RIFM fragrance ingredient safety assessment, undecane, CAS Registry Number 1120-21-4

Abstract

The existing information supports the use of this material as described in this safety assessment. Undecane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog nonane (CAS # 111-84-2) show that undecane is not expected to be genotoxic. Data on undecane provide a calculated Margin of Exposure (MOE) >100 for the repeated dose and reproductive toxicity endpoints. Based on existing data and the application of the Dermal Sensitization Threshold (DST), undecane does not present a safety concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; undecane is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to undecane is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; undecane 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., PEC/PNEC [Predicted Environmental Concentration/Predicted No Effect Concentration]), are <1.