NOAEL Data IARC Group 3 REACH Registered Cosmetic Ingredient

FD&C Blue No. 1

Also known as: FD & C Blue No. 1 (Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt), Aizen Food Blue No. 2, Brilliant Blue FCF Supra, Canacert Brilliant Blue FCF, Cosmetic Blue Lake (+15 more)

CAS 3844-45-9

FD&C Blue No. 1 (CAS 3844-45-9) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: REACH registered, 21 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, IARC, ECHA REACH.

View cosmetic safety profile for FD&C Blue No. 1 (CI 42090) →

SOURCE NOAEL studies

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 25 fields

Name

FD&C Blue No. 1

CAS Number

3844-45-9

Molecular Formula

C37H36N2O9S3.2Na

InChI Key

SGHZXLIDFTYFHQ-UHFFFAOYSA-L

Monoisotopic Mass

794.137833

Synonyms

FD & C Blue No. 1 (Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt)Aizen Food Blue No. 2Brilliant Blue FCF SupraCanacert Brilliant Blue FCFCosmetic Blue LakeEINECS 223-339-8FD & C Blue No. 1FDC Blue No. 1Fenazo Blue XIFood Blue Dye No. 1Hexacol Brilliant Blue AIntracid Pure Blue L

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	16, Sup 7

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 60 records

DyeFragrance

Regulatory Lists

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

SOURCE EPA CPDat 21 records

List	Keyword	Source
Europe; Personal care - hair coloring	Danish Environmental Protection Agency	Danish EPA
Europe; Personal care - hair coloring	Danish Environmental Protection Agency	Danish EPA
IFRA Transparency	IFRA	IFRA
inert_ingredient; non_food_use; Pesticides	EPA	CPCat
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 - hair styling and care - shampoo	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
children; Europe; Personal care	Danish Environmental Protection Agency	Danish EPA
Europe; Personal care	Danish Environmental Protection Agency	Danish EPA
Europe; Personal care	Danish Environmental Protection Agency	Danish EPA
Arts and crafts/Office supplies - body paint - tattoo ink; Europe	Danish Environmental Protection Agency	Danish EPA
general_foods	FDA	United States Food and Drug Administration (FDA)
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