Initial Submission: Pathology Results from a Two-Year Chronic Dermal Study of Diethanolamine in B6C3F1 Mice with Cover Letter dated 05/03/1996

摘要

B.C,F, mice were exposed dermally for two years at diethanolamine doses of either 0, 40, 80, or 160 mg/kg. According to the interim report, incidences of hepatocellular adenoma, hepatocellular carcinoma, and hepatablastoma were greater in treated male and female mice compared to control animals. Also according to the interim report, incidences of renal tubule adenoma were greater in treated male groups than in controls. The interim report further states that the Pathology Working Group Chairman confirmed the absence of liver lesions consistent with Helicobacter infection; however, the report did not describe the specific methods used to rule out the presence of Helicobacter infection. In fact, certain methods may not detect the presence of this bacteria. Helicobacter infection is a major tumor risk factor, and Helicobacter has been detected recently in animal colonies being supplied to the National Toxicology Program.