RIFM fragrance ingredient safety assessment, eicosane, CAS Registry Number 112-95-8

Abstract

Eicosane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that eicosane is not genotoxic. Data on read-across analog heneicosane (CAS # 629-94-7) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog undecane (CAS # 1120-21-4) provide a calculated MOE >100 for the reproductive toxicity endpoint. Data from read-across analog paraffin wax (CAS # 8002-74-2) show that there are no safety concerns for eicosane for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on structural analysis. There is no chromophore present in the structure of eicosane, so UV (ultraviolet) absorbance is not possible. Based on the lack of a chromophore, eicosane does not present a concern for photoirritation or photoallergenicity. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to eicosane is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; eicosane was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients (RQs), based on its current volume of use (VoU) in Europe (EU), North America (NA), Asia-Pacific (AP), and South America (SA) (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.