Reliability and relevance evaluations of REACH data

Ingre-Khans, Ellen; Ågerstrand, Marlene; Beronius, Anna; Rudén, Christina

doi:10.1039/c8tx00216a

Cited by 18 publications

(10 citation statements)

References 24 publications

(24 reference statements)

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“…At this point authors are not required to provide these details and can also not be criticized for not doing so. We want to stress that insufficient documentation does not mean poor study design, or poor study quality, but rather prevents taking the study results along in safety assessments [ 36 ].…”

Section: Resultsmentioning

confidence: 99%

Towards a reporting guideline for developmental and reproductive toxicology testing in C. elegans and other nematodes

Voet¹,

Teunis

Haar

et al. 2021

Toxicology Research

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Implementation of reliable methodologies allowing Reduction, Refinement, and Replacement (3Rs) of animal testing is a process that takes several decades and is still not complete. Reliable methods are essential for regulatory hazard assessment of chemicals where differences in test protocol can influence the test outcomes and thus affect the confidence in the predictive value of the organisms used as an alternative for mammals. Although test guidelines are common for mammalian studies, they are scarce for non-vertebrate organisms that would allow for the 3Rs of animal testing. Here, we present a set of 30 reporting criteria as the basis for such a guideline for Developmental and Reproductive Toxicology (DART) testing in the nematode Caenorhabditis elegans. Small organisms like C. elegans are upcoming in new approach methodologies for hazard assessment; thus, reliable and robust test protocols are urgently needed. A literature assessment of the fulfilment of the reporting criteria demonstrates that although studies describe methodological details, essential information such as compound purity and lot/batch number or type of container is often not reported. The formulated set of reporting criteria for C. elegans testing can be used by (i) researchers to describe essential experimental details (ii) data scientists that aggregate information to assess data quality and include data in aggregated databases (iii) regulators to assess study data for inclusion in regulatory hazard assessment of chemicals.

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Section: Resultsmentioning

confidence: 99%

Towards a reporting guideline for developmental and reproductive toxicology testing in C. elegans and other nematodes

Voet¹,

Teunis

Haar

et al. 2021

Toxicology Research

View full text Add to dashboard Cite

show abstract

“…Due to the importance the different advisory and regulatory agencies [ 45 , 50 ] placed on these WoE principles, this study adopted Klimisch et al’s criteria for reliability for this checklist. However, the Klimisch scoring method, which has been criticized for lacking detailed “criteria” and “guidance” as well as being biased towards standard practices, was excluded [ 51 ]. ECHA also requires companies to gather all available information on the chemical [ 13 ].…”

Section: Methodsmentioning

confidence: 99%

Multi-Strategy Assessment of Different Uses of QSAR under REACH Analysis of Alternatives to Advance Information Transparency

Chinen

Malloy

2022

IJERPH

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Under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) analysis of alternatives (AoA) process, quantitative structure–activity relationship (QSAR) models play an important role in expanding information gathering and organizing frameworks. Increasingly recognized as an alternative to testing under registration. QSARs have become a relevant tool in bridging data gaps and supporting weight of evidence (WoE) when assessing alternative substances. Additionally, QSARs are growing in importance in integrated testing strategies (ITS).For example, the REACH ITS framework for specific endpoints directs registrants to consider non-testing results, including QSAR predictions, when deciding if further animal testing is needed. Despite the raised profile of QSARs in these frameworks, a gap exists in the evaluation of QSAR use and QSAR documentation under authorization. An assessment of the different uses (e.g., WoE and ITS) in which QSAR predictions play a role in evidence gathering and organizing remains unaddressed for AoA. This study approached the disparity in information for QSAR predictions by conducting a substantive review of 24 AoA through May 2017, which contained higher-tier endpoints under REACH. Understanding the manner in which applicants manage QSAR prediction information in AoA and assessing their potential within ITS will be valuable in promoting regulatory use of QSARs and building out future platforms in the face of rapidly evolving technology while advancing information transparency.

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“…Australia and New Zealand have based inferences in their water quality guidelines on WoE (Australia & New Zealand, 2017). Also, both a Society for Environmental Toxicology and Chemistry (SETAC) Pellston Workshop and a project of Stockholm University have produced deep analyses of the two most commonly weighted properties of evidence, relevance and reliability (Ingre-Khans et al, 2019;Moermond et al, 2017;Ruden et al, 2017). A SETAC technical issue paper advocating WoE incorporates these advances from the USEPA and others (SETAC, 2018).…”

Section: To the Editormentioning

confidence: 99%

Environmental Assessors Should Use State‐of‐Practice Weight‐of‐Evidence Processes

Suter¹

2021

Enviro Toxic and Chemistry

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Reliability and relevance evaluations of REACH data

Abstract: This study highlights that the procedures for evaluating data under REACH and reporting these evaluations are neither systematic nor transparent.

Cited by 18 publications

References 24 publications

Towards a reporting guideline for developmental and reproductive toxicology testing in C. elegans and other nematodes

Towards a reporting guideline for developmental and reproductive toxicology testing in C. elegans and other nematodes

Multi-Strategy Assessment of Different Uses of QSAR under REACH Analysis of Alternatives to Advance Information Transparency

Environmental Assessors Should Use State‐of‐Practice Weight‐of‐Evidence Processes

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