Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Acetone

Also known as: Caswell No. 004, Chevron acetone, Dimethylketal, EINECS 200-662-2, EPA Pesticide Chemical Code 004101 (+13 more)

INCI: ACETONE

Acetone (CAS 67-64-1) is a cosmetic cosmetic ingredient functioning as Solvent, denaturant. NOAEL 100 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 67-64-1 →

Auto-generated CPSR Part A draft with source citations
Function
Solvent, denaturant
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
200-662-2

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes Permitted without specific restriction. FDA GRAS for food contact. Widely used in OTC drug products (nail polish removers).

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Acetone.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Acetone. 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 500 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 1144 mg/kg bw/day oral mouse Immunotoxicology COSMOS_DB
NOAEL 1700 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1788 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2500 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
NOAEL 3896 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 4312 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 6400 mg/kg bw/day oral syrian hamster Immunotoxicology COSMOS_DB
NOAEL =500 mg/kg bw/day oral Rat Subchronic toxicity INCHEM_WHO_ehc_ehc_ehc207

GHS Hazard Classification

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

Signal Word
DANGER
Pictograms
FlamFlameExcl markWarn
Hazard Statements
Highly flammable liquid and vapour Causes eye irritation May cause respiratory irritation
Short-term Exposure Effects
The substance is irritating to the eyes and respiratory tract. Exposure at high levels could cause lowering of consciousness.
Long-term Exposure Effects
The substance defats the skin, which may cause dryness or cracking.
Routes of Exposure
The substance can be absorbed into the body by inhalation.

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Acetone 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
MRL =19.0038 mg/m3 Human inhalation - ATSDR MRLs
MRL =0.6 mg/kg-day Human oral - ATSDR MRLs
LOAEL =539.232 mg/m3 Human inhalation acute TX TCEQ
LOAEL =890.802 mg/m3 Human inhalation chronic TX TCEQ
NOAEL =900 mg/kg-day Rat oral subchronic EFSA
LEL =61762.3 mg/m3 Human inhalation - DOE Protective Action Criteria
NOAEL =900 mg/kg-day Rat oral subchronic Mass. ORSG
NOEL =200 uL Mouse dermal chronic ECOTOX
NOEL =200 uL Mouse dermal chronic ECOTOX
OEL =1187.74 mg/m3 Human inhalation - EU SCOEL

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Danger
Pictograms
FlammableHarmful / Irritant
Hazard Class and Category
Flam. Liq. 2; STOT SE 3; Eye Irrit. 2
Hazard Statements
  • H225 Highly flammable liquid and vapour
  • H336 May cause drowsiness or dizziness
  • H319 Causes serious eye irritation

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 - - -

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)

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Nail Polish Remover 50–80 100 CIR/VCRP

Additional Ingredient Properties

2 property records from structured ingredient metadata.

ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "3-7", "bioaccumulative": "no", "aquatic_toxicity_level": "moderate", "coral_reef_safe": "yes", "marine_toxicity": "moderate aquatic toxicity", "freshwater_toxicity": "LC50 fish 5-10 g/L", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmental…
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "avoid", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "caution", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.0", "adult_max_concentration_pct": "10.0", "pediatric_dermal_absorption_factor": "high", "immature_skin_barrier_risk": "high", "oral_ingestion_risk": "moderate", "eye_irritation_risk": "high"…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Adhesion/cohesion promoter Binder Cleaning agent Degradant/impurity Diluent Flavouring and nutrient Fragrance No specific technical function Solubility enhancer Solvent
Regulatory List Membership (3)
IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL) FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for Acetone.

Regulatory Flags

endocrine_disruptor epa_safer_alternative ifra_fragrance fda_food_additive jecfa_safe

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Acetone by CAS number or substance name.

Studies
23
Lowest NOAEL
100
Highest NOAEL
6400

Units vary across source rows: mg/kg bw/day, mg/kg bw

COSMOS_DB ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip INCHEM_WHO_ehc_ehc_ehc207

Known Synonyms

Caswell No. 004 Chevron acetone Dimethylketal EINECS 200-662-2 EPA Pesticide Chemical Code 004101 FEMA No. 3326 Ketone, dimethyl Ketone propane Pyroacetic acid RCRA waste number U002 UNII-1364PS73AF Aceton Azeton Dimethylketon Propanon beta-Ketopropane dimethylcetone dimethylketone

Chemical Function

Solvent

Regulatory Lists

air; detected; emissions; Europe; Other direct contact consumer goods drinking_water; Europe; manufacturing; plastic_additive inert_ingredient; non_food_use; Pesticides Arts and crafts/Office supplies - general arts and crafts supplies; Europe Arts and crafts/Office supplies - general arts and crafts supplies; Europe air; Cons electronics mech appliances and machinery; detected; emissions; Europe air; Cons electronics mech appliances and machinery; detected; emissions; Europe Cons electronics mech appliances and machinery; detected; emissions; Europe Cleaning products and household care - shoes; Europe Cleaning products and household care - shoes; Europe Arts and crafts/Office supplies - fabric treatment and dye; detected air; Arts and crafts/Office supplies - fabric treatment and dye; detected; emissions; Europe Arts and crafts/Office supplies - fabric treatment and dye; detected; Europe CEDI air; detected; emissions; Europe; Furniture and Furnishings air; detected; emissions; Europe; Other indirect contact consumer goods air; detected; emissions; Europe; Furniture and Furnishings air; Construction and building materials; detected; emissions; Europe

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
ACETONE
ChEMBL ID
CHEMBL14253
Max Phase
-1
Adverse Event Associations
43
View full pharmaceutical profile →

Frequently Asked Questions

Is Acetone safe in cosmetics?

Acetone has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.

Is Acetone allowed in the EU?

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

What does Acetone do in cosmetics?

Acetone functions as: Solvent, denaturant. It is classified as a cosmetic ingredient in our database. CAS number: 67-64-1.

What is the NOAEL for Acetone?

The NOAEL (No Observed Adverse Effect Level) for Acetone is 500 mg/kg bw/day based on a Reproductive study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Acetone classified as hazardous under GHS?

Acetone carries a GHS signal word of "DANGER". Hazard statements: Highly flammable liquid and vapour Causes eye irritation May cause respiratory irritation. 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 Acetone used outside cosmetics?

Acetone 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 Acetone have different safety status in cosmetics vs industrial chemicals?

Acetone is classified GHS Danger (H225, H319, H336) in the chemicals database but is allowed in EU cosmetics.

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