化妆品原料芒果(MANGIFERA INDICA)籽脂的安全评估信息

Safety Assessment of mangifera indica (mango) seed butter 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:芒果(MANGIFERA INDICA)籽脂(INCI名称:MANGIFERA INDICA (MANGO) SEED BUTTER ),来源于被子植物门 Angiospermae >> 漆树科 Anacardiaceae >> 杧果属 Mangifera 植物,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。该原料已收录于《已使用化妆品原料目录(2021年版)》序号为04598,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农药残留, 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,对芒果(MANGIFERA INDICA)籽脂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 驻留类产品最高历史使用量为37.7%, 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:0.5 %) (驻留类为:5 %) 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:芒果(MANGIFERA INDICA)籽脂;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:淋洗类产品相关评估数据, 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【芒果(MANGIFERA INDICA)籽脂】相关的原料数量共计: 55
序号04598
INCI英文名称 MANGIFERA INDICA (MANGO) SEED BUTTER
标准中文名称 芒果(MANGIFERA INDICA)籽脂
日本成分名称マンゴー種子脂
韩国成分名称망고씨버터
CAS No
EC No290-045-4
可能含有的风险物质农药残留
常规使用目的皮肤保护剂
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 芒果(MANGIFERA INDICA)籽脂 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: The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 244 plant-derived fatty acid oils as used in cosmetics. Oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, and moisturizing properties. Since many of these oils are edible, and their systemic toxicity potential is low, the review focused on potential dermal effects. The Panel concluded that the 244 plant-derived fatty acid oils are safe as used in cosmetics.ogijicnln

CONCLUSION: The Panel concluded that the 244 plant-derived fatty acid oils included in this review are safe in the present practices of use and concentration described in this safety assessment.
LUPINUS ALBUS SEED OIL*, PERSEA GRATISSIMA (AVOCADO) BUTTER*, SOLANUM LYCOPERSICUM (TOMATO) SEED OIL*, POTASSIUM OLIVATE*, MORINDA CITRIFOLIA SEED OIL*, ADANSONIA DIGITATA SEED OIL*, CARYA ILLINOINENSIS (PECAN) SEED OIL*, CORYLUS AMERICANA (HAZELNUT) SEED OIL*, RICE BRAN ACID*, COTTONSEED ACID*, LYCIUM BARBARUM SEED OIL*, ARCTIUM LAPPA SEED OIL*, PYRUS MALUS (APPLE) SEED OIL*, HYDROGENATED MACADAMIA SEED OIL*, HYDROGENATED SAFFLOWER SEED OIL*, HYDROGENATED RICE BRAN OIL*, HYDROGENATED WHEAT GERM OIL*, HYDROGENATED APRICOT KERNEL OIL*, HYDROGENATED PALM ACID*, TORREYA NUCIFERA SEED OIL*, HIPPOPHAE RHAMNOIDES SEED OIL*, ALEURITES MOLUCCANUS BAKOLY SEED OIL*, LUFFA CYLINDRICA SEED OIL*, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL UNSAPONIFIABLES*, CITRUS AURANTIUM DULCIS (ORANGE) SEED OIL*, CITRUS AURANTIUM DULCIS (ORANGE) SEED OIL UNSAPONIFIABLES*, PRUNUS ARMENIACA (APRICOT) KERNEL OIL UNSAPONIFIABLES*, LINSEED ACID*, MAGNESIUM COCOATE*, COCOS NUCIFERA (COCONUT) SEED BUTTER*, OLEA EUROPAEA (OLIVE) HUSK OIL*, CITRUS GRANDIS (GRAPEFRUIT) SEED OIL*, CITRUS GRANDIS (GRAPEFRUIT) SEED OIL UNSAPONIFIABLES*, ZEA MAYS (CORN) GERM EXTRACT*, ZEA MAYS (CORN) KERNEL MEAL*, ZEA MAYS (CORN) OIL UNSAPONIFIABLES*, POTASSIUM CORNATE*, VACCINIUM VITIS-IDAEA SEED OIL*, VEGETABLE OIL*, GEVUINA AVELLANA SEED OIL*, PERILLA OCYMOIDES SEED OIL*, BRASSICA NAPUS SEED OIL*, HYDROGENATED CANOLA OIL*
Were ingredients not in current use (as indicated by *) to be used in the future, the expectation is that they would be used in product categories and concentrations comparable to others in this group.ogijicnln

CITE: Safety Assessment of Plant-Derived Fatty Acid Oils

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: IJT 36(Suppl. 3):51-129, 2017
    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)
    Country Region:
  • China
  • Japan
  • Korea
  • India
  • Pakistan
  • Afghanistan
  • Iran
  • Saudi Arabia
  • Israel
  • Turkey
  • Russia
  • Germany
  • France
  • Italy
  • Spain
  • United Kingdom
  • Poland
  • Ukraine
  • Sweden
  • Greece
  • Egypt
  • Sudan
  • Kenya
  • Nigeria
  • South Africa
  • Ghana
  • Morocco
  • Algeria
  • Tunisia
  • Ethiopia
  • United States
  • Canada
  • Mexico
  • Cuba
  • Jamaica
  • Panama
  • Haiti
  • Dominican Republic
  • Guatemala
  • Honduras
  • Brazil
  • Argentina
  • Peru
  • Chile
  • Colombia
  • Venezuela
  • Uruguay
  • Paraguay
  • Bolivia
  • Ecuador
  • Australia
  • New Zealand
  • Papua New Guinea
  • Solomon Islands
  • Vanuatu
  • Fiji
  • Samoa
  • Kiribati
  • Nauru
  • Marshall Islands