Is Ethanol safe in cosmetics?
Ethanol has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 1 toxicological study endpoint(s) are available in our database.
Ethanol
Also known as: Ethyl alcohol, EtOH, Alcohol, anhydrous, Alcohol dehydrated, Alcohol, diluted (+15 more)
INCI: ALCOHOL
Ethanol (CAS 64-17-5) is a cosmetic cosmetic ingredient functioning as Antimicrobial, Solvent, Penetration Enhancer. NOAEL 13.3 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word DANGER. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 64-17-5 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Ethanol is classified GHS Danger (H225, H319, H320, H335, H336, H350, H360, H372) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Antimicrobial, Solvent, Penetration Enhancer
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
ethanol
InChIKey
LFQSCWFLJHTTHZ-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US 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 multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Ethanol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint 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 | =2500 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
DANGER
Pictograms
FlamFlameExcl markWarnCancerHealth 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.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Ethanol across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOAEL | =1730 mg/kg-day | Rat | oral | subchronic | EFSA |
| LEL | =62179.3 mg/m3 | Human | inhalation | - | DOE Protective Action Criteria |
| LOEL | =1 mg/L | Mouse | environmental | short-term | ECOTOX |
| LOEL | =5 % v/v | Mouse | oral | subchronic | ECOTOX |
| NOEL | =5 % v/v | Mouse | oral | subchronic | ECOTOX |
| LOEL | =20 % w/v | Mouse | oral | chronic | ECOTOX |
| LOEL | =30 % | Rat | oral | subchronic | ECOTOX |
| LOEL | =30 % | Rat | oral | short-term | ECOTOX |
| LOEL | =30 % | Rat | oral | short-term | ECOTOX |
| LOEL | =25 % v/v | Mouse | oral | short-term | ECOTOX |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
1
Volume
96, 100E
Evaluation Year
2009
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Flammable
Hazard Class and Category
Flam. Liq. 2
Hazard Statements
- H225 Highly flammable liquid and vapour
Inserted via ATP: CLP00
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HRIPT | - | 0 | 62992.13 | - | - |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000,000 - 10,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | restricted | - | All products |
| AU | restricted | - | sanitizers/toners |
| GCC | restricted | - | Oral hygiene products |
| GCC | halal_prohibited | - | Leave-on cosmetics, fragrance at intoxicating concentrations |
| SA | banned | - | Oral rinse / mouthwash products |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
EPA Dryad Skin Absorption (physics-based)
MW: 46.069
LogP: -0.309717
Kp epidermis: 0.99609 cm/h
Source: EPA_Dryad_Skin_Absorption_2024
Roberts Skin Permeation (Mendeley 2022)
MW: 46
Log Kow: -0.31
Log Kp: -3.0969100130080562
Log Jmax: -4.87
Source: Roberts_Cheruvu_Mendeley_2022
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (7)
Carcinogen Classification
Ethanol in alcoholic beverages is carcinogenic to humans (Group 1). (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Ethanol in alcoholic beverages | Group 1: Carcinogenic to humans | Volume 96: (2010) Alcohol Consumption and Ethyl Carbamate | Volume 100E: (2012) Personal Habits and Indoor Combustions
Source: International Agency for Research on Cancer (IARC)
Carcinogen Classification
Ethanol | TR-510: Toxicology and Carcinogenesis Studies of Urethane + Ethanol (CASRNs 51-79-6 & 64-17-5) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies) (2004 ) | 09/05/02 | Chemical Not Tested in Species/Sex | Chemical Not Tested in Species/Sex | Inadequate Experiment | Inadequate Experiment | Under the conditions of this 2-year drinking water study, there was clear evidence of
Source: NTP Technical Reports
Evidence for Carcinogenicity
A3; Confirmed animal carcinogen with unknown relevance to humans.
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Regulatory (3)
JECFA Number
41
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
ALCOHOL | 1970 | LIMITED BY GMP (use as solvent, 1970) | At the forty-sixth meeting (1996), the Committee concluded that ethanol posed no safety concern at its current level of intake when ethyl esters are used as flavouring agents; see TRS 868-JECFA 46/21, 64 | NMRS 48/TRS 462-JECFA 14/20 | FAS 70.39/NMRS 48A-JECFA 15/99
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
ETHYL ALCOHOL | 1970 | LIMITED BY GMP (use as solvent, 1970) | At the forty-sixth meeting (1996), the Committee concluded that ethanol posed no safety concern at its current level of intake when ethyl esters are used as flavouring agents; see TRS 868-JECFA 46/21, 64 | NMRS 48/TRS 462-JECFA 14/20 | FAS 70.39/NMRS 48A-JECFA 15/99
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Astringent
Biocide
Cleaning agent
Defoamer
Deodorizer
Diluent
Drier
Emulsifier
Flavouring and nutrient
Fragrance
Regulatory List Membership (7)
California Proposition 65 (OEHHA)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
Expert Verdict
Expert safety assessment and concern-level summary for Ethanol.
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
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Ethanol by CAS number or substance name.
Studies
1
Lowest NOAEL
2500 mg/kg bw/day
Highest NOAEL
2500 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
Ethyl alcohol
EtOH
Alcohol, anhydrous
Alcohol dehydrated
Alcohol, diluted
Alcohol, ethyl
Caswell No. 430
Denatured alcohol CD-10
Denatured alcohol CD-5
Denatured alcohol CD-5a
Denatured alcohol SD-1
Denatured alcohol SD-13a
Denatured alcohol SD-17
Denatured alcohol SD-23a
Denatured alcohol SD-28
Denatured alcohol SD-3a
Denatured alcohol SD-30
Denatured alcohol SD-39b
Denatured alcohol SD-39c
Denatured alcohol SD-40m
Chemical Function
Solvent
Biocide
Regulatory Lists
Arts and crafts/Office supplies - fabric treatment and dye; detected
Arts and crafts/Office supplies - fabric treatment and dye; detected; Europe
consumer_product; detected; Europe
consumer_product; detected; Europe
Europe; Personal care
Europe; Vehicle - car interior
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
children; Europe; Personal care - hair styling and care - shampoo
children; Europe; Personal care
children; Europe; Personal care
Cleaning products and household care; Europe
Europe; Personal care - liniment
Europe; Personal care
Europe; Personal care
Europe; Personal care
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
ALCOHOL
ChEMBL ID
CHEMBL545
Max Phase
4
Adverse Event Associations
1495
Frequently Asked Questions
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 NOAEL for Ethanol?
The NOAEL (No Observed Adverse Effect Level) for Ethanol is =2500 mg/kg bw/day based on a reproduction developmental study via oral route in Rat. Source: ToxValDB_ECHA_IUCLID.
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.
Is Ethanol used outside cosmetics?
Ethanol also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Ethanol have different safety status in cosmetics vs industrial chemicals?
Ethanol is classified GHS Danger (H225, H319, H320, H335, H336, H350, H360, H372) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Ethanol 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 multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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