RIFM fragrance ingredient safety assessment, cedrene, CAS Registry Number 11028-42-5

Abstract

Cedrene was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that cedrene is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to cedrene is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data provided cedrene a No Expected Sensitization Induction Level (NESIL) of 3500 μg/cm2 for the skin sensitization endpoint. The photoirritation/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; cedrene is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; cedrene 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 (VoU) for Europe (EU), North America (NA), Asia-Pacific (AP), and Japan (JP) in the 2023 IFRA Survey was <1. Cedrene was not able to be risk screened for South America (SA) as there was no reported volume of use (VoU) for this regions in the 2023 IFRA Survey.