원료 사전 탐색/ethylhexylglycerin/ETHYLHEXYLGLYCERIN
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
합성 (Synthetic)

ETHYLHEXYLGLYCERIN

식약처 한글 표준명: 에틸헥실글리세린
데오도란트피부컨디셔닝제
[식약처 공정서 기원 및 정의] 이 원료는 다음의 구조를 갖는 유기화합물이다.
[EU CosIng Official Definition] Ethylhexylglycerin is the organic compound that conforms to the formula
결론 선행 Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

화장품에서 에틸헥실글리세린 (ETHYLHEXYLGLYCERIN)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?

에틸헥실글리세린(표준 INCI: ETHYLHEXYLGLYCERIN, CAS 번호: 70445-33-9)은 화장품 처방에서 주로 데오도란트, 피부컨디셔닝제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.03–0.15%(적정 pH 3–10) 범위에서 안정적으로 처방됩니다.

7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스

각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건
7-Track Official Statutory Label Names for ETHYLHEXYLGLYCERIN
국가·규제 트랙공식 고시 전성분 표기명원클릭 복사
① 한국 (MFDS 화장품 한글 표준명)에틸헥실글리세린
② 한국 구명칭 (개정 전 이력 · 301 리다이렉트)에칠헥실글리세린
③ 유럽 (EU CosIng EC 1223/2009)ETHYLHEXYLGLYCERIN
④ 미국 일반화장품 (US PCPC / MoCRA INCI)ETHYLHEXYLGLYCERIN
⑤ 미국 OTC (FDA Active Ingredient Monograph)— (비-OTC 일반 화장품 원료)—
⑥ 중국 (NMPA IECIC 표준 중문명)乙基己基甘油
⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW)エチルヘキシルグリセリン · [QD: グリセリルモノ2-エチルヘキシルエーテル]

Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태

Layer 1 Statutory Regulatory Limits Across 6 Regions for ETHYLHEXYLGLYCERIN
권역규제 상태배합 한도제한 조건 및 1차 법원 출처
한국 (MFDS)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
유럽 (CosIng)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
미국 (FDA/CIR)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
중국 (NMPA)등재·허용GMPIECIC Entry #7706
일본 (MHLW)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
아세안 (ACD)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)

Layer 2 — 독성·안전성 평가 한도 (US CIR · EU SCCS MoS≥100 · CN IECIC 최고역사사용량)

「SCCS 안전 판정 상한」은 유럽 소비자안전과학위원회가 안전역(MoS≥100)으로 판정한 상한이며, 「CIR 시판 보고 농도」와 「중국 IECIC 최고역사사용량」은 실제 시판 제품에 보고된 최대 농도입니다.

Layer 2 Toxicological & Historical Safe Use Concentrations for ETHYLHEXYLGLYCERIN
안전성 평가 기준적용 부위·유형안전 농도 범위판정 결과 및 문헌 번호
CIR 시판 보고 농도rinse_off0~8%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도eye0.02~1%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도ingestion0.08~0.5%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도spray0.01~2%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도powder0.2~0.5%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도dermal0.000001~8%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도deodorant0.04~2%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도hair0.0003~2%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도nail0.1~0.1%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도mucous0.000001~0.5%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도leave_on0.002~2%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도bath0.1~0.1%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
CIR 시판 보고 농도total0.000001~8%안전 판정(MoS≥100)ethylh122011finalx.pdf (2011)
중국 IECIC 최고역사사용량leave_on≤ 5%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 07834 (2025)
중국 IECIC 최고역사사용량rinse_off≤ 2%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 07834 (2025)
⚠️ 참조용 안내 (법적 면책 공지): 이 사전의 성분명·규제 한도·배합 가이드는 연구·개발 참조용으로만 제공됩니다. 각국 고시 개정 시차나 데이터 오기·누락이 있을 수 있으므로, 실제 제품 처방·라벨 표기·인허가 전에는 반드시 관할 기관(식약처 등)의 최신 공식 고시 원문을 직접 확인하시기 바라며, 본 사전의 정보를 잘못 사용하여 발생하는 문제에 대해 운영 주체는 법적 책임을 지지 않습니다.
제형군별 사분위수(Min–Q1–Median–Q3–Max) 분포 그래프

Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조

수성 토너·세럼·앰플n=112
Min 0.03% · Q1 0.04% · Median 0.05% · Q3 0.08% · Max 0.15%
O/W · W/O 에멀전·크림n=245
Min 0.03% · Q1 0.05% · Median 0.08% · Q3 0.1% · Max 0.3%
세정 폼·샴푸 (린스오프)n=7
Min 0.8% · Q1 1% · Median 1% · Q3 1% · Max 1%
자외선차단·색조n=22
Min 0.5% · Q1 0.7% · Median 0.85% · Q3 1% · Max 20%
수성 토너·세럼·앰플 — 미생물 세포막 표면장력 약화 방부 부스터
공식 검증 원천: Schülke sensiva SC 50 TDS & CIR Assessment (cir_safety) · Ashland/Schuelke 64 · Evonik 48
권장 중앙값: 0.05%

Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드

Layer 3 Formulation Concentration Quartiles by Product Category for ETHYLHEXYLGLYCERIN
제형군 분류Min – Q1 – Median – Q3 – Max (%)처방 역할 및 기전Source ID
제형군 A — 수성 토너 · 세럼 · 고농축 앰플0.03% · 0.04% · 0.05% · 0.08% · 0.15%미생물 세포막 표면장력 약화 방부 부스터Schülke sensiva SC 50 TDS & CIR Assessment
제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O)0.03% · 0.05% · 0.08% · 0.1% · 0.3%페녹시에탄올 또는 1,2-헥산다이올 방부 시너지 부스터Schülke sensiva SC 50 / Euxyl PE 9010 TDS
제형군 C — 세정 워시오프 · 폼 · 샴푸 · 바디워시0.8% · 1% · 1% · 1% · 1%린스오프 세정·클렌징 처방 계면 안정화 및 사용감 개선Global Starter Formulation Library Statistical Distribution (n=7, SEPPIC 6 · EVONIK 1)
제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션0.5% · 0.7% · 0.85% · 1% · 20%선케어·색조 메이크업 분산 안정화 및 발림성 조절Global Starter Formulation Library Statistical Distribution (n=22, EVONIK 12 · SEPPIC 6 · GRANT 4)
피부 투과 과학 시각화 (Bos & Meinardi 500 Dalton Rule)MW: 204.31 Da · LogP: 2.4

각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션

각질층 (Stratum Corneum · 10~20 µm)500 Dalton 장벽 (고분자·친수성 성분 차단)생존 표피층 (Viable Epidermis · 50~100 µm)멜라닌세포 · 각질형성세포 타깃 (미백·장벽·턴오버)진피 유두층 (Papillary Dermis · 150~300 µm)섬유아세포 콜라겐 I/III · 엘라스틴 · PDRN 재생 타깃표피~상부 진피 확산 (<500 Da)
분자량(MW) & 친유성(LogP) 투과 판정
저분자 영역 (204.31 Da ≤ 500 Da) — 각질층 수동 확산 가능

단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.

예상 도달 깊이
40–90 µm
권장 전달 시스템
Polyol Enhancer / Serum
계면화학 · pH · 열역학 공정 시각화

pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동

Slightly soluble in water (~0.1%); soluble in glycols, alcohols, oils
적정 처방 pH 안전 윈도우 (pH 0 ~ 14 스펙트럼)pH 3.0 – 10.0
0245.5791114

권장 구간 밖(pH < 3 또는 pH > 10)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.

공정 가열 한계 온도 (Max Process Temp)≤ 80°C
25°C45°C60°C75°C85°C100°C

최대 80°C 가열 공정에서 열적 안정성이 유지됩니다.

