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Toxicologic Pathology, Vol. 35, No. 4, 589-593 (2007)
DOI: 10.1080/01926230701383202
© 2007 Society of Toxicologic Pathology

Articles

Early Onset of Spontaneous Renal Preneoplastic and Neoplastic Lesions in Young Conventional Rats in Toxicity Studies

Anna Lanzoni1, Alessandro Piaia1, Jeffrey Everitt2, Ivo Faustinelli1, Rossella Defazio1, Luca Cavaliere1 and Patrizia Cristofori1

1 Pathology Department, GlaxoSmithKline, Verona, 4-37135, Italy
2 Laboratory Animal Science, GlaxoSmithKline, Research Triangle Park, NC USA

Correspondence: Address correspondence to: Lanzoni Anna, Pathology Department, GlaxoSmithKline—Centro Ricerche, Via A. Fleming, 4-37135 Verona, Italy; e-mail:anna.r.lanzoni{at}gsk.com

Although occurring in aged laboratory rodents, spontaneous renal tumour are unknown in animals younger than 18 weeks. A survey on renal preneoplastic and neoplastic lesions has been performed on Sprague-Dawley rats from general toxicology studies over the period January 2004—May 2006. Data from 2249 rats necropsied and 1206 rats (688 males and 518 females) examined microscopically from 52 studies, are reported. The age range at necropsy was between 12 and 18 weeks and all the animals were obtained from the same supplier. Three cases of tubular carcinoma, 1 tubular adenoma, and 4 cases of atypical tubular hyperplasia were observed in 5 females and 3 males from both control and treated groups from 6 studies with unrelated test compounds. In treated rats, the lesions were considered spontaneous in nature, rather than related to treatment, because of: (1) their sporadic incidence, (2) the short duration of the studies, and (3) the absence of similar lesions in other rats given the same test compound. These lesions are considered a recently occurring spontaneous finding, and the similarities with the familial renal cancer models, namely the Eker and the Nihon models, strongly suggest genetic factors as responsible for the lesions.

Key Words: Sprague-Dawley rat • spontaneous neoplasia • kidney carcinogenesis • genetic predisposition • background pathology


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G. C. Hard, J. C. Seely, G. E. Kissling, and L. J. Betz
Spontaneous Occurrence of a Distinctive Renal Tubule Tumor Phenotype in Rat Carcinogenicity Studies Conducted by the National Toxicology Program
Toxicol Pathol, April 1, 2008; 36(3): 388 - 396.
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