AMMONIUM LAURYL SULFATE
화장품에서 암모늄라우릴설페이트 (AMMONIUM LAURYL SULFATE)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?
암모늄라우릴설페이트(표준 INCI: AMMONIUM LAURYL SULFATE, CAS 번호: 2235-54-3)은 화장품 처방에서 주로 세정제, 기포형성제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 6–30%(적정 pH 4–8) 범위에서 안정적으로 처방됩니다.
7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스
각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건| 국가·규제 트랙 | 공식 고시 전성분 표기명 | 원클릭 복사 |
|---|---|---|
| ① 한국 (MFDS 화장품 한글 표준명) | 암모늄라우릴설페이트 | |
| ② 한국 구명칭 (개정 전 이력 · 301 리다이렉트) | — | — |
| ③ 유럽 (EU CosIng EC 1223/2009) | AMMONIUM LAURYL SULFATE | |
| ④ 미국 일반화장품 (US PCPC / MoCRA INCI) | AMMONIUM LAURYL SULFATE | |
| ⑤ 미국 OTC (FDA Active Ingredient Monograph) | — (비-OTC 일반 화장품 원료) | — |
| ⑥ 중국 (NMPA IECIC 표준 중문명) | 月桂醇硫酸酯铵 | |
| ⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW) | AMMONIUM LAURYL SULFATE (표준 INCI 기준 · 임의 가타카나 변환 배제) |
Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태
| 권역 | 규제 상태 | 배합 한도 | 제한 조건 및 1차 법원 출처 |
|---|---|---|---|
| 한국 (MFDS) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 유럽 (CosIng) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 미국 (FDA/CIR) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 중국 (NMPA) | 등재·허용 | GMP | IECIC Entry #8343 |
| 일본 (MHLW) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 아세안 (ACD) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조
Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드
| 제형군 분류 | Min – Q1 – Median – Q3 – Max (%) | 처방 역할 및 기전 | Source ID |
|---|---|---|---|
| 제형군 C — 세정 워시오프 · 폼 · 샴푸 · 바디워시 | 6% · 10% · 13% · 26% · 30% | 린스오프 세정·클렌징 처방 계면 안정화 및 사용감 개선 | Global Starter Formulation Library Statistical Distribution (n=5, ELEMENTIS 3 · EVONIK 1 · SEPPIC 1) |
각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션
단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.
pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동
권장 구간 밖(pH < 4 또는 pH > 8)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.
최대 50°C 가열 공정에서 열적 안정성이 유지됩니다.
세포·분자 타깃 작용 기전 플로우 다이어그램
권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도
🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.
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 Synthesis이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.
근거 동료심사 학술 논문 (미국 NIH PubMed) (5)
Soapwort (Saponaria officinalis L.) Extract vs. Synthetic Surfactants-Effect on Skin-Mimetic Models [PMID: 34577098 · 2021]
Our skin is continuously exposed to different amphiphilic substances capable of interaction with its lipids and proteins. We describe the effect of a saponin-rich soapwort extract and of four commonly employed synthetic surfactants: sodium lauryl sulfate (SLS), sodium laureth sulfate (SLES), ammonium lauryl sulfate (ALS), cocamidopropyl betaine (CAPB) on different human skin models. Two human skin cell lines were employed: normal keratinocytes (HaCaT) and human melanoma cells (A375). The liposomes consisting of a dipalmitoylphosphatidylcholine/cholesterol mixture in a molar ratio of 7:3, mimicking the cell membrane of keratinocytes and melanoma cells were employed as the second model. Using dynamic light scattering (DLS), the particle size distribution of liposomes was analyzed before and after contact with the tested (bio)surfactants. The results, supplemented by the protein solubilization tests (albumin denaturation test, zein test) and oil emulsification capacity (using olive oil and engine oil), showed that the soapwort extract affects the skin models to a clearly different extent than any of the tested synthetic surfactants. Its protein and lipid solubilizing potential are much smaller than for the three anionic surfactants (SLS, ALS, SLES). In terms of protein solubilization potential, the soapwort extract is comparable to CAPB, which, however, is much harsher to lipids.
Final report on the safety assessment of sodium cetearyl sulfate and related alkyl sulfates as used in cosmetics [PMID: 20448271 · 2010]
Sodium cetearyl sulfate is the sodium salt of a mixture of cetyl and stearyl sulfate. The other ingredients in this safety assessment are also alkyl salts, including ammonium coco-sulfate, ammonium myristyl sulfate, magnesium coco-sulfate, sodium cetyl sulfate, sodium coco/hydrogenated tallow sulfate, sodium coco-sulfate, sodium decyl sulfate, sodium ethylhexyl sulfate, sodium myristyl sulfate, sodium oleyl sulfate, sodium stearyl sulfate, sodium tallow sulfate, sodium tridecyl sulfate, and zinc coco-sulfate. These ingredients are surfactants used at concentrations from 0.1% to 29%, primarily in soaps and shampoos. Many of these ingredients are not in current use. The Cosmetic Ingredient Review (CIR) Expert Panel previously completed a safety assessment of sodium and ammonium lauryl sulfate. The data available for sodium lauryl sulfate and ammonium lauryl sulfate provide sufficient basis for concluding that sodium cetearyl sulfate and related alkyl sulfates are safe in the practices of use and concentration described in the safety assessment.
