Is Ponceau SX safe in cosmetics?
Ponceau SX has a safety rating of "POOR" in our database. EU status: prohibited. US status: restricted. 3 toxicological study endpoint(s) are available in our database.
Ponceau SX
Also known as: C.I. Food Red 1, D&C Red No. 4, 3-((2,4-Dimethyl-5-sulfophenyl)azo)-4-hydroxy-1-naphthalenesulfonic acid, disodium salt, 3-((2,4-Dimethyl-5-sulphophenyl)azo)-4-hydroxy-1-naphthalenesulphonic acid, disodium salt, Disodium 3-((2,4-dimethyl-5-sulfophenyl)azo)-4-hydroxy-1-naphthalenesulfonate (+14 more)
INCI: PONCEAU SX
Ponceau SX (CAS 4548-53-2) is a cosmetic cosmetic ingredient functioning as Colorant (monoazo dye). Reported NOAEL =1.5 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: prohibited. 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 4548-53-2 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Ponceau SX is prohibited in EU cosmetics but has active industrial GHS classifications.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word
Function
Colorant (monoazo dye)
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
disodium;3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate
InChIKey
ONTQJDKFANPPKK-UHFFFAOYSA-L
Regulatory Status
EU EU Status
prohibited
US US Status
restricted
US Notes
FD&C Red No. 4 — restricted to externally applied drugs and cosmetics only; prohibited in food, lip products, and eye-area products
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Ponceau SX.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for Ponceau SX. 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 | =1.5 mg/kg bw/day | dermal | Rat | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =1500 mg/kg bw/day | dermal | Mouse | reproduction developmental | ToxValDB_ECHA_IUCLID |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
8, Sup 7
Evaluation Year
1987
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1341
(EC) 2013/344
Annex IV — Permitted Colorants
Product type: Red
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)
ASEAN Cosmetic Directive (II)
Ref: 1341
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
India: Permitted Colorant
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Carcinogen Classification
Ponceau SX | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 8: (1975) Some Aromatic Azo Compounds | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print)
Source: International Agency for Research on Cancer (IARC)
Regulatory (1)
JECFA Evaluation
PONCEAU SX | 1980 | NO ADI ALLOCATED | A multigeneration reproduction/teratology study and studies in dogs requested by JECFA at its 21st meeting were not available. Therefore no ADO could be established. | TRS 653-JECFA 24/20 | FAS 12-JECFA 21/90 (1977)
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Fragrance
Regulatory List Membership (7)
EU Banned in Cosmetics
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Ponceau SX.
Regulatory Flags
colorant
eu_banned_cosmetics
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
eu_cosing_listed
jecfa_concern
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Ponceau SX by CAS number or substance name.
Studies
3
Lowest NOAEL
1.5 mg/kg bw/day
Highest NOAEL
1500 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
C.I. Food Red 1
D&C Red No. 4
3-((2,4-Dimethyl-5-sulfophenyl)azo)-4-hydroxy-1-naphthalenesulfonic acid, disodium salt
3-((2,4-Dimethyl-5-sulphophenyl)azo)-4-hydroxy-1-naphthalenesulphonic acid, disodium salt
Disodium 3-((2,4-dimethyl-5-sulfophenyl)azo)-4-hydroxy-1-naphthalenesulfonate
Disodium 2-(5-sulfo-2,4-xylylazo)-1-naphthol-4-sulfonate
Dye FD & C Red No. 4
Dye FD and C Red No. 4
EINECS 224-909-9
Ext. D&C Red No. 24
FD & C Red No. 4
FD&C Red No. 4 - Aluminium Lake
4-Hydroxy-3-((5-sulfo-2,4-xylyl)azo)-1-naphthalenesulfonic acid, disodium salt
4-Hydroxy-3-((5-sulpho-2,4-xylyl)azo)-1-naphthalenesulphonic acid, disodium salt
Maple Ponceau SX
Ponceau SX Lake
Red Lake 89865N
Red shade #24
2-(6-Sulfo-2,4-xylylazo)-1-naphthol-4-sulfonic acid, disodium salt
Chemical Function
Dye
Fragrance
Regulatory Lists
IFRA Transparency
inert_ingredient; non_food_use; Pesticides
SCIL (9/2019)
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - body hygiene - body wash
children; Europe; Personal care - specialized bath products - bubble bath
children; Europe; Personal care
children; Europe; Personal care
Europe; Personal care
Europe; Personal care; restricted
banned; Europe; Personal care
pharmaceutical
Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; Personal care; Substances in PCP - Canada (4/2014)
SCIL (9/2019)
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
Ponceau SX / Scarlet GN
E Number
E125
Food Category
colorant
Frequently Asked Questions
Is Ponceau SX allowed in the EU?
Ponceau SX EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Ponceau SX do in cosmetics?
Ponceau SX functions as: Colorant (monoazo dye). It is classified as a cosmetic ingredient in our database. CAS number: 4548-53-2.
What is the NOAEL for Ponceau SX?
The NOAEL (No Observed Adverse Effect Level) for Ponceau SX is =1.5 mg/kg bw/day based on a chronic study via dermal route in Rat. A total of 3 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Ponceau SX used outside cosmetics?
Ponceau SX 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.
Does Ponceau SX have different safety status in cosmetics vs industrial chemicals?
Ponceau SX is prohibited in EU cosmetics but has active industrial GHS classifications.
Compliance Tools
Check Ponceau SX 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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