Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Methyl Amyl Ketone

INCI: METHYL AMYL KETONE (SYNONYM: 2-HEPTANONE)

CAS Number
110-43-0
Function
Solvent, Fragrance ingredient
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Allowed. Also has FEMA GRAS status (FEMA 2544) for flavor use, indicating a well-characterized safety profile

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

4 study endpoints found for Methyl Amyl Ketone. 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 100 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOEL 1025 other 1995 rat inhalation REACH
NOEL 20 other oral rat oral REACH
NOEL 1025 other 1995 monkey inhalation REACH

GHS Hazard Classification

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

Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract. The substance may cause effects on the central nervous system. Exposure far above the OEL 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 of its vapour.

Expert Verdict

Volatile ketone - potential respiratory irritant at high concentrations; skin defatting with prolonged contact. Standard occupational exposure limits apply during manufacturing. Low concern at typical cosmetic use levels. Fruity/banana-like odor; naturally occurring in certain fruits and fermented foods; available in natural-certified grades; FEMA 2544

⚠️
Concern Level: Moderate

Regulatory Flags

fragrance-component ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Methyl Amyl Ketone safe in cosmetics?

Volatile ketone - potential respiratory irritant at high concentrations; skin defatting with prolonged contact. Standard occupational exposure limits apply during manufacturing. Low concern at typical cosmetic use levels. Fruity/banana-like odor; naturally occurring in certain fruits and fermented foods; available in natural-certified grades; FEMA 2544 The EU classifies Methyl Amyl Ketone as "permitted". Safety rating: MODERATE. 4 toxicological study endpoint(s) are available in our database.

Is Methyl Amyl Ketone allowed in the EU?

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

What does Methyl Amyl Ketone do in cosmetics?

Methyl Amyl Ketone functions as: Solvent, Fragrance ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 110-43-0.

What is the Margin of Safety for Methyl Amyl Ketone?

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 Methyl Amyl Ketone?

The NOAEL (No Observed Adverse Effect Level) for Methyl Amyl Ketone is 100 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 4 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Methyl Amyl Ketone compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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