계면활성·유화 HLB 스펙트럼 (0 ~ 20) & 미셀/액정 배열 시뮬레이터
O/W 수중유형 미셀 에멀전 (수분 크림·로션)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
생화학 신호전달 경로 (Biochemical Pathway Map)

세포·분자 타깃 작용 기전 플로우 다이어그램

1. 각질층·표피 작용→ 촉진·활성 (Activation)
각질층 세포간 지질 & 수분 결합 네트워크
→
경피수분손실(TEWL) 억제 및 피부결 개선
2. 염증 매개체 조절⊣ 억제·차단 (Inhibition)
외부 자극 유도 산화 스트레스(ROS) 및 사이토카인
⊣
피부 진정 및 항상성 유지
처방 온톨로지 네트워크 그래프

권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도

+ 1,2-HEXANEDIOL+ PHENOXYETHANOL+ PENTYLENE GLYCOL+ CAPRYLYL GLYCOL✕ 물 용해도가 약 0.1%로 낮아 가용…ETHYLHEXYLGLYCERIN
노드 인터랙션 가이드

🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.

대표 상용명 참고 (상표법 제90조 제1항 제2호 설명적 표기)
sensiva® SC 50Euxyl® PE 9010 (90% Phenoxyethanol + 10% EHG)

상용명 표기는 상표법 제90조 제1항 제2호에 의거하여 연구원에게 원료 등급·규격을 설명하기 위한 참고용이며, 각 상표의 권리는 해당 원료사에 귀속됩니다.

학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)

Tier 1 Synthesis

이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.

■ [1. 화학적 정체성 및 규격 (Chemical Identity & Standard Nomenclature)] - 표준명: 에틸헥실글리세린 | INCI: ETHYLHEXYLGLYCERIN | CAS No.: 70445-33-9 | EC No.: 408-080-2 - 기원 및 분류: SYNTHETIC | 주요 기능: 데오도란트, 피부컨디셔닝제 - 물리화학 스펙: 분자식 C11H24O3 | 분자량 204.31 g/mol | LogP 2.4 | 이온성: non-ionic | PubChem CID 98663 - 7대 권역 공식 라벨 표기: KR [에틸헥실글리세린] · EU [ETHYLHEXYLGLYCERIN] · US [ETHYLHEXYLGLYCERIN] · CN [乙基己基甘油] · JP [エチルヘキシルグリセリン] · JP의약부외품 [グリセリルモノ2-エチルヘキシルエーテル] ■ [2. 피부과학적 작용 기전 및 제형 내 역할 (Mechanism of Action & Function)] - 이 원료는 다음의 구조를 갖는 유기화합물이다. 물리화학적 분류상 기원(synthetic)에 기반하여 피부 장벽 및 제형 매트릭스 내에서 고유한 기능(데오도란트, 피부컨디셔닝제)을 수행하며, 계면 안정화·보습·피부 컨디셔닝 또는 유효성분 전달에 기여합니다. ■ [3. 글로벌 6대 권역 법정 규제 및 안전성 한도 (Layer 1 & Layer 2 Regulatory Matrix)] - 6개국 요약: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (중국 IECIC(2025) 등재번호 7706 (乙基己基甘油)) - 6대 주요 권역(KR·EU·US·CN·JP·ASEAN) 별도 배합금지/특수제한 고시 없음 (GMP 일반 안전 기준 내 배합 허용). - 공인 안전성·역사적 사용 농도(Layer 2): cir (reported_use, rinse_off): 0~8% / cir (reported_use, eye): 0.02~1% / cir (reported_use, ingestion): 0.08~0.5% ■ [4. 제형군별 통상 배합 가이드 (Layer 3-A Formulation Dosage Guide)] - [aqueous_serum] 권장 범위: 0.03 ~ 0.15% (중앙값 0.05%, 근거: Schülke sensiva SC 50 TDS & CIR Assessment) — 미생물 세포막 표면장력 약화 방부 부스터 - [emulsion_cream] 권장 범위: 0.03 ~ 0.3% (중앙값 0.08%, 근거: Schülke sensiva SC 50 / Euxyl PE 9010 TDS) — 페녹시에탄올 또는 1,2-헥산다이올 방부 시너지 부스터 - [cleanser_rinse] 권장 범위: 0.8 ~ 1.0% (중앙값 1.0%, 근거: Global Starter Formulation Library Statistical Distribution (n=7, SEPPIC 6 · EVONIK 1)) — 린스오프 세정·클렌징 처방 계면 안정화 및 사용감 개선 ■ [5. 연구원 공정 설계 · 안정성 · 배합 금기 (Layer 3-B Process & Compatibility)] - 투입 공정(Phase): Pre-dissolve in 1,2-Hexanediol, Butylene Glycol, or Phenoxyethanol before adding to Water/Cool-down Phase - 적정 pH 구간: pH 3.0 ~ 10.0 | 공정 내열 온도: 최대 80°C | 전해질(염) 내성: HIGH - 배합 주의/금기: 물 용해도가 약 0.1%로 낮아 가용화제 없는 투명 수성 토너에 0.1% 초과 단독 투입 시 백탁(Cloudiness) 및 카보머 점도 저하 유발 - 시너지 추천 원료: 1,2-HEXANEDIOL, PHENOXYETHANOL, PENTYLENE GLYCOL, CAPRYLYL GLYCOL | 참고 상용 원료명: sensiva® SC 50, Euxyl® PE 9010 (90% Phenoxyethanol + 10% EHG) ■ [6. 학술 논문 및 공인 문헌 근거 (Peer-Reviewed Literature & Compendia)] - PMID 38017612 (2024, Contact Dermatitis): A non-cosmetic allergic contact dermatitis to ethylhexylglycerin - PMID 34570737 (2022, Dermatitis): Patch Testing to Ethylhexylglycerin: The North American Contact Dermatitis Group Experience, 2013-2018 - PMID 32804659 (2020, Wounds): Synergistic Effect and Antibiofilm Activity of a Skin and Wound Cleanser

