NOAEL Data REACH Registered Cosmetic Ingredient

FD&C Red 3

Also known as: Spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one,3',6'-dihydroxy-2',4',5',7'-tetraiodo-, disodium salt, Erythrosine B, Ceplac, E 127, Erythrosine 3 (+15 more)

CAS 16423-68-0

FD&C Red 3 (CAS 16423-68-0) is a chemical substance. Key regulatory status: REACH registered, 11 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, SCCS, ECHA REACH.

View cosmetic safety profile for Erythrosin →

SOURCE NOAEL studies
NOAEL studies
36
SOURCE Chemical inventory jurisdictions
Regulatory lists
11
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 25 fields
Name
FD&C Red 3
CAS Number
16423-68-0
Molecular Formula
C20H8I4O5.2Na
InChI Key
RAGZEDHHTPQLAI-UHFFFAOYSA-L
Monoisotopic Mass
881.6346
Synonyms
Spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one,3',6'-dihydroxy-2',4',5',7'-tetraiodo-, disodium saltErythrosine BCeplacE 127Erythrosine 3Erythrosine E 127Erythrosine Red 3FDC Red 3Food Red 3Japan Food Red No. 3Japan Red 3Japan Red No. 3

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 7 records
DyeSolvent

Regulatory Lists

Inventory, screening, and regulatory list matches from public chemical databases.

SOURCE EPA CPDat 11 records
ListKeywordSource
Europe; Personal care - hair coloringDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal careDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal care - specialized bath products - bath saltsDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal care - specialized bath products - bubble bathDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal care - dental care - toothpasteDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal careDanish Environmental Protection AgencyDanish EPA
inert_ingredient; non_food_use; PesticidesEPACPCat
general_foodsFDAUnited States Food and Drug Administration (FDA)
pharmaceuticalFDAUnited States Food and Drug Administration (FDA)
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)
Canada; consumer_product; Substances in Products - Canada (4/2014)Government of CanadaCPCat

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 36 of 36 studies
ValueUnitEndpointRouteSpeciesSource
<=0.1mg/kgADIoralHumanWHO/JECFA
<=0.1mg/kg bw/dayADI-ConsumersEFSA
8TL7LH93FMUNIIFDA UNII substance identifier--openFDA substances
=1840mg/kg bwLD50oralRatNTP ICE acute oral
>2889mg/kg bwLD50oralRatNTP ICE acute oral
=2891mg/kg bwLD50oralRatNTP ICE acute oral
<2892mg/kg bwLD50oralRatNTP ICE acute oral
=167mg/kg bw/dayLOAELoralPigECHA
=1000mg/kg bw/dayLOAELoralRatECHA
=100mg/kg bw/dayLOELoralMouseToxValDB ECOTOX
0unitlessModel Score--NTP ICE endocrine
=1mg/kg bw/dayNOAELoralHumanEFSA
=1mg/kg bw/dayNOAELoral: capsuleHumanEFSA
=10g/kgNOAELoral: feedDogEFSA
12.5mg/kg bw/dayNOAELoralrabbitCOSMOS DB
=25mg/kg bw/dayNOAELoralMouseECHA
37mg/kg bw/dayNOAELoralmouseCOSMOS DB
57mg/kg bw/dayNOAELoralmouseCOSMOS DB
68mg/kg bw/dayNOAELoralmouseCOSMOS DB
=75mg/kg bw/dayNOAELoralMouseECHA
=125mg/kg bw/dayNOAELoralRatECHA
=125mg/kg bw/dayNOAELoralRatEFSA
=125mg/kg bwNOAELoral: feedRatEFSA
=149mg/kg bw/dayNOAELoralRatECHA
=251mg/kg bw/dayNOAELoralRatECHA
=255mg/kg bw/dayNOAELoralRatECHA
=472mg/kg bw/dayNOAELoralRatECHA
=500mg/kg bw/dayNOAELoralDogECHA
=641mg/kg bw/dayNOAELoralRatECHA
=800mg/kg bw/dayNOAELoralRatECHA
=1000mg/kg bw/dayNOAELoralRatECHA
=1428mg/kg bw/dayNOAELdermalMouseECHA
=1834mg/kg bw/dayNOAELoralMouseECHA
=3750mg/kg bw/dayNOAELoralMouseECHA
=4579mg/kg bw/dayNOAELoralMouseECHA
=10mg/kg bw/dayNOELoralMouseToxValDB ECOTOX

Showing 36 of 36 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA 1 records
StatusNameEC NumberLink
RegisteredDisodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate240-474-8ECHA overview →

Australian Status (AICIS)

Australian industrial chemicals inventory status and applicable conditions.

SOURCE AICIS inventory 1 records
Inventory Status
listed

SCCS Opinions

EU Scientific Committee opinions tied to the matched substance.

SOURCE SCCS Opinion 1 opinions
OpinionDateConclusionMax Conc.Concerns
SCCS/1397/1022 June 2010safe with restrictionsSpecific concentrations in designated productsSynthetic dye; iodine-containing (thyroid effects concern); use restricted to specific product types

Cosmetic Safety Profile

Same-CAS cosmetic ingredient record for cross-vertical context.

SOURCE CosIng / Ingredients DB
EU Status
restricted
Max
0.0025% in toothpaste only
Category
Colorants
View full cosmetic safety profile →

Food Safety Data

Same-CAS food additive, ADI, and GRAS records where available.

SOURCE EFSA 1 records

E127 — ADI: 0.1 mg/kg bw

View full food safety profile →

Cannabis Data

Same-CAS cannabis compliance and lab records where available.

SOURCE Cannabis regulatory / lab data efsa substances

1 cannabis record found in efsa substances.

View full cannabis profile →

Frequently Asked Questions

What is the NOAEL for FD&C Red 3?

FD&C Red 3 has 36 NOAEL studies in the database. The lowest reported value is 0.1 mg/kg via oral in Human. Source: WHO/JECFA.

What regulatory lists include FD&C Red 3?

FD&C Red 3 appears on 10 regulatory/inventory lists including Europe; Personal care - hair coloring, children; Europe; Personal care, children; Europe; Personal care - specialized bath products - bath salts, and 7 more. Source: EPA CPDat.

Is FD&C Red 3 used in cosmetics?

Yes, FD&C Red 3 is also indexed as a cosmetic ingredient under the name Erythrosin. 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 3 come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, ECHA REACH, CosIng / Ingredients DB, EFSA / FDA GRAS, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.

Is FD&C Red 3 used outside industrial chemicals?

FD&C Red 3 also appears in cosmetics, food safety, cannabis databases.