Abstract
The existing information supports the use of this material as described in this safety assessment. cis-3-Hexenyl tiglate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analogs 2-methyl-trans-2-butenoic acid (CAS # 80-59-1) and cis-3-hexenol (CAS # 928-96-1) show that cis-3-hexenyl tiglate is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold for Toxicological Concern (TTC) for a Cramer Class I material; exposure to cis-3-hexenyl tiglate is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day and 1.4 mg/day, respectively). Data from analog 2-hexenoic acid, 2-methyl-, methyl ester, (2E)- (CAS # 16493-96-2) provided cis-3-hexenyl tiglate a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; cis-3-hexenyl tiglate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; cis-3-hexenyl tiglate 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., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
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