化妆品原料氢化霍霍巴油的安全评估信息

Safety Assessment of hydrogenated jojoba oil Ingredients as Used in Cosmetics

原创 评估人： 李锦聪李锦聪，化妆品违禁词网创始人，知名化妆品法规博主/媒体评论人，广东省日化商会原料安全评估专委会副主任委员等多个化妆品行业协会政策法规专委会委员，在化妆品生产质量管理、新品开发、法律法规、安全评估等领域具有15年从业经验。 日期：

摘要：氢化霍霍巴油（INCI名称：HYDROGENATED JOJOBA OIL ；CAS号：92457-12-0;61789-91-1 ），已被广泛应用于化妆品等个人护理品，在化妆品中使用目的为皮肤保护剂、润肤剂。该原料已收录于《已使用化妆品原料目录（2021年版）》序号为05370，不属于《化妆品安全技术规范（2015年版）》中的禁用物质，参考《化妆品注册和备案检验项目要求》有关规定，对该原料的重金属、微生物、有害物质和稳定性等进行了检测。相关毒理学终点有：经口/经皮急性毒性（LD50）、皮肤和眼刺激性/腐蚀性、皮肤变态反应/致敏性、光毒性、光变态反应/光敏性、遗传毒性、重复剂量毒性/亚慢性（NOAEL/BMD）、生殖发育毒性、慢性毒性/致癌性等。该原料可能含有的风险物质为二甘醇，按照《化妆品安全评估技术导则》的要求，基于当前科学认知水平，对氢化霍霍巴油可能由化妆品原料带入、生产过程中产生或带入的风险物质进行了评估。在《已使用化妆品原料目录（2021年版）》中淋洗类产品最高历史使用量为17%，驻留类产品最高历史使用量为5.224%，并且有CIR、SCCS等权威机构评估结论数据，美国化妆品原料评价委员会（CIR）评估结果显示，浓度不高于（淋洗类为：31 %）（驻留类为：31 %）时，，该原料用于化妆品是安全的。当配方中的添加量低于该浓度时，该原料在正常、合理及可预见的使用条件下不会对人体健康造成危害。

关键词：氢化霍霍巴油;化妆品原料;安全评估报告;毒理学终点;权威数据;CIR;驻留类;淋洗类;最高历史使用量

评估意见：有淋洗类产品相关评估数据，有驻留类产品相关评估数据，经评估该原料满足化妆品完整版安全评估, 可根据原料在配方中实际应用浓度进行安全评估。

报送码系统中与【氢化霍霍巴油】相关的原料数量共计: 49 个

序号	05370
INCI英文名称	HYDROGENATED JOJOBA OIL
标准中文名称	氢化霍霍巴油
日本成分名称	水添ホホバ油
韩国成分名称	하이드로제네이티드호호바오일
CAS No	92457-12-0;61789-91-1
EC No	296-292-4
可能含有的风险物质	二甘醇
常规使用目的	皮肤保护剂、润肤剂
备注
已上市产品原料使用信息完整版安评可用20250209
国际化妆品安全评估数据索引完整版安评可用20250410
化妆品安全技术规范要求
标签上必须标印的警告语
牙膏技术规范要求
口腔清洁护理用品工业协会牙膏最高历史使用量（%）仅供参考不可用
完整版安全评估报告	氢化霍霍巴油完整版安全评估报告.pdf

化妆品原料主要的安全评估数据类型（完整版安评）

数据1：《化妆品安全技术规范》中的限用组分、准用防腐剂、准用防晒剂、准用着色剂和准用染发剂

数据2：国际权威化妆品安全评估机构公布的评估结论

数据3：世界卫生组织（WHO）、联合国粮农组织（FAO）等权威机构已公布的安全限量或结论

数据4：监管部门公布的已上市产品原料使用信息

数据5：化妆品“原料3年使用历史”评估要点

化妆品原料可豁免部分毒理试验和数据的方法（完整版安评）

方法1：化妆品原料“安全食用历史”评估要点

方法2：化学结构和性质稳定的高分子聚合物（具有较高生物活性的原料除外）

方法3：化妆品终产品安全性测试评估要点

方法4：毒理学关注阈值（TTC）方法评估要点

方法5：交叉参照（Read-across）方法评估要点

注意：对于无法使用上述任一证据类型的原料和/或风险物质，应按照《化妆品安全评估技术导则（2021年版）》要求的评估程序（1.危害识别 > 2.剂量反应关系评估 > 3.暴露评估 > 4.风险特征描述）进行评估证明其安全性。