근거 동료심사 학술 논문 (미국 NIH PubMed) (12)

A non-cosmetic allergic contact dermatitis to ethylhexylglycerin [PMID: 38017612 · 2024]
Allichon S, Trebuchon F, Dereure O, Raison-Peyron N · Contact Dermatitis (2024)
Patch Testing to Ethylhexylglycerin: The North American Contact Dermatitis Group Experience, 2013-2018 [PMID: 34570737 · 2022]
Warshaw EM, Buonomo M, Maibach HI, Taylor JS, Zug KA, Atwater AR, Silverberg JI, Belsito DV, Fransway AF, DeKoven JG, Reeder MJ, Sasseville D, Fowler JF, Pratt MD, DeLeo VA · Dermatitis (2022)

Ethylhexylglycerin (EHG) is a recently recognized contact allergen. The aims of the study were to characterize individuals with positive patch test reactions to EHG and to analyze reaction strength, clinical relevance, and allergen sources. This study was a retrospective analysis of the patients patch tested to EHG (5% petrolatum) by the North American Contact Dermatitis Group (2013-2018). Of 15,560 patients tested to EHG, 39 (0.25%) had positive (final interpretation of "allergic") reactions. Most were female (71.8%) and/or older than 40 years (76.9%). There were no statistically significant differences between age, sex, or atopic history when compared with EHG-negative patients. The most common anatomic sites of dermatitis were the face (28.2%) and scattered generalized distribution (25.6%). Most EHG-positive reactions were + (35.9%) or ++ (33.3%). Current clinical relevance was high (79.5%); none, however, were related to occupation. Personal care products were the most common source of exposure to EHG (59.0%). Ethylhexylglycerin is a rare contact allergen; the positive frequency of 0.25% is similar to other low allergenic preservatives including parabens, benzyl alcohol, and phenoxyethanol. The patch test concentration of 5.0% seems to be nonirritating. Although relatively uncommon, EHG reactions were usually clinically relevant (79.5%), often because of moisturizers/lotions/creams.

