ao-Ieong4,Li Weilong5,Song Zhuoheng5,Xiao Mengyun3,Meng Yu3,Hu Bo3,Guan Baozhang3,Yang Lifeng2,Ye Mingjun6,Zeng Huiyi6,Morgera Stanislao1,Krämer Bernhard7,Wolfganng 8,Yin Lianghong3,Luan Shaodong5,Xu Suhua2,Hocher Berthold7

Affiliation:

1. Department of Nephrology, Charité-Universitätsmedizin Berlin, Campus Mitte, Berlin, 10117, Germany

2. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663, China

3. Institute of Nephrology and Blood Purification of Jinan University, The First Affiliated Hospital of Jinan University, Guangzhou, 510632, China

4. Kiang Wu Hospital, Macao, 820002, China

5. Department of Nephrology, Shenzhen Longhua District Central Hospital, Shenzhen, 518110, China

6. Institute of Nephrology and Blood Purification, The First Affiliated Hospital of Jinan University, Jinan University, Guangzhou, 510632, China

7. Fifth Department of Medicine (Nephrology/Endocrinology/Rheumatology), University Medical Centre Mannheim, University of Heidelberg, Heidelberg, 68167, Germany

8. KfH Kuratoriumfuer Dialyse und Nierentransplantatione.V., Bildungszentrum, Neu-Isenburg, 63263, Germany

Abstract

The effect of trace solvent bisphenol A (BPA) in polyether sulfone hollow fiber membrane Enttex™-16LF (E60) (produced by 3 M) low-throughput dialyzer was tested in this study. Animal experiments were conducted to evaluate its genotoxicity, carcinogenicity, and teratogenicity upon chronic exposure. The dialyzer was operated at 200 mL/min and 400 mL/min and coupled with LC-20AT liquid chromatography to detect BPA, which showed that the BPA content was less than 5 μg/kg/d at both flow rates. In animal experiments, the tolerable intake (T.I.) was calculated to be 0.5 μg/kg/d. With hemodialysis three times per week, the average patient weight was calculated at 70 kg, and the average daily BPA exposure was 0.0306 μg/kg/d. The risk of residual BPA was within the acceptable limit with polyether sulfone membrane Enttex™-16LF (E60) hollow fiber dialyzer from 3 M, without inducing risk for disability, teratogenicity, or genotoxicity.

Publisher

American Scientific Publishers

Subject

General Materials Science

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