Also known as: EINECS 220-620-7, NSC 322874, UNII-QCG4ES2A26
INCI: 6-AMINO-M-CRESOL
6-Amino-M-Cresol (CAS 2835-98-5) is a cosmetic cosmetic ingredient functioning as Hair colorant (oxidative and non-oxidative/semi-permanent hair dye). Reported NOAEL =50 mg/kg bw/d in rat (SCCS_vision_codex); EU Regulation 1223/2009 status: prohibited; 1 safety opinion reviewed (cir). Industrial safety data is also available in the chemical safety database.
US NotesCIR originally concluded safe; re-opened the assessment after the EU ban. Current status: Insufficient Data Announcement (IDA) — needs method of manufacture data and in vivo genotoxicity studies
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for 6-Amino-M-Cresol.
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Toxicological Studies
10 study endpoints found for 6-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
=50 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=50 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=50 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=50 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
NOAEL
=200 mg/kg bw/d
-
-
NOAEL study
SCCS_vision_codex
NOAEL
=200 mg/kg bw/d
-
-
NOAEL study
SCCS_vision_codex
NOAEL
=200 mg/kg bw/d
-
-
NOAEL study
SCCS_vision_codex
NOAEL
=200 mg/kg bw/d
-
-
NOAEL study
SCCS_vision_codex
NOAEL
=500 mg/kg bw/d
-
rat
genotoxicity
SCCS_vision_codex
NOAEL
=500 mg/kg bw/d
-
rat
genotoxicity
SCCS_vision_codex
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
cirSeptember 28, 2023
Verdict: insufficient data
ata to determine the safety of this ingredient. The Panel concluded that the available data are insufficient to make a determination of safety for 6-Amino-m- Cresol under the intended conditions of use as a hair dye ingredient. INTRODUCTION 6-Amino-m-Cresol, which according to the web-based International
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1643
(EU) 2020/1683
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.
SA Saudi SFDA (II - Prohibited)
BRIN Brazil/India Cosmetics
India: Prohibited (GNRAS)
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (5 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
measured
5.1%
-
-
SCCS/0095
measured
0.59%
in_vitro
-
SCCS/0095
measured
14.25%
-
-
SCCS/0095
measured
74.48%
-
-
SCCS/0095
measured
82.78%
-
-
SCCS/0095
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Expert Verdict
Expert safety assessment and concern-level summary for 6-Amino-M-Cresol.
Canada; Personal care; Substances in PCP - Canada (4/2014)Europe; Personal care - hair coloringdetected; Europe; Personal care - hair coloring - hair color - professionaldetected; Europe; Personal care - hair coloring - hair color - professionaldetected; Europe; Personal care - hair coloringdetected; Europe; Personal care - hair coloring - hair color - professionaldetected; Europe; Personal care - hair coloring - hair color - professionaldetected; Europe; Personal care - hair coloringdetected; Europe; Personal care - hair coloring - hair color - permanentdetected; Europe; Personal care - hair coloring - hair color - professionaldetected; Europe; Personal care - hair coloringdetected; Europe; Personal care - hair coloringdetected; Europe; Personal care - hair coloring
Australian Status
AICIS status:listed
Frequently Asked Questions
Is 6-Amino-M-Cresol safe in cosmetics?
6-Amino-M-Cresol has a safety rating of "POOR" in our database. EU status: prohibited. US status: restricted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
Is 6-Amino-M-Cresol allowed in the EU?
6-Amino-M-Cresol EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does 6-Amino-M-Cresol do in cosmetics?
6-Amino-M-Cresol functions as: Hair colorant (oxidative and non-oxidative/semi-permanent hair dye). It is classified as a cosmetic ingredient in our database. CAS number: 2835-98-5.
What is the NOAEL for 6-Amino-M-Cresol?
The NOAEL (No Observed Adverse Effect Level) for 6-Amino-M-Cresol is =50 mg/kg bw/d based on a repeated dose toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
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