Initial Submission: Study of the Prenatal Toxicity of Isodecanol, 2-Ethylhexanol, and 711 Alcohol in Rats after Oral Administration (Gavage) with Cover Letter dated 09/28/1992

摘要

Groups of ten female rats were administered daily doses of the test compounds by gavage on gestation Days 6 through 15 at the following dose levels: isodecanol: 158, 790, and 1,580 mgfkg/day; 2-ethylhexanol: 130, 650, and 1,300 mg/kg/day. Maternal toxicity, including lethality, was observed at the high dose levels. Embryofetotoxicity observed at these dose levels included increased number of resorptions, decreased mean fetal body weight, and an increased incidence of skeletal retardations. In addition, increased skeletal variations and malformations, and dilated renal pelvis and/or hydroureter were observed in the offspring of dams treated with 2-ethylhexanol. Maternal toxicity, including decreased feed intake and body weight gain, and abnormal clinical signs, was observed in the isodecanol mid-dose group; no embryofetal toxicity was observed. Piloerection was observed in dams in the 2-ethylhexanol mid-dose group and embryoferotoxicity was observed in the offspring. Embryofetal effects included decreased mean fetal body weight, and an increased frequency of skeletal variations and retardation. No treatment-related effects were observed in dams or fetuses at the low dose levels.