Subject(s)
Acetals/toxicity , Odorants , Perfume/toxicity , Animals , Bacteria/drug effects , Consumer Product Safety , Endpoint Determination , Humans , Risk AssessmentSubject(s)
Nitriles/toxicity , Odorants , Perfume/toxicity , Animals , Bacteria/drug effects , Consumer Product Safety , Endpoint Determination , Humans , Risk AssessmentSubject(s)
Nitriles/toxicity , Odorants , Perfume/toxicity , Animals , Bacteria/drug effects , Consumer Product Safety , Endpoint Determination , Humans , Risk AssessmentSubject(s)
Hexanols/toxicity , Odorants , Perfume/toxicity , Sulfides/toxicity , Animals , Bacteria/drug effects , Consumer Product Safety , Endpoint Determination , Humans , Risk AssessmentABSTRACT
The existing information supports the use of this material as described in this safety assessment. Ethyl 2-methyl-4-pentenoate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog methyl undec-10-enoate (CAS # 111-81-9) show that ethyl 2-methyl-4-pentenoate is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to ethyl 2-methyl-4-pentenoate is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 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 ultraviolet/visible (UV/Vis) spectra; ethyl 2-methyl-4-pentenoate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; ethyl 2-methyl-4-pentenoate 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.
Subject(s)
Fatty Acids, Monounsaturated/toxicity , Odorants , Perfume/toxicity , Valerates/toxicity , Animals , Bacteria/drug effects , Consumer Product Safety , Endpoint Determination , Humans , Risk AssessmentABSTRACT
The existing information supports the use of this material as described in this safety assessment. Butyl lactate 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 (L)-lactate (CAS # 687-47-8) show that butyl lactate is not expected to be genotoxic. Data on read-across materials butyl alcohol (CAS # 71-36-3) and lactic acid (CAS # 50-21-5) provide a calculated margin of exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. 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 ultraviolet (UV) spectra; butyl lactate is not expected to be phototoxic/photoallergenic. Data on butyl lactate provide a calculated MOE >100 for the local respiratory endpoint. The environmental endpoints were evaluated; butyl lactate 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.