A new method to evaluate toxicological data reliability in risk assessments.

Toxicological data used for risk assessments must undergo an evaluation of reliability. Nevertheless, a reliability evaluation scheme for such data has yet to be established in China. A method termed TRAM (Toxicological data Reliability Assessment Method) was developed to evaluate toxicological data reliability. A questionnaire survey was performed to identify the most important criteria for reliability, and was divided into three parts: laboratory animal data (LAD), in vitro data (IVD), and human data (HD). The criteria selected from the questionnaire survey and numerical score categorization finally reached a consensus after two conferences. TRAM comprises 22 criteria for LAD, 15 for IVD, and 12 for HD. Furthermore, a combination of a quick and detailed evaluation of approaches for LAD and IVD were proposed to improve evaluation efficiency. Different weights (1-4) were assigned to each criterion, and 0-4 points were allocated according to how well each criterion was met, then a Quality score was calculated. TRAM uses three reliability categories: high (Quality score: 81-100 or met a quick evaluation approach), moderate (60-80) and low(<60). TRAM provides a transparent, easy-to-use, and quantitative method for evaluating toxicological data reliability.

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