Poor Cosmetic Ingredient NOAEL Data GHS Classified

m-Cresol

INCI: M-CRESOL

CAS Number

108-39-4

Function

Antimicrobial, denaturant

Safety Rating

POOR

Regulatory Status

🇪🇺 EU Status restricted

EU Max Conc. 0.2%

🇺🇸 US Status restricted

US Notes Not specifically prohibited by FDA for cosmetics but subject to general safety requirements; classified as toxic (OSHA/EPA).

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

Safety Data

Margin of Safety (MoS)

not established

Dermal Absorption

low

Sensitization

high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for m-Cresol. 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	50 mg/kg bw/day	oral	rat	Short Term Toxicity	COSMOS_DB
NOAEL	100 mg/kg bw/day	oral	rabbit	Developmental	COSMOS_DB
NOAEL	291 mg/kg bw/day	oral	rabbit	Developmental	COSMOS_DB
NOAEL	800 mg/kg bw/day	oral	mouse	Short Term Toxicity	COSMOS_DB
NOAEL	450 mg/kg bw/day	oral	rat	Multigeneration Reproductive	COSMOS_DB
NOAEL	862 mg/kg bw/day	oral	rat	Short Term Toxicity	COSMOS_DB
NOAEL	210 mg/kg bw/day	oral	mouse	Short Term Toxicity	COSMOS_DB
NOAEL	470 mg/kg bw/day	oral	rat	Developmental	COSMOS_DB
dose_tested	50 mg/kg bw/day	oral	rat	Short Term Toxicity	COSMOS_DB
dose_tested	100 mg/kg bw/day	oral	rabbit	Developmental	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

corr; skull;toxic; cancer;health haz

Hazard Statements

Toxic if swallowed Harmful in contact with skin Fatal if inhaled Causes severe skin burns and eye damage Causes damage to central nervous system and blood if blood Causes damage to the nervous system and the blood through prolonged or repeated exposure if the blood Toxic to aquatic life

Short-term Exposure Effects

The substance is corrosive to the eyes, skin and respiratory tract. Corrosive on ingestion. Inhalation may cause lung oedema, but only after initial corrosive effects on eyes and/or airways have become manifest. The substance may cause effects on the central nervous system. This may result in lowering of consciousness. The substance may cause effects on the blood. This may result in destruction of blood cells. Exposure far above the OEL could cause death. Medical observation is indicated.

Long-term Exposure Effects

Repeated or prolonged contact with skin may cause dermatitis. The substance may have effects on the nervous system. This may result in impaired functions. The substance may have effects on the blood. This may result in anaemia.

Routes of Exposure

The substance can be absorbed into the body by inhalation of its vapour, through the skin and by ingestion. Serious local effects by all routes of exposure.

Expert Verdict

⚠️

Concern Level: High

Regulatory Flags

ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is m-Cresol safe in cosmetics?

Corrosive to skin and eyes with acute toxicity via all routes. Not suitable for leave-on products; if used only in rinse-off products at very low concentrations with full safety dossier. CLP classified Acute Tox. 3 (H301, H311, H331), Skin Corr. 1B (H314). The EU classifies m-Cresol as "restricted". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database.

Is m-Cresol allowed in the EU?

m-Cresol EU regulatory status: restricted. Maximum allowed concentration: 0.2%. This is based on EU Regulation 1223/2009 and its amendments.

What does m-Cresol do in cosmetics?

m-Cresol functions as: Antimicrobial, denaturant. It is classified as a cosmetic ingredient in our database. CAS number: 108-39-4.

What is the Margin of Safety for m-Cresol?

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 m-Cresol?

The NOAEL (No Observed Adverse Effect Level) for m-Cresol is 50 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is m-Cresol classified as hazardous under GHS?

m-Cresol carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed Harmful in contact with skin Fatal if inhaled Causes severe skin burns and eye damage Causes damage to central nervous system and blood if blood Causes damage to the nervous system and the blood through prolonged or repeated exposure if the blood Toxic 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 — at cosmetic use concentrations, hazard thresholds may not be met.

Compliance Tools

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Substance Compliance

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MoS Calculator

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Heavy Metal Limits

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