Good Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed Dermal Penetration

Hexylene Glycol

INCI: HEXYLENE GLYCOL

CAS Number
107-41-5
Function
solvent
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No FDA pre-market approval required for cosmetic use. Indirect food additive (IFA) status as defoaming agent under 21 CFR 176.210. No cosmetic-specific restrictions. EPA Safer Chemical Program classifies 2-Methyl-2,4-pentanediol as expected to be of low concern. CIR Expert Panel has concluded safe as presently used.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for Hexylene Glycol. 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 450 mg/kg bw/day oral rat oral REACH
NOAEL >=1000 mg/kg bw/day oral rat oral REACH
NOAEL 300 mg/kg bw/day oral rat oral REACH
NOAEL >800 mg/kg bw/day other rat oral REACH
NOAEL >590 mg/kg bw/day oral rat oral REACH
NOAEL >310 mg/kg bw/day oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir Number 5, 1985
Verdict: unknown

Dermal Penetration Profile

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

Absorption %
8-15%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
118.2 Da
Log P
0.58
Systemic Absorption
minimal
Topical Bioavailability
5-12%
Safety Margin Factor
moderate
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: CIR

Expert Verdict

Hexylene Glycol is permitted in EU cosmetics without concentration restrictions and is safe as presently used at concentrations of 0.1-25% according to the CIR Expert Panel; it is not a skin sensitizer and exhibits only reversible, minimal irritation.

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Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion eu_children_restricted epa_safer_alternative ifra_fragrance

Frequently Asked Questions

Is Hexylene Glycol safe in cosmetics?

Hexylene Glycol is permitted in EU cosmetics without concentration restrictions and is safe as presently used at concentrations of 0.1-25% according to the CIR Expert Panel; it is not a skin sensitizer and exhibits only reversible, minimal irritation. The EU classifies Hexylene Glycol as "permitted". Safety rating: GOOD. 6 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Hexylene Glycol allowed in the EU?

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

What does Hexylene Glycol do in cosmetics?

Hexylene Glycol functions as: solvent. It is classified as a cosmetic ingredient in our database. CAS number: 107-41-5.

What is the Margin of Safety for Hexylene 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.

What is the NOAEL for Hexylene Glycol?

The NOAEL (No Observed Adverse Effect Level) for Hexylene Glycol is 450 mg/kg bw/day based on a oral study via oral route in rat. A total of 6 study endpoints are available. Source: REACH.

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