Abstract

This article presents the historical control data of spontaneous tumors in Tg.rasH2 published in 2013 (2004-2012) and compares and contrasts it to more recent data collected from 2013 to 2018, reporting differences in the average percentage incidences or incidence ranges as well as the incidence of new tumors. In 2013, we published a comprehensive review of spontaneous tumors in Tg.rasH2 mice used in 26-week carcinogenicity studies, which included data from control dose groups from 26 studies and a total of 710 mice per sex. The total database, now including the more recent data, has nearly doubled the number of animals, completing to date a total of 52 studies in males and 51 studies in females for a total of 1,615 male mice and 1,560 female mice, respectively. In this article, we compare the data collected from 2004 to 2012 against the data collected from 2013 to 2018 and the overall tumor incidence change.

Highlights

  • This article presents the historical control data of spontaneous tumors in Tg.rasH2 published in 2013 (2004–2012) and compares and contrasts it to more recent data collected from 2013 to 2018, reporting differences in the average percentage incidences or incidence ranges as well as the incidence of new tumors

  • We demonstrated that the combined incidence of all spontaneous tumors in Tg.rasH2 mice is generally low and below 25% in each sex

  • The incidence of spontaneous tumors in Tg.rasH2 mice at 26 weeks is much lower than the incidence of spontaneous tumors in conventional 2-year B6C3F1 and CD1 mice (Jacobs and Hatfield 2013; Nambiar, Turnquist, and Morton 2012; Paranjpe et al 2013)

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Summary

Introduction

This article presents the historical control data of spontaneous tumors in Tg.rasH2 published in 2013 (2004–2012) and compares and contrasts it to more recent data collected from 2013 to 2018, reporting differences in the average percentage incidences or incidence ranges as well as the incidence of new tumors. In 2013, we published a comprehensive review of spontaneous tumors in Tg.rasH2 mice used in 26-week carcinogenicity studies, which included data from control dose groups from 26 studies and a total of 710 mice per sex. The original publication reporting data from 2004 to 2012 demonstrated that pulmonary tumors (adenomas and carcinomas), splenic and other hemangiosarcomas, and Harderian gland tumors were the most common tumors in Tg.rasH2 mice of both sexes (Paranjpe et al 2013). While we present the entire data on tumors observed during two different time intervals (2004–2012 and 2013– 2018), in this article, we mainly discuss statistically significant differences in the most common tumors: primary lung tumors, hemangiosarcomas in multiple organs including spleen, Harderian gland tumors, and other tumors

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