全身暴露量（SED）=日均使用量 × 驻留因子 × 成分在配方中百分比 × 经皮吸收率 ÷ 体重
安全边际值（MoS） × 不确定因子（UF）= 未观察到有害作用的剂量（NOAEL/BMDL）÷ 全身暴露量（mg/kg·bw/day）
在通常情况下, 当MoS ≥ 100 × 不确定因子（UF）时，可以判定是安全的。

Assessment conclusions by international authoritative cosmetic safety assessment agencies:

ABSTRACT: Several cosmetic ingriedients derive from the desert shrub Simmondsia chinensis, including Simmondsia Chinensis (Jojoba) Seed Oil, Simmondsia Chinensis (Jojoba) Seed, and Simmondsia Chinensis (Jojoba) Butter. Further processing produces other ingredients including Hydrogenated Jojoba Oil, Hydrolyzed Jojoba Esters, Isomerized Jojoba Oil, Jojoba Esters, and Jojoba Alcohol. Synthetic Jojoba Oil also is used in cosmetics. In this group Simmondsia Chinensis (Jojoba) Seed Oil, the most widely used ingredient, and safe at concentrations up to 100% in body and hand creams, is expressed from seeds and is composed almost completely (97%) of wax esters of monounsaturated, straight-chain fatty acids and alcohols with high-molecular weights. Amounts and composition of the expressed oil varies with maturity of the seeds and somewhat with plant location and climate. Plant derived material may also contain pesticide residues and/or heavy metals. Most available safety test data examined the expressed oil. For example Simmondsia Chinensis (Jojoba) Seed Oil was reported to readily penetrate nude mouse skin and to increase penetration of other agents such as aminophylline in clinical tests. Simmondsia Chinensis (Jojoba) Seed Oil was not an acute oral toxicant to mice or rats (LD50 generally greater than 5.0 g/kg). Short-term subcutaneous administration of Simmondsia Chinensis (Jojoba) Seed Wax to rats at 1 ml/kg was not toxic. Neither the wax nor the oil were toxic when applied dermally to the shaved backs of guinea pigs in short-term tests. A dermal irritation test found aqueous Hydrolyzed Jojoba Esters (20%) to be non-irritating to guinea pigs. Jojoba Alcohol was found to be nonirritating to the skin of albino marmots at 10.0%. Simmondisa Chinensis (Jojoba) Butter was classified as a non-irritant when applied to the intact and abraded skin of New Zealand white rabbits at 0.5 ml for 24 h under an occluded patch. Jojoba Alcohol at concentrations up to 50% was minimally irritating in rabbits. Simmondsia Chinensis (Jojoba) Seed Oil was non- to slightly irritating when instilled into the eyes of white rabbits, but Simmondsia Chinensis (Jojoba) Seed Wax, Jojoba Esters, and Jojoba Alcohol were not. Simmondsia Chinensis (Jojoba) Seed Wax was moderately comedogenic in tests using rabbits, but Jojoba Esters was noncomedogenic, and Jojoba Esters were non- to slightly- comedogenic. Simmondsia Chinensis (Jojoba) Butter, Jojoba Alcohol, and Jojoba Esters were non-mutagenic in Ames testing. No carcinogenicity and no reproductive or developmental toxicity data were available. In clinical tests, Simmondsia Chinensis (Jojoba) Seed Oil was neither a significant dermal irritant, nor a sensitizer. In repeat insult patch tests Jojoba Alcohol , Jojoba Esters and Hydrolyzed Jojoba Esters were not irritating during induction or sensitizing at challenge. Simmondsia Chinensis (Jojoba) Seed Oil and Jojoba Alcohol were not phototoxic. The available safety test data were combined with the expected uses of these ingredients, which includes use in aerosolized products. Because the particle size of aerosol hair sprays (-38 μm) and pump hair sprays (>80 μm) is large compared to respirable particulate sizes (#10 μm), the ingredient particle size is cosmetic aerosols is not respirable. Relevant information also included uses with baby and eye products at low concentrations, and at 100% in hand and body creams. There were no structural alerts for the fatty acids, fatty alcohols, or other structures that would be found in these ingredients relative to reproductive/developmental toxicity, and these ingredients are not expected to easily penetrate skin. None of the tested ingredients were genotoxic and there were no structural alerts for carcinogenicity. The cosmetic industry should continue to limit pesticide and heavy metal impurities in the plant-derived ingredients before blending into cosmetic formulations. The CIR Expert Panel recognizes the gaps in use and use concentration data of these ingredients. Generally, the information available on the product types that include these ingredients and at what concentrations indicate a pattern to the Expert Panel when it assessed ingredient safety. Were unused ingredients used in the future, use is expected in comparable product categories and concentrations.gcioilnnj

