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.
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 Opinion); 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.
Function
colorant
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
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 Opinion |
| NOAEL | =150 mg/kg | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =150 mg/kg bw/day | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =150 mg/kg | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =150 mg/kg bw/day | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =150 mg/kg | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =150 mg/kg bw/day | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =150 mg/kg | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | = mg/kg bw/day | oral | dog | NOAEL study | SCCS Opinion |
| NOAEL | = mg/kg bw/day | oral | dog | NOAEL study | SCCS Opinion |
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 |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Pigment
Regulatory List Membership (1)
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for D&C Red No. 6 — not a computed safety verdict. See the sourced toxicological data above.
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 Opinion
SCCNFP Opinion
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
Frequently Asked Questions
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 Opinion.
Is D&C Red No. 6 used outside cosmetics?
D&C Red No. 6 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.
Compliance Tools
Check D&C Red No. 6 compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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
Compare limits across jurisdictions
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