Butylene Glycol

Basic Information

Name: Butylene Glycol

CAS No: 1,3-Butanediol [107-88-0]

Functional Categories

Antimicrobial preservative Humectant Solvent Water-miscible cosolvent

1. Nonproprietary Names

None adopted.

2. Synonyms

Butane-1,3-diol; 1,3-butylene glycol; b-butylene glycol; 1,3-dihydroxybutane; methyltrimethylene glycol.

3. Chemical Name & CAS Registry

1,3-Butanediol [107-88-0]

4. Empirical Formula & Molecular Weight

C4H10O2 90.14

5. Structural Formula

6. Applications

Butylene glycol is used as a solvent and cosolvent for injectables.(1) It is used in topical ointments, creams, and lotions,(2–4) and it is also used as a vehicle in transdermal patches. Butylene glycol is a good solvent for many pharmaceuticals, especially estrogenic substances.(5) In an oil-in-water emulsion, butylene glycol exerts its best antimicrobial effects at 8% concentration.(6) Higher concentrations above 16.7% are required to inhibit fungal growth.(7)

7. Description

Butylene glycol occurs as a clear, colorless, viscous liquid with a sweet flavor and bitter aftertaste.

9. Typical Properties

Antimicrobial activity Butylene glycol is effective against Grampositive and Gram-negative bacteria, molds, and yeast, though it is not sporicidal.(6) Density 1.004–1.006 (at 208C) Flash point 115–1218C (open cup) Hygroscopicity Absorbs 38.5% w/w of water in 144 hours at 81% RH. Melting point 778C Refractive index nD 20 = 1.440 Solubility Miscible with acetone, ethanol (95%), castor oil, dibutyl phthalate, ether, water; practically insoluble in mineral oil, linseed oil, ethanolamine, aliphatic hydrocarbons; dissolves most essential oils and synthetic flavoring substances. Specific heat 2.34 J/g (0.56 cal/g) at 208C Surface tension 37.8 mN/m (37.8 dyne/cm) at 258C Vapor density (relative) 3.1 (air = 1) Vapor pressure 8 Pa (0.06 mmHg) at 208C Viscosity (dynamic) 104 mPa s (104 cP) at 258C

10. Stability & Storage

Butylene glycol is hygroscopic and should be stored in a well-closed container in a cool, dry, well-ventilated place. When heated to decomposition, butylene glycol emits acrid smoke and irritating fumes.

11. Incompatibilities

Butylene glycol is incompatible with oxidizing reagents.

12. Method of Manufacture

Butylene glycol is prepared by catalytic hydrogenation of aldol using Raney nickel.

13. Safety

Butylene glycol is used in a wide variety of cosmetic formulations and is generally regarded as a relatively nontoxic material. It is mildly toxic by oral and subcutaneous routes. In topical preparations, butylene glycol is regarded as minimally irritant. Butylene glycol can cause allergic contact dermatitis, with local sensitivity reported in patch tests.(3,9–12) Some local irritation is produced on eye contact. LD50 (guinea pig, oral): 11.0 g/kg(8) LD50 (mouse, oral): 12.98 g/kg LD50 (rat, oral): 18.61 g/kg LD50 (rat, SC): 20.0 g/kg

14. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of the material handled. Butylene glycol should be handled in a well-ventilated environment; eye protection is recommended. Butylene glycol is combustible when exposed to heat or flame.

15. Regulatory Status

GRAS listed. Included in the FDA Inactive Ingredients Database (transdermal patches). Included in licensed medicines in the UK (topical gel patches/medicated plasters).

16. Related Substances

Propylene glycol.

17. Comments

Butylene glycol is used in shaving lather preparations and cosmetics, where it can be used to replace glycerin.(2) Because of its high viscosity at low temperatures, heating may be required for pumping. A specification for butylene glycol is included in the Food Chemicals Codex (FCC); see Table I. The EINECS number for butylene glycol is 203-529-7. The PubChem Compound ID (CID) for butylene glycol is 7896.