RIFM fragrance ingredient safety assessment, benzyl isobutyrate, CAS Registry Number 103-28-6
| Autor: | W. Dekant, Peter Calow, I. G. Sipes, V. T. Politano, B Wall, D. Salvito, A. Lapczynski, Maria Lúcia Zaidan Dagli, Allison D. Fryer, J. Shen, S. La Cava, D. Belsito, D. C. Liebler, L Kromidas, G. Ritacco, S.P. Bhatia, Magnus Bruze, A.M. Api, T. W. Schultz, D K Wilcox, J F Lalko |
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| Rok vydání: | 2016 |
| Předmět: |
No-observed-adverse-effect level
Endpoint Determination Drug Evaluation Preclinical TOXICOLOGIA AMBIENTAL Pharmacology Toxicology medicine.disease_cause Risk Assessment 0404 agricultural biotechnology Isobutyrates Environmental safety Benzyl Compounds Toxicity Tests medicine Animals Predicted no-effect concentration No-Observed-Adverse-Effect Level Dose-Response Relationship Drug business.industry Skin sensitization 04 agricultural and veterinary sciences General Medicine 040401 food science Perfume Rats Consumer Product Safety Toxicity Reproductive toxicity Phototoxicity business Genotoxicity DNA Damage Food Science |
| Zdroj: | Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual) Universidade de São Paulo (USP) instacron:USP |
| ISSN: | 0278-6915 |
| DOI: | 10.1016/j.fct.2016.04.027 |
| Popis: | The existing information supports the use of this material as described in this safety assessment. p-Tolyl isobutyrate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analogs ethyl p-tolyl carbonate (CAS # 22,719-81-9) and p-tolyl acetate (CAS # 140-39-6) show that p-tolyl isobutyrate 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 p-tolyl isobutyrate 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 reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; p-tolyl isobutyrate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolyl isobutyrate 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 |
| Databáze: | OpenAIRE |
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