Abstract
The RITA (Registry of Industrial Toxicology Animal Data) database is a proprietary database for the collection of Historical Control Data of rodent carcinogenicity studies. A number of study- and animal-related variables are collected in addition to the quality and peer reviewed histological diagnoses. Standardization of nomenclature, diagnostic criteria as well as technical procedures like tissue sampling and trimming are prerequisites for the long-term comparability of the Historical Control data. The benefits/advantages of the RITA historical control data will be shown for Leydig cell tumors in rats. In a first step, the “reliable historical control data” for a given case (Leydig cell carcinoma and its differential diagnosis of Leydig cell adenoma) will be defined by analysing the influence of strain, breeder and years of study conduct. Secondly, the historical data will be set into relation to other variables like age at necropsy, body weight or caging and feeding conditions. This example shows the value that RITA Historical Control Data can add to the interpretation of rodent carcinogenicity studies. It will also demonstrate that the analysis of RITA data may give new insights into the biology of a given neoplastic entity and discover variables with influence on its spontaneous incidence.
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