Synergistic Effect and Antibiofilm Activity of a Skin and Wound Cleanser [PMID: 32804659 · 2020]
Salamone AB, Salamone JC, McMahon RE, Poleon S, Bionda N, D'Arpa P · Wounds (2020)

Biofilm in chronic wounds impedes the wound healing process. Each biofilm has differing characteristics requiring a multifaceted approach for removal while maintaining a surrounding environment conducive to wound healing. In this study, 3 of the components in a wound cleanser are tested to determine synergy in eradicating biofilms of methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa in vitro. The 3 components assessed for synergy were ethylenediamine tetraacetic acid sodium salts (EDTA), vicinal diols (VD; ethylhexylglycerin and octane-1,2-diol), and polyhexamethylene biguanide (PHMB). Each component was assessed individually and in combination while dissolved in a base solution. The Calgary assay method was used for biofilm growth and treatment. Kull Equation analysis for synergy was conducted using viable count results. Synergy is defined as the interaction of components to produce a combined effect greater than the sum of their separate effects. The base solution containing all 3 components (EDTA, VD, and PHMB) reduced biofilm viability by more than 5 logs, demonstrating statistically significant synergy. The 3 components tested individually in the base solution resulted in the following: EDTA did not reduce bacteria viability; VD reduced viability by about 1 log; and PHMB reduced P aeruginosa viability by about 2.5 logs and MRSA viability by about 4 logs. Of importance, the MRSA biofilm failed to regrow in the recovery plates after combined treatment, indicating complete elimination of the biofilm bacteria. The experimental and calculated results indicate the 3 components (VD, EDTA, and PHMB) when used together act synergistically to eradicate MRSA and P aeruginosa biofilms in vitro.

The Latest Occult "Hypoallergenic" Allergen: Ethylhexylglycerin [PMID: 28002237 · 2017]
Hagen SL, Warshaw E · Dermatitis (2017)
Ethylhexylglycerin Impairs Membrane Integrity and Enhances the Lethal Effect of Phenoxyethanol [PMID: 27783695 · 2016]
Langsrud S, Steinhauer K, L&#xfc;thje S, Weber K, Goroncy-Bermes P, Holck AL · PLoS One (2016)

Preservatives are added to cosmetics to protect the consumers from infections and prevent product spoilage. The concentration of preservatives should be kept as low as possible and this can be achieved by adding potentiating agents. The aim of the study was to investigate the mechanisms behind potentiation of the bactericidal effect of a commonly used preservative, 2-phenoxyethanol (PE), by the potentiating agent ethylhexylglycerin (EHG). Sub-lethal concentrations of EHG (0.075%) and PE (0.675%) in combination led to rapid killing of E. coli (&gt; 5 log reduction of cfu after 30 min), leakage of cellular constituents, disruption of the energy metabolism, morphological deformities of cells and condensation of DNA. Used alone, EHG disrupted the membrane integrity even at low concentrations. In conclusion, sub-lethal concentrations of EHG potentiate the effect of PE through damage of the cell membrane integrity. Thus, adding EHG to PE in a 1:9 ratio has a similar effect on membrane damage and bacterial viability as doubling the concentration of PE. This study provides insight about the mechanism of action of a strong potentiating agent, EHG, which is commonly used in cosmetics together with PE.

Deciphering trends in replacing preservatives in cosmetics intended for infants and sensitive population [PMID: 39153997 · 2024]
Chen T, Chang H · Sci Rep (2024)

The present study aims to investigate the current trends in replacing conventional preservatives with multifunctional ingredients with antimicrobial properties for preservation of cosmetics for infants or sensitive population, to decrease their potential for contact dermatitis. We first reviewed the labels of cosmetics purchased from the Chinese market for conventional preservatives and multifunctional ingredients with antimicrobial properties, of which the actual contents were further quantified by chromatographic methods. We identified 7 traditional preservatives (phenoxyethanol, benzoic acid (salts), methylparaben, benzyl alcohol, sorbic acid (salts), propylparaben, and methylisothiazolinone), and 11 alternative ingredients with antimicrobial activities (ethylhexylglycerin, butylene glycol, caprylyl glycol, propylene glycol, 1,2-hexanediol, p-anisic acid, hydroxyacetophenone, pentylene glycol, decylene glycol, caprylhydroxamic acid, and aminomethyl propanol) in descending order of prevalence. The contents of all identified preservatives and ingredients were either below regulatory limits or in the range that is generally regarded to be safe. Further challenge with microorganisms indicated irrespective of the composition of preservation systems, product preservation could be compromised under test conditions. We conclude that multifunctional ingredients with antimicrobial properties in cosmetics have the potential to completely replace or significantly reduce the use of traditional preservatives while retaining comparative preservative efficacy. Future attentions may need to be shifted to the safety of those multifunctional ingredients with antimicrobial properties.

