Abstract |
The results of the completed study corroborated the preliminary findings, indicating an increased incidence of hepatocellular adenomas at the two highest doses in males and at the highest dose in females, and an increased incidence of hepatocellular carcinomas at the two highest doses for both males and females. In addition, there was an increased incidence of Leydig-cell tumors in the testes of high-dose males. Treatment-related increases in non- neoplastic lesions were also found, primarily at the two highest doses, including hyperplasia and hypertrophy in the liver, degenerative vascular and tubular changes in the papillary region of the kidney, colloid changes in the thyroid, alveolar macrophage accumulation, Leydig-cell hyperplasia and tubular atrophy and aspermia in the testes, and chronic degenerative myelinopathy of the sciatic nerve. |