RITA-Registry of Industrial Toxicology Animal data: The application of historical control data for Leydig cell tumors in rats

Autor: Eberhard Karbe, Birgit Kittel, Rupert Kellner, Matthias Rinke, Ulrich Deschl, Susanne Rittinghausen, Thomas Nolte
Přispěvatelé: Boehringer Ingelheim Pharma GmbH & Co. KG, Fraunhofer Institute for Toxicology and Experimental Medicine (Fraunhofer ITEM), Fraunhofer (Fraunhofer-Gesellschaft), Novartis Institutes for BioMedical Research (NIBR)
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Male
Databases
Factual
Physiology
Toxicology
Rats
Sprague-Dawley
0403 veterinary science
oncogenicity
Reference Values
carcinogenicity
Industrial toxicology
rat
Registries
0303 health sciences
Leydig cell
Data Collection
Incidence (epidemiology)
rodent
04 agricultural and veterinary sciences
General Medicine
Leydig cell tumor
medicine.anatomical_structure
[SDV.TOX]Life Sciences [q-bio]/Toxicology
Adenoma
medicine.medical_specialty
endocrine system
Registry of Industrial Toxicology Animal-data
interstitial cell adenoma
Carcinogenicity Tests
040301 veterinary sciences
Leydig cell carcinoma
testes
Adenocarcinoma
Biology
testis
Pathology and Forensic Medicine
historical control data
03 medical and health sciences
Animal data
Internal medicine
RITA
medicine
Carcinoma
Animals
interstitial cell carcinoma
Leydig cell adenoma
Rats
Wistar
Carcinogen
030304 developmental biology
interstitial cell tumor
Cell Biology
medicine.disease
Rats
Endocrinology
Leydig Cell Tumor
carcinogenicity testing
Carcinogens
Historical control
Zdroj: Experimental and Toxicologic Pathology
Experimental and Toxicologic Pathology, Elsevier, 2011, 63 (7-8), pp.645. ⟨10.1016/j.etp.2010.05.006⟩
ISSN: 0940-2993
DOI: 10.1016/j.etp.2010.05.006⟩
Popis: Historical data for Leydig cell tumors from untreated or vehicle treated rats from carcinogenicity studies collected in the RITA database are presented. Examples are given for analyses of these data for dependency on variables considered to be of possible influence on the spontaneous incidence of Leydig cell tumors. In the 7453 male rats available for analysis, only one case of a Leydig cell carcinoma was identified. The incidence of Leydig cell adenomas differed markedly between strains. High incidences of close to 100% have been found in F344 rats, while the mean incidence was 4.2% in Sprague-Dawley rats and 13.7% in Wistar rats. Incidences in Wistar rats were highly variable, primarily caused by different sources of animals. Mean incidences per breeder varied from 2.8 to 39.9%. Analyses for the dependency on further parameters have been performed in Wistar rats. In breeders G and I, the Leydig cell tumor incidence decreased over the observation period and with increasing mean terminal body weight. The incidence of Leydig cell tumors increased with mean age at necropsy and was higher in studies with dietary admixture compared to gavage studies. These parameters had no effect on Leydig cell tumor incidence in breeders A and B. Animals from almost all breeders had a considerably higher mean age at necropsy when bearing a Leydig cell adenoma than animals without a Leydig cell adenoma. Studies with longitudinal trimming of the testes had a higher incidence than studies with transverse trimming. The observed dependencies and breeder differences are discussed and explanations are given. Consequences for the use of historical control data are outlined. With the retrospective analyses presented here we were able to confirm the published features of Leydig cell adenomas and carcinomas. This indicates that the RITA database is a valuable tool for analyses of tumors for their biological features. Furthermore, it demonstrates that the RITA database is highly beneficial for the definition of reliable historical control data for carcinogenicity studies on a scientifically solid basis.
Databáze: OpenAIRE
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