A protocol to assess ToxRTool use in peer-reviewed literature

Context Study reliability impacts toxicology assessments and the confidence associated with them. Klimisch et al. (1997) first formalised reliability evaluation by standardising study reliability. Then, in 2009 ToxRTool was developed to improve the transparency and objectivity of Klimisch et al.’s (1997) reliability assessment under the EU chemical regulation REACH. Objective Given the observed trend showing higher ToxRTool use since 2020, we intend to further explore how ToxRTool is used and in what context(s). This protocol outlines our plan to to discuss current usage patterns by summarising ToxRTool applications in peer-reviewed scientific literature.Planned methods The JARS-Qual (Levitt et al. 2018) checklist guides this protocol. Since this project assesses toxicological studies, we use study characteristics of interest (e.g., data type, exposure, field of study) and bibliographic information. The search and confirmation of a picklist, code book, and categorization groups has been completed. The search occurred in November 2023 where five databases (PubMed, Embase, Scopus, Web of Science, and Google Scholar) were assessed without any language restrictions for publications from 2009 to 2024. After duplication removal, a total of 530 publications were identified and uploaded to Covidence (2025). Of the 530 publications, a randomly selected sample set were used to confirm the eligibility criteria, extraction steps, and decision-making process. The remaining publications have not been assessed nor has any data been extracted.Discussion ToxRTool helps reviewers evaluate study reliability, so an understanding of how ToxRTool is used or has been modified can inform toxicologists and evidence-based practitioners about current usage patterns. The results could also clarify any incorrect interpretations of ToxRTool use and illustrate useful applications of ToxRTool.