RIFM fragrance ingredient safety assessment, ethyl lactate, CAS registry number 97-64-3

The existing information supports the use of this material as described in this safety assessment. Ethyl lactate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data on ethyl lactate show that ethyl lactate is not genotoxic and provided a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity, reproductive toxicity, and local respiratory endpoints. Data from ethyl lactate and additional material ethyl (L)-lactate (CAS # 687-47-8) show that there are no safety concerns for ethyl lactate for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; ethyl lactate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; ethyl lactate was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.