Functional Category:
Film-forming agent; flavoring agent; solvent.
Applications in Pharmaceutical Formulation
Ethyl lactate is used as a solvent or co-solvent in liquid formulations(1,2) and recently as a co-solvent in emulsions and microemulsion technologies. It has also been used as a solvent for nitrocellulose, cellulose acetate, cellulose ethers, polyvinyl and other resins.(3) It has been applied topically in the treatment of acne vulgaris,(4,5) where it accumulates in the sebaceous glands and is hydrolyzed to ethanol and lactic acid, lowering the skin pH and exerting a bactericidal effect
Description
Ethyl lactate occurs as a clear colorless liquid with a sharp characteristic odor
Stability and Storage Conditions
Stable at normal temperature and pressure. Ethyl lactate is a flammable liquid and vapor. Store in a cool, dry, and well-ventilated location away from any fire hazard area, in a tightly closed container.
Incompatibilities
Incompatible with bases or strong alkalis and may cause fire or explosion with strong oxidizing agents.
Safety
Ethyl lactate is used as a flavoring agent in pharmaceutical preparations, and is found in food products. The estimated acceptable daily intake for lactic acid is 12.5 mg/kg body-weight. In general, lactate esters have an oral LD50 > 2000 mg/kg; and the inhalation LC50 is generally above 5000 mg/m3 . They have the potential of causing eye and skin irritation (on prolonged contact), but not sensitization.(6) Ethyl lactate is moderately toxic by intraperitoneal, subcutaneous, and intravenous routes. There is low oral and skin contact toxicity; although ingestion may cause nausea, stomach and throat pain, and narcosis. Inhalation of concentrated vapor of ethyl lactate may cause irritation of the mucous membranes, drowsiness, and narcosis. LD50 (rat, oral): >5.0 g/kg(7) LD50 (mouse, oral): 2.5 g/kg LD50 (mouse, SC): 2.5 g/kg LD50 (mouse, IV): 0.6 g/kg LD50 (rabbit, skin): >5.0 g/k