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High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents HPHC
Published on: May 10, 2016
RIFM fragrance ingredient safety assessment, pentadecane, CAS Registry Number 629-62-9
A M Api1, A Bartlett1, D Belsito2
1Research Institute for Fragrance Materials, Inc., 1200 MacArthur Boulevard, Suite 306, Mahwah, NJ, 07430, USA.
Abstract:
The existing information supports the use of this material as described in this safety assessment. Pentadecane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that pentadecane is not genotoxic and 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 hexadecane (CAS # 544-76-3) show that there are no safety concerns for pentadecane for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; pentadecane is not expected to be photoirritating/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 pentadecane is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; pentadecane 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.
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