Is Xylitol safe in cosmetics?
Xylitol has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Xylitol
Also known as: BRN 1720523, EINECS 201-788-0, UNII-VCQ006KQ1E, (2R,4S)-pentane-1,2,3,4,5-pentol, Eutrit (+6 more)
INCI: XYLITOL
Xylitol (CAS 87-99-0) is a cosmetic humectant functioning as Humectant, Prebiotic, S. aureus Biofilm Inhibitor, Microbiome Support, Acid. NOAEL 6770 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 87-99-0 →
Auto-generated CPSR Part A draft with source citations
Function
Humectant, Prebiotic, S. aureus Biofilm Inhibitor, Microbiome Support, Acid Mantle Support, Skin Conditioning
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA approved direct food additive under 21 CFR 172.395. No pre-market approval required for cosmetic use. CIR Expert Panel (2025) concluded safe in cosmetics at present concentrations. Appears in 472 cosmetic formulations per 2019 FDA VCRP data, with maximum reported concentration of 14% in dentifrices and 2% in dermal leave-on products.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Xylitol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Xylitol. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 680 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | monkey | Subchronic | COSMOS_DB |
| NOAEL | 1250 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 2200 mg/kg bw/day | oral | mouse | Subchronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS_DB |
| NOAEL | 6770 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 7500 mg/kg bw/day | oral | mouse | Special Toxicology Study | COSMOS_DB |
| NOAEL | 8500 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 9167 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Xylitol across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Xylitol, relevant to systemic exposure and MoS calculations.
Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
152.1 Da
Log P
-2.5
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low
Source: Cosmetic Science
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >4000 mg/kg | Rat | oral | - | ECHA IUCLID |
| LD50 | >2000 mg/kg | Rabbit | oral | - | ECHA IUCLID |
| LD50 | >640 mg/kg | Dog | oral | - | ECHA IUCLID |
| LD50 | >4000 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | >=20960 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | <=23620 mg/kg | Mouse | oral | - | ECHA IUCLID |
| NOAEL | =6770 mg/kg-day | Rabbit | oral | - | ECHA IUCLID |
| LD50 | =12500 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =25000 mg/kg | Rabbit | oral | - | ChemIDplus |
| LD50 | =16500 mg/kg | Rat | oral | - | ChemIDplus |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Toothpaste | 1–10 | 25 | CIR/VCRP |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "87-99-0", "anti_acne_mechanism": "antibacterial", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "inflammatory", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu_cosmetic_restriction_acne":…
anti_aging
{"anti_aging_claim": "hydration-plumping, prebiotic", "mechanism_of_action": "Microbiome modulation, barrier support", "target_skin_layer": "stratum corneum, epidermis", "collagen_stimulation": "No", "elastin_protection": "No", "wrinkle_reduction_pct": "6-12", "clinical_study_duration_weeks": "8", "sample_size": "30", "double_blind": "Yes", "placebo_controlled": "Yes", "published_journal": "Microb…
anti_pollution
{"cas_number": "87-99-0", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibition…
baby_pediatric
{"cas_number": "87-99-0", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Sugar alcohol, GRAS", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Humectant penetr…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,combination,normal,acne-prone", "acne_safe": "yes", "source": "Humectant"}
cost_pricing
{"cost_tier": "budget", "estimated_cost_per_kg_usd_low": "6", "estimated_cost_per_kg_usd_high": "12", "natural_premium_markup_pct": "0", "organic_certified_premium_pct": "0", "supply_chain_volatility": "low", "primary_source_region": "China/Finland", "bulk_discount_threshold_kg": "500", "seasonal_price_variation": "low", "commodity_or_specialty": "commodity", "substitute_ingredients": "Sorbitol, E…
dermal_absorption
{"molecular_weight_da": "152.1", "log_p_value": "-2.5", "skin_penetration_level": "surface", "penetration_depth": "stratum corneum", "absorption_pct": "2-5", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "no", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "1-3", "safety_margin_factor": "low", "source": "Cosmetic Sc…
hair_care
{"hair_function": "moisturizing", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "moisture", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "neutral", "ker…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Humectant
Softener and conditioner
Regulatory List Membership (3)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Xylitol.
Regulatory Flags
eu-unrestricted
cir-approved
gras-fda
non-sensitizing
humectant
eu_children_restricted
fda_food_additive
jecfa_safe
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Xylitol by CAS number or substance name.
Studies
23
Lowest NOAEL
680 mg/kg bw/day
Highest NOAEL
50000 mg/kg bw/day
COSMOS_DB
ToxValDB_ECHA_IUCLID
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip
Known Synonyms
BRN 1720523
EINECS 201-788-0
UNII-VCQ006KQ1E
(2R,4S)-pentane-1,2,3,4,5-pentol
Eutrit
Klinit
Kylit
L-xylitol
Xylit
Xylite (sugar)
xylite
Chemical Function
Humectant
Softener and conditioner
Flavouring and nutrient
Regulatory Lists
Canada; Personal care; Substances in PCP - Canada (4/2014)
Canada; consumer_product; Substances in Products - Canada (4/2014)
children; Europe; Personal care
children; Europe; Personal care - dental care - toothpaste
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
Canada; pharmaceutical
Europe; Personal care - oral and dental care - teeth whitener
Europe; Personal care - oral and dental care - teeth whitener
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
XYLITOL
ChEMBL ID
CHEMBL96783
Max Phase
3
Adverse Event Associations
27
Frequently Asked Questions
Is Xylitol allowed in the EU?
Xylitol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Xylitol do in cosmetics?
Xylitol functions as: Humectant, Prebiotic, S. aureus Biofilm Inhibitor, Microbiome Support, Acid Mantle Support, Skin Conditioning. It is classified as a Humectant in our database. CAS number: 87-99-0.
What is the NOAEL for Xylitol?
The NOAEL (No Observed Adverse Effect Level) for Xylitol is 680 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is Xylitol used outside cosmetics?
Xylitol also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Xylitol compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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