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外観
無色の結晶又は白色の結晶性粉末
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定義
本品は、パラヒドロキシ安息香酸とプロパノール(*)のエステルであり、次の化学式で表される。
参照表示名称：プロパノール
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溶解性
水に難溶。エタノール, エーテルに可溶。
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用途
保存料。
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化粧品の成分用途
防腐剤、香料
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効能
防腐剤
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化学的特性
Propylparaben occurs as a white, crystalline, odorless, and tasteless
powder.
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使用
propylparaben is one of the most frequently used preservatives against bacteria and mold. It has a low sensitizing and low toxicity factor, is reputed to be very safe, and considered to be a noncomedogenic raw material.
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定義
ChEBI: The benzoate ester that is the propyl ester of 4-hydroxybenzoic acid. Preservative typically found in many water-based cosmetics, such as creams, lotions, shampoos and bath products. Also used as a food additive.
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調製方法
Propylparaben is prepared by the esterification of p-hydroxybenzoic
acid with n-propanol.
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製造方法
Produced by esterfying p-hydroxybenzoic acid with n-propanol, using an acid catalyst such as sulfuric acid and an excess
of propanol. The materials are heated in a glass-lined reactor under reflux. The acid is then neutralized with caustic soda and the
product is crystallized by cooling. The crystallized product is centrifuged, washed, dried under vacuum, milled and blended, all in
corrosion-resistant equipment to avoid metallic contamination.
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一般的な説明
Colorless crystals or white powder or chunky white solid. Melting point 95-98°C. Odorless or faint aromatic odor. Low toxicity, Tasteless (numbs the tongue). pH: 6.5-7.0 (slightly acidic) in solution.
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空気と水の反応
Water soluble [Hawley].
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反応プロフィール
Maximum stability of Propylparaben occurs at a pH of 4 to 5. Incompatible with alkalis and iron salts. Also incompatible with strong oxidizing agents and strong acids .
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火災危険
Flash point data for Propylparaben are not available; however, Propylparaben is probably combustible.
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応用例（製薬）
Propylparaben is widely used as an antimicrobial preservative in
cosmetics, food products, and pharmaceutical formulations.
It may be used alone, in combination with other paraben esters,
or with other antimicrobial agents. It is one of the most frequently
used preservatives in cosmetics.
The parabens are effective over a wide pH range and have a
broad spectrum of antimicrobial activity, although they are most
effective against yeasts and molds.
Owing to the poor solubility of the parabens, the paraben salts,
particularly the sodium salt, are frequently used in formulations.
This may cause the pH of poorly buffered formulations to become
more alkaline.
Propylparaben (0.02% w/v) together with methylparaben
(0.18% w/v) has been used for the preservation of various
parenteral pharmaceutical formulations.
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接触アレルゲン
This substance is one of the parabens family. Parabens are esters formed by p-hydroxybenzoic acid
and an alcohol. They are largely used as biocides in
cosmetics and toiletries, medicaments, or food. They
have synergistic power with other biocides. Parabens
can induce allergic contact dermatitis, mainly in
chronic dermatitis and wounded skin.
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安全性
Propylparaben and other parabens are widely used as antimicrobial
preservatives in cosmetics, food products, and oral and topical
pharmaceutical formulations.
Propylparaben and methylparaben have been used as preservatives
in injections and ophthalmic preparations; however, they are
now generally regarded as being unsuitable for these types of
formulations owing to the irritant potential of the parabens.
Systemically, no adverse reactions to parabens have been
reported, although they have been associated with hypersensitivity
reactions. The WHO has set an estimated acceptable total daily
intake for methyl, ethyl, and propyl parabens at up to 10 mg/kg
body-weight.
LD50 (mouse, IP): 0.2 g/kg
LD50 (mouse, oral): 6.33 g/kg
LD50 (mouse, SC): 1.65 g/kg
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貯蔵
Aqueous propylparaben solutions at pH 3–6 can be sterilized by
autoclaving, without decomposition.At pH 3–6, aqueous
solutions are stable (less than 10% decomposition) for up to about
4 years at room temperature, while solutions at pH 8 or above are
subject to rapid hydrolysis (10% or more after about 60 days at
room temperature).
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不和合性
The antimicrobial activity of propylparaben is reduced considerably
in the presence of nonionic surfactants as a result of micellization.
Absorption of propylparaben by plastics has been reported, with
the amount absorbed dependent upon the type of plastic and the
vehicle. Magnesium aluminum silicate, magnesium trisilicate,
yellow iron oxide, and ultramarine blue have also been reported to
absorb propylparaben, thereby reducing preservative efficacy.
Propylparaben is discolored in the presence of iron and is subject
to hydrolysis by weak alkalis and strong acids.
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規制状況(Regulatory Status)
Propylparaben and methylparaben are affirmed GRAS direct food
substances in the USA at levels up to 0.1%. All esters except the
benzyl ester are allowed for injection in Japan.
In cosmetics, the EU and Brazil allow use of each paraben at
0.4%, but the total of all parabens may not exceed 0.8%. The upper
limit in Japan is 1.0%.
Accepted as a food additive in Europe. Included in the FDA
Inactive Ingredients Database (IM, IV, and SC injections; inhalations;
ophthalmic preparations; oral capsules, solutions, suspensions,
and tablets; otic, rectal, topical, and vaginal preparations).
Included in parenteral and nonparenteral medicines licensed in the
UK. Included in the Canadian List of Acceptable Non-medicinal
Ingredients.
