EPA Science Inventory

Evaluation of the ToxRTool's ability to rate the reliability of toxicological data for human health hazard assessments

Citation:

Segal, D., S. Makris, A. Kraft, A. Bale, M. Gilbert, D. Bergfelt, K. Raffaele, R. Blain, K. Fedak, M. Selegrade, AND K. Crofton. Evaluation of the ToxRTool's ability to rate the reliability of toxicological data for human health hazard assessments. REGULATORY TOXICOLOGY AND PHARMACOLOGY. Elsevier Science Ltd, New York, NY, 72(1):94-101, (2015).

Description:

Regulatory agencies often utilize results from peer reviewed publications for hazard assessments.A problem in doing so is the lack of well-accepted tools to objectively, efficiently and systematically assess the quality of published toxicological studies. Herein, we evaluated the publicly available software-based ToxRTool (Toxicological data Reliability assessment Tool) for use in human health hazard assessments. The ToxRTool was developed by the European Commission's Joint Research Center in 2009. It builds on Klimisch categories, a rating system established in 1997,by providing additional criteria and guidance for assessing the reliability of toxicological studies. It also transparently documents the study-selection process. Eight scientists used the ToxRTool to rate the same 20 journal articles on thyroid toxicants. Results were then compared using the Finn coefficient and "AC1" to determine inter-rater consistency. Ratings were most consistent for high-quality journal articles, but less consistent as study quality decreased.Primary reasons for inconsistencies were that some criteria were subjective and some were not clearly described. It was concluded, however, that the ToxRTool has potential and, with refinement, could provide a more objective approach for screening pubished toxicology studies for use in health risk evaluations, although the ToxRTool ratings are primarily based on study reporting quality.

Purpose/Objective:

EPA relies heavily on results from peer reviewed publications for its health hazard assessments, such as its IRIS chemical assessments, which are produced by the National Center for Environmental Assessment. Data from all sources, including the open published literature are used to develop exposure/dose limits, which if exceeded, are deemed potentially harmful to human health. Although these benchmarks are non-enforceable standards, they are frequently considered in regulatory decisions. Therefore, having high-quality data that accurately reflect the risk of negative health consequences is critical ifEPA is to adequately protect human health. However, a major problem for the Agency in its examination of peer reviewed literature is the lack of well-accepted tools to objectively, efficiently and systematically assess the quality of the data published in toxicological studies. To this end, this manuscript reports on the results of an evaluation of the publicly available software-based tool to assess the quality of data in published reports. The ToxRTool (Toxicological data Reliability Assessment Tool) was developed by the European Centre for the Validation of Alternative Methods (ECVAM), of the European Commission Joint Research Centre, in 2009, in an effort to provide a means to systematically and transparently assess the quality of published toxicological studies. The ToxRTool builds on the Klimisch categories, a rating system established in 1997, but provides additional criteria and guidance as well as a software-based format utilizing Microsoft® Office Excel spreadsheets. The spreadsheets allow one to document the evaluation of each published study, making the study selection process transparent for inclusion or exclusion in health hazard assessments. Providing criteria, as the ToxRTool does, enables one to more consistently assess the quality of studies under consideration for use in health hazard assessments. Therefore, if reliable, the ToxRTool could provide EPA with an improved mechanism for systematic reviews of the published toxicological literature. To determine the ToxRTool's

URLs/Downloads:

Record Details:

Record Type: DOCUMENT (JOURNAL/PEER REVIEWED JOURNAL)
Start Date: 06/01/2015
Completion Date: 06/01/2015
Record Last Revised: 06/19/2015
Record Created: 05/07/2015
Record Released: 05/07/2015
OMB Category: Other
Record ID: 307928

Organization:

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF RESEARCH AND DEVELOPMENT

NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LAB

TOXICOLOGY ASSESSMENT DIVISION

NEUROTOXICOLOGY BRANCH