# ECTOIN (ectoin) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/ectoin
- **Standard INCI**: `ECTOIN`
- **KR MFDS Standard Name**: `엑토인`
- **CAS No.**: `96702-03-3`
- **EC / EINECS No.**: `N/A`
- **Origin**: `synthetic`
- **Functions**: 피부컨디셔닝제
- **Molecular Formula / MW**: `C6H10N2O2` (142.16 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 엑토인 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | ECTOIN |
| US (PCPC / MoCRA INCI) | ECTOIN |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 四氢甲基嘧啶羧酸 |
| JP (JCIA / MHLW QD) | エクトイン (QD: エクトイン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `6443`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 7% — NMPA IECIC (2025) Entry 06285 (2025)
- **cn_iecic_max** (rinse_off): ≤ 2% — NMPA IECIC (2025) Entry 06285 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 3 – 9
- **Max Process Temp**: ≤ 85°C
- **Synergy Pairings**: CERAMIDE NP, PANTHENOL, HYDROXYECTOIN, NIACINAMIDE
- **Incompatibilities**: Exceptionally stable against heat, light, and pH extremes; compatible with acrylic rheology modifiers

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: ECTOIN | CAS No.: 96702-03-3 | EC No.: N/A
  - Origin: SYNTHETIC | Functions: Skin Conditioning
  - Physicochemical Profile: Formula C6H10N2O2 | MW 142.16 g/mol | LogP -2.6 | Ionic Nature: amphoteric | PubChem CID 126041
  - Official Regional Label Names: US [ECTOIN] · EU [ECTOIN] · CN [四氢甲基嘧啶羧酸] · JP [エクトイン] · JP Quasi-Drug [エクトイン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Natural extremolyte (cyclic tetrahydropyrimidine) produced by halophilic microorganisms. Forms stable kosmotropic hydration shells ('Ectoin Hydro Complex') around cell membranes and proteins, shielding epidermal Langerhans cells against UV, thermal stress, dehydration, and particulate pollution.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 6443 (四氢甲基嘧啶羧酸))
  - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment).
  - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 7.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 2.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 0.3 ~ 5.0% (Median 1.0%, Ref: bitop Ectoin natural Monograph & PubMed Clinical Trials) — Extremolyte hydration-shell cell protectant & anti-inflammatory active
  - [emulsion_cream] Typical range: 0.3 ~ 7.0% (Median 1.0%, Ref: bitop Ectoin Clinical Dossier & CN IECIC) — Barrier-repair dermatological cream active (up to 7% in clinical studies)
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase
  - Optimal pH Range: pH 3.0 ~ 9.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Exceptionally stable against heat, light, and pH extremes; compatible with acrylic rheology modifiers
  - Synergy Pairings: CERAMIDE NP, PANTHENOL, HYDROXYECTOIN, NIACINAMIDE | Reference Trade Names: Ectoin® natural
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 17519560 (2007, Skin Pharmacol Physiol): In vivo assessment of Ectoin: a randomized, vehicle-controlled clinical trial
  - PMID 30987568 (2019, Curr Pediatr Rev): Testing an Ectoin Containing Emollient for Atopic Dermatitis
  - PMID 38157997 (2024, Biotechnol Adv): Strategies for the biological production of ectoine by using different chassis strains

## 6. Linked PubMed Literature
- [PMID: 17519560] In vivo assessment of Ectoin: a randomized, vehicle-controlled clinical trial — *Skin Pharmacol Physiol* (2007)
- [PMID: 30987568] Testing an Ectoin Containing Emollient for Atopic Dermatitis — *Curr Pediatr Rev* (2019)
- [PMID: 38157997] Strategies for the biological production of ectoine by using different chassis strains — *Biotechnol Adv* (2024)
- [PMID: 33628826] Ectoine in the Treatment of Irritations and Inflammations of the Eye Surface — *Biomed Res Int* (2021)
- [PMID: 31534961] Topical Ectoine: A Promising Molecule in the Upper Airways Inflammation-A Systematic Review — *Biomed Res Int* (2019)