International Numbering System (INS) for Food Additives: 260
Food additives Europe numbers: E260
Functional Category
Acidifying agent.
Applications in Pharmaceutical Formulation
Glacial and diluted acetic acid solutions are widely used asacidifying agents in a variety of pharmaceutical formulations and food preparations. Acetic acid is used in pharmaceutical products asa buffer system when combined with an acetate salt such as sodium acetate. Acetic acid is also claimed to have some antibacterial and antifungal properties.
Description
Glacial acetic acid occurs as a crystalline mass or a clear, colorlessvolatile solution with a pungent odor
Stability and Storage Conditions
Acetic acid should be stored in an airtight container in a cool, dryplace
Incompatibilities
Acetic acid reacts with alkaline substances.
Safety
Acetic acid is widely used in pharmaceutical applications primarilyto adjust the pH of formulations and is thus generally regarded asrelatively nontoxic and nonirritant. However, glacial acetic acid orsolutions containing over 50% w/w acetic acid in water or organicsolvents are considered corrosive and can cause damage to skin,eyes, nose, and mouth. If swallowed glacial acetic acid causes severe gastric irritation similar to that caused by hydrochloric acid.(1) Dilute acetic acid solutions containing up to 10% w/w of acetic acid have been used topically following jellyfish stings.(2) Dilute acetic acid solutions containing up to 5% w/w of acetic acid have also been applied topically to treat wounds and burns infected with Pseudomonas aeruginosa. (3) The lowest lethal oral dose of glacial acetic acid in humans is reported to be 1470 mg/kg.(4) The lowest lethal concentration on inhalation in humans is reported to be 816 ppm.(4) Humans, are, however, estimated to consume approximately 1 g/day of acetic acid frothe diet.LD50 (mouse, IV): 0.525 g/kg(4)LD50 (rabbit, skin): 1.06 g/kgLD50 (rat, oral): 3.31 g/kg