Natural Is Not Always Better: The Prevalence of Allergenic Ingredients in "Clean" Beauty Products [PMID: 35256558 · 2022]
Tran JM, Comstock JR, Reeder MJ · Dermatitis (2022)

Consumers seek "clean" and "natural" products based on their perception of safety. However, there is no standard, scientific basis, or regulatory oversight in the marketing or ingredient use for "clean" products. The aim of this study was to determine the prevalence of allergenic ingredients in "clean" products. Target and Walgreens Web sites were queried for "clean" products with inclusion of 1470 products. Ingredient lists were analyzed for potential allergens. Analysis included descriptive statistics and &#x3c7;2 test. The most common allergens were fragrances/botanicals (1218/1470, 82.9%), phenoxyethanol (591/1470, 40.2%), tocopherol (545/1470, 40.2%), benzoic acid and benzoates (434/1470, 29.5%), propylene glycol (369/1470, 25.1%), alkyl glucosides (305/1470, 20.7%), ethylhexylglycerin (304/1470, 20.7%), cetyl alcohol (282/1470, 19.2%), cocamidopropyl betaine (258/1470, 17.6%), and benzyl alcohol (232/1470, 15.8%). Among fragrances/botanicals, the most common ingredients found were fragrance/perfume/aroma (911/1470, 68.2%), citrus derivatives (375/1470, 25.5%), linalool (305/1470, 20.7%), limonene (279/1470, 19.0%), and benzyl alcohol (231/1470, 15.7%). A total of 93.8% of the products (1379/1470) contained at least 1 potential allergen. Most "clean" products contain a potential allergen, predominately fragrances and botanicals.

In vitro study to evaluate the antimicrobial activity of various multifunctional cosmetic ingredients and chlorphenesin on bacterial species at risk in the cosmetic industry [PMID: 34333822 · 2022]
Youenou B, Chauviat A, Ngari C, et al. · J Appl Microbiol (2022)

We evaluated the activity of the preservative chlorphenesin and of four antimicrobial cosmetic multifunctional ingredients against various strains of gram-negative and gram-positive human opportunistic pathogens. Growth kinetics, modelling growth parameters and statistical analyses enabled comparing bacterial behaviour in the presence and in the absence of the compound. Whatever compound tested (i.e. chlorphenesin, phenylpropanol, hexanediol, ethylhexylglycerin, hydroxyacetophenone) and strain origin (i.e. clinical versus industrial), the growth of 42&#xa0;strains belonging to Acinetobacter spp., Burkholderia cepacia complex and Stenotrophomonas maltophilia, was totally inhibited. On the opposite all of the P. aeruginosa strains (n&#xa0;=&#xa0;13) as well as 4 and 6 out of 10&#xa0;strains of Pluralibacter gergoviae grew in the presence of chlorphenesin and ethylhexylglycerin, respectively. Some P. gergoviae and Staphylococcus hominis strains withstand hydroxyacetophenone. Within a species, the different strains show variable latency phase, growth rate (r) and carrying capacity (K). They can be similar, lower or higher than those measured in control conditions. Data showed differences in the antimicrobial activity of compounds. Upon exposure, strains differed in their behaviour between and within species. Whatever species and strains, compound sensitivity could not be related to antibiotic resistance. Most multifunctional ingredients showed significant antimicrobial properties against the wide panel of species and strains evaluated. This will help adjusting preservation strategies in the cosmetic industry.

Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives [PMID: 33624850 · 2021]
Canavez ADPM, de Oliveira Prado Corrêa G, Isaac VLB, et al. · J Appl Toxicol (2021)

The safety assessment of cosmetic products is based on the safety of the ingredients, which requires information on chemical structures, toxicological profiles, and exposure data. Approximately 6% of the population is sensitized to cosmetic ingredients, especially preservatives and fragrances. In this context, the aim of this study was to perform a hazard assessment and risk characterization of benzalkonium chloride (BAC), benzyl alcohol (BA), caprylyl glycol (CG), ethylhexylglycerin (EG), chlorphenesin (CP), dehydroacetic acid (DHA), sodium dehydroacetate (SDH), iodopropynyl butylcarbamate (IPBC), methylchloroisothiazolinone and methylisothiazolinone (MCI/MIT), methylisothiazolinone (MIT), phenoxyethanol (PE), potassium sorbate (PS), and sodium benzoate (SB). Considering the integrated approaches to testing and assessment (IATA) and weight of evidence (WoE) as a decision tree, based on published safety reports. The hazard assessment was composed of a toxicological matrix correlating the toxicity level, defined as low (L), moderate (M), or high (H) and local or systemic exposure, considering the endpoints of skin sensitization, skin irritation, eye irritation, phototoxicity, acute oral toxicity, carcinogenicity, mutagenicity/genotoxicity, and endocrine activity. In a risk assessment approach, most preservatives had a margin of safety (MoS) above 100, except for DHA, SDH, and EG, considering the worst-case scenario (100% dermal absorption). However, isolated data do not set up a safety assessment. It is necessary to carry out a rational risk characterization considering hazard and exposure assessment to estimate the level of risk of an adverse health outcome, based on the concentration in a product, frequency of use, type of product, route of exposure, body surface location, and target population.

Effect of cosmetic chemical preservatives on resident flora isolated from healthy facial skin [PMID: 30548758 · 2019]
Wang Q, Cui S, Zhou L, et al. · J Cosmet Dermatol (2019)

Healthy skin harbors numerous microbes known to maintain its health and prevent attacks from external pathogens. The influence of chemical preservatives commonly used in cosmetic products on facial resident flora remains poorly characterized. In this study, we aimed to investigate the antibacterial activity of five such preservatives on in vitro cultivated skin-resident bacteria. Both Gram-positive and Gram-negative bacteria were isolated on blood agar, tryptic soy agar, and nutrient agar; Gram-negative bacteria were then selected on Hank's balanced salt solution containing antibiotics and Reasoner's 2A. The minimum inhibitory concentrations (MICs) of methylisothiazolinone (MTI), iodopropynyl butylcarbamate (IPBC), ethylhexylglycerin (EHG), methylparaben (MP), and phenoxyethanol (PE) were estimated for nine facial resident bacteria, Escherichia coli, and Staphylococcus aureus using serial broth dilution in vitro. The maximum test concentrations coincided with the upper limits set by the "Cosmetic Safety and Technical Specification" (2015 edition, China). Nine facial resident bacteria were isolated from 14 healthy adults: Staphylococcus epidermidis, Staphylococcus capitis, Kocuria, Micrococcus luteus, Bacillus, Acinetobacter, Pseudomonas parafulva, Pseudomonas oleovorans, and Roseomonas cervicalis. MTI and IPBC displayed the strongest effect on all tested strains (MICs &#x2264;0.01%), followed by EHG and MP (MICs &#x2264;0.3%), and finally PE with the weakest effect (MIC &#x2264;1%). The five chemical preservatives assayed inhibited survival of the nine facial resident bacteria isolates, when tested at the maximum allowed limit. The corresponding MICs will provide a reference for the effective utilization of these compounds in product formulations.

