Good Colorant NOAEL Data

D&C Red No. 6

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: D&C RED NO. 6

D&C Red No. 6 (CAS 5858-81-1) is a cosmetic colorant functioning as colorant. 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 data.

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

Auto-generated CPSR Part A draft with source citations
Function
colorant
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
227-497-9

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes Subject to mandatory FDA batch certification per 21 CFR 74.2306. Combined D&C Red No. 6 + No. 7 limit of 5 mg/daily dose applies to drug products. Prohibited in eye-area cosmetics.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for D&C Red No. 6.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for D&C Red No. 6. 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

Additional Ingredient Properties

2 property records from structured ingredient metadata.

hair_dye
{"cas_number": "5858-81-1", "ingredient_class": "direct_dye", "color_index_CI_number": "15850", "chemical_class": "azo", "color_result_on_hair": "Red", "shade_range": "red", "primary_function": "direct_deposit", "requires_developer": "no", "deposit_only": "yes", "permanence": "temporary", "wash_fastness_shampoos": "1-4", "light_fastness": "moderate", "oxidation_mechanism": "direct_absorption", "ha…
pregnancy_detail
{"pregnancy_safe": "insufficient-data", "breastfeeding_safe": "insufficient-data", "risk_category": "not-rated", "reason": "Synthetic dye; limited pregnancy-specific data", "alternative_ingredient": "Mineral colorants", "source": "FDA"}

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 D&C Red No. 6.

Regulatory Flags

batch-certification-required not-for-eye-area azo-dye sccs-reviewed color-additive eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to D&C Red No. 6 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

Frequently Asked Questions

Is D&C Red No. 6 safe in cosmetics?

D&C Red No. 6 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 D&C Red No. 6 allowed in the EU?

D&C Red No. 6 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does D&C Red No. 6 do in cosmetics?

D&C Red No. 6 functions as: colorant. It is classified as a Colorant in our database. CAS number: 5858-81-1.

What is the NOAEL for D&C Red No. 6?

The NOAEL (No Observed Adverse Effect Level) for D&C Red No. 6 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 D&C Red No. 6 used outside cosmetics?

D&C Red No. 6 also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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