G. Sullivan

RIFM fragrance ingredient safety assessment, 2-(p-menth-1-ene-10-yl)cyclopentanone, CAS Registry Number 95962-14-4

The use of this material under current conditions is supported by existing information. 2-(p-Menth-1-ene-10-yl)cyclopentanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that this material is not genotoxic and provided an MOE >100 for the repeated dose toxicity endpoint. Data show that there are no safety concerns for 2-(p-Menth-1-ene-10-yl)cyclopentanone for skin sensitization under the current declared levels of use. The developmental and reproductive as well as the local respiratory toxicity endpoints were completed using the Threshold of Toxicological Concern (TTC) for a Cramer Class II material (0.009u202fmg/kg/day and 0.47u202fmg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra. The environmental endpoints were evaluated; 2-(p-menth-1-ene-10-yl)cyclopentanone was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

RIFM fragrance ingredient safety assessment, 1,1-diethoxyheptane, CAS Registry Number 688-82-4

The use of this material under current conditions is supported by existing information. 1,1-Diethoxyheptane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the read-across analog octanal dimethyl acetal (CAS # 10022-28-3) show that 1,1-diethoxyheptane is not expected to be genotoxic. Based on the application of the non-reactive DST, 1,1-diethoxyheptane does not present a concern for skin sensitization. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using the TTC for a Cramer Class I material (0.03u202fmg/kg/day, 0.03u202fmg/kg/day, and 1.4u202fmg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra. The environmental endpoints were evaluated; 1,1-diethoxyheptane was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

RIFM fragrance ingredient safety assessment, ethyl 2-methyl-1,3-dioxolane-2-acetate, CAS Registry Number 6413-10-1

Ethyl 2-methyl-1,3-dioxolane-2-acetate (CAS # 6413-10-1) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that ethyl 2-methyl-1,3-dioxolane-2-acetate is not genotoxic. Data from ethyl 2-methyl-1,3-dioxolane-2-acetate show that there are no safety concerns for skin sensitization under the current, declared levels of use. Data on ethyl 2-methyl-1,3-dioxolane-2-acetate provide a calculated MOE >100 for the repeated dose, developmental, and reproductive toxicity endpoints. The local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to ethyl 2-methyl-1,3-dioxolane-2-acetate is below the TTC (0.47 mg/day). The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; ethyl 2-methyl-1,3-dioxolane-2-acetate is not expected to be phototoxic/photoallergenic. For the environmental endpoints, ethyl 2-methyl-1,3-dioxolane-2-acetate is not PBT as per the IFRA Environmental Standards, and its risk quotients (i.e., PEC/PNEC) for the aquatic environment based on its current volume of use in Europe and North America are <1.