Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Ethanol

INCI: ALCOHOL

CAS Number
64-17-5
Function
Antimicrobial, Solvent, Penetration Enhancer
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes CIR safe as used for Alcohol Denat.; OTC Drug status required if antimicrobial drug claims made (≥60% v/v)

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Ethanol. 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

Broadly permitted with no ingredient-specific concentration cap; penetration enhancement raises systemic exposure of co-formulated actives; skin barrier disruption documented; avoid high concentrations in pediatric, atopic, or compromised-skin formulations.

⚠️
Concern Level: Moderate

Regulatory Flags

penetration-enhancer barrier-disruptive sensitization-rare pediatric-risk inhalation-risk-aerosol otc-drug-if-antimicrobial-claim endocrine_disruptor prop65 eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Ethanol safe in cosmetics?

Broadly permitted with no ingredient-specific concentration cap; penetration enhancement raises systemic exposure of co-formulated actives; skin barrier disruption documented; avoid high concentrations in pediatric, atopic, or compromised-skin formulations. The EU classifies Ethanol as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Ethanol allowed in the EU?

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

What does Ethanol do in cosmetics?

Ethanol functions as: Antimicrobial, Solvent, Penetration Enhancer. It is classified as a cosmetic ingredient in our database. CAS number: 64-17-5.

What is the Margin of Safety for Ethanol?

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 Ethanol?

The NOAEL (No Observed Adverse Effect Level) for Ethanol 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 Ethanol classified as hazardous under GHS?

Ethanol 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 Ethanol 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
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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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