Acetyl Triethyl Citrate
Safety Information
The Food and Drug Administration (FDA) includes acetyl triethyl citrate and acetyl tributyl citrate on its list of indirect food additives that may be used in adhesives and in resinous and polymeric coatings for polyolefin films. The safety of acetyl triethyl citrate, acetyl tributyl citrate, acetyl trihexyl citrate and acetyl triethylhexyl citrate has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that these ingredients were safe as used in cosmetics and personal care products.
The Expert Panel reviewed the data on acetyl tributyl citrate, acetyl triethyl citrate, acetyl trihexyl citrate and acetyl triethylhexyl citrate. The Expert Panel noted that acetyl triethyl citrate was classified as a strong sensitizer in the maximization test, whereas, tributyl citrate was classified as a nonsensitizer. Clinical testing of acetyl triethyl and acetyl tributyl citrate was negative for both skin irritation and sensitization. After reviewing these data, and considering that acetyl triethyl citrate and acetyl tributyl citrate are used mostly in nail products at concentrations up to 7%, the Expert Panel concluded that is not likely that any of the esters in this safety assessment, as used in cosmetics, poses a risk for sensitization.
The Expert Panel determined that because of structural similarities between the aliphatic esters included in this review, the available toxicity data on acetyl triethyl citrate, acetyl tributyl citrate, and acetyl trihexyl citrate were sufficient for evaluating the safety of acetyl triethylhexyl citrate in cosmetics. Furthermore, after considering these data along with current use concentration data (on acetyl triethyl citrate and acetyl tributyl citrate) provided by the cosmetics industry, the Expert Panel determined that the available data do not warrant any restrictions on the use of these ingredients in rinse-off or leave-on cosmetic products.
FDA: Link to the Code of Federal Regulations for acetyl triethyl citrate and acetyl tributyl citrate.
Acetyl triethyl citrate, acetyl tributyl citrate, acetyl trihexyl citrate and acetyl triethylhexyl citrate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.
