RIFM fragrance ingredient safety assessment, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol, CAS Registry Number 526218-21-3.,Food and Chemical Toxicology

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RIFM fragrance ingredient safety assessment, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol, CAS Registry Number 526218-21-3.
Food and Chemical Toxicology ( IF 3.9 ) Pub Date : 2020-07-04 , DOI: 10.1016/j.fct.2020.111492
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), Department of Dermatology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.

Summary

The existing information supports the use of this material as described in this safety assessment. 1-(2-Methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not genotoxic. Data on 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. The 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 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is below the TTC (0.0015 mg/kg/day and 0.47 mg/day, respectively). Data show that there are no safety concerns for 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol 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.

中文翻译：

RIFM香料成分安全性评估，1-（2-甲基丙-2-烯氧基）-2,2,4-三甲基戊-3-醇，CAS登记号526218-21-3。

概要

现有信息支持本安全评估中所述的此材料的使用。评价了1-（2-甲基丙-2-烯氧基）-2,2,4-三甲基戊-3-醇的遗传毒性，重复剂量毒性，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。数据表明1-（2-甲基丙-2-烯氧基）-2,2,4-三甲基戊-3-醇没有遗传毒性。1-（2-甲基丙-2-烯氧基）-2,2,4-三甲基戊-3-醇的数据为重复剂量毒性终点提供了大于100的计算的暴露裕度（MOE）。使用Cramer III类材料的毒理学阈值（TTC）以及暴露于1-（2-甲基丙-2-烯醇氧基）-2,2,4-三甲基戊烷-3中来评估生殖和局部呼吸道毒性终点-ol低于TTC（0.0015 mg / kg / day和0。分别为47毫克/天）。数据表明，在目前声明的使用水平下，1-（2-甲基丙-2-烯醇氧基）-2,2,4-三甲基戊-3-醇对皮肤过敏没有安全性问题。基于紫外线（UV）光谱评估了光毒性/光致敏性终点；1-（2-甲基丙-2-烯醇氧基）-2,2,4-三甲基戊-3-醇预计不会具有光毒性/光致敏性。评估了环境指标；根据筛查数据进行危害评估，根据国际香料协会，1-（2-甲基丙-2-烯醇氧基）-2,2,4-三甲基戊-3-醇不是持久性，生物蓄积性和有毒的（PBT）（IFRA）环境标准。为了进行风险评估，请使用1-（2-methylprop-2-enoloxy）-2,2

更新日期：2020-07-05

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