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CEBSR: DTT Clinical Pathology Data

DOI: http://doi.org/10.22427/NTP-DATA-022-00002-0023-000-1

This dataset contains clinical pathology summary data from the CEBSR database, including legacy and recently reported studies. The test names and units have been harmonized for this dataset.  Documentation including test name descriptions and study exclusion are available here: https://cebs.niehs.nih.gov/cebs/paper/14893.

Regarding statistical analyses and interpretation of clinical pathology data: statistical analyses are a starting point in the interpretation of clinical pathology data and should not be used as a primary tool to identify test article-related effects.  Statistical significance testing of clinical pathology data should not replace critical scientific interpretation of data (ideally by an experienced veterinary toxicologic clinical pathologist) and consideration of clinical and biological relevance of any observed changes.  Clinical pathology data should be evaluated in context with all other available study data including in-life data (e.g., food consumption, body weight) and histopathology.  For more information about statistical significance testing for clinical pathology in toxicology studies, please refer to the below listed references.  

Aulbach A, Vitsky A, Arndt T, et al. Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies. Vet Clin Pathol. 2019;48:389–399. https://doi.org/10.1111/vcp.12772

Hall RL. Practical Considerations in Clinical Pathology Data Interpretation and Description: The Use of Statistics, Reference Intervals, and Severity Descriptors. Toxiol Path. 2017;45:362-365.  https://doi.org/10.1177/0192623316669824

Siska W, Gupta A, Tomlinson L, Tripathi N, von Beust B. Recommendations for clinical pathology data generation, interpretation, and reporting in target animal safety studies for veterinary drug development. Int J Toxicol. 2017;36:293-302.  https://doi.org/10.1177/1091581817711876

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CEBS CAS Number CEBS Stressor Name Test Name Test Unit Species Strain Sex Dose Dose Unit Mean Standard Deviation STE Percent of Control Trend Significance Level Trend Direction Pairwise Significance Level NEL LEL Route Vehicle Is Vehicle Control? Number Examined Time in Study Time in Study Unit Phase Type DTXSID Study Title Accession Number Chemtrack Number TDMS Number

Trend Significance Level: 0 = not significant, 1 =  significant at P <= 0.05, 2 = significant at P <= 0.01

Pairwise Significance Level: 0 = not significant, 1 =  significant at P <= 0.05, 2 = significant at P <= 0.01

Phase Type: PND = Postnatal Day, SD = Study Day