Бронопол

Описание

Bronopol, a formaldehyde releaser, was reported as an allergen in dairy workers. In a recent case report, bronopol was contained in a lubricant jelly used for ultrasound examination and caused contact dermatitis in a veterinary surgeon.

Химические свойства

Bronopol is a white or almost white crystalline powder; odorless or with a faint characteristic odor.

Использование

First synthesized in 1897, bronopol was primarily used as an effective preservative agent and possesses a wide spectrum of antibacterial activity and inhibits the growth of fungi and yeasts. It can be used in the formulation of a wide variety of cosmetic and personal care products, especially in leave-on and rinse-off shampoos, creams, lotions, rinses and eye makeup to protect the product integrity by preventing or slowing bacterial growth.
Bronopol is used as a microbiocide/microbiostat in oil field systems, air washer systems, air conditioning/humidifying systems, cooling water systems, papermills, absorbent clays, metal working fluids, printing inks, paints, adhesives and consumer/institutional products. A formulating technical material is also registered.
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Методы производства

Bronopol is synthesized by the reaction of nitromethane with paraformaldehyde in an alkaline environment, followed by bromination. After crystallization, bronopol powder may be milled to produce a powder of the required fineness.

Общее описание

White crystals. Ignite easily and burn readily. May detonate under strong shock. Decomposes when heated, evolving toxic gases. Toxic by skin absorption, inhalation or ingestion.

Реакции воздуха и воды

Highly flammable. Water soluble.

Профиль реактивности

Incompatible with strong oxidizing agents, strong bases, strong reducing agents, acid chlorides and acid anhydrides. 2-Bromo-2-nitro-1,3-propanediol is also incompatible with sulfhydryl compounds or with aluminum or iron containers (it is stable in contact with tin or stainless steel).

Опасность

Toxic by all routes of exposure; skin irritant.

Угроза здоровью

Fire may produce irritating and/or toxic gases. Contact may cause burns to skin and eyes. Contact with molten substance may cause severe burns to skin and eyes. Runoff from fire control may cause pollution.

Пожароопасность

Flammable/combustible material. May be ignited by friction, heat, sparks or flames. Some may burn rapidly with flare burning effect. Powders, dusts, shavings, borings, turnings or cuttings may explode or burn with explosive violence. Substance may be transported in a molten form at a temperature that may be above its flash point. May re-ignite after fire is extinguished.

Фармацевтические приложения

Bronopol 0.01–0.1% w/v is used as an antimicrobial preservative either alone or in combination with other preservatives in topical pharmaceutical formulations, cosmetics, and toiletries; the usual concentration is 0.02% w/v.

Контактные аллергены

Bronopol is a preservative sometimes considered as a formaldehyde releaser. It was reported to be an allergen in cosmetics, cleaning agents, dairy workers, and a lubricant jelly used for ultrasound examination.
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https://www.contactdermatitisinstitute.com

Профиль безопасности

Poison by ingestion, subcutaneous, intravenous, and intraperitoneal routes. Moderately toxic by skin contact. An eye and human skin irritant. An antiseptic. When heated to decomposition it emits very toxic fumes of NOx, and Br-.

хранилище

Bronopol is stable and its antimicrobial activity is practically unaffected when stored as a solid at room temperature and ambient relative humidity for up to 2 years.
The pH of a 1.0% w/v aqueous solution is 5.0–6.0 and falls slowly during storage; solutions are more stable in acid conditions.
Microbiological assay results indicate longer half-lives than those obtained by HPLC and thus suggest that degradation products may contribute to antimicrobial activity. Formaldehyde and nitrites are among the decomposition products, but formaldehyde arises in such low concentrations that its antimicrobial effect is not likely to be significant. On exposure to light, especially under alkaline conditions, solutions become yellow or brown-colored but the degree of discoloration does not directly correlate with loss of antimicrobial activity.
The bulk material should be stored in a well-closed, nonaluminum container protected from light, in a cool, dry place.

Несовместимости

Sulfhydryl compounds cause significant reductions in the activity of bronopol, and cysteine hydrochloride may be used as the deactivating agent in preservative efficacy tests; lecithin/polysorbate combinations are unsuitable for this purpose. Bronopol is incompatible with sodium thiosulfate, with sodium metabisulfite, and with amine oxide or protein hydrolysate surfactants. Owing to an incompatibility with aluminum, the use of aluminum in the packaging of products that contain bronopol should be avoided.

Регуляторный статус

Included in topical pharmaceutical formulations licensed in Europe. Included in the Canadian List of Acceptable Non-medicinal Ingredients.