Ingredient Dictionary/anhydroxylitol/ANHYDROXYLITOL
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
Synthetic

ANHYDROXYLITOL

HumectantSkin Conditioning
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

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
7-Track Official Statutory Label Names for ANHYDROXYLITOL
Jurisdiction TrackOfficial Statutory Label NameOne-Click Copy
1. Korea (MFDS Standard Name)ANHYDROXYLITOL (KR MFDS Registered)
2. Korea Former Nomenclature HistoryFormer 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

Layer 1 Statutory Regulatory Limits Across 6 Regions for ANHYDROXYLITOL
RegionStatusMax LimitConditions & Statutory Source
Korea (MFDS)UnregulatedGMPListed in official cosmetic inventory
Europe (EU)UnregulatedGMPListed in official cosmetic inventory
United States (FDA)UnregulatedGMPListed in official cosmetic inventory
China (NMPA)Listed / AllowedGMPIECIC Entry #6749
Japan (MHLW)UnregulatedGMPListed in official cosmetic inventory
ASEAN (ACD)UnregulatedGMPListed in official cosmetic inventory
⚠️ Reference Only (Legal Disclaimer): The regulatory limits, ingredient names, and formulation ranges in this dictionary are provided for R&D reference only. Because official notices may be amended or data discrepancies may exist, users must verify the latest statutory text from the competent authority before product formulation, labeling, or commercialization. UNIZ LAB assumes no legal liability for the use of this information.
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Aqueous Serum / Ampoulen=9
Min 1% · Q1 3% · Median 3% · Q3 3% · Max 3%
Rinse-off Cleansern=6
Min 1% · Q1 1.125% · Median 1.75% · Q3 2% · Max 3%
Emulsion / Creamn=20
Min 1% · Q1 1.5% · Median 3% · Q3 3% · Max 3%
Sunscreen / Colorn=5
Min 1% · Q1 1.5% · Median 1.5% · Q3 3% · Max 3%
Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component
Verified Source: Global Starter Formulation Library Statistical Distribution (n=9, SEPPIC 9) (cir_safety) · SEPPIC 9
Typical Median: 3%

Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility

Layer 3 Formulation Concentration Quartiles by Product Category for ANHYDROXYLITOL
Formulation GroupMin – Q1 – Median – Q3 – Max (%)Role & MechanismSource ID
Group A — Aqueous Toner / Serum / Ampoule1% · 3% · 3% · 3% · 3%Aqueous serum, toner & hydrogel matrix formulation componentGlobal Starter Formulation Library Statistical Distribution (n=9, SEPPIC 9)
Group C — Rinse-Off Cleanser / Shampoo / Body Wash1% · 1.125% · 1.75% · 2% · 3%Rinse-off cleanser & surfactant system modifierGlobal Starter Formulation Library Statistical Distribution (n=6, SEPPIC 6)
Group B — O/W & W/O Emulsion / Lotion / Cream1% · 1.5% · 3% · 3% · 3%Emulsion cream & lotion structural / conditioning agentGlobal Starter Formulation Library Statistical Distribution (n=20, SEPPIC 20)
Group D — Sunscreen (UV) / Color Cosmetics / Foundation1% · 1.5% · 1.5% · 3% · 3%Sun care & color cosmetics dispersion / sensory modifierGlobal Starter Formulation Library Statistical Distribution (n=5, SEPPIC 5)
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible

Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.

Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Water or glycol phase soluble/dispersible
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0
0245.5791114

Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 50°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 50°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
Biochemical Signaling & Mechanism Pathway

Cellular & Molecular Target Mechanism Flow

1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→
TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣
Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph

Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ Verify phase compati…ANHYDROXYLITOL
Interactive Node Guide

Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.

Nominative Trade Name References (Trademark Act Art. 90(1)(2))
ANHYDROXYLITOL

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 Synthesis

Synthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: ANHYDROXYLITOL | CAS No.: 53448-53-6 | EC No.: 258-560-9 - Origin: SYNTHETIC | Functions: , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [ANHYDROXYLITOL] · EU [ANHYDROXYLITOL] · CN [脱水木糖醇] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - ANHYDROXYLITOL functions primarily as , in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver , performance and structural formulation stability. ■ [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. 6749 (脱水木糖醇)) - 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): Quantum satis (QS) within standard cosmetic safety margins ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 1.0 ~ 3.0% (Median 3.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=9, SEPPIC 9)) — Aqueous serum, toner & hydrogel matrix formulation component - [cleanser_rinse] Typical range: 1.0 ~ 3.0% (Median 1.75%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, SEPPIC 6)) — Rinse-off cleanser & surfactant system modifier - [emulsion_cream] Typical range: 1.0 ~ 3.0% (Median 3.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=20, SEPPIC 20)) — Emulsion cream & lotion structural / conditioning agent ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase or Cool-down Phase (< 45°C) - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: ANHYDROXYLITOL ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 41243164 (2025, Int J Toxicol): Safety Assessment of Anhydrogalactose, Anhydroglucitol, Anhydroxylitol, Arabinose, Psicose, Saccharide Hydrolysate, and - PMID 36541033 (2023, Skin Res Technol): Evaluation of a new connected portable camera for the analysis of skin microrelief and the assessment of the effect of s - PMID 19250164 (2009, J Cosmet Dermatol): Hydrating effects of moisturizer active compounds incorporated into hydrogels: in vivo assessment and comparison between

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]
Johnson W, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Liebler DC, Marks JG, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume MM, Heldreth B · Int J Toxicol (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]
Gougeon S, Hernandez E, Chevrot N, et al. · Skin Res Technol (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&#xa0;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]
Leite e Silva VR, Schulman MA, Ferelli C, et al. · J Cosmet Dermatol (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]
van Bastelaere P, Vangrysperre W, Kersters-Hilderson H · Biochem J (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.