TY - JOUR
T1 - RIFM fragrance ingredient safety assessment, 4,8-decadienal, (4Z,8Z)-, CAS Registry Number 1958027-35-4
AU - Api, A. M.
AU - Belsito, D.
AU - Botelho, D.
AU - Bruze, M.
AU - Burton, G. A.
AU - Buschmann, J.
AU - Cancellieri, M. A.
AU - Dagli, M. L.
AU - Date, M.
AU - Dekant, W.
AU - Deodhar, C.
AU - Fryer, A. D.
AU - Jones, L.
AU - Joshi, K.
AU - Kumar, M.
AU - Lapczynski, A.
AU - Lavelle, M.
AU - Lee, I.
AU - Liebler, D. C.
AU - Moustakas, H.
AU - Na, M.
AU - Penning, T. M.
AU - Ritacco, G.
AU - Romine, J.
AU - Sadekar, N.
AU - Schultz, T. W.
AU - Selechnik, D.
AU - Siddiqi, F.
AU - Sipes, I. G.
AU - Sullivan, G.
AU - Thakkar, Y.
AU - Tokura, Y.
N1 - Publisher Copyright:
Copyright © 2021 Elsevier Ltd. All rights reserved.
PY - 2021/10/1
Y1 - 2021/10/1
N2 - The existing information supports the use of this material as described in this safety assessment. 4,8-Decadienal, (4Z,8Z)- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analogs 4,7-decadienal (CAS # 934534-30-2) and nona-2-trans-6-cis-dienal (CAS # 557-48-2) show that 4,8-decadienal, (4Z,8Z)- is not expected to be genotoxic. Data on analog 10-undecenal (CAS # 112-45-8) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and fertility endpoints and a No Expected Sensitization Induction Level (NESIL) of 1700 μg/cm2 for the skin sensitization endpoint. The developmental toxicity and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for Cramer Class I materials; exposure is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 4,8-decadienal, (4Z,8Z)- is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4,8-decadienal, (4Z,8Z)- was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. Its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
AB - The existing information supports the use of this material as described in this safety assessment. 4,8-Decadienal, (4Z,8Z)- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analogs 4,7-decadienal (CAS # 934534-30-2) and nona-2-trans-6-cis-dienal (CAS # 557-48-2) show that 4,8-decadienal, (4Z,8Z)- is not expected to be genotoxic. Data on analog 10-undecenal (CAS # 112-45-8) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and fertility endpoints and a No Expected Sensitization Induction Level (NESIL) of 1700 μg/cm2 for the skin sensitization endpoint. The developmental toxicity and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for Cramer Class I materials; exposure is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 4,8-decadienal, (4Z,8Z)- is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4,8-decadienal, (4Z,8Z)- was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. Its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
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U2 - 10.1016/j.fct.2021.112453
DO - 10.1016/j.fct.2021.112453
M3 - Article
C2 - 34364959
AN - SCOPUS:85118286314
SN - 0278-6915
VL - 156
SP - 112453
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
ER -