“ToxRTool”, a new tool to assess the reliability of toxicological data

Schneider, Klaus; Schwarz, Maik; Burkholder, Iris; Kopp‐Schneider, Annette; Edler, Lutz; Kinsner‐Ovaskainen, Agnieszka; Hartung, Thomas; Hoffmann, Sebastian

doi:10.1016/j.toxlet.2009.05.013

Cited by 298 publications

(269 citation statements)

References 24 publications

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“…The four evaluation methods used in this study are described by Klimisch et al [10], Durda and Preziosi [11], Hobbs et al [12], and Schneider et al [13]. The reporting requirements from the OECD guidelines 201, 210, and 211 were used as a reference in the evaluation of the four methods.…”

Section: Evaluation Of Existing Reliability Evaluation Methodsmentioning

confidence: 99%

“…Schneider et al [13] evaluation question is also wide and concerns relevance, rather than reliability. In the accompanying guidance material to the question, a variety of aspects are included: the chosen test system and its applicability domain, consideration of physiochemical properties and stability of test substance, number of replicates, number of concentration levels and their range and spread, suitability of administration method, inclusion of all relevant endpoints, and statistical evaluation.…”

Section: Usefulness Of Proposed Criteriamentioning

confidence: 99%

“…interpreted into Schneider et al [13] method. The OECD guidelines do not report of any other factors in addition to the ones mentioned by the four methods.…”

Section: Mandatory/ Recommendedmentioning

confidence: 99%

“…The OECD guidelines recommend that light quality, residual chlorine levels, total organic carbon (TOC), and chemical oxygen demand (COD) are reported in addition to the other factors. Schneider et al [13] did not specify which factors related to the test environment that should be evaluated and only consider it relevant for repeated dose toxicity studies.…”

Section: Test Environment Usefulness Of Proposed Criteriamentioning

confidence: 99%

“…Durda and Preziosi [11] is the only method that covers all aspects. Both Durda and Preziosi [11] and Schneider et al [13] consider administrated concentrations, administration route, frequency and duration of exposure as "must" Is the purity of the substance given? Recommended, 0, or 1 Not stated in six studies.…”

Section: Dosing System Usefulness Of Proposed Criteriamentioning

confidence: 99%

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Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

2011

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Background: Standard test data are still preferred and recommended for regulatory environmental risk assessments of pharmaceuticals even though data generated by non-standard tests could improve the scientific basis of risk assessments by providing relevant and more sensitive endpoints. The aim of this study was to investigate if non-standard ecotoxicity data can be evaluated systematically in risk assessments of pharmaceuticals. This has been done by evaluating the usefulness of four reliability evaluation methods, and by investigating whether recently published non-standard ecotoxicity studies from the open scientific literature fulfill the criteria that these methods propose.Results: The same test data were evaluated differently by the four methods in seven out of nine cases. The selected non-standard test data were considered reliable/acceptable in only 14 out of 36 cases. Conclusions: The four evaluation methods differ in scope, user friendliness, and how criteria are weighted and summarized. This affected the outcome of the data evaluation. The results suggest that there is room for improvements in how data are reported in the open scientific literature. Reliability evaluation criteria could be used as a checklist to ensure that all important aspects are reported and thereby increasing the possibility that the data could be used for regulatory risk assessment.

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Section: Evaluation Of Existing Reliability Evaluation Methodsmentioning

confidence: 99%

Section: Usefulness Of Proposed Criteriamentioning

confidence: 99%

“…interpreted into Schneider et al [13] method. The OECD guidelines do not report of any other factors in addition to the ones mentioned by the four methods.…”

Section: Mandatory/ Recommendedmentioning

confidence: 99%

Section: Test Environment Usefulness Of Proposed Criteriamentioning

confidence: 99%

Section: Dosing System Usefulness Of Proposed Criteriamentioning

confidence: 99%

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Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

2011

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Noncancer Risk Assessment: Principles and Practice in Environmental and Occupational Settings

Pecquet,

Haber

2023

Patty's Toxicology

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The scientific process of risk assessment aims to define hazards associated with human exposure to chemicals. This chapter focuses primarily on the first two steps of the risk assessment process for noncancer endpoints, or more broadly, for modes of action not involving interaction with DNA. Hazard characterization consists of a systematic evaluation of available data to identify toxicologically relevant adverse outcomes, the associated mode of action, and evaluation of human relevance of the effects. Data quality and the overall weight of evidence are also evaluated. We summarize available technologies for dose–response assessment to define the critical effect and to extrapolate effect levels to human exposure scenarios and exposure durations, and we discuss methods for addressing uncertainties. Methods for evaluating data–poor chemicals or conducting screening assessments are also reviewed. Finally, we discuss how to interpret the dose–response information in the context of specific exposure data. Although this chapter focuses on the methods for deriving risk values from in vivo studies, we also address the use of data from the rapidly evolving field of new approach methodologies (including in vitro methods such as high‐throughput transcriptomics and in silico approaches such as modeling of structure–activity relationships). Ultimately, these new methodologies will foster a better understanding of how chemical exposures may cause toxicity, allow for more rapid assessment of chemicals, and support a reduction in the need for future toxicity testing in animals.

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References

2018

Statistical Analysis of Ecotoxicity Studies

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“ToxRTool”, a new tool to assess the reliability of toxicological data

Cited by 298 publications

References 24 publications

Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

Noncancer Risk Assessment: Principles and Practice in Environmental and Occupational Settings

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