Abstract

Summary The existing information supports the use of this material as described in this safety assessment. Hexyl 2-hydroxypropionate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog ethyl lactate (CAS # 97-64-3) show that hexyl 2-hydroxypropionate is not expected to be genotoxic, provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints, and show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; hexyl 2-hydroxypropionate is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; the exposure is below the TTC (1.4 mg/day). The environmental endpoints were evaluated. For the hazard assessment based on the screening data, hexyl 2-hydroxypropionate is not persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, hexyl 2-hydroxypropionate was not able to be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.

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