ANHYDROXYLITOL
What is ANHYDROXYLITOL (CAS 53448-53-6) in cosmetics and what are its global regulatory limits?
ANHYDROXYLITOL (CAS No. 53448-53-6) is a verified cosmetic ingredient primarily functioning as Humectant, Skin Conditioning in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 1–3% within an optimal stability window of pH 4–8.
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) | ANHYDROXYLITOL (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | Former KR Nomenclature Redirect Active | — |
| 3. European Union (EU CosIng Glossary) | ANHYDROXYLITOL | |
| 4. United States (US PCPC / MoCRA INCI) | ANHYDROXYLITOL | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 脱水木糖醇 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | ANHYDROXYLITOL (Standard INCI Reference) |
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 #6749 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
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 | 1% · 3% · 3% · 3% · 3% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=9, SEPPIC 9) |
| Group C — Rinse-Off Cleanser / Shampoo / Body Wash | 1% · 1.125% · 1.75% · 2% · 3% | Rinse-off cleanser & surfactant system modifier | Global Starter Formulation Library Statistical Distribution (n=6, SEPPIC 6) |
| Group B — O/W & W/O Emulsion / Lotion / Cream | 1% · 1.5% · 3% · 3% · 3% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=20, SEPPIC 20) |
| Group D — Sunscreen (UV) / Color Cosmetics / Foundation | 1% · 1.5% · 1.5% · 3% · 3% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=5, SEPPIC 5) |
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 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°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) (4)
Safety Assessment of Anhydrogalactose, Anhydroglucitol, Anhydroxylitol, Arabinose, Psicose, Saccharide Hydrolysate, and Saccharide Isomerate as Used in Cosmetics [PMID: 41243164 · 2025]
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 7 saccharides/saccharide derivatives as used in cosmetic products; all of these ingredients are reported to function as skin-conditioning agents-humectant in cosmetics. The Panel reviewed data relevant to the safety of these ingredients in cosmetic formulations and concluded that Anhydrogalactose, Anhydroglucitol, Anhydroxylitol, Arabinose, Psicose, Saccharide Hydrolysate, and Saccharide Isomerate are safe in cosmetics in the present practices of use and concentration described in this safety assessment.
Evaluation of a new connected portable camera for the analysis of skin microrelief and the assessment of the effect of skin moisturisers [PMID: 36541033 · 2023]
Silicone replicas and non-contact methods are effective methods to analyse the micrometric scale of the skin microrelief. Yet, they imply data capture in research facilities. The capabilities of a new connected portable camera were evaluated to analyse microrelief under nomadic conditions, also studying the effect of moisturisers. 3D depth maps were constructed using shape-from-shading algorithms. Roughness heterogeneity (Spa) was computed, and skin profiles were extracted to calculate roughness amplitude (Ra, Rq), as well as furrows/plateaus characteristics. Validation of the connected camera was performed on tanned cowhide leather and on the inner forearm skin of a single subject. The forearms of 18 subjects (23-60 years old) were also evaluated. While living their regular life, they self-performed triplicate acquisitions at various times. The effects of a placebo and of cream containing moisturisers-saccharide isomerate, urea or xylitylglucoside-anhydroxylitol-xylitol-were investigated, using untreated control skin as a reference. Validation of the device on leather and forearm skin shows high repeatability. The 18 subjects show the known correlation between age and changes in microrelief. While testing formulas, 8 h after a single application, all decreased Spa (-1.6/-2.1 folds). Only saccharide isomerate and xylitylglucoside-anhydroxylitol-xylitol decreased Ra (-2.4/-2.8 folds). The sectional area of plateaus was reduced from -1.5 (urea) to -2.1 folds (xylitylglucoside-anhydroxylitol-xylitol). The height of plateaus is also decreased by all moisturisers, from -1.5 (urea) to -2.1 folds (xylitylglucoside-anhydroxylitol-xylitol). This novel camera device enables microrelief analysis under nomadic conditions, allowing monitoring its changes along the day and upon moisturisers' application.
Hydrating effects of moisturizer active compounds incorporated into hydrogels: in vivo assessment and comparison between devices [PMID: 19250164 · 2009]
Water is an important factor on the appearance and function of the skin and, when dehydrated, it becomes rough and flaky. The measurement of stratum corneum hydration is widely employed to verify the moisture effect of topical products. This study has evaluated in vivo the stratum corneum hydration, by the electrical measurements of skin, after treatment with different moisturizers presented in gel base. MoistureMeter and Corneometer were used as bio-instruments. Urea, the herbal extract (Imperata cylindrical), the NMF components and the carbohydrate derivate compound (xylityglucoside, anhydroxylitol, and xylitol) were used as the active substances. The study protocol was carried out according to the three-factor factorial design. The gels were applied on both forearms of eight female volunteers. However, each volunteer had one untreated skin area as the skin moisture control. The electrical capacitance of the skin was measured by both instruments in different times: after application (0 time), 30, 60, 120, 240 and 360 min. Gel base, gel containing herbal extract, and gel containing NMF components statistically have equal moisture effect measurements, according to both bio-instruments. However, the values obtained for urea, carbohydrate derivate compound, and untreated skin (control) have statically different results in both devices. The gel containing urea and the carbohydrate derivate compound gel have promoted the most intense moisture effect compared with the other formulations. The measurements of hydration between the devices generated different absolute values; however, the statistical analysis has shown similar precision among the measurements.
Kinetic studies of Mg(2+)-, Co(2+)- and Mn(2+)-activated D-xylose isomerases [PMID: 1831974 · 1991]
The kinetic parameters for the interconverting substrates D-xylose in equilibrium D-xylulose and D-glucose in equilibrium D-fructose were determined for several D-xylose isomerases, with Mg2+, Co2+ and Mn2+ as metal ion activators. The Km, kcat. and kcat./Km values are tabulated for the anomeric mixtures (observed parameters) as well as for the respective reactive species, i.e. the alpha-pyranose anomers of D-xylose and D-glucose and the alpha-furanose forms of D-xylulose and D-fructose (real parameters). The real Km values and catalytic efficiencies are more favourable for the ketose sugars (reverse reaction) than for the aldose sugars (forward reaction). Comparisons of the kinetic parameters further support the existence of two distinct groups of D-xylose isomerases. Inhibition constants for the cyclic substrate analogues 5-thio-alpha-D-xylopyranose and alpha-D-xylopyranosyl fluoride and for the acyclic substrate analogue xylitol and its dehydrated form 1,5-anhydroxylitol were determined and are discussed.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for ANHYDROXYLITOL?
- Standard label names are US PCPC INCI: 'ANHYDROXYLITOL', EU CosIng: 'ANHYDROXYLITOL', KR MFDS: 'ANHYDROXYLITOL (KR MFDS Registered)', CN NMPA IECIC: '脱水木糖醇', and JP JCIA: 'ANHYDROXYLITOL'.
- Q2. Is ANHYDROXYLITOL 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 ANHYDROXYLITOL?
- In aqueous_serum systems, ANHYDROXYLITOL is typically formulated between 1% and 3% (median 3%), with an optimal stability window of pH 4–8.
- Q4. What are the known formulation incompatibilities and synergy pairings for ANHYDROXYLITOL?
- Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.