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

A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, M. Francis, A. D. Fryer, L. Jones, K. Joshi, S. La Cava, A. Lapczynski, D. C. Liebler, D. O'Brien, A. Patel, T. M. PenningG. Ritacco, J. Romine, N. Sadekar, D. Salvito, T. W. Schultz, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura, S. Tsang

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)S438-S444
JournalFood and Chemical Toxicology
Volume122
DOIs
StatePublished - Dec 2018

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ASJC Scopus subject areas

  • Food Science
  • Toxicology

Cite this

Api, A. M., Belsito, D., Botelho, D., Bruze, M., Burton, G. A., Buschmann, J., Dagli, M. L., Date, M., Dekant, W., Deodhar, C., Francis, M., Fryer, A. D., Jones, L., Joshi, K., La Cava, S., Lapczynski, A., Liebler, D. C., O'Brien, D., Patel, A., ... Tsang, S. (2018). RIFM fragrance ingredient safety assessment, ethyl 2-methyl-1,3-dioxolane-2-acetate, CAS Registry Number 6413-10-1. Food and Chemical Toxicology, 122, S438-S444. https://doi.org/10.1016/j.fct.2018.09.076