Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Alcohol Denat

INCI: ALCOHOL DENAT

CAS Number

64-17-5

Function

Solvent; astringent vehicle; antimicrobial; penetration enhancer

Safety Rating

MODERATE

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

US Notes Used at 20–60% in FDA OTC drug-classified astringents (21 CFR Part 347). Cosmetic use unrestricted. Industry trend toward alcohol-free formulations (K-beauty influence, 2024–2025). Products >20% classified as alcohol-containing.

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

Safety Data

Margin of Safety (MoS)

adequate

Dermal Absorption

high

Sensitization

moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Alcohol Denat. 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	1730 mg/kg bw/day	oral	rat	oral	REACH
LOAEL	2340 mg/kg bw/day	oral	monkey	oral	REACH
NOAEL	2 other	other	rat	oral	REACH
NOAEL	ca.3250 mg/kg bw/day	oral	rat	oral	REACH
NOEL	6200 mg/kg bw/day	oral	monkey	oral	REACH
NOAEL	9700 mg/kg bw/day	oral	mouse	oral	REACH
NOAEL	13.3 2100	1995	rat	inhalation	REACH
NOAEL	>20 mg/L air	1991	rat	inhalation	REACH
NOAEL	>20 mg/L air	1991	rat	inhalation	REACH
NOAEL	2 other	other	rat	oral	REACH

GHS Hazard Classification

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

Signal Word

DANGER

Pictograms

flam;flame; excl mark;warn; cancer;health haz

Hazard Statements

Highly flammable liquid and vapour Harmful if swallowed Causes serious eye irritation May cause damage to organs through prolonged or repeated exposure

Short-term Exposure Effects

The substance is severely irritating to the eyes. The vapour at high levels is irritating to the eyes and respiratory tract. The substance may cause effects on the central nervous system.

Long-term Exposure Effects

The substance defats the skin, which may cause dryness or cracking. The substance may have effects on the upper respiratory tract and central nervous system. This may result in irritation, headache, fatigue and lack of concentration. See Notes.

Routes of Exposure

The substance can be absorbed into the body by inhalation of its vapour and by ingestion.

Expert Verdict

Alcohol denat (denatured ethanol) is a traditional vehicle for cosmetic toners and FDA OTC drug astringents used at 20–60% for rapid evaporation, degreasing, and antimicrobial action. Sustained high-concentration use disrupts stratum corneum barrier lipids, increasing TEWL and sensitization risk to co-formulated ingredients. The 2024–2025 market has shifted toward alcohol-free formulations driven by K-beauty innovation and consumer preference. Products >20% alcohol denat are classified as alcohol-containing, while alcohol-free versions require full antimicrobial challenge testing.

⚠️

Concern Level: Moderate

Regulatory Flags

barrier-disruptor declining-trend alcohol-free-alternative otc-drug-vehicle penetration-enhancer prop65 eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Alcohol Denat safe in cosmetics?

Is Alcohol Denat allowed in the EU?

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

What does Alcohol Denat do in cosmetics?

Alcohol Denat functions as: Solvent; astringent vehicle; antimicrobial; penetration enhancer. It is classified as a cosmetic ingredient in our database. CAS number: 64-17-5.

What is the Margin of Safety for Alcohol Denat?

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 Alcohol Denat?

The NOAEL (No Observed Adverse Effect Level) for Alcohol Denat is 1730 mg/kg bw/day based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.

Is Alcohol Denat classified as hazardous under GHS?

Alcohol Denat carries a GHS signal word of "DANGER". Hazard statements: Highly flammable liquid and vapour Harmful if swallowed Causes serious eye irritation May cause damage to organs through prolonged or repeated exposure. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.

Compliance Tools

Check Alcohol Denat compliance across multiple jurisdictions:

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82 Allergen Checker

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Substance Compliance

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MoS Calculator

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Heavy Metal Limits

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