RIFM fragrance ingredient safety assessment, 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile, CAS registry number 68084-04-8.,Food and Chemical Toxicology

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RIFM fragrance ingredient safety assessment, 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile, CAS registry number 68084-04-8.
Food and Chemical Toxicology ( IF 4.3 ) Pub Date : 2020-07-04 , DOI: 10.1016/j.fct.2020.111491
A M Api ₁ , D Belsito ₂ , D Botelho ₁ , M Bruze ₃ , G A Burton ₄ , J Buschmann ₅ , M L Dagli ₆ , M Date ₁ , W Dekant ₇ , C Deodhar ₁ , M Francis ₁ , A D Fryer ₈ , L Jones ₁ , K Joshi ₁ , S La Cava ₁ , A Lapczynski ₁ , D C Liebler ₉ , D O'Brien ₁ , A Patel ₁ , T M Penning ₁₀ , G Ritacco ₁ , J Romine ₁ , N Sadekar ₁ , D Salvito ₁ , T W Schultz ₁₁ , 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.

The existing information supports the use of this material as described in this safety assessment. 3-(4-Methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile is not genotoxic. Data show that there are no safety concerns for 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile for skin sensitization under the current declared levels of use. The repeated dose, 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 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated, 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile 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-（4-甲基-3-戊烯基）-3-环己烯-1-腈，CAS注册号68084-04-8。

现有信息支持本安全评估中所述的此材料的使用。评价了3-（4-甲基-3-戊烯基）-3-环己烯-1-腈的遗传毒性，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3-（4-甲基-3-戊烯基）-3-环己烯-1-腈没有遗传毒性。数据表明，在目前宣布的使用水平下，3-（4-甲基-3-戊烯基）-3-环己烯-1-腈没有任何安全方面的问题。使用Cramer III类材料的毒理学阈值（TTC）以及暴露于3-（4-甲基-3-戊烯基）-3-环己烯-1中，评估重复剂量，生殖和局部呼吸毒性终点-腈低于TTC（0。0015 mg / kg /天，0.0015 mg / kg /天和0.47 mg /天）。基于UV光谱评估了光毒性/光致敏性终点。3-（4-甲基-3-戊烯基）-3-环己烯-1-腈预计不会具有光毒性/光致敏性。根据国际香料协会（IFRA）环境标准，评估了环境指标，发现3-（4-甲基-3-戊烯基）-3-环己烯-1-腈不是持久性，生物蓄积性和有毒的（PBT），以及根据当前在欧洲和北美的使用量（即预测的环境浓度/预测的无影响浓度[PEC / PNEC]）得出的风险商数均小于1。3-（4-甲基-3-戊烯基）-3-环己烯-1-腈预计不会具有光毒性/光致敏性。根据国际香料协会（IFRA）环境标准，评估了环境指标，发现3-（4-甲基-3-戊烯基）-3-环己烯-1-腈不是持久性，生物蓄积性和有毒的（PBT），以及根据当前在欧洲和北美的使用量（即预测的环境浓度/预测的无影响浓度[PEC / PNEC]）得出的风险商数均小于1。3-（4-甲基-3-戊烯基）-3-环己烯-1-腈预计不会具有光毒性/光致敏性。根据国际香料协会（IFRA）环境标准，评估了环境指标，发现3-（4-甲基-3-戊烯基）-3-环己烯-1-腈不是持久性，生物蓄积性和有毒的（PBT），以及根据当前在欧洲和北美的使用量（即预测的环境浓度/预测的无影响浓度[PEC / PNEC]）得出的风险商数均小于1。

更新日期：2020-07-05

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