Good Cosmetic Ingredient NOAEL Data GHS Classified

MEK

Also known as: 2-Butanone, AI3-07540, Caswell No. 569, EINECS 201-159-0, EPA Pesticide Chemical Code 044103 (+14 more)

MEK (CAS 78-93-3) is a cosmetic cosmetic ingredient functioning as Perfuming, Solvent. NOAEL 340 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word DANGER. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 78-93-3 →

Auto-generated CPSR Part A draft with source citations
Function
Perfuming, Solvent
Safety Rating
GOOD

Chemistry & Identifiers

Formula
C4H8O
MW
72.11 g/mol
EC Number
201-159-0
PubChem CID
6569
IUPAC Name
butan-2-one
InChIKey
ZWEHNKRNPOVVGH-UHFFFAOYSA-N

Regulatory Status

EU EU Status permitted
US US Status Not specifically regulated

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

Toxicological Studies

2 study endpoints found for MEK. 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 490 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 981 mg/kg bw/day oral rat Short Term Toxicity 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
FlamFlameExcl markWarnCancerHealth haz
Hazard Statements
Highly flammable liquid and vapour Causes serious eye irritation May cause respiratory irritation May cause drowsiness or dizziness Suspected of damaging fertility or the unborn child May be harmful if swallowed and enters airways
Short-term Exposure Effects
The substance is irritating to the eyes and respiratory tract. The substance may cause effects on the central nervous system. Exposure could cause unconsciousness. If swallowed the substance easily enters the airways and could result in aspiration pneumonitis.
Long-term Exposure Effects
The substance defats the skin, which may cause dryness or cracking. Animal tests show that this substance possibly causes toxicity to human reproduction or development.
Routes of Exposure
The substance can be absorbed into the body by inhalation, by ingestion and through the skin.

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for MEK across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
NOAEL =589.835 mg/m3 Human inhalation acute TX TCEQ
NOAEL =14866.8 mg/m3 Rat inhalation subchronic TX TCEQ
MRL =2.94918 mg/m3 Human inhalation - ATSDR MRLs
RfD =0.6 mg/kg-day Human oral - OW Drinking Water Standards
LEL =53085.2 mg/m3 Human inhalation - DOE Protective Action Criteria
LOAEL =796.278 mg/m3 Human inhalation acute Cal OEHHA REL derivations
LD50 >10 mL/kg bw Rabbit dermal acute ECHA IUCLID
LD50 =4.29 mL/kg bw Rat oral - ECHA IUCLID
LOAEL =20000 mg/L Rat oral - ECHA IUCLID
LOAEL =20000 mg/L Rat oral - ECHA IUCLID

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Danger
Pictograms
FlammableHarmful / Irritant
Hazard Class and Category
Flam. Liq. 2; STOT SE 3; Eye Irrit. 2
Hazard Statements
  • H225 Highly flammable liquid and vapour
  • H336 May cause drowsiness or dizziness
  • H319 Causes serious eye irritation

Inserted via ATP: CLP00

HRIPT Human Patch Test Studies

1 human repeat insult patch test aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HMT - 0 13500 - -

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Suspected Evidence: Limited (2018)
Health effects: Yes
Affected pathways: Thyroid
Regulatory framework: REACH

Source list: II

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
100,000 - 1,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Roberts Skin Permeation (Mendeley 2022)
MW: 72.1
Log Kow: 0.37
Log Kp: -2.3467874862246565
Log Jmax: -4.86

