Acetyl Triethyl Citrate,
Acetyl Tributyl Citrate,
Acetyl Trihexyl Citrate, and
Acetyl Trioctyl Citrate all function as
plasticizers in
cosmetics. Additionally, the Trihexyl and Trioctyl forms are described as skin-conditioning agents-
emollients, although there are currently no reported uses of
Acetyl Trihexyl Citrate or
Acetyl Trioctyl Citrate.
Acetyl Triethyl Citrate and
Acetyl Tributyl Citrate are used in nail products at concentrations up to 7%. Recognizing that there are no reported uses of Acetyl Trihexyl or Trioctyl
Citrate, if they were to be used in the future, their concentration of use is expected to be no higher than that reported for Acetyl Triethyl and
Tributyl Citrate. These ingredients were sufficiently similar in structure that safety test data on one were considered applicable to all. Approximately 99% of orally administered
Acetyl Tributyl Citrate is excreted-intermediate metabolites include acetyl
citrate, monobutyl
citrate, acetyl monobutyl
citrate, dibutyl
citrate, and acetyl dibutyl
citrate. In acute, short-term, subchronic, and chronic feeding studies, these ingredients were relatively nontoxic. Differences from controls were either not statistically significant or not related to any organ toxicity. Ocular exposures produced moderate reactions that cleared by 48 hours after instillation. Dermal application was not toxic in rabbits. In a guinea pig maximization test,
Acetyl Triethyl Citrate was a sensitizer whereas
Acetyl Tributyl Citrate was not. Limited clinical testing of
Acetyl Triethyl Citrate and
Acetyl Tributyl Citrate was negative for both skin irritation and sensitization. These clinical data were considered more relevant than the guinea pig maximization data, suggesting to the Cosmetic Ingredient Review Expert Panel that none of these ingredients would be a sensitizer. Physiologic effects noted with intravenous delivery of
Acetyl Triethyl Citrate or
Acetyl Tributyl Citrate include dose-related decreases in blood pressure and intestinal
muscular spasms. These ingredients were not genotoxic in bacterial or mammalian test systems. No significant differences in
tumor induction (
lymphomas) were noted in rats fed
Acetyl Tributyl Citrate for 2 year.
Acetyl Tributyl Citrate was not a developmental or reproductive toxicant in studies in mice and rats. Based on all the available data, these ingredients were considered safe as used in
cosmetics.