title: Evaluation of the ToxRTool's ability to rate the reliability of toxicological data for human health hazard assessments.
abstract: 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 published toxicology studies for use in health risk evaluations, although the ToxRTool ratings are primarily based on study reporting quality.
authors.affiliation: EPA Office of Research and Development (ORD), National Center for Environmental Assessment, United States. Electronic address: segal.deborah@epa.gov.
authors.forename: D
authors.initials: D
authors.lastname: Segal
authors.affiliation: EPA Office of Research and Development (ORD), National Center for Environmental Assessment, United States.
authors.forename: S L
authors.initials: SL
authors.lastname: Makris
authors.affiliation: EPA Office of Research and Development (ORD), National Center for Environmental Assessment, United States.
authors.forename: A D
authors.initials: AD
authors.lastname: Kraft
authors.affiliation: EPA Office of Research and Development (ORD), National Center for Environmental Assessment, United States.
authors.forename: A S
authors.initials: AS
authors.lastname: Bale
authors.affiliation: EPA Office of Research and Development (ORD), National Center for Environmental Assessment, United States.
authors.forename: J
authors.initials: J
authors.lastname: Fox
authors.affiliation: EPA ORD National Health and Environmental Effects Research Laboratory, United States.
authors.forename: M
authors.initials: M
authors.lastname: Gilbert
authors.affiliation: Dept. of Biomedical Sciences, Ross University School of Veterinary Medicine, St. Kitts, St. Kitts and Nevis.
authors.forename: D R
authors.initials: DR
authors.lastname: Bergfelt
authors.affiliation: EPA Office of Solid Waste and Emergency Response, United States.
authors.forename: K C
authors.initials: KC
authors.lastname: Raffaele
authors.affiliation: ICF International Environment and Social Sustainability Division, United States.
authors.forename: R B
authors.initials: RB
authors.lastname: Blain
authors.affiliation: ICF International Environment and Social Sustainability Division, United States.
authors.forename: K M
authors.initials: KM
authors.lastname: Fedak
authors.affiliation: ICF International Environment and Social Sustainability Division, United States.
authors.forename: M K
authors.initials: MK
authors.lastname: Selgrade
authors.affiliation: EPA ORD National Center for Computational Toxicology, United States.
authors.forename: K M
authors.initials: KM
authors.lastname: Crofton
mesh_terms: D015386:Hazardous Substances / Q000633:toxicity*; D062489:Health Impact Assessment / Q000379:methods* / Q000592:standards*; D006801:Humans; D015203:Reproducibility of Results; D012106:Research / Q000592:standards*; D012984:Software; D014116:Toxicology / Q000379:methods* / Q000592:standards*
chemical_list: D015386:Hazardous Substances
keywords: Data quality; Human health risk assessment; Risk of bias; Systematic review; ToxRTool