Good Cosmetic Ingredient NOAEL Data

Pigment Red 57

Also known as: Disodium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]naphthalene-2-carboxylate, C.I. Pigment Red 57, disodium salt, C.I. 15850, D&c red no.6, EINECS 227-497-9 (+7 more)

INCI: CI 15850

Pigment Red 57 (CAS 5858-81-1) is a cosmetic cosmetic ingredient functioning as Colorant (monoazo sulfonated pigment); also used as semi-permanent hair dye at. Reported NOAEL =150 mg/kg bw/day in rat (SCCNFP_vision_codex); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and food safety data.

View industrial chemical safety profile for CAS 5858-81-1 →

Auto-generated CPSR Part A draft with source citations
Function
Colorant (monoazo sulfonated pigment); also used as semi-permanent hair dye at ≤0.4%
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
227-497-9

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes D&C Red No. 6 — general use including lipstick + external use; not for eye area

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Pigment Red 57.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Pigment Red 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 =150 mg/kg bw/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =150 mg/kg oral rat reproductive toxicity SCCNFP_vision_codex
NOAEL =150 mg/kg bw/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =150 mg/kg oral rat reproductive toxicity SCCNFP_vision_codex
NOAEL =150 mg/kg bw/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =150 mg/kg oral rat reproductive toxicity SCCNFP_vision_codex
NOAEL =150 mg/kg bw/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =150 mg/kg oral rat reproductive toxicity SCCNFP_vision_codex
NOAEL = mg/kg bw/day oral dog NOAEL study SCCS_vision_codex
NOAEL = mg/kg bw/day oral dog NOAEL study SCCS_vision_codex

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: 0,4 %.
BRIN Brazil/India Cosmetics
India: Restricted · max 0,4 %
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
CN permitted_colorant - All cosmetics (Class 1)

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 0.007% - - SCCS/1411/11

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Lipstick 1–10 20 CIR/VCRP

Additional Ingredient Properties

2 property records from structured ingredient metadata.

colorant
{"Common_Name": "D&C Red No. 7", "Chemical_Name": "Lithol Rubin B Ca", "CAS_Number": "5281-04-9", "Colorant_Type": "Synthetic Lake", "Approved_Uses": "Lipstick, external cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Not approved", "US_FDA_Status": "Approved 21 CFR 74.307", "Notes": "US only, calcium salt"}
colorant_formulator
{"ci_number": "15850", "ci_name": "Pigment Red 7", "color_category": "red", "color_hex_code": "#EA4335", "natural_or_synthetic": "synthetic", "organic_or_inorganic": "organic", "lake_or_dye": "pigment", "fda_approved_use": "general", "eu_approved_cosmetic": "yes", "japan_approved": "yes", "china_approved": "yes", "coverage_opacity": "semi_opaque", "tinting_strength": "very_high", "lightfastness_ra…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye Pigment
Regulatory List Membership (1)
EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Pigment Red 57.

Regulatory Flags

colorant eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Pigment Red 57 by CAS number or substance name.

Studies
28
Lowest NOAEL
0
Highest NOAEL
150

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

SCCS_vision_codex SCCNFP_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.007% SCCS PDF direct extraction -

Known Synonyms

Disodium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]naphthalene-2-carboxylate C.I. Pigment Red 57, disodium salt C.I. 15850 D&c red no.6 EINECS 227-497-9 Japan Red 201 Cerven pigment 57 UNII-481744AI4O FD&C Red No. 6 disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate EC No.: 227-497-9 227-497-9

Chemical Function

Pigment Dye

Regulatory Lists

Arts and crafts/Office supplies - body paint; detected; Europe Arts and crafts/Office supplies - body paint; detected; Europe pharmaceutical Personal care Europe; Personal care; restricted

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in food safety data.

SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
D&C Red 6 (Lithol Rubine B)
Food Category
colorant
View full food safety profile →

Frequently Asked Questions

Is Pigment Red 57 safe in cosmetics?

Pigment Red 57 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.

Is Pigment Red 57 allowed in the EU?

Pigment Red 57 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Pigment Red 57 do in cosmetics?

Pigment Red 57 functions as: Colorant (monoazo sulfonated pigment); also used as semi-permanent hair dye at ≤0.4%. It is classified as a cosmetic ingredient in our database. CAS number: 5858-81-1.

What is the NOAEL for Pigment Red 57?

The NOAEL (No Observed Adverse Effect Level) for Pigment Red 57 is =150 mg/kg bw/day based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCNFP_vision_codex.

Is Pigment Red 57 used outside cosmetics?

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

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Good Similar safety
Antioxidant
CI 15630
Good Chemical family
Colorant (red)
CI 15850
Good Chemical family
Colorant (red)
CI 15850 Red 7 Lake
Good Chemical family
Colorant

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