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Controversy on health-based guidance values for bisphenol A : the need of criteria for studies that serve as a basis for risk assessment

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2024

Autor:innen

Buettner, Andrea
Diel, Patrick
Eisenbrand, Gerhard
Epe, Bernd
Först, Petra
Grune, Tilman
Haller, Dirk
Heinz, Volker
Hengstler, Jan G.
et al.

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Deutsche Forschungsgemeinschaft (DFG): HE 2509/15-12
European Union (EU): 964537
European Union (EU): 101057014

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RISK-HUNT3R
PARC: Partnership for the Assessment of Risks from Chemicals
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Archives of Toxicology. Springer. 2024, 98(7), S. 1967-1973. ISSN 0340-5761. eISSN 1432-0738. Verfügbar unter: doi: 10.1007/s00204-024-03778-3

Zusammenfassung

Since 2006, the responsible regulatory bodies have proposed five health-based guidance values (HBGV) for bisphenol A (BPA) that differ by a factor of 250,000. This range of HBGVs covers a considerable part of the range from highly toxic to relatively non-toxic substances. As such heterogeneity of regulatory opinions is a challenge not only for scientific risk assessment but also for all stakeholders, the Senate Commission on Food Safety (SKLM) of the German Research Foundation (DFG) analyzed the reasons for the current discrepancy and used this example to suggest improvements for the process of HBGV recommendations. A key aspect for deriving a HBGV is the selection of appropriate studies that allow the identification of a point of departure (PoD) for risk assessment. In the case of BPA, the HBGV derived in the 2023 EFSA assessment was based on a study that reported an increase of Th17 cells in mice with a benchmark dose lower bound (BMDL 40 ) of 0.53 µg/kg bw/day. However, this study does not comply with several criteria that are important for scientific risk assessment: (1) the selected end-point, Th17 cell frequency in the spleen of mice, is insufficiently understood with respect to health outcomes. (2) It is unclear, by which mechanism BPA may cause an increase in Th17 cell frequency. (3) It is unknown, if an increase of Th17 cell frequency in rodents is comparably observed in humans. (4) Toxicokinetics were not addressed. (5) Neither the raw data nor the experimental protocols are available. A further particularly important criterion (6) is independent data confirmation which is not available in the present case. Previous studies using other readouts did not observe immune-related adverse effects such as inflammation, even at doses orders of magnitude higher than in the Th17 cell-based study. The SKLM not only provides here key criteria for the use of such studies, but also suggests that the use of such a “checklist” requires a careful and comprehensive scientific judgement of each item. It is concluded that the Th17 cell-based study data do not represent an adequate basis for risk assessment of BPA.

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570 Biowissenschaften, Biologie

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ISO 690LEIST, Marcel, Andrea BUETTNER, Patrick DIEL, Gerhard EISENBRAND, Bernd EPE, Petra FÖRST, Tilman GRUNE, Dirk HALLER, Volker HEINZ, Jan G. HENGSTLER, 2024. Controversy on health-based guidance values for bisphenol A : the need of criteria for studies that serve as a basis for risk assessment. In: Archives of Toxicology. Springer. 2024, 98(7), S. 1967-1973. ISSN 0340-5761. eISSN 1432-0738. Verfügbar unter: doi: 10.1007/s00204-024-03778-3
BibTex
@article{Leist2024-07Contr-70147,
  year={2024},
  doi={10.1007/s00204-024-03778-3},
  title={Controversy on health-based guidance values for bisphenol A : the need of criteria for studies that serve as a basis for risk assessment},
  number={7},
  volume={98},
  issn={0340-5761},
  journal={Archives of Toxicology},
  pages={1967--1973},
  author={Leist, Marcel and Buettner, Andrea and Diel, Patrick and Eisenbrand, Gerhard and Epe, Bernd and Först, Petra and Grune, Tilman and Haller, Dirk and Heinz, Volker and Hengstler, Jan G.}
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