RIFM fragrance ingredient safety assessment, 3(2H)-furanone, 5-ethyl-4-hydroxy-2-methyl-, CAS Registry Number 27538-09-6

The existing information supports the use of this material as described in this safety assessment. 3(2H)-Furanone, 5-ethyl-4-hydroxy-2-methyl- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3(2H)-furanone, 5-ethyl-4-hydroxy-2-methyl- is not genotoxic. Data on read-across material 4-hydroxy-2,5-dimethyl-3(2H)-furanone (CAS # 3658-77-3) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and fertility endpoints. Data and read-across to 4-hydroxy-2,5-dimethyl-3(2H)-furanone (CAS # 3658-77-3) provided 3(2H)-furanone, 5-ethyl-4-hydroxy-2-methyl- a No Expected Sensitization Induction Level (NESIL) of 590 mu g/cm(2) for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on data; 3(2H)-furanone, 5-ethyl-4-hydroxy-2-methyl- is not expected to be phototoxic/photoallergenic. The developmental toxicity and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class III material; exposure to 3(2H)-furanone, 5-ethyl-4-hydroxy-2-methyl- is below the TTC (0.009 mg/kg/day and 0.47 mg/day). The environmental endpoints were evaluated; 3(2H)-furanone, 5-ethyl-4-hydroxy-2-methyl- 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.

Automated summary

The material was found to be non-genotoxic and non-irritating in various toxicological tests, meeting environmental safety standards.