Poor Cosmetic Ingredient NOAEL Data GHS Classified

p-Cresol

INCI: P-CRESOL

CAS Number
106-44-5
Function
Fragrance ingredient, denaturant
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.005%
🇺🇸 US Status permitted
US Notes FDA - CIR concluded insufficient data to support safety; no safe-use level established

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

9 study endpoints found for p-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 175 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 50.1 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 144 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
LOAEL 50 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 300 mg/kg bw/day oral mouse Chronic COSMOS_DB
LOAEL 100 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 720 mg/kg bw/day oral rat Chronic 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 Fatal if inhaled 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

Skin and hair depigmentation at 0.5% in mice. CIR could not derive a safe cosmetic use level. Maximum safe-use level is 0.005%. Causes CNS effects at higher doses including tremors and convulsions.

⚠️
Concern Level: High

Regulatory Flags

fragrance-component ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is p-Cresol safe in cosmetics?

Skin and hair depigmentation at 0.5% in mice. CIR could not derive a safe cosmetic use level. Maximum safe-use level is 0.005%. Causes CNS effects at higher doses including tremors and convulsions. The EU classifies p-Cresol as "restricted". Safety rating: POOR. 9 toxicological study endpoint(s) are available in our database.

Is p-Cresol allowed in the EU?

p-Cresol EU regulatory status: restricted. Maximum allowed concentration: 0.005%. This is based on EU Regulation 1223/2009 and its amendments.

What does p-Cresol do in cosmetics?

p-Cresol functions as: Fragrance ingredient, denaturant. It is classified as a cosmetic ingredient in our database. CAS number: 106-44-5.

What is the Margin of Safety for p-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 p-Cresol?

The NOAEL (No Observed Adverse Effect Level) for p-Cresol is 175 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS_DB.

Is p-Cresol classified as hazardous under GHS?

p-Cresol carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed or in contact with skin Fatal if inhaled 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 p-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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