Poor Cosmetic Ingredient NOAEL Data GHS Classified

O-Cresol

Also known as: 2-Methylphenol, EINECS 202-423-8, FEMA No. 3480, UNII-YW84DH5I7U, 2-cresol (+2 more)

INCI: O-CRESOL

O-Cresol (CAS 95-48-7) is a cosmetic cosmetic ingredient functioning as Denaturant, fragrance. NOAEL 10 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted; 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 95-48-7 →

Auto-generated CPSR Part A draft with source citations

Cross-Vertical Regulatory Divergence

O-Cresol is classified GHS Danger (H301, H311, H314, H412, H318, H335, H361, H372) in the chemicals database but is restricted in EU cosmetics.

Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code

CAS Number

95-48-7

View industrial chemical safety profile →

Function

Denaturant, fragrance

Safety Rating

POOR

Chemistry & Identifiers

Formula

C7H8O

108.14 g/mol

EC Number

202-423-8

PubChem CID

335

IUPAC Name

2-methylphenol

InChIKey

QWVGKYWNOKOFNN-UHFFFAOYSA-N

ChEBI: CHEBI:28054 UNII: YW84DH5I7U Wikidata: Q312708

Regulatory Status

EU EU Status restricted

US US Status permitted

US Notes CIR/SCCS Review

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for O-Cresol.

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	434 mg/kg bw/day	oral	rat	Developmental	COSMOS_DB
NOAEL	=240 mg/kg diet	oral	-	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168
NOAEL	=240 mg/kg diet	oral	-	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168
NOAEL	=778 mg/kg diet	oral	-	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168
NOAEL	=778 mg/kg diet	oral	-	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168
NOAEL	=1250 mg/kg diet	oral	Mouse	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168
NOAEL	=1250 mg/kg diet	oral	Mouse	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168
NOAEL	=3750 mg/kg diet	oral	Rat	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168
NOAEL	=3750 mg/kg diet	oral	Rat	Toxicology study	INCHEM_WHO_ehc_ehc_ehc168

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word

DANGER

Pictograms

CorrSkullToxicCancerHealth 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.

Pre-Calculated Safety Assessment

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

ECHA REACH Registration

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

Registration Type

Full

Tonnage Band

10,000 - 100,000 tonnes

Substance Type

SUBSTANCE

SVHC Candidate

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: 108.1

Log Kow: 1.95

Log Kp: -1.8017278360175935

Log Jmax: -5.44

Source: Roberts_Cheruvu_Mendeley_2022

PubChem Annotations

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

Safety (4)

Carcinogen Classification

No indication of carcinogenicity to humans (not listed by IARC).

Source: Toxin and Toxin Target Database (T3DB)

Evidence for Carcinogenicity

CLASSIFICATION: C; possible human carcinogen. BASIS FOR CLASSIFICATION: Based on an increased incidence of skin papillomas in mice in an initiation-promotion study. The three cresol isomers produced positive results in genetic toxicity studies both alone and in combination. HUMAN CARCINOGENICITY DATA: Inadequate. ANIMAL CARCINOGENICITY DATA: Limited. | A4: Not classifiable as a human carcinogen. /

Source: Hazardous Substances Data Bank (HSDB)

ICSC Safety Card

0030

Source: ILO-WHO International Chemical Safety Cards (ICSCs)

Skin Eye Respiratory Irritation

Vapors cause irritation of eyes, nose, and throat. | Corrosive. Causes severe eye and skin burns. May be harmful if absorbed through skin or inhaled. Irritating to skin, eyes, and respiratory system. Symptoms include severe irritation of eyes with tearing, conjunctivitis, and corneal edema. May act as a skin sensitizer. | o-Cresol is a respiratory irritant in humans. Eight of 10 subjects exposed t

Source: Hazardous Substances Data Bank (HSDB)

Regulatory (6)

JECFA Number

691