Name: Dibutyl Sebacate
CAS No: Decanedioic acid, di-n-butyl ester [109-43-3]
USP-NF: Dibutyl Sebacate
Bis(n-butyl)sebacate; butyl sebacate; DBS; decanedioic acid, dibutyl ester; dibutyl decanedioate; dibutyl 1,8-octanedicarboxylate; Kodaflex DBS; Morflex DBS
Decanedioic acid, di-n-butyl ester [109-43-3]
C18H34O4 314.47 The USP32–NF27 describes dibutyl sebacate as consisting of the esters of n-butyl alcohol and saturated dibasic acids, principally sebacic acid.
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.
Dibutyl sebacate is a clear, colorless, oily liquid with a bland to slight butyl odor.
See Table I.
Acid value 0.02 Boiling point 344–3498C; 1808C at 3 mmHg for Morflex DBS. Flash point 1938C; 1788C (OC) for Morflex DBS. Melting point 108C Refractive index n D 25 = 1.4401 Solubility Soluble in ethanol (95%), ether, isopropanol, mineral oil, and toluene; practically insoluble in water. Specific gravity 0.937 at 208C Vapor density (relative) 10.8 (air = 1) Vapor pressure 0.4 kPa (3 mmHg) at 1808C
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.
Dibutyl sebacate is incompatible with strong oxidizing materials and strong alkalis.
Dibutyl sebacate is manufactured by the esterification of n-butanol and sebacic acid in the presence of a suitable catalyst, and by the distillation of sebacic acid with n-butanol in the presence of concentrated acid.
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)
Observe normal precautions appropriate to the circumstances and quantity of material handled. It is recommended that eye protection be used at all times. When heating this product, it is recommended to have a well-ventilated area, and the use of a respirator is advised.
Included in the FDA Inactive Ingredients Database (oral capsules, granules, film-coated, sustained action, and tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients.
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As dibutyl sebacate is an emollient ester, the personal care grade is recommended for use in cosmetics, hair products, lotions, and creams. The EINECS number for dibutyl sebacate is 203-672-5. The PubChem Compound ID (CID) for dibutyl sebacate is 7986.