Functional Category
Plasticizer.
Applications in Pharmaceutical Formulation
Dibutyl sebacate is used in oral pharmaceutical formulations as a plasticizer for film coatings on tablets, beads, and granules, at concentrations of 10–30% by weight of polymer.(1,2) It is also used as a plasticizer in controlled-release tablets and microcapsule preparations.(3,4) Dibutyl sebacate is also used as a synthetic flavor and flavor adjuvant in food products;(5) for example, up to 5 ppm is used in ice cream and nonalcoholic beverages.
Description
Dibutyl sebacate is a clear, colorless, oily liquid with a bland to slight butyl odor
Stability and Storage Conditions
Dibutyl sebacate should be stored in a closed container in a cool, dry location. Dibutyl sebacate is stable under the recommended storage conditions and as used in specified applications under most conditions of use. As an ester, dibutyl sebacate may hydrolyze in the presence of water at high or low pH conditions.
Incompatibilities
Dibutyl sebacate is incompatible with strong oxidizing materials and strong alkalis
Safety
Dibutyl sebacate is used in cosmetics, foods, and oral pharmaceutical formulations, and is generally regarded as a nontoxic and nonirritant material. Following oral administration, dibutyl sebacate is metabolized in the same way as fats. In humans, direct eye contact and prolonged or repeated contact with the skin may cause very mild irritation. Acute animal toxicity tests and long-term animal feeding studies have shown no serious adverse effects to be associated with orally administered dibutyl sebacate. LD50 (rat, oral): 16 g/kg(6)