Moderate Cosmetic Ingredient NOAEL Data GHS Classified

MIBK (Methyl Isobutyl Ketone)

INCI: MIBK

CAS Number
108-10-1
Function
Denaturant, fragrance ingredient, solvent
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status permitted
US Notes Allowed with limitations - the CIR Expert Panel concluded MIBK is safe as used in nail care products and as an alcohol denaturant in cosmetics at current practices of use and concentration

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

8 study endpoints found for MIBK (Methyl Isobutyl 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 681 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 1362 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 681 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 681 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 681 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
dose_tested 681 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
dose_tested 1362 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOEL 50 mg/kg bw/day oral rat oral 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 and the vapour are irritating to the eyes, skin and respiratory tract. If this liquid is swallowed, aspiration into the lungs may result in chemical pneumonitis. The substance may cause effects on the central nervous system at high concentrations. This may result in narcosis.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour and by ingestion.

Expert Verdict

Classified as CMR Category 2 (suspected carcinogen) under EU CLP Regulation, which triggered the EU ban. Inhalation exposure is the primary concern; MIBK is volatile and has documented neurotoxic and hepatotoxic effects at high exposures. It is approved for direct food addition in the US as a synthetic flavoring substance. Highly volatile aliphatic ketone with a characteristic sweet odor. Its EU prohibition is strictly cosmetics-specific; it remains permitted in other industrial applications....

⚠️
Concern Level: High

Regulatory Flags

fragrance-component prop65 ifra_fragrance fda_food_additive

Frequently Asked Questions

Is MIBK (Methyl Isobutyl Ketone) safe in cosmetics?

Classified as CMR Category 2 (suspected carcinogen) under EU CLP Regulation, which triggered the EU ban. Inhalation exposure is the primary concern; MIBK is volatile and has documented neurotoxic and hepatotoxic effects at high exposures. It is approved for direct food addition in the US as a synthetic flavoring substance. Highly volatile aliphatic ketone with a characteristic sweet odor. Its EU prohibition is strictly cosmetics-specific; it remains permitted in other industrial applications.... The EU classifies MIBK (Methyl Isobutyl Ketone) as "prohibited". Safety rating: MODERATE. 8 toxicological study endpoint(s) are available in our database.

Is MIBK (Methyl Isobutyl Ketone) allowed in the EU?

MIBK (Methyl Isobutyl Ketone) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does MIBK (Methyl Isobutyl Ketone) do in cosmetics?

MIBK (Methyl Isobutyl Ketone) functions as: Denaturant, fragrance ingredient, solvent. It is classified as a cosmetic ingredient in our database. CAS number: 108-10-1.

What is the Margin of Safety for MIBK (Methyl Isobutyl 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 MIBK (Methyl Isobutyl Ketone)?

The NOAEL (No Observed Adverse Effect Level) for MIBK (Methyl Isobutyl Ketone) is 681 mg/kg bw/day based on a Special Toxicology Study study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check MIBK (Methyl Isobutyl Ketone) compliance across multiple jurisdictions:

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Substance Compliance
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MoS Calculator
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