Is 4-Amino-M-Cresol safe in cosmetics?
4-Amino-M-Cresol has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 4 toxicological study endpoint(s) are available in our database.
4-Amino-M-Cresol
Also known as: Phenol, 4-amino-3-methyl-, BRN 2078803, EINECS 220-621-2, NSC 72170, UNII-12R07I1K8C (+11 more)
INCI: 4-AMINO-M-CRESOL
4-Amino-M-Cresol (CAS 2835-99-6) is a cosmetic cosmetic ingredient functioning as Oxidative hair dyeing. Reported NOAEL =60 mg/kg in rat (SCCS_vision_codex); EU Regulation 1223/2009 status: prohibited, max 1.5%. 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 2835-99-6 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
4-Amino-M-Cresol is prohibited in EU cosmetics at max 1.5% but has active industrial GHS classifications (H302, H315, H317, H319, H335, H400, H410).
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Oxidative hair dyeing
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
4-amino-3-methylphenol
InChIKey
QGNGOGOOPUYKMC-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
EU Max Conc.
1.5%
US US Status
permitted
US Notes
CIR Panel concluded safe as used in oxidative hair dyes (reassessed 2024). Coal-tar hair dye exemption under FD&C Act applies
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for 4-Amino-M-Cresol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for 4-Amino-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 | =60 mg/kg | oral | rat | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =60 mg/kg | oral | rat | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =60 mg/kg | oral | rat | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =60 mg/kg | oral | rat | repeated dose toxicity | SCCS_vision_codex |
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
74.14%
DPRA Lys %
28.44%
KeratinoSens IC50
67.648 µM
hCLAT CV75
22.7 µg/mL
LLNA EC3
1.8%
NESIL
450 µg/cm²
LLNA: Strong (1A)
GHS: 1A
Source: LLNA: Scientific Committee for Consumer Products (SCCP). Opinion on 4-amino-m-cresol. 2005 Sep 20. COUP A No.: A74; SCCP/0898/05. | Kern et al. (2010); DPRA: Cosmetics Europe | Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]; KS: Cosmetics Europe | Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]; hCLAT: Cosmetics Europe
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
KR Korea MFDS Annex 2 (Restricted)
Category: Restricted. Max: 산화염모제에 1.5%. 기타 제품에는 사용금지
SA Saudi SFDA (III - Restricted)
Product type: (a) Hair dye substance in oxidative hair dye products (b) Products intended for colouring eyelashes.
BRIN Brazil/India Cosmetics
India: Restricted
Additional Jurisdictional Restrictions (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | banned | - | - |
| CN | permitted_hair_dye | 1 | Oxidative hair dye products |
| CN | permitted_hair_dye | 1 | Oxidative hair dye products |
| BR | permitted_hair_dye | - | Oxidative hair dye (4-amino-m-cresol) |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_sccs_opinion | 2.73% | - | - | SCCP/0898 |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
hair_dye
{"cas_number": "2835-99-6", "ingredient_class": "oxidative_dye_coupler", "chemical_class": "para_aminophenol", "molecular_weight_Da": "123.15", "color_result_on_hair": "Red-mahogany", "shade_range": "red", "primary_function": "coupler", "oxidative_dye_type": "coupler", "requires_developer": "yes", "permanence": "permanent", "oxidation_mechanism": "coupling", "coupling_position": "meta", "hair_pene…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (1)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for 4-Amino-M-Cresol.
Regulatory Flags
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to 4-Amino-M-Cresol by CAS number or substance name.
Studies
4
Lowest NOAEL
60 mg/kg
Highest NOAEL
60 mg/kg
SCCS_vision_codex
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 2.73% | SCCS opinion extraction | - |
Known Synonyms
Phenol, 4-amino-3-methyl-
BRN 2078803
EINECS 220-621-2
NSC 72170
UNII-12R07I1K8C
2-Amino-5-hydroxytoluene
2-Methyl-4-hydroxyaniline
3-Methyl-4-aminophenol
4-Amino-3-methylphenol
4-Hydroxy-2-methylaniline
4-Hydroxy-o-toluidine
4-OH-6'-methylalanine
4-hydroxy-6'-methylalanine
p-Amino-m-cresol
p-Hydroxy-o-toluidine
4-hydroxy-6-methylaniline
Chemical Function
Dye
Regulatory Lists
Europe; Personal care; restricted
Canada; Personal care; Substances in PCP - Canada (4/2014)
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
Australian Status
AICIS status: listed
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.
ChEMBL ID
CHEMBL3092390
Frequently Asked Questions
Is 4-Amino-M-Cresol allowed in the EU?
4-Amino-M-Cresol EU regulatory status: prohibited. Maximum allowed concentration: 1.5%. This is based on EU Regulation 1223/2009 and its amendments.
What does 4-Amino-M-Cresol do in cosmetics?
4-Amino-M-Cresol functions as: Oxidative hair dyeing. It is classified as a cosmetic ingredient in our database. CAS number: 2835-99-6.
What is the NOAEL for 4-Amino-M-Cresol?
The NOAEL (No Observed Adverse Effect Level) for 4-Amino-M-Cresol is =60 mg/kg based on a repeated dose toxicity study via oral route in rat. A total of 4 study endpoints are available. Source: SCCS_vision_codex.
Is 4-Amino-M-Cresol used outside cosmetics?
4-Amino-M-Cresol 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 4-Amino-M-Cresol have different safety status in cosmetics vs industrial chemicals?
4-Amino-M-Cresol is prohibited in EU cosmetics at max 1.5% but has active industrial GHS classifications (H302, H315, H317, H319, H335, H400, H410).
Compliance Tools
Check 4-Amino-M-Cresol compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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