A critical review of frameworks used for evaluating reliability and relevance of (eco)toxicity data: Perspectives for an integrated eco-human decision-making framework

Roth, Nicolas; Ciffroy, Philippe

doi:10.1016/j.envint.2016.07.011

Cited by 20 publications

(13 citation statements)

References 38 publications

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“…Their contribution to the overall weight of evidence is influenced by the test organism, study design, statistical methods, documentation, and reporting of methods and results. Criteria for relevance and reliability of toxicological data need to be considered when this type of information is used for regulatory purposes (Roth and Ciffroy 2016;Kaltenhäuser et al 2017).…”

Section: The Role and Critical Assessment Of The Reliability And Relementioning

confidence: 99%

Critical assessment and integration of separate lines of evidence for risk assessment of chemical mixtures

et al. 2019

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Humans are exposed to multiple chemicals on a daily basis instead of to just a single chemical, yet the majority of existing toxicity data comes from single-chemical exposure. Multiple factors must be considered such as the route, concentration, duration, and the timing of exposure when determining toxicity to the organism. The need for adequate model systems (in vivo, in vitro, in silico and mathematical) is paramount for better understanding of chemical mixture toxicity. Currently, shortcomings plague each model system as investigators struggle to find the appropriate balance of rigor, reproducibility and appropriateness in mixture toxicity studies. Significant questions exist when comparing single-to mixture-chemical toxicity concerning additivity, synergism, potentiation, or antagonism. Dose/concentration relevance is a major consideration and should be subthreshold for better accuracy in toxicity assessment. Previous work was limited by the technology and methodology of the time, but recent advances have resulted in significant progress in the study of mixture toxicology. Novel technologies have added insight to data obtained from in vivo studies for predictive toxicity testing. These include new in vitro models: omics-related tools, organs-on-a-chip and 3D cell culture, and in silico methods. Taken together, all these modern methodologies improve the understanding of the multiple toxicity pathways associated with adverse outcomes (e.g., adverse outcome pathways), thus allowing investigators to better predict risks linked to exposure to chemical mixtures. As technology and knowledge advance, our ability to harness and integrate separate streams of evidence regarding outcomes associated with chemical mixture exposure improves. As many national and international organizations are currently stressing, studies on chemical mixture toxicity are of primary importance.

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Section: The Role and Critical Assessment Of The Reliability And Relementioning

confidence: 99%

Critical assessment and integration of separate lines of evidence for risk assessment of chemical mixtures

et al. 2019

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“…The workshop participants agreed that a qWoE framework would serve to improve the transparency and reproducibility of decisions derived from WoE approaches. Therefore, it constitutes a useful decision-making tool for regulatory science when assessing the quality of different types of data and integrating them for hazard and risk assessment (Roth and Ciffroy, 2016). Similar approaches have been proposed both for the MoA and AOP frameworks using modified or tailored Bradford-Hill considerations (Meek et al, 2014; Becker et al, 2015).…”

Section: Work Stream 4: Best Practices For Woe Approaches For Integramentioning

confidence: 99%

Applying 'omics technologies in chemicals risk assessment: Report of an ECETOC workshop

Buesen

Chorley

Silva‐Lima

et al. 2017

Regulatory Toxicology and Pharmacology

105

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Prevailing knowledge gaps in linking specific molecular changes to apical outcomes and methodological uncertainties in the generation, storage, processing, and interpretation of ‘omics data limit the application of ‘omics technologies in regulatory toxicology. Against this background, the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) convened a workshop Applying ‘omics technologies in chemicals risk assessment that is reported herein. Ahead of the workshop, multi-expert teams drafted frameworks on best practices for (i) a Good-Laboratory Practice-like context for collecting, storing and curating ‘omics data; (ii) the processing of ‘omics data; and (iii) weight-of-evidence approaches for integrating ‘omics data. The workshop participants confirmed the relevance of these Frameworks to facilitate the regulatory applicability and use of ‘omics data, and the workshop discussions provided input for their further elaboration. Additionally, the key objective (iv) to establish approaches to connect ‘omics perturbations to phenotypic alterations was addressed. Generally, it was considered promising to strive to link gene expression changes and pathway perturbations to the phenotype by mapping them to specific adverse outcome pathways. While further work is necessary before gene expression changes can be used to establish safe levels of substance exposure, the ECETOC workshop provided important incentives towards achieving this goal.

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“…Several frameworks have been developed for evaluating reliability and to some extent relevance of (eco)toxicological studies for risk assessment 5,6. The Klimisch method is a common approach for evaluating data in regulatory settings and is also the method recommended under REACH 4.…”

Section: Introductionmentioning

confidence: 99%

Reliability and relevance evaluations of REACH data

et al. 2019

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A critical review of frameworks used for evaluating reliability and relevance of (eco)toxicity data: Perspectives for an integrated eco-human decision-making framework

Cited by 20 publications

References 38 publications

Critical assessment and integration of separate lines of evidence for risk assessment of chemical mixtures

Critical assessment and integration of separate lines of evidence for risk assessment of chemical mixtures

Applying 'omics technologies in chemicals risk assessment: Report of an ECETOC workshop

Reliability and relevance evaluations of REACH data

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