Source: Roberts_Cheruvu_Mendeley_2022

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (5)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
Evidence for Carcinogenicity
Cancer Classification: Group D Not Classifiable as to Human Carcinogenicity | CLASSIFICATION: D; not classifiable as to human carcinogenicity. BASIS FOR CLASSIFICATION: Based on no human carcinogenicity data and inadequate animal data. HUMAN CARCINOGENICITY DATA: None. ANIMAL CARCINOGENICITY DATA: Inadequate.
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
ICSC Safety Card
0179
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
High atm concn ... are irritating to the eyes, nose, and throat ... . | Irritates the eyes and the respiratory tract.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (2)
JECFA Number
278
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
ETHYL METHYL KETONE | 1998 | No safety concern at current levels of intake when used as a flavouring agent | TRS 891-JECFA 51/59 | FAS 42-JECFA 51/235
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Adhesion/cohesion promoter Catalyst Degradant/impurity Flavouring and nutrient Fragrance No specific technical function Solvent
Regulatory List Membership (3)
IFRA Fragrance Transparency List FDA Substances Added to Food (EAFUS) Consumer Product Chemical

Expert Verdict

Expert safety assessment and concern-level summary for MEK.

Regulatory Flags

cosing-sourced eu-permitted fragrance needs-enrichment ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to MEK by CAS number or substance name.

Studies
2
Lowest NOAEL
490 mg/kg bw/day
Highest NOAEL
981 mg/kg bw/day
COSMOS_DB

Known Synonyms

2-Butanone AI3-07540 Caswell No. 569 EINECS 201-159-0 EPA Pesticide Chemical Code 044103 FEMA No. 2170 Ketone, ethyl methyl Methylethylketone Metyl ethyl ketone RCRA waste number U159 Ethylmethylcetone Metiletilcetona Metiletilchetone Metyloetyloketon UNII-6PT9KLV9IO 2-Butanon 3-butanone Aethylmethylketon C2H5COCH3

Chemical Function

Solvent Fragrance Flavouring and nutrient Adhesion/cohesion promoter Catalyst

Regulatory Lists

air; Arts and crafts/Office supplies - fabric treatment and dye; detected; emissions; Europe air; detected; emissions; Europe; Toys and children's products detected; Europe; Vehicle - car interior air; detected; emissions; Europe; Vehicle - car interior air; detected; emissions; Europe; Other direct contact consumer goods air; Cleaning products and household care - air freshener; detected; emissions; Europe air; detected; emissions; Europe; Toys and children's products air; detected; emissions; Europe; Toys and children's products air; detected; emissions; Europe; Other direct contact consumer goods air; Cons electronics mech appliances and machinery; detected; emissions; Europe Cleaning products and household care - laundry and fabric treatment - laundry stain remover; detected; Europe artificial_saliva; detected; emissions; Europe; Other indirect contact consumer goods consumer_product; detected consumer_product; detected; Europe consumer_product; Europe; nondetect air; detected; emissions; Europe; Vehicle - car interior air; detected; emissions; Europe; Other direct contact consumer goods air; detected; emissions; Europe; Other direct contact consumer goods

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
BUTANONE
ChEMBL ID
CHEMBL15849
View full pharmaceutical profile →

Frequently Asked Questions

Is MEK safe in cosmetics?

MEK has a safety rating of "GOOD" in our database. EU status: permitted. 2 toxicological study endpoint(s) are available in our database.

Is MEK allowed in the EU?

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

What does MEK do in cosmetics?

MEK functions as: Perfuming, Solvent. It is classified as a cosmetic ingredient in our database. CAS number: 78-93-3.

What is the NOAEL for MEK?

The NOAEL (No Observed Adverse Effect Level) for MEK is 490 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

Is MEK classified as hazardous under GHS?

MEK carries a GHS signal word of "DANGER". Hazard statements: Highly flammable liquid and vapour Causes serious eye irritation May cause respiratory irritation May cause drowsiness or dizziness Suspected of damaging fertility or the unborn child May be harmful if swallowed and enters airways. 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.

Is MEK used outside cosmetics?

MEK also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does MEK have different safety status in cosmetics vs industrial chemicals?

MEK is classified GHS Danger (H225, H319, H336, H335, H303, H305, H315, H320) in the chemicals database but is allowed in EU cosmetics.

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