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 public

NOAEL studies

SOURCE chemical inventory jurisdictions

Regulatory lists

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 3

CAS Number

16423-68-0

DTXSID

DTXSID7021233

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

List	Keyword	Source
Europe; Personal care - hair coloring	Danish Environmental Protection Agency	Danish EPA
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 - specialized bath products - bubble bath	Danish Environmental Protection Agency	Danish EPA
children; Europe; Personal care - dental care - toothpaste	Danish Environmental Protection Agency	Danish EPA
children; Europe; Personal care	Danish Environmental Protection Agency	Danish EPA
inert_ingredient; non_food_use; Pesticides	EPA	CPCat
general_foods	FDA	United States Food and Drug Administration (FDA)
pharmaceutical	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; consumer_product; Substances in Products - Canada (4/2014)	Government of Canada	CPCat

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 40 of 40 studies

Value	Unit	Endpoint	Route	Species	Source
<=0.1	mg/kg	ADI	oral	Human	ToxValDB_WHO_JECFA_ADI
<=0.1	mg/kg bw/day	ADI	-	Consumers	EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx
<=0.1	mg/kg bw/day	ADI	-	Consumers	EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx
8TL7LH93FM	UNII	FDA UNII substance identifier	-	-	openFDA substances
8TL7LH93FM	UNII	FDA UNII substance identifier	-	-	openFDA substances
8TL7LH93FM	UNII	FDA UNII substance identifier	-	-	openFDA substances
8TL7LH93FM	UNII	FDA UNII substance identifier	-	-	openFDA substances
=1840	mg/kg bw	LD50	oral	Rat	NTP_ICE_acute_oral
>2889	mg/kg bw	LD50	oral	Rat	NTP_ICE_acute_oral
=2891	mg/kg bw	LD50	oral	Rat	NTP_ICE_acute_oral
<2892	mg/kg bw	LD50	oral	Rat	NTP_ICE_acute_oral
=167	mg/kg bw/day	LOAEL	oral	Pig	ToxValDB_ECHA_IUCLID
=1000	mg/kg bw/day	LOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=100	mg/kg bw/day	LOEL	oral	Mouse	ToxValDB_ECOTOX
-	unitless	Model Score	-	-	NTP_ICE_endocrine
=1	mg/kg bw/day	NOAEL	oral	Human	ToxValDB_EFSA
=1	mg/kg bw/day	NOAEL	oral: capsule	Human	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=10	g/kg	NOAEL	oral: feed	Dog	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
12.5	mg/kg bw/day	NOAEL	oral	rabbit	COSMOS_DB
=25	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
37	mg/kg bw/day	NOAEL	oral	mouse	COSMOS_DB
57	mg/kg bw/day	NOAEL	oral	mouse	COSMOS_DB
68	mg/kg bw/day	NOAEL	oral	mouse	COSMOS_DB
=75	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
=125	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=125	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_EFSA
=125	mg/kg bw	NOAEL	oral: feed	Rat	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=149	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=251	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=255	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=472	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=500	mg/kg bw/day	NOAEL	oral	Dog	ToxValDB_ECHA_IUCLID
=641	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=800	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=1000	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=1428	mg/kg bw/day	NOAEL	dermal	Mouse	ToxValDB_ECHA_IUCLID
=1834	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
=3750	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
=4579	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
=10	mg/kg bw/day	NOEL	oral	Mouse	ToxValDB_ECOTOX

Showing 40 of 40 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA (EU) 1 records

Status	Name	EC Number	Link
Registered	Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate	240-474-8	ECHA 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 EU SCCS 1 opinions

Opinion	Date	Conclusion	Max Conc.	Concerns
SCCS/1397/10	22 June 2010	safe with restrictions	Specific concentrations in designated products	Synthetic 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

Food Safety Data

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

SOURCE EFSA / FDA GRAS 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 40 NOAEL studies in the database. The lowest reported value is 0.1 mg/kg via oral in Human. Source: ToxValDB_WHO_JECFA_ADI.

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.