Effects of pyrithiones and surfactants on zinc and enzyme levels in rabbits [PMID: 7395740 · 1980]
The effects of zinc pyrithione (ZnPT) and sodium pyrithione (NaPT), including the influence of various vehicles, upon whole blood and plasma zinc levels and serum alkaline phosphatase (SAP) have been investigated in rabbits following dermal and/or iv administration. Two such vehicles, ammonium lauryl sulfate (ALS) and triethanolamine lauryl sulfate, affected zinc homeostasis differently than the pyrithiones, in that, unlike the pyrithiones, no whole blood changes were observed, although there were delayed and sustained declines in plasma zinc and SAP values. These changes were most likely related to the skin irritation caused by the surfactants. In contrast, NaPT-dimethyl sulfoxide (DMSO) dermal and iv exposures produced rapid decreases in plasma zinc followed by quick recovery, coupled with smaller and unsustained declines in SAP. Large increases in whole blood zinc were also observed in both cases, as well as in a ZnPT-DMSO iv exposure. DMSO itself had no effects on the measured parameters. Experiments involving combinations of the pyrithiones and ALS demonstrated effects on zinc homeostasis that were attributable to both substances, i.e. large increases in whole blood zinc (PT effect), quick drops in plasma zinc (PT effect) and slowly recovering plasma zinc and SAP values (surfactant effect). The chelating nature of the PT molecule may have been responsible for some of the observed changes in zinc distribution.
The determination of the irritancy potential of surfactants using various methods of assessment [PMID: 755672 · 1978]
Several animal irritancy test methods whose criteria include sensory response, pain/discomfort or tissue damage were evaluated as to their ability to assess relative irritancy potential of the following surfactants: sodium lauryl polyether (12) sulfate (SLES), Miranol C2M (MC2M), Miranol MHT (MMHT), sodium coco methyl tauride (SCMT), triethanolamine lauryl sulfate (TEALS), ammonium lauryl sulfate (ALS) and sodium lauryl sulfate (SLS). Data from the mouse upper respiratory tract and mouse writhing tests indicated that SLES, MC2M and MMHT were the least irritating and SLS, ALS and TEALS were the most irritating. The blepharospasm test did not lend itself to this type of evaluation because sequential instillation of the surfactants produced eye anesthesia. Data from the Draize eye test indicated that SLES was the least irritating while MC2M was slightly more irritating. All other surfactants were equally irritating. The Draize skin test results showed that SLES again was the least irritating at all concentrations tested and that SLS and ALS along with TEALS and SCMT were the most irritating.
The Effect of Detergents on the Morphology and Immunomodulatory Activity of Malassezia furfur [PMID: 20523770 · 2009]
Several workers have found that Malassezia are capable of suppressing cytokine release and downregulating the phagocytic function of monocytes. But lipid-depleted Malassezia furfur (M. furfur) extracts have also been shown to induce increased production of TNF-alpha, IL-6 and IL-1beta in monocytes. We thought that the detergents in shampoos or soaps could change the composition of the lipid in the M. furfur cell wall. We studied whether detergents affect the morphology of M. furfur and if the inflammatory cytokine profiles change in the monocytes treated with detergent-treated M. furfur. Commonly used detergents such as sodium lauryl sulfate, ammonium lauryl sulfate and tween-80 were respectively added to the modified Leeming-Notman's media. M. furfur was cultivated in each media (detergent-added or untreated). Thereafter, the surface morphology of the yeast was evaluated by scanning and transmission electron microscopy. The cytokine profiles of monocytes, which were treated by M. furfur with or without detergents, were also evaluated. The detergent-treated M. furfur were similar to the lipid-extracted form of M. furfur on the electron microscopic study, with a recessed, withered surface and with thinner and rather electron transparent cell walls than the detergent-untreated M. furfur. The levels of TNF-alpha were higher in monocytes treated with detergent-treated Malassezia than that in the monocytes treated with the detergent-untreated Malassezia (p<0.05). According to the findings in this study, it could be inferred that the detergents in shampoos or soaps affect the lipid layers of the Malassezia cell wall and these lipid-extracted Malassezia induce or aggravate some inflammatory conditions. But to correlate the relationship between detergents and Malassezia-associated diseases, in vivo experiments that will focus on short-term contact with detergents in real life conditions should be done.
자주 묻는 질문 (AEO 스니펫 최적화 FAQ)
- Q1. 암모늄라우릴설페이트 (AMMONIUM LAURYL SULFATE)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
- 한국 식약처 표준명은 '암모늄라우릴설페이트', 미국 PCPC 및 유럽 CosIng INCI 표기는 'AMMONIUM LAURYL SULFATE', 중국 NMPA IECIC 표준명은 '月桂醇硫酸酯铵', 일본 화장품 표시명칭은 'AMMONIUM LAURYL SULFATE'입니다.
- Q2. 암모늄라우릴설페이트의 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 암모늄라우릴설페이트의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
- 대표 제형군(cleanser_rinse) 기준 통상 6~30%(권장 중앙값 13%) 범위로 투입하며, 적정 pH는 4~8입니다.
- Q4. 암모늄라우릴설페이트 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
- 주요 권장 시너지 조합은 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL이며, 배합 주의사항은 처방 내 극단적 pH 조건 및 고농도 전해질과의 상용성 사전 확인 권장입니다.