Excellent Humectant NOAEL Data Dermal Penetration

Xylitol

INCI: XYLITOL

CAS Number
87-99-0
Function
Humectant, Prebiotic, S. aureus Biofilm Inhibitor, Microbiome Support, Acid Mantle Support, Skin Conditioning
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
none

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 5000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 9167 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 10000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 10000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 9847 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 25200 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 20100 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 1000 mg/kg bw/day oral monkey Subchronic COSMOS_DB

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

Expert Verdict

Xylitol is safe in present practices of use and concentration per CIR Expert Panel (2025). Excellent safety profile supported by negative sensitization and irritation findings, favorable toxicology, negative genotoxicity battery, and long history of safe dietary and topical use.

⚠️
Concern Level: None

Regulatory Flags

eu-unrestricted cir-approved gras-fda non-sensitizing humectant eu_children_restricted fda_food_additive jecfa_safe

Frequently Asked Questions

Is Xylitol safe in cosmetics?

Xylitol is safe in present practices of use and concentration per CIR Expert Panel (2025). Excellent safety profile supported by negative sensitization and irritation findings, favorable toxicology, negative genotoxicity battery, and long history of safe dietary and topical use. The EU classifies Xylitol as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

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 Margin of Safety for Xylitol?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Xylitol?

The NOAEL (No Observed Adverse Effect Level) for Xylitol is 5000 mg/kg bw/day based on a Special Toxicology Study study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Xylitol compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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