CONCLUSION: Simmondsia Chinensis (Jojoba) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Wax, Hydrogenated Jojoba Oil, Hydrolyzed Jojoba Esters, Isomerized Jojoba Oil, Jojoba Esters, Simmondsia Chinensis (Jojoba) Butter, Jojoba Alcohol, and Synthetic Jojoba Oil are safe as cosmetic ingredients in the practices of use and concentration as discussed in this safety assessment.gcioilnnj

CITE: Safety Assessment of Simmondsia Chinensis (Jojoba) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Wax, Hydrogenated Jojoba Oil, Hydrolyzed Jojoba Esters, Isomerized Jojoba Oil, Jojoba Esters, Simmondsia Chinensis (Jojoba) Butter, Jojoba Alcohol, and Synthetic Jojoba Oil

CIR Conclusion：S - Safe in the present practices of use and concentration. Ingredient, concentration, and use information are available in documents discoverable at CIR. Citation: Final Report 9/2008 Available from CIR

International Authorities:

Andean Community
Association of Southeast Asian Nations (ASEAN)
Caribbean Community (CARICOM)
East African Community (EAC)
Central American Customs Union (CACU)
Cosmetic Ingredient Review (CIR)
Eurasian Economic Union (EAEU)
European Union (EU)
Global Treaties
Gulf Cooperation Council (GCC)
Southern Common Market (MERCOSUR)

Security Assessment Database:

INCI names
CAS numbers
chemical/technical names
additional terms will be used as appropriate
Pubmed
Toxnet(includes Toxline; HSDB; ChemIDPlus; DART; IRIS; CCRIS; CPDB; GENE-TOX)
Scifinder
wINCI
FDA databases
FDA search databases
EAFUS
GRAS listing
SCOGS database
Indirect Food Additives
Drug Approvals and Database
FDA Orange Book
OTC ingredient list
inactive ingredients approved for drugs
HPVIS(EPA High-Production Volume Info Systems)
NIOSH(National Institute for Occupational Safety and Health)
NTIS(National Technical Information Service)
NTP(National Toxicology Program)
Office of Dietary Supplements
FEMA(Flavor & Extract Manufacturers Association)
EU CosIng database
ECHA(European Chemicals Agency – REACH dossiers)
ECETOC(European Centre for Ecotoxicology and Toxicology of Chemicals)
European Medicines Agency (EMA)
IUCLID(International Uniform Chemical Information Database)
OECD SIDS(Organisation for Economic Co-operation and Development Screening Info Data Sets)
SCCS(Scientific Committee for Consumer Safety) opinions
NICNAS (Australian National Industrial Chemical Notification and Assessment Scheme)
International Programme on Chemical Safety
FAO(Food and Agriculture Organization of the United Nations)
WHO(World Health Organization) technical reports
Dr. Duke’s
Taxonomy database
GRIN(U.S. National Plant Germplasm System)
Sigma Aldrich plant profiler
American Herbal Products Association Botanical Safety Handbook (database)
European Medicines Agency Herbal Medicines
AGRICOLA(National Agricultural Library NAL Catalog)
The Seasoning and Spice Association List of Culinary Herbs and Spices
IFRA(International Fragrance Association)
RIFM(Research Institute for Fragrance Materials)