RIFM fragrance ingredient safety assessment, 3-(m-tert-butylphenyl)-2-methylpropionaldehyde, CAS Registry Number 62518-65-4.,Food and Chemical Toxicology

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RIFM fragrance ingredient safety assessment, 3-(m-tert-butylphenyl)-2-methylpropionaldehyde, CAS Registry Number 62518-65-4.
Food and Chemical Toxicology ( IF 3.9 ) Pub Date : 2020-07-05 , DOI: 10.1016/j.fct.2020.111496
A M Api ₁ , D Belsito ₂ , S Biserta ₁ , D Botelho ₁ , M Bruze ₃ , G A Burton ₄ , J Buschmann ₅ , M A Cancellieri ₁ , M L Dagli ₆ , M Date ₁ , W Dekant ₇ , C Deodhar ₁ , A D Fryer ₈ , S Gadhia ₁ , L Jones ₁ , K Joshi ₁ , A Lapczynski ₁ , M Lavelle ₁ , D C Liebler ₉ , M Na ₁ , D O'Brien ₁ , A Patel ₁ , T M Penning ₁₀ , G Ritacco ₁ , F Rodriguez-Ropero ₁ , J Romine ₁ , N Sadekar ₁ , D Salvito ₁ , T W Schultz ₁₁ , F Siddiqi ₁ , I G Sipes ₁₂ , G Sullivan ₁ , Y Thakkar ₁ , Y Tokura ₁₃ , S Tsang ₁

Affiliation

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave, New York, NY, 10032, USA.
Malmo University Hospital, Department of Occupational & Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo, SE-20502, Sweden.
School of Natural Resources & Environment, University of Michigan, Dana Building G110, 440 Church St, Ann Arbor, MI, 58109, USA.
Fraunhofer Institute for Toxicology and Experimental Medicine, Nikolai-Fuchs-Strasse 1, 30625, Hannover, Germany.
University of Sao Paulo, School of Veterinary Medicine and Animal Science, Department of Pathology, Av. Prof. dr. Orlando Marques de Paiva, 87, Sao Paulo, CEP 05508-900, Brazil.
University of Wuerzburg, Department of Toxicology, Versbacher Str. 9, 97078, Würzburg, Germany.
Oregon Health Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.
Vanderbilt University School of Medicine, Department of Biochemistry, Center in Molecular Toxicology, 638 Robinson Research Building, 2200 Pierce Avenue, Nashville, TN, 37232-0146, USA.
University of Pennsylvania, Perelman School of Medicine, Center of Excellence in Environmental Toxicology, 1316 Biomedical Research Building (BRB) II/III, 421 Curie Boulevard, Philadelphia, PA, 19104-3083, USA.
The University of Tennessee, College of Veterinary Medicine, Department of Comparative Medicine, 2407 River Dr, Knoxville, TN, 37996- 4500, USA.
Department of Pharmacology, University of Arizona, College of Medicine, 1501 North Campbell Avenue, P.O. Box 245050, Tucson, AZ, 85724-5050, USA.
The Journal of Dermatological Science (JDS), Editor-in-Chief, Professor and Chairman, Department of Dermatology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.

The existing information supports the use of 3-(m-tert-butylphenyl)-2-methylpropionaldehyde as described in this safety assessment.

3-(m-tert-Butylphenyl)-2-methylpropionaldehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog p-t-butyl-α-methylhydrocinnamic aldehyde (CAS # 80-54-6) show that 3-(m-tert-butylphenyl)-2-methylpropionaldehyde is not expected to be genotoxic. Data on 3-(m-tert-butylphenyl)-2-methylpropionaldehyde provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and developmental and reproductive toxicity endpoints. Data from read-across analog p-t-butyl-α-methylhydrocinnamic aldehyde (CAS # 80-54-6) provided 3-(m-tert-butylphenyl)-2-methylpropionaldehyde a No Expected Sensitization Induction Level (NESIL) of 4100 μg/cm² for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3-(m-tert-butylphenyl)-2-methylpropionaldehyde 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 to 3-(m-tert-butylphenyl)-2-methylpropionaldehyde is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3-(m-tert-butylphenyl)-2-methylpropionaldehyde 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.

中文翻译：

RIFM香料成分安全性评估，3-（间叔丁基苯基）-2-甲基丙醛，CAS登记号62518-65-4。

现有的信息支持使用3-（米-叔丁基苯基）-2-甲基丙醛在本安全评估说明。

评价3-（间叔丁基苯基）-2-甲基丙醛的遗传毒性，重复剂量毒性，发育和生殖毒性，局部呼吸毒性，光毒性/光致敏性，皮肤致敏性和环境安全性。从模拟跨越只读数据PT-丁基α甲基氢化醛（CAS＃80-54-6）表明3-（间叔丁基苯基）-2-甲基丙醛预计不会具有遗传毒性。3-（间叔丁基苯基）-2-甲基丙醛的数据为重复剂量毒性以及发育和生殖毒性终点提供了大于100的计算的暴露裕度（MOE）。来自跨模拟pt-的数据丁基-α-甲基氢肉桂醛（CAS＃80-54-6）提供3-（间-叔丁基苯基）-2-甲基丙醛对于皮肤敏化终点的未预期的敏化诱导水平（NESIL）为4100μg/ cm ²。基于紫外线（UV）光谱评估了光毒性/光致敏性终点；3-（间叔丁基苯基）-2-甲基丙醛预计不会有光毒性/光致敏性。使用Cramer I类材料的毒理学关注阈值（TTC）评估了局部呼吸毒性终点。3-（间叔丁基苯基）-2-甲基丙醛的暴露量低于TTC（1.4 mg /天）。评估了环境指标；3-（m-tert根据国际香水协会（IFRA）环境标准及其风险商，根据欧洲和北美目前的使用量，发现-丁基苯基）-2-甲基丙醛不是具有持久性，生物累积性和毒性（PBT）。（即，预测的环境浓度/预测的无效浓度[PEC / PNEC]）小于1。

更新日期：2020-07-05

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