Influence of glycerol and an alternative humectant on the immediate and 3-hours bactericidal efficacies of two isopropanol-based antiseptics in laboratory experiments in vivo according to EN 12791 [PMID: 28670452 · 2017]
Suchomel M, Weinlich M, Kundi M · Antimicrob Resist Infect Control (2017)

Guidelines for hand hygiene recommend the use of alcohol-based hand rubs containing humectants in order to improve dermal tolerance. However, the bactericidal efficacy of pre-surgical hand rubs is negatively affected by the WHO-recommended humectant glycerol, especially the 3-h efficacy. The aim of this study was to investigate whether replacing glycerol as humectant increases the bactericidal efficacy of surgical hand rubs based on isopropanol (75%, wt/wt). The efficacy of 3 and 5&#xa0;min applications of a modified WHO II-formulation (containing lower glycerol concentrations) and the TPH 5766 hand rub which contains a new humectant (containing ethylhexylglycerin, dexpanthenol and a fatty alcohol) were compared to the European Norm 12,791 reference (n-propanol, 60%, vol/vol) immediately following and 3&#xa0;h after application. Immediately after application both isopropanol-based surgical rubs approximated the performance of the reference. The 3-h effect of the modified WHO II-formulation was found to be less efficacious than the EN 12791, showing a 30% decrease in log 10 reduction values. The 3-h post application effect for the TPH 5766 hand rub was found to not be different from EN 12791. Based on our data, the bactericidal efficacy of isopropanol-based surgical hand rubs can best be obtained if glycerol is not used in the formulation. Unlike glycerol, a humectant comprised of ethylhexylglycerin, dexpanthenol and a fatty alcohol was found not to decrease hand rub effectiveness. Further investigation of the bactericidal efficacy of other humectants is necessary and may prove useful.

Determination of alternative preservatives in cosmetic products by chromophoric derivatization followed by vortex-assisted liquid-liquid semimicroextraction and liquid chromatography [PMID: 27154641 · 2016]
Miralles P, Vrouvaki I, Chisvert A, et al. · Talanta (2016)

An analytical method for the simultaneous determination of phenethyl alcohol, methylpropanediol, phenylpropanol, caprylyl glycol, and ethylhexylglycerin, which are used as alternative preservatives in cosmetic products, has been developed. The method is based on liquid chromatography with UV spectrophotometric detection after chromophoric derivatization with benzoyl chloride and vortex-assisted liquid-liquid semimicroextraction. Different chromatographic parameters, derivatization conditions, and sample preparation variables were studied. Under optimized conditions, the limits of detection values for the analytes ranged from 0.02 to 0.06&#xb5;gmL(-1). The method was validated with good recovery values (84-118%) and precision values (3.9-9.5%). It was successfully applied to 10 commercially available cosmetic samples. The good analytical features of the proposed method besides of its environmentally-friendly characteristics, make it useful to carry out the quality control of cosmetic products containing the target compounds as preservative agents.

자주 묻는 질문 (AEO 스니펫 최적화 FAQ)

Q1. 에틸헥실글리세린 (ETHYLHEXYLGLYCERIN)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
한국 식약처 표준명은 '에틸헥실글리세린', 미국 PCPC 및 유럽 CosIng INCI 표기는 'ETHYLHEXYLGLYCERIN', 중국 NMPA IECIC 표준명은 '乙基己基甘油', 일본 화장품 표시명칭은 'エチルヘキシルグリセリン'입니다.
Q2. 에틸헥실글리세린의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: none), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
Q3. 제형 설계 시 에틸헥실글리세린의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
대표 제형군(aqueous_serum) 기준 통상 0.03~0.15%(권장 중앙값 0.05%) 범위로 투입하며, 적정 pH는 3~10입니다.
Q4. 에틸헥실글리세린 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
주요 권장 시너지 조합은 1,2-HEXANEDIOL, PHENOXYETHANOL, PENTYLENE GLYCOL, CAPRYLYL GLYCOL이며, 배합 주의사항은 물 용해도가 약 0.1%로 낮아 가용화제 없는 투명 수성 토너에 0.1% 초과 단독 투입 시 백탁(Cloudiness) 및 카보머 점도 저하 유발입니다.