Good Humectant Sensitization Data Dermal Penetration

Pentylene Glycol

INCI: PENTYLENE GLYCOL

CAS Number
5343-92-0
Function
humectant
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Not subject to FDA premarket approval for cosmetic use. Not listed in 21 CFR Parts 172-184 (GRAS) or 21 CFR Part 700. Not an active sunscreen ingredient; no GRASE designation. FDA 510(k)-cleared as component in prescription hydrogel wound dressings (21 CFR 878.4022) for medical device use only.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Pentylene Glycol based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

Dermal Penetration Profile

Skin absorption and penetration characteristics of Pentylene Glycol, relevant to systemic exposure and MoS calculations.

Absorption %
10-20%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
104.1 Da
Log P
0.08
Systemic Absorption
minimal
Topical Bioavailability
6-15%
Safety Margin Factor
moderate
Vehicle Dependent
Yes — absorption varies by formulation

Source: Cosmetic Science

Expert Verdict

Pentylene Glycol (CAS 5343-92-0) is permitted for unrestricted general cosmetic use in the EU with no concentration limits. The CIR Expert Panel concluded it is safe at present practices of use and concentration. Sensitization data from a large multi-center study identified a 0.57% allergic reaction rate, higher than propylene glycol, with multiple case reports of allergic contact dermatitis warranting caution in products for sensitive skin.

⚠️
Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion penetration-enhancer humectant epa_safer_alternative ifra_fragrance

Frequently Asked Questions

Is Pentylene Glycol safe in cosmetics?

Pentylene Glycol (CAS 5343-92-0) is permitted for unrestricted general cosmetic use in the EU with no concentration limits. The CIR Expert Panel concluded it is safe at present practices of use and concentration. Sensitization data from a large multi-center study identified a 0.57% allergic reaction rate, higher than propylene glycol, with multiple case reports of allergic contact dermatitis warranting caution in products for sensitive skin. The EU classifies Pentylene Glycol as "permitted". Safety rating: GOOD.

Is Pentylene Glycol allowed in the EU?

Pentylene Glycol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Pentylene Glycol do in cosmetics?

Pentylene Glycol functions as: humectant. It is classified as a Humectant in our database. CAS number: 5343-92-0.

What is the Margin of Safety for Pentylene Glycol?

adequate 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.

Compliance Tools

Check Pentylene Glycol 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 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

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