化妆品原料聚丙二醇-30的安全评估信息

Safety Assessment of ppg-30 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：2025年09月03日

摘要：聚丙二醇-30（INCI名称：PPG-30 ；CAS号：25322-69-4 ；化学结构式：C₆H₁₄O₃ ；分子量：134.17 ），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03697，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，对聚丙二醇-30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3.2%，驻留类产品最高历史使用量为0.005%，暂时未检索到CIR、SCCS等相关权威机构评估结论数据，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：聚丙二醇-30;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，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【聚丙二醇-30】相关的原料数量共计: ＜10 个

序号	03697
INCI英文名称	PPG-30
标准中文名称	聚丙二醇-30
日本成分名称	ＰＰＧ－３０
韩国成分名称	피피지-30
CAS No	25322-69-4
EC No
可能含有的风险物质	二甘醇
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	聚丙二醇-30 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: Propylene glycol is an aliphatic alcohol that functions as a skin conditioning agent, viscosity decreasing agent, solvent, and fragrance ingredient in cosmetics. Tripropylene glycol functions as a humectant, antioxidant, and emulsion stabilizer. Polypropylene glycols (PPGs), including PPG-3, PPG-7, PPG-9, PPG-12, PPG-13, PPG-15, PPG-16, PPG-17, PPG-20, PPG-26, PPG-30, PPG-33, PPG-34, PPG-51, PPG-52, and PPG-69, function primarily as skin conditioning agents, with some solvent use. The majority of the safety and toxicity information presented is for propylene glycol (PG). Propylene glycol is generally nontoxic and is noncarcinogenic. Clinical studies demonstrated an absence of dermal sensitization at use concentrations, although concerns about irritation remained. The CIR Expert Panel determined that the available information support the safety of tripropylene glycol as well as all the PPGs. The Expert Panel concluded that PG, tripropylene glycol, and PPGs ?3 are safe as used in cosmetic formulations when formulated to be nonirritating.jncnlioig

CONCLUSION: The CIR Expert Panel concluded that PG, tripropylene glycol, PPG-3, -7, -9, -12, -13, -15, -16, -17, 20, -26, -30, -33, -34, -51, -52, -69, and any PPG ?3 are safe as cosmetic ingredients in the present practices of use and concentration as described in this safety assessment when formulated to be nonirritating. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in the group.
PPG-15*, PPG-16*, PPG-20*, PPG-30*, PPG-7*jncnlioig

CITE: Safety Assessment of Propylene Glycol, Tripropylene Glycol, and PPGs as Used in Cosmetics

CIR Conclusion：The CIR Expert Panel concluded that ... PPG-30 and any PG >= 3 are safe as cosmetic ingredients in present practices of useand concentration as described in this safety assessment when formulated to be nonirritating. Finding: SQ - safe for use in cosmetics, with qualifications. Citation: JACT 13(6):437-491, 1994;IJT 31(Suppl2):245-260, 2012

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)