Poor Cosmetic Ingredient NOAEL Data GHS Classified

Diacetyl

INCI: DIACETYL

CAS Number
431-03-8
Function
Masking agent, fragrance ingredient
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted as GRAS food flavoring (FEMA 2370); no specific FDA cosmetic prohibition

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Diacetyl. 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 540 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 300 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; skull;toxic; cancer;health haz
Hazard Statements
Highly flammable liquid and vapour Harmful if swallowed Toxic if inhaled Causes skin irritation Causes serious eye irritation Causes damage to respiratory system if inhaled Causes damage to respiratory system through prolonged or repeated exposure if inhaled Harmful to aquatic life
Short-term Exposure Effects
The substance is severely irritating to the eyes. The substance is irritating to the skin and respiratory tract. The substance may cause effects on the central nervous system, lungs and respiratory tract. Exposure at high levels could cause lowering of consciousness.
Long-term Exposure Effects
Lungs may be affected by repeated or prolongated exposure to the vapour. This may result in impaired functions. See Notes.
Routes of Exposure
The substance can be absorbed into the body by inhalation and by ingestion.

Expert Verdict

Critical inhalation hazard with well-documented cause of bronchiolitis obliterans from occupational exposure; NIOSH health hazard alerts issued. Must not be used in aerosolizable, sprayable, or powder cosmetics. Dermal-only applications at low concentrations carry lower risk, but absence of cosmetic-specific margin of safety is a major data gap.

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Concern Level: High

Regulatory Flags

fragrance-component ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Diacetyl safe in cosmetics?

Critical inhalation hazard with well-documented cause of bronchiolitis obliterans from occupational exposure; NIOSH health hazard alerts issued. Must not be used in aerosolizable, sprayable, or powder cosmetics. Dermal-only applications at low concentrations carry lower risk, but absence of cosmetic-specific margin of safety is a major data gap. The EU classifies Diacetyl as "prohibited". Safety rating: POOR. 2 toxicological study endpoint(s) are available in our database.

Is Diacetyl allowed in the EU?

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

What does Diacetyl do in cosmetics?

Diacetyl functions as: Masking agent, fragrance ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 431-03-8.

What is the Margin of Safety for Diacetyl?

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 Diacetyl?

The NOAEL (No Observed Adverse Effect Level) for Diacetyl is 540 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

Is Diacetyl classified as hazardous under GHS?

Diacetyl carries a GHS signal word of "DANGER". Hazard statements: Highly flammable liquid and vapour Harmful if swallowed Toxic if inhaled Causes skin irritation Causes serious eye irritation Causes damage to respiratory system if inhaled Causes damage to respiratory system through prolonged or repeated exposure if inhaled Harmful to aquatic life. 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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