ECTOIN
What is ECTOIN (CAS 96702-03-3) in cosmetics and what are its global regulatory limits?
ECTOIN (CAS No. 96702-03-3) is a verified cosmetic ingredient primarily functioning as Skin Conditioning in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.3–5% within an optimal stability window of pH 3–9.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | ECTOIN (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | ECTOIN | |
| 4. United States (US PCPC / MoCRA INCI) | ECTOIN | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 四氢甲基嘧啶羧酸 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | エクトイン · [QD: エクトイン] |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Korea (MFDS) | Unregulated | GMP | Listed in official cosmetic inventory |
| Europe (EU) | Unregulated | GMP | Listed in official cosmetic inventory |
| United States (FDA) | Unregulated | GMP | Listed in official cosmetic inventory |
| China (NMPA) | Listed / Allowed | GMP | IECIC Entry #6443 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
Layer 2 — Toxicological & Historical Safe Use Concentrations (CIR / SCCS / CN IECIC / IFRA)
“EU SCCS Safe Opinion Limit” is the toxicological safe threshold (MoS≥100), whereas “US CIR Reported Max Use” and “CN IECIC Historical Max Use” represent historical maximum concentrations in commercial products.
| Assessment Basis | Application Scope | Concentration Range | Verdict & Dossier Reference |
|---|---|---|---|
| CN IECIC Historical Max Use | leave_on | ≤ 7% | Safe (MoS≥100)NMPA IECIC (2025) Entry 06285 (2025) |
| CN IECIC Historical Max Use | rinse_off | ≤ 2% | Safe (MoS≥100)NMPA IECIC (2025) Entry 06285 (2025) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group A — Aqueous Toner / Serum / Ampoule | 0.3% · 0.5% · 1% · 2% · 5% | Extremolyte hydration-shell cell protectant & anti-inflammatory active | bitop Ectoin natural Monograph & PubMed Clinical Trials |
| Group B — O/W & W/O Emulsion / Lotion / Cream | 0.3% · 0.5% · 1% · 2% · 7% | Barrier-repair dermatological cream active (up to 7% in clinical studies) | bitop Ectoin Clinical Dossier & CN IECIC |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 3–9, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 85°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.
Academic & Toxicological Synthesis
Tier 1 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
Linked Peer-Reviewed Literature (NIH PubMed) (5)
In vivo assessment of Ectoin: a randomized, vehicle-controlled clinical trial [PMID: 17519560 · 2007]
The aim of the study was to assess an Ectoin formulation with regard to the antiageing properties. The study was designed as a monocentric, randomized, double-blind application test, in order to ensure the compatibility and the efficacy of Ectoin in comparison to a vehicle emulsion. A total of 104 voluntary healthy female test subjects were included in the study. Moisturizing properties as well as other parameters of skin ageing, like skin surface structure and skin elasticity, were determined for treatment A (vehicle) and treatment B (with 2% Ectoin) versus an untreated control. Statistical evaluations according to the Wilcoxon rank-sum test indicate a general preference for the Ectoin treatment by the test subjects in both the application and the efficacy tests. None of the participating test subjects had any side effects throughout the study. In terms of antiageing properties, previous in vitro studies could be confirmed by this clinical trial, clarifying that the natural cell protection concept of Ectoin is transferable to skin care with manifold benefits.
Testing an Ectoin Containing Emollient for Atopic Dermatitis [PMID: 30987568 · 2019]
To describe the methodology in studying patient's acceptability and efficacy of an ectoin containing emollient for atopic dermatitis (AD). We described the methodology that we used in studying emollients and moisturisers, and patient acceptability of a group of AD patients before and following usage of an ectoin-containing proprietary emollient. These data were also compared with other brand emollients that we previously reported, namely Restoradom®, Ezerra® and Ezerra plus®. 30 subjects (50% Male, Mean (SD) age: 9.8 (3.6) years with AD used the trial emollient W for four weeks. AD severity of subjects (by objective SCORAD) was moderate (n=22) and severe (n=8). Compliance was good and patients generally managed to use the moisturisers daily, with individual reports of a 'tingly' sensation by some subjects when applied to inflamed wounds. 63% reported "very good" or "good", whereas 37% reported "fair" or "poor" acceptability of the moisturisers. Following use of the trial emollient, area affected, disease intensity and severity significantly improved, as demonstrated in objective SCORAD (p=0.002). There were also significant improvements in POEM (p=0.035), and PADQLQ scores (p=0.017). For skin measurements, only transepidermal water loss had improved (p=0.035) after the treatment. There was no significant improvement of itch or sleep scores, skin hydration, pH, S. aureus colonization status, or need for use of topical medications. When compared with historical data of other emollients, the mean age of patients on emollient W was younger; efficacy and acceptability among these emollients were similar. Methodology of emollient research is described. Doctors should provide evidencebased information about the efficacy of emollients. The ectoin-containing proprietary emollient improves disease and quality of life following its use in 4 weeks. Efficacy and acceptability are similar among 4 proprietary emollients.
