What is the NOAEL for FD&C Red 4?
FD&C Red 4 has 12 NOAEL studies in the database. The lowest reported value is X3W0AM1JLX UNII. Source: openFDA substances.
NOAEL Data
IARC Group 3
REACH Registered
Cosmetic Ingredient
FD&C Red 4
Also known as: C.I. Food Red 1, Ponceau SX, 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 (+15 more)
CAS 4548-53-2
FD&C Red 4 (CAS 4548-53-2) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: REACH registered, 17 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, IARC, ECHA REACH.
View cosmetic safety profile for CI 14700 (FD&C Red No. 4 / Red 4) →
SOURCE
noael studies public
NOAEL studies
12
SOURCE
chemical inventory jurisdictions
Regulatory lists
17
SOURCE
eu clp annex vi
GHS signal
Not classified
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
26 fields
Name
FD&C Red 4
CAS Number
4548-53-2
DTXSID
DTXSID2021234
Molecular Formula
C18H16N2O7S2.2Na
InChI Key
ONTQJDKFANPPKK-UHFFFAOYSA-L
Monoisotopic Mass
482.019432
Synonyms
C.I. Food Red 1Ponceau SXD&C Red No. 43-((2,4-Dimethyl-5-sulfophenyl)azo)-4-hydroxy-1-naphthalenesulfonic acid, disodium salt3-((2,4-Dimethyl-5-sulphophenyl)azo)-4-hydroxy-1-naphthalenesulphonic acid, disodium saltDisodium 3-((2,4-dimethyl-5-sulfophenyl)azo)-4-hydroxy-1-naphthalenesulfonateDisodium 2-(5-sulfo-2,4-xylylazo)-1-naphthol-4-sulfonateDye FD & C Red No. 4Dye FD and C Red No. 4EINECS 224-909-9Ext. D&C Red No. 24FD & C Red No. 4
IARC Carcinogen Classification
Carcinogenic hazard classification from IARC monograph evaluations.
SOURCE
IARC Monographs on the Identification of Carcinogenic Hazards to Humans
1 records
| Group | Meaning | Evaluated | Volume |
|---|---|---|---|
| Group 3 | Not classifiable | 1987 | 8, Sup 7 |
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
34 records
DyeFragrance
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
17 records
| List | Keyword | Source |
|---|---|---|
| IFRA Transparency | IFRA | IFRA |
| inert_ingredient; non_food_use; Pesticides | EPA | CPCat |
| SCIL (9/2019) | USEPA | Safer Chemical Ingredients List |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - specialized bath products - bath salts | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - body hygiene - body wash | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - specialized bath products - bubble bath | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care | European Commission | CosIng |
| Europe; Personal care; restricted | European Commission | CosIng |
| banned; Europe; Personal care | European Commission | CosIng |
| pharmaceutical | FDA | United States Food and Drug Administration (FDA) |
| Personal care | FDA | United States Food and Drug Administration (FDA) |
| food_additive; Substances Added to Food (formerly EAFUS) (2/2019) | FDA | United States Food and Drug Administration (FDA) |
| Canada; Personal care; Substances in PCP - Canada (4/2014) | Government of Canada | CPCat |
| SCIL (9/2019) | USEPA | Safer Chemical Ingredients List |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 12 of 12 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| X3W0AM1JLX | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X3W0AM1JLX | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X3W0AM1JLX | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X3W0AM1JLX | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 3 | IARC group | IARC carcinogenicity classification | - | - | IARC Monographs |
| 3 | unitless | IARC group | - | - | NTP_ICE_cancer |
| >2000 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
| =1.5 | mg/kg bw/day | LOAEL | dermal | Hamster | ToxValDB_ECHA_IUCLID |
| - | unitless | Model Score | - | - | NTP_ICE_endocrine |
| =1.5 | mg/kg bw/day | NOAEL | dermal | Rat | ToxValDB_ECHA_IUCLID |
| =1000 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =1500 | mg/kg bw/day | NOAEL | dermal | Mouse | ToxValDB_ECHA_IUCLID |
Showing 12 of 12 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA (EU)
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate | 224-909-9 | ECHA overview → |
Australian Status (AICIS)
Australian industrial chemicals inventory status and applicable conditions.
SOURCE
AICIS inventory
1 records
Inventory Status
listed
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
permitted
Max
-
Category
Colorants
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
SOURCE
EFSA / FDA GRAS
1 records
E125 — 1 food-safety record found.
View full food safety profile →Frequently Asked Questions
What regulatory lists include FD&C Red 4?
FD&C Red 4 appears on 14 regulatory/inventory lists including IFRA Transparency, inert_ingredient; non_food_use; Pesticides, SCIL (9/2019), and 11 more. Source: EPA CPDat.
Is FD&C Red 4 a carcinogen according to IARC?
FD&C Red 4 is classified by IARC as Group 3 — not classifiable as to its carcinogenicity to humans (evaluated 1987). Source: IARC Monographs on the Identification of Carcinogenic Hazards to Humans.
Is FD&C Red 4 used in cosmetics?
Yes, FD&C Red 4 is also indexed as a cosmetic ingredient under the name CI 14700 (FD&C Red No. 4 / Red 4). View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for FD&C Red 4 come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, IARC Monographs, ECHA REACH, CosIng / Ingredients DB, EFSA / FDA GRAS. All data traces to primary regulatory sources and is updated from official government databases.
Is FD&C Red 4 used outside industrial chemicals?
FD&C Red 4 also appears in cosmetics, food safety databases.