Good Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

Basic Yellow 57

Also known as: 3-((4,5-Dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo)-N,N,- N-trimethylbenzenaminium chloride

INCI: BASIC YELLOW 57

Basic Yellow 57 (CAS 68391-31-1) is a cosmetic cosmetic ingredient functioning as Hair dyeing (semi-permanent cationic dye). Reported NOAEL =20 mg/kg (SCCNFP_vision_codex); EU Regulation 1223/2009 status: restricted; 5 safety opinions reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 68391-31-1 →

Auto-generated CPSR Part A draft with source citations
Function
Hair dyeing (semi-permanent cationic dye)
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
269-943-5

Regulatory Status

EU EU Status restricted
US US Status permitted
US Notes CIR Expert Panel concluded safe for use as a hair dye at present practices of use and concentration

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Basic Yellow 57.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for Basic Yellow 57. 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 =20 mg/kg dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =20 mg/kg dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =20 mg/kg dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =20 mg/kg dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =50 mg/kg bw/day oral rat irritation SCCNFP_vision_codex
NOAEL =50 mg/kg bw/day oral rat irritation SCCNFP_vision_codex
NOAEL =50 mg/kg bw/day oral rat irritation SCCNFP_vision_codex
NOAEL =50 mg/kg bw/day oral rat irritation SCCNFP_vision_codex

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: safe
NOAEL: 300 mg/kg bw/d (not specified)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 20 mg/kg bw/d (oral)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 300 mg/kg/d (oral)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 20 mg/kg (oral)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

cir
Verdict: safe
NOAEL: 100 mg/kg bw/d (not specified)

data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 57 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safet

Sensitization Profile

Contact sensitization data for Basic Yellow 57 based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: IVDK; NACDG; ESSCA

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.

SA Saudi SFDA (III - Restricted)
Product type: Hair dye substance in non-oxidative hair dye products. Max: 2,0%.
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 2.0%
BRIN Brazil/India Cosmetics
India: Restricted · max 2,0%
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
CN permitted_hair_dye 2 Non-oxidative hair dye (direct)

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 7.87% - - 2010-03-23

Additional Ingredient Properties

2 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "dye", "cross_reactivity_group": "para-amino-group", "patch_test_frequency_pct": "0.1", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "IVDK; NACDG; ESSCA"}
hair_dye
{"cas_number": "68391-31-1", "ingredient_class": "direct_dye", "color_index_CI_number": "12719", "chemical_class": "azo", "color_result_on_hair": "Yellow", "shade_range": "blonde", "primary_function": "direct_deposit", "requires_developer": "no", "deposit_only": "yes", "permanence": "semi_permanent", "wash_fastness_shampoos": "8-15", "light_fastness": "moderate", "oxidation_mechanism": "direct_abs…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (2)
EU Restricted for Children (Cosmetics) EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Basic Yellow 57.

Regulatory Flags

eu_children_restricted eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Basic Yellow 57 by CAS number or substance name.

Studies
8
Lowest NOAEL
20
Highest NOAEL
50

Units vary across source rows: mg/kg, mg/kg bw/day

SCCNFP_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
7.87% SCCS opinion extraction -

Known Synonyms

3-((4,5-Dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo)-N,N,- N-trimethylbenzenaminium chloride

Chemical Function

Dye

Regulatory Lists

Canada; Personal care; Substances in PCP - Canada (4/2014) children; Europe; Personal care children; Europe; Personal care Europe; Personal care - hair coloring Europe; Personal care - hair coloring Europe; Personal care - hair coloring Europe; Personal care; restricted

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Basic Yellow 57 safe in cosmetics?

Basic Yellow 57 has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 8 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Basic Yellow 57 allowed in the EU?

Basic Yellow 57 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Basic Yellow 57 do in cosmetics?

Basic Yellow 57 functions as: Hair dyeing (semi-permanent cationic dye). It is classified as a cosmetic ingredient in our database. CAS number: 68391-31-1.

What is the NOAEL for Basic Yellow 57?

The NOAEL (No Observed Adverse Effect Level) for Basic Yellow 57 is =20 mg/kg based on a repeated dose toxicity study via dermal route in rat. A total of 8 study endpoints are available. Source: SCCNFP_vision_codex.

Is Basic Yellow 57 used outside cosmetics?

Basic Yellow 57 also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Basic Yellow 57 have different safety status in cosmetics vs industrial chemicals?

Basic Yellow 57 is classified GHS CMR hazard (H361d) in the chemicals database but is restricted in EU cosmetics.

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