Strategies for the biological production of ectoine by using different chassis strains [PMID: 38157997 · 2024]
As an amino acid derivative and a typical compatible solute, ectoine can assist microorganisms in resisting high osmotic pressure. Own to its long-term moisturizing effects, ectoine shows extensive applications in cosmetics, medicine and other fields. With the rapid development of synthetic biology and fermentation engineering, many biological strategies have been developed to improve the ectoine production and simplify the production process. Currently, the microbial fermentation has been widely used for large scaling ectoine production. Accordingly, this review will introduce the metabolic pathway for ectoine synthesis and also comprehensively evaluate both wild-type and genetically modified strains for ectoine production. Furthermore, process parameters affecting the ectoine production efficiency and adoption of low cost substrates will be evaluated. Lastly, future prospects on the improvement of ectoine production will be proposed.
Ectoine in the Treatment of Irritations and Inflammations of the Eye Surface [PMID: 33628826 · 2021]
The ocular surface is facing various unspecific stress factors resulting in irritation and inflammation of the epithelia, causing discomfort to the patients. Ectoine is a bacteria-derived extremolyte with the ability to protect proteins and biological membranes from damage caused by extreme environmental conditions like heat, UV-light, high osmolarity, or dryness. Evidence from preclinical and clinical studies attest its effectiveness in treating several epithelium-associated inflammatory diseases, including the eye surface. In this review, we analysed 16 recent clinical trials investigating ectoine eye drops in patients with allergic conjunctivitis or with other unspecific ocular inflammations caused by e.g. ophthalmic surgery. Findings from these studies were reviewed in context with other published work on ectoine. In summary, patients with irritations and unspecific inflammations of the ocular surface have been treated successfully with ectoine-containing eye drops. In these patients, significant improvement was observed in ocular symptoms of allergic rhinoconjunctivitis, postoperative secondary dry eye syndrome, or ocular reepithelisation after surgery. Using ectoine as an add-on therapy to antihistamines, in allergy patients accelerated symptom relief by days, and its use as an add-on to antibiotics resulted in faster wound closure. Ectoine is a natural substance with an excellent tolerability and safety profile thus representing a helpful alternative for patients with inflammatory irritation of the ocular surface, who wish to avoid local reactions and side effects associated with pharmacological therapies or wish to increase the efficacy of standard treatment regimen.
Topical Ectoine: A Promising Molecule in the Upper Airways Inflammation-A Systematic Review [PMID: 31534961 · 2019]
To date, topical therapies guarantee a better delivery of high concentrations of pharmacologic agents to the mucosa of the upper airways (UA). Recently, topical administration of ectoine has just been recognized as adjuvant treatment in the Allergic Rhinitis (AR) and Rhinosinusitis (ARS). The aim of this work is to review the published literature regarding all the potential therapeutic effects of ectoine in the acute and chronic inflammatory diseases of UA. Pertinent studies published without temporal limitation were selected searching on MEDLINE the following terms: "ectoine" and "nasal spray," "oral spray," "upper respiratory tract infections," "rhinosinusitis," "rhinitis," "rhinoconjunctivitis," "pharyngitis," and "laryngitis." At the end of our selection process, six relevant publications were included: two studies about the effect of ectoine on AR, one study about ARS, one study about rhinitis sicca anterior, and two studies about acute pharyngitis and/or laryngitis. Due to its moisturizing and anti-inflammatory properties, topical administration of ectoine could play a potential additional role in treatment of acute and chronic inflammatory diseases of UA, in particular in the management of sinonasal conditions improving symptoms and endoscopic findings. However, these results should be viewed cautiously as they are based on a limited number of studies; some of them were probably underpowered because of their small patient samples.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for ECTOIN?
- Standard label names are US PCPC INCI: 'ECTOIN', EU CosIng: 'ECTOIN', KR MFDS: 'ECTOIN (KR MFDS Registered)', CN NMPA IECIC: '四氢甲基嘧啶羧酸', and JP JCIA: 'エクトイン'.
- Q2. Is ECTOIN restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for ECTOIN?
- In aqueous_serum systems, ECTOIN is typically formulated between 0.3% and 5% (median 1%), with an optimal stability window of pH 3–9.
- Q4. What are the known formulation incompatibilities and synergy pairings for ECTOIN?
- Recommended synergy pairings include CERAMIDE NP, PANTHENOL, HYDROXYECTOIN, NIACINAMIDE. Key incompatibilities to avoid: Exceptionally stable against heat, light, and pH extremes; compatible with acrylic rheology modifiers.