Food additives Europe numbers: E1504
Functional Category
Flavoring agent; solvent.
Applications in Pharmaceutical Formulation
In pharmaceutical preparations, ethyl acetate is primarily used as a solvent, although it has also been used as a flavoring agent. As a solvent, it is included in topical solutions and gels, and in edible printing inks used for tablets. Ethyl acetate has also been shown to increase the solubility of chlortalidone(1) and to modify the polymorphic crystal forms obtained for piroxicam pivalate,(2) mefenamic acid,(3) and fluconazole,(4) and has been used in the formulation of microspheres.(5–8) Ethyl acetate has been used as a solvent in the preparation of a liposomal amphotericin B dry powder inhaler formulation.(9) Its use as a chemical enhancer for the transdermal iontophoresis of insulin has been investigated.(10) In food applications, ethyl acetate is mainly used as a flavoring agent. It is also used in artificial fruit essence and as an extractionsolvent in food processing.
Description
Ethyl acetate is a clear, colorless, volatile liquid with a pleasant fruity, fragrant, and slightly acetous odor, and has a pleasant taste when diluted. Ethyl acetate is flammable
Stability and Storage Conditions
Ethyl acetate should be stored in an airtight container, protected from light and at a temperature not exceeding 308C. Ethyl acetate is slowly decomposed by moisture and becomes acidic; the material can absorb up to 3.3% w/w water. Ethyl acetate decomposes on heating to produce ethanol and acetic acid, and will emit acrid smoke and irritating fumes. It is flammable and its vapor may travel a
Ethyl acetate is used in foods, and oral and topical pharmaceutical formulations. It is generally regarded as a relatively nontoxic and nonirritant material when used as an excipient. However, ethyl acetate may be irritant to mucous membranes, and high concentrations may cause central nervous system depression. Potential symptoms of overexposure include irritation of the eyes, nose, and throat, narcosis, and dermatitis. Ethyl acetate has not been shown to be a human carcinogen or a reproductive or developmental toxin. The WHO has set an estimated acceptable daily intake of ethyl acetate at up to 25 mg/kg body-weigh considerable distance to an ignition source and cause a ‘flashback’. The alkaline hydrolysis of ethyl acetate has been shown to be inhibited by polyethylene glycol and by mixed micelle systems.(11
Incompatibilities
Ethyl acetate can react vigorously with strong oxidizers, strong alkalis, strong acids, and nitrates to cause fires or explosions. It also reacts vigorously with chlorosulfonic acid, lithium aluminum hydride, 2-chloromethylfuran, and potassium tert-butoxide.
Safetyt.
Ethyl acetate is used in foods, and oral and topical pharmaceutical formulations. It is generally regarded as a relatively nontoxic and nonirritant material when used as an excipient. However, ethyl acetate may be irritant to mucous membranes, and high concentrations may cause central nervous system depression. Potential symptoms of overexposure include irritation of the eyes, nose, and throat, narcosis, and dermatitis. Ethyl acetate has not been shown to be a human carcinogen or a reproductive or developmental toxin. The WHO has set an estimated acceptable daily intake of ethyl acetate at up to 25 mg/kg body-weight.(12) In the UK, it has been recommended that ethyl acetate be temporarily permitted for use as a solvent in food and that the maximum concentration consumed in food should be set at 1000 ppm.(13) LD50 (cat, SC): 3.00 g/kg(14) LD50 (guinea-pig, oral): 5.50 g/kg LD50 (guinea-pig, SC): 3.00 g/kg LD50 (mouse, IP): 0.709 g/kg LD50 (mouse, oral): 4.10 g/kg LD50 (rabbit, oral): 4.935 g/kg LD50 (rat, oral): 5.62 g/kg