The existing information supports the use of this material as described in this safety assessment. 2-Thiophenecarboxylic acid, ethyl ester was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-thiophenecarboxylic acid, ethyl ester 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 III material, and the exposure to 2-thiophenecarboxylic acid, ethyl ester is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for non-reactive materials (900 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 2-thiophenecarboxylic acid, ethyl ester is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 2-thiophenecarboxylic acid, ethyl ester was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.
Keywords: Developmental, and Reproductive Toxicity; Environmental Safety; Genotoxicity; Local Respiratory Toxicity; Phototoxicity/Photoallergenicity; Repeated Dose; Skin Sensitization.
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