API Publ 4743:2005 pdf download

API Publ 4743:2005 pdf download.Hazard Narrative for Tertiary-Butyl Alcohol (TBA).
A dose-related increase in water consumption in male rats was observed during the second year of the study. while a dose-related decrease in water consumption was observed in female rats (NTP 1995). Water consumption was unaffected in male and female treated mice.
Ilehavioral and general health and appearance was unaffected by treatment in rats and mice of both sexes with the exception of an increased incidence of hyperactivity in the female rats in the high-dosc group. Urinary and hcmatological observations were not considcred to bc treatment-related. A significant increase in urine specific gravity and a significant decrease in urine volume were noted in thc female rats receiving 330 and 650 mg/kg/day, which was consistent with the decreased water consumption noted in the female rats.
At the 15-month interim sacrifice (10 rats per group), mean body weights were significantly decreased in male and female rats in the high-dose group (NTP 1995). In the male rats, relative brain, right kidney, and liver weights were increased in the high-dose group and relative right kidney weights were decreased in the mid-dose group. In the female high-dose group, relative brain and liver weights were significantly increased. Also, in the female rats. absolute and relative right kidney weights were significantly increased in all treated groups at the 15-month interim sacrifice. One renal tubule adenoma was observed in male rats at the IS- month interim sacrifice in the high-dose group. In addition, the incidence and severity of mineralization of the kidney was significantly increased in the high-dose male rats when compared to controls sacrificed at IS-months. Nephropathy was observed in all male and female rats, including controls, at the 15-month interim sacrifice, and the severity was slightly increased in treated male rats and the mid- and high-dose group females. Incidence data for male and female rats at the 15-month interim evaluation are presented in Tables I and 2. Due to decreased survival in mice, a 15-month interim evaluation was not pertiirmed.
At the end of the 2-year study. microscopic evaluations noted changes in the kidneys of male and female rats and in the thyroid gland of male and female mice. In rats, while the incidence of nephropathy was the same across all groups. including controls, the severity of the observed ncphropathy increased in both the male and female rats in the high-dose groups (NTP 1995). In the female rats, there was a significant increase in kidney inflammation in the 330 and
650 mg/kg/day group, and a significant increase in the kidney transitional epithelium hyperplasia at 650 mg/kg/day (Table 3). No renal tumors were found in any of the treated females.