Support: Reproduction/Developmental Toxicity Screening Test in the Rat with 2,2,4-Trimethyl-1,3-Pentanediol Diiosbutyrate, Final Report with Cover Letter dated 08/24/2001

摘要

The potential toxicity of the test substance was evaluated using a reproduction/developmental toxicity screening test. The study consisted of four phases: pre-mating (14 days), mating (1 to 8 days), gestation (21 to 23 days), and early lactation (4 to 5 days). Groups of 12 male and 12 female Sprague-Dawley rats were offered diets containing 15.0 (1.50%), 4.5 (0.45%), 1.5 (0.15%), or 0.0 (0.0%) mg of the test substance per gram of feed ad libitum until they were euthanatized, a total of 38-50 days. These dietary concentrations produced dose levels of approximately 905, 276, 91, and 0 mg/kg body weight/day for male rats, and 1135, 359, 120, and 0 mg/kg body weight/day for female rats. All adult animals were observed daily for clinical signs of toxicity, and body weights were measured at least once each week. Feed consumption was also measured at least weekly, except during the mating phase when the males and females were housed in pairs. Pups were observed daily and weighed as a group on Days 0 and 4 postpartum. All adult animals survived to study termination. Clinical abnormalities that may be related to test substance-exposure included reductions in the amount of feces and/or softened feces, which were generally observed in the high-dose group. Other abnormalities were considered incidental to treatment. Clinical abnormalities were also observed in pups from all dose levels. However, since the frequency of occurrence of these abnormalities was similar between treated and control groups, they were not considered to be treatment-related.