Chlorobutanol

Synonyms:  Acetone chloroform; anhydrous chlorbutol; chlorbutanol; chlorobutanolum anhydricum; chlorbutol; chloretone; Coliquifilm; Methaform; Sedaform; trichloro-tert-butanol; b,b,b-trichloro-tertbutyl alcohol; trichloro-t-butyl alcohol

Description:  Volatile, colorless or white crystals with a musty, camphoraceous
odor.

Chemical Name: 1,1,1-Trichloro-2-methyl-2-propanol 
1,1,1-Trichloro-2-methyl-2-propanol hemihydrate

Antimicrobial preservative; plasticizer.

• Chlorobutanol is primarily used in ophthalmic or parenteral dosage forms as an antimicrobial preservative at concentrations up to 0.5% w/v.

• It is commonly used as an antibacterial agent for epinephrine solutions, posterior pituitary extract solutions, and ophthalmic preparations intended for the treatment of miosis.

• It is especially useful as an antibacterial agent in nonaqueous formulations. Chlorobutanol is also used as a preservative in cosmetics as a plasticizer for cellulose esters and ethers; and has been used therapeutically as a mild sedative and local analgesic in dentistry

Owing to problems associated with sorption, chlorobutanol is incompatible with plastic vials, rubber stoppers, bentonite, magnesium trisilicate, polyethylene, and polyhydroxyethylmethacrylate, which has been used in soft contact lenses.

To a lesser extent, carboxymethylcellulose and polysorbate 80 reduce antimicrobial activity by sorption or complex formation

Chlorobutanol is widely used as a preservative in a number of pharmaceutical formulations, particularly ophthalmic preparations. Although animal studies have suggested that chlorobutanol may be harmful to the eye, in practice the widespread use of chlorobutanol as a preservative in ophthalmic preparations has been associated with few reports of adverse reactions. A study of the irritation potential of a local anesthetic on the murine cornea indicated significant corneal surface damage in the presence of 0.5% w/v chlorobutanol, which may be related to the preservative’s effective concentration. Reported adverse reactions to chlorobutanol include: cardiovascular effects following intravenous administration of heparin sodium injection preserved with chlorobutanol; neurological effects following administration of a large dose of morphine infusion preserved with chlorobutanol; and hypersensitivity reactions, although these are regarded as rare.

Observe normal precautions appropriate to the circumstances and quantity of material handled. Chlorobutanol may be irritant to the skin, eyes, and mucous membranes. Eye protection and gloves are recommended along with a respirator in poorly ventilated environments. There is a slight fire hazard on exposure to heat or flame.

Phenoxyethanol; phenylethyl alcohol.