Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Acetone

INCI: ACETONE

CAS Number
67-64-1
Function
Solvent, denaturant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
low

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 4312 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 3896 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 1700 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 11298 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 2500 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
NOAEL 1788 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 6400 mg/kg bw/day oral syrian hamster Immunotoxicology COSMOS_DB
NOAEL 1144 mg/kg bw/day oral mouse Immunotoxicology COSMOS_DB

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
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.

Expert Verdict

Potent defatting agent causing dryness, cracking, and irritant contact dermatitis with repeated dermal exposure. Inhalation risk as CNS depressant at high concentrations. VOC with workplace exposure limits (OSHA PEL 1000 ppm TWA). Flammable; adequate ventilation required in nail salon applications.

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Concern Level: Moderate

Regulatory Flags

endocrine_disruptor epa_safer_alternative ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Acetone safe in cosmetics?

Potent defatting agent causing dryness, cracking, and irritant contact dermatitis with repeated dermal exposure. Inhalation risk as CNS depressant at high concentrations. VOC with workplace exposure limits (OSHA PEL 1000 ppm TWA). Flammable; adequate ventilation required in nail salon applications. The EU classifies Acetone as "permitted". Safety rating: MODERATE. 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 Margin of Safety for Acetone?

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 Acetone?

The NOAEL (No Observed Adverse Effect Level) for Acetone is 4312 mg/kg bw/day based on a Short Term Toxicity 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 โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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