Evaluation of the developmental toxicity of 4-tert-butylcyclohexyl acetate in Sprague-Dawley rats.

The fragrance ingredient 4-tert-butylcyclohexyl acetate (4-tBCHA) was evaluated for potential developmental toxicity in pregnant rats at oral dosages of 0, 40, 160, or 640 mg/kg per d in corn oil on gestational days 7 to 20. Increased salivation was observed at 160 and 640 mg/kg per d. The 640 mg/kg per d dosage was associated with the presence of a red perioral substance, ungroomed, sparse hair coat on the limbs, localized alopecia, reduced feed and body weight gains, or body weight losses, and mortality. Fetal body weights also were reduced at 640 mg/kg per d. This effect was associated with transient delays in fetal development, including significant increases in fetal incidences of moderate enlargement of the renal pelvis and reversible delays in ossification of the caudal vertebrae, fore and hind limb phalanges, and hind limb metatarsals. Maternal and developmental no observable adverse effect levels (NOAELs) were 160 mg/kg per d. It was concluded that 4-tBCHA is not a developmental toxicant in rats.