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그림문자(GHS)

• 그림문자(GHS)

  

• 신호 어

  Warning

• 유해·위험 문구

  H302：삼키면 유해함

  H315：피부에 자극을 일으킴

  H319：눈에 심한 자극을 일으킴

  H335：호흡 자극성을 일으킬 수 있음

• 예방조치문구

  P261：분진·흄·가스·미스트·증기·...·스프레이의 흡입을 피하시오.

  P280：보호장갑/보호의/보안경/안면보호구를 착용하시오.

  P301+P312：삼켜서 불편함을 느끼면 의료기관(의사)의 진찰을 받으시오.

  P302+P352：피부에 묻으면 다량의 물로 씻으시오.

  P305+P351+P338：눈에 묻으면 몇 분간 물로 조심해서 씻으시오. 가능하면 콘택트렌즈를 제거하시오. 계속 씻으시오.

클로로부탄올 화학적 특성, 용도, 생산

• 화학적 성질

  White or almost white, crystalline powder or colourless crystals, sublimes readily

• 용도

  Chlorobutanol is used as a preservative and sedative. It has also been shown to exhibit antibacterial properties.

• 생산 방법

  Chlorobutanol is prepared by condensing acetone and chloroform in the presence of solid potassium hydroxide.

• 위험도

  Action similar to chloral hydrate. Combustible.

• Pharmaceutical Applications

  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.

• Safety Profile

  Poison by ingestion. A narcotic. A skin and eye irritant. Mutation data reported. See also CHLORAL HYDRATE, whch acts similarly. Dangerous; can react with oxidizing materials. Combustible when exposed to heat or flame. When heated to decomposition it emits toxic fumes of Cl-. See also PHOSGENE.

• Safety

  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.
  The lethal human dose of chlorobutanol is estimated to be 50–500 mg/kg.
  LD₅₀ (dog, oral): 0.24 g/kg
  LD₅₀ (mouse, oral): 0.99 g/kg
  LD₅₀ (rabbit, oral): 0.21 g/kg

• 저장

  Chlorobutanol is volatile and readily sublimes. In aqueous solution, degradation to carbon monoxide, acetone and chloride ion is catalyzed by hydroxide ions. Stability is good at pH 3 but becomes progressively worse with increasing pH. The half-life at pH 7.5 for a chlorobutanol solution stored at 258℃ was determined to be approximately 3 months. In a 0.5% w/v aqueous chlorobutanol solution at room temperature, chlorobutanol is almost saturated and may crystallize out of solution if the temperature is reduced.
  Losses of chlorobutanol also occur owing to its volatility, with appreciable amounts being lost during autoclaving; at pH 5 about 30% of chlorobutanol is lost. Porous containers result in losses from solutions, and polyethylene containers result in rapid loss. Losses of chlorobutanol during autoclaving in polyethylene containers may be reduced by pre-autoclaving the containers in a solution of chlorobutanol; the containers should then be used immediately. There is also appreciable loss of chlorobutanol through stoppers in parenteral vials.
  The bulk material should be stored in an airtight container at a temperature of 8–158℃.

• 비 호환성

  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.

• Regulatory Status

  Included in the FDA Inactive Ingredients Database (IM, IV, and SC injection; inhalations; nasal, otic, ophthalmic, and topical preparations). Labeling must state ‘contains chlorobutanol up to 0.5%.’ Included in nonparenteral and parenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
  In the UK, the maximum concentration of chlorobutanol permitted for use in cosmetics, other than foams, is 0.5%. It is not suitable for use in aerosols.

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