Comparison of NTP Historical Control Tumor Incidence Rates in Female Harlan Sprague Dawley and Fischer 344/N Rats

Abstract

The National Toxicology Program (NTP) has historically used Fischer 344/N (F344/N) rats for the majority of its bioassays. Recently the NTP began using the Harlan Sprague Dawley (SD) as the primary rat model for NTP studies. The NTP had previously used female SD rats in nine bioassays. This article compares historical control (HC) tumor incidence rates from these nine SD rat studies with HC tumor rates from matched NTP F344/N rat bioassays to identify similarities and differences. Matching on sex, laboratory, diet, and route led to nine comparable F344/N rat studies. Our analyses revealed statistically significant strain differences, with female SD rats having lower incidence rates for clitoral gland adenoma (0.2% vs. 5.8%) and mononuclear cell leukemia (0.9% vs. 16.7%) and higher incidence rates for mammary gland fibroadenoma (67.4% vs. 48.4%), mammary gland carcinoma (10.2% vs. 2.4%), and thyroid gland C cell adenoma (25.4% vs. 13.6%) relative to female F344/N rats. These represent five of the seven most common tumor types among female SD and F344/N rats in the NTP HC database. When vehicle was included as an additional matching criterion, the number of comparable F344/N rat studies dropped to four, but similar results were obtained.