Poor Cosmetic Ingredient NOAEL Data GHS Classified

Hexane

INCI: HEXANE

CAS Number
110-54-3
Function
Solvent
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status restricted
US Notes Not explicitly prohibited in 21 CFR for cosmetics but subject to OSHA PEL (50 ppm TWA); effectively restricted due to neurotoxicity; MoCRA may trigger further scrutiny

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Hexane. 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 4000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1650 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 9900 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 2200 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 20000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 10000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 6250 mg/kg bw/day oral rat Neurotoxicity COSMOS_DB
dose_tested 1650 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 20000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
dose_tested 10000 mg/kg bw/day oral rat Special Toxicology Study 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; cancer;health haz; enviro;aqua
Hazard Statements
Flammable liquid and vapour Causes skin irritation May cause drowsiness or dizziness Causes damage to the nervous system through prolonged or repeated exposure May damage fertility or the unborn child if inhaled May be fatal if swallowed and enters airways Toxic to aquatic life with long lasting effects
Short-term Exposure Effects
The substance is irritating to the skin. The substance is mildly irritating to the eyes and respiratory tract. Exposure to high concentrations of vapour could cause unconsciousness. If this liquid is swallowed, aspiration into the lungs may result in chemical pneumonitis. See Notes.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis. The substance may have effects on the central nervous system and peripheral nervous system. This may result in polyneuropathy. Animal tests show that this substance possibly causes toxic effects upon human reproduction.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour and by ingestion.

Expert Verdict

Neurotoxic — causes peripheral neuropathy via metabolite 2,5-hexanedione; classified Repr. 2 (H361f), Asp. Tox. 1 (H304), and STOT RE 2 (H373); highly volatile and flammable; not permitted in finished cosmetic products.

⚠️
Concern Level: High

Regulatory Flags

prop65 eu_banned_cosmetics ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Hexane safe in cosmetics?

Neurotoxic — causes peripheral neuropathy via metabolite 2,5-hexanedione; classified Repr. 2 (H361f), Asp. Tox. 1 (H304), and STOT RE 2 (H373); highly volatile and flammable; not permitted in finished cosmetic products. The EU classifies Hexane as "prohibited". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database.

Is Hexane allowed in the EU?

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

What does Hexane do in cosmetics?

Hexane functions as: Solvent. It is classified as a cosmetic ingredient in our database. CAS number: 110-54-3.

What is the Margin of Safety for Hexane?

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 Hexane?

The NOAEL (No Observed Adverse Effect Level) for Hexane is 4000 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Hexane classified as hazardous under GHS?

Hexane carries a GHS signal word of "DANGER". Hazard statements: Flammable liquid and vapour Causes skin irritation May cause drowsiness or dizziness Causes damage to the nervous system through prolonged or repeated exposure May damage fertility or the unborn child if inhaled May be fatal if swallowed and enters airways Toxic to aquatic life with long lasting effects. 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 Hexane 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
Check compliance across 55 jurisdictions
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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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