Facilitating the use of non-standard<i>in vivo</i>studies in health risk assessment of chemicals: a proposal to improve evaluation criteria and reporting

Beronius, Anna; Molander, Linda; Rudén, Christina; Hanberg, Annika

doi:10.1002/jat.2991

Cited by 54 publications

(66 citation statements)

References 26 publications

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“…For example, a publication that does not allow to clearly distinguish whether the active substance or a plant protection product containing it was used in the experiments, has low value for the purpose of regulating the active substance. In this context, recent progress towards the development of guidelines for the reporting of non-standard tests has been made (Beronius et al, 2014;Kilkenny et al, 2010). Non-standard data may well be considered for regulatory risk assessment, especially for closing of potential data gaps on the mode or mechanism of action of a specific substance, which is regarded highly important in the context of endocrine disruption.…”

Section: Windows Of Susceptibility and Data Requirementsmentioning

confidence: 99%

Assessment of three approaches for regulatory decision making on pesticides with endocrine disrupting properties

Marx‐Stoelting

Niemann

Ritz

et al. 2014

Regulatory Toxicology and Pharmacology

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Recent EU legislation has introduced endocrine disrupting properties as a hazard-based "cut-off" criterion for the approval of active substances as pesticides and biocides. Currently, no specific science-based approach for the assessment of substances with endocrine disrupting properties has been agreed upon, although this new legislation provides interim criteria based on classification and labelling. Different proposals for decision making on potential endocrine disrupting properties in human health risk assessment have been developed by the German Federal Institute for Risk Assessment (BfR) and other regulatory bodies. All these frameworks, although differing with regard to hazard characterisation, include a toxicological assessment of adversity of the effects, the evaluation of underlying modes/mechanisms of action in animals and considerations concerning the relevance of effects to humans. Three options for regulatory decision making were tested upon 39 pesticides for their applicability and to analyze their potential impact on the regulatory status of active substances that are currently approved for use in Europe: Option 1, based purely on hazard identification (adversity, mode of action, and the plausibility that both are related); Option 2, based on hazard identification and additional elements of hazard characterisation (severity and potency); Option 3, based on the interim criteria laid down in the recent EU pesticides legislation. Additionally, the data analysed in this study were used to address the questions, which parts of the endocrine system were affected, which studies were the most sensitive and whether no observed adverse effect levels were observed for substance with ED properties. The results of this exercise represent preliminary categorisations and must not be used as a basis for definitive regulatory decisions. They demonstrate that a combination of criteria for hazard identification with additional criteria of hazard characterisation allows prioritising and differentiating between substances with regard to their regulatory concern. It is proposed to integrate these elements into a decision matrix to be used within a weight of evidence approach for the toxicological categorisation of relevant endocrine disruptors and to consider all parts of the endocrine system for regulatory decision making on endocrine disruption.

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Section: Windows Of Susceptibility and Data Requirementsmentioning

confidence: 99%

Assessment of three approaches for regulatory decision making on pesticides with endocrine disrupting properties

Marx‐Stoelting

Niemann

Ritz

et al. 2014

Regulatory Toxicology and Pharmacology

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“…will be used to appraise the studies: in the tool some questions are identified as key based on the study design. Some of the elements reported in SciRAP (Science in Risk Assessment and Policy; Beronius et al, 2014, revised version at www.scirap.org) have been introduced in the appraisal tool for experimental animal studies.…”

Section: Internal Validity Of the Studiesmentioning

confidence: 99%

“…Appendix C reports the criteria, as taken from the SciRAP tool (www.scirap.org; Beronius et al, 2014) which will be used to evaluate the relevance of the animal model and of the endpoint to human.…”

Section: External Validitymentioning

confidence: 99%

Bisphenol A (BPA) hazard assessment protocol

Gundert‐Remy¹,

Bodin²,

Bosetti³

et al. 2017

EFSA Supporting Publications

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To ensure an efficient, transparent and methodologically rigorous re-assessment of the safety for consumers of bisphenol A (BPA), the European Food Safety Authority (EFSA) has undertaken the task to develop a protocol detailing a priori the approach and methodology for performing BPA hazard identification and characterisation. The general aim of this hazard assessment will be to assess whether the new scientific evidence (published from 2013 onwards and not previously appraised by EFSA) still supports the current temporary Tolerable Daily Intake (t-TDI) for BPA of 4 µg/kg bw per day. In line with the principles highlighted in the EFSA project PROmoting METHods for Evidence Use in scientific assessments (PROMETHEUS, https://www.efsa.europa.eu/en/efsajournal/pub/4121), the protocol states upfront and in detail the methods and/or the criteria that will be used in the planned BPA re-evaluation for data collection, study inclusion, evidence appraisal and integration. To pursue the goal of openness, this protocol was subjected to a web-based public consultation and was presented publicly in a stakeholder event. All the relevant comments and feedback received through these procedures were considered in this version of the protocol which will be implemented in the next BPA re-evaluation.

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“…It potentially allows for better use of academic research studies in regulatory risk assessment, for example by providing structured criteria to evaluate the validity and adequacy of studies for that purpose [135, 133, 134]. …”

Section: Systematic Review – What Is It and How Can It Help?mentioning

confidence: 99%

Using systematic reviews for hazard and risk assessment of endocrine disrupting chemicals

Beronius

Vandenberg

2015

Rev Endocr Metab Disord

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The possibility that endocrine disrupting chemicals (EDCs) in our environment contribute to hormonally related effects and diseases observed in human and wildlife populations has caused concern among decision makers and researchers alike. EDCs challenge principles traditionally applied in chemical risk assessment and the identification and assessment of these compounds has been a much debated topic during the last decade. State of the science reports and risk assessments of potential EDCs have been criticized for not using systematic and transparent approaches in the evaluation of evidence. In the fields of medicine and health care, systematic review methodologies have been developed and used to enable objectivity and transparency in the evaluation of scientific evidence for decision making. Lately, such approaches have also been promoted for use in the environmental health sciences and risk assessment of chemicals. Systematic review approaches could provide a tool for improving the evaluation of evidence for decision making regarding EDCs, e.g. by enabling systematic and transparent use of academic research data in this process. In this review we discuss the advantages and challenges of applying systematic review methodology in the identification and assessment of EDCs.

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Facilitating the use of non-standardin vivostudies in health risk assessment of chemicals: a proposal to improve evaluation criteria and reporting

Cited by 54 publications

References 26 publications

Assessment of three approaches for regulatory decision making on pesticides with endocrine disrupting properties

Assessment of three approaches for regulatory decision making on pesticides with endocrine disrupting properties

Bisphenol A (BPA) hazard assessment protocol

Using systematic reviews for hazard and risk assessment of endocrine disrupting chemicals

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