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Grant support

The first author is partially supported by the grant CSC #202106240169 from the P. R. China. Translational modelling, data analysis and manuscript writing have partially been supported by the Partnership for the Assessment of Risk from Chemicals (PARC) funding by the European Union's Horizon Europe research and innovation programme under Grant Agreement No. 101057014.

Analysis of institutional authors

Deepika DAuthorVikas KumarAuthor

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Article

IVIVE-PBPK based new approach methodology for addressing early life toxicity induced by bisphenol A

Publicated to:Environmental Research. 240 (Pt 1): 117343-117343 - 2024-01-01 240(Pt 1), DOI: 10.1016/j.envres.2023.117343

Authors: Ni, Mengmei; Deepika, Deepika; Li, Xiaomeng; Xiong, Wei; Zhang, Lishi; Chen, Jinyao; Kumar, Vikas

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Abstract

Bisphenol A (BPA) is a known endocrine disruptor mimicking natural estrogens with the potential to affect human health, especially during prenatal and postnatal exposure at or below current acceptable daily intake levels. Different adverse effects of BPA are still under investigation, and multiple mechanisms of action remain unexplored. This may be one of the reasons for the continuously changing tolerable daily intake (TDI) of BPA with the emergence of new adverse health effects over time. In addition, translational modelling through in vitro-in vivo extrapolation (IVIVE) can act as prerequisite bridge for translating in-vitro finding into human risk assessment. The objective of this study was to conduct in-vitro experiments and utilize an IVIVE-pregnancy physiologically based pharmacokinetic (P-PBPK) modeling to investigate developmental neurotoxicity and embryotoxicity in humans. The data obtained from human embryonic stem cells-based assays (study conducted between October 2020-2021) were used for the IVIVE-P-PBPK models to obtain the human equivalent doses (HEDs) which were further extrapolated to reference doses (RfDs). The results showed that simulated mean RfDs (μg/kg/day) derived from the HSD3B1 and NFATC2 gene of embryotoxicity and neurodevelopmental toxicity tests, respectively, were 4.94 and 5.18. The simulated RfDs were close to the temporary-tolerable daily intake (t-TDI) recommended by European Food Safety Authority (EFSA) in 2015 (t-TDI: 4 μg/kg·bw) and higher than the TDI of 2023 (0.2 ng/kg·bw). In conclusion, in-vitro toxicogenomics dose-response data combined with PBPK modeling can become a promising alternativenew approach methodology (NAM) to support decision-making in chemical risk assessment. Based on the simulated RfDs derived from this NAM, the t-TDI set by EFSA in 2015 may be considered a safe exposure limit for mothers and fetuses at the current BPA intake levels in Chinese mothers. This study provided an animal-free new strategy for NAMs based risk assessment by combining toxicogenomics and computational toxicology.Copyright © 2023. Published by Elsevier Inc.

Keywords

analogsdosimetryembryotoxicityexposurehuman embryonic stem cellsintegrationiviveneurotoxicitypbpkrisk-assessmentstem-cell testtoxicogenomicsvitrowaterBenzhydryl compoundsBisphenol aEmbryotoxicityFemaleFood safetyHuman embryonic stem cellsHumansIn-vivo extrapolationIviveNeurotoxicityPbpkPhenolsPregnancyToxicity testsToxicogenomics

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Environmental Research due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2024 there are still no calculated indicators, but in 2023, it was in position 36/358, thus managing to position itself as a Q1 (Primer Cuartil), in the category Environmental Sciences. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 1.94, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions Jun 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-06-01, the following number of citations:

  • WoS: 1
  • Scopus: 4

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-06-01:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 22.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 22 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 1.35.
  • The number of mentions on the social network X (formerly Twitter): 2 (Altmetric).

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: China; Germany.

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: First Author (Ni M) and Last Author (Kumar, Vikas).