||Springborn Labs., Inc., Wareham, MA.; Chemical Manufacturers Association, Washington, DC.; Environmental Protection Agency, Washington, DC. Office of Toxic Substances.
Oleylamine was evaluated for potential teratogenicity to mated female rats (28/group) administered oral doses of 0, 10, 40, or 80 mg/kg/day by gavage in corn oil on gestation days 6 through 15. Doses were selected by means of a range-finding study. No treatment-related mortalities occurred. Clinical signs were observed in the 40 (salivation) and 80 mg/kg/day (salivation and rales) groups, along with dose-dependent body weight losses, reduced weight gain, and decreased food consumption at these levels. No evidence of embryotoxicity, fetotoxicity, or teratogenicity was noted. A developmental study was conducted in rabbits (22 inseminated females/group) orally administered 0, 3, 10, or 30 mg/kg/day by gavage in corn oil on gestation days 6 through 18. Doses were determined in a range-finding study. Dose- related maternal toxicity (2 deaths in high-dose group, 1 female from each treatment group aborted prior to scheduled sacrifice, rales, irritation of mouth area, decreased body weight, weight gain, and food consumption) was noted at 10 mg/kg/day and above. No signs of embryotoxicity, fetotoxicity or teratogenicity were noted.