Poor Cosmetic Ingredient NOAEL Data GHS Classified

O-Cresol

INCI: O-CRESOL

CAS Number
95-48-7
Function
Denaturant, fragrance
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status permitted
US Notes CIR/SCCS Review

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for O-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 100 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 50 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 750 mg/kg bw/day oral mouse Multigeneration Reproductive COSMOS_DB
NOAEL 2048 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 434 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 861 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 763 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 510 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1500 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 175 mg/kg bw/day oral rat Multigeneration Reproductive 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 or in contact with skin Causes severe skin burns and eye damage Causes damage to central nervous system and blood Causes damage to the nervous system and the blood through prolonged or repeated exposure 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, through the skin and by ingestion. Serious local effects by all routes of exposure.

Expert Verdict

O-Cresol is a fragrance and denaturant with poor safety profile and high skin sensitization potential despite low inherent sensitization risk; restricted in EU with adequate margin of safety.

⚠️
Concern Level: High

Regulatory Flags

fragrance-component ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is O-Cresol safe in cosmetics?

O-Cresol is a fragrance and denaturant with poor safety profile and high skin sensitization potential despite low inherent sensitization risk; restricted in EU with adequate margin of safety. The EU classifies O-Cresol as "restricted". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database.

Is O-Cresol allowed in the EU?

O-Cresol EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does O-Cresol do in cosmetics?

O-Cresol functions as: Denaturant, fragrance. It is classified as a cosmetic ingredient in our database. CAS number: 95-48-7.

What is the Margin of Safety for O-Cresol?

adequate 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 O-Cresol?

The NOAEL (No Observed Adverse Effect Level) for O-Cresol is 100 mg/kg bw/day based on a Developmental study via oral route in rabbit. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is O-Cresol classified as hazardous under GHS?

O-Cresol carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed or in contact with skin Causes severe skin burns and eye damage Causes damage to central nervous system and blood Causes damage to the nervous system and the blood through prolonged or repeated exposure 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

Check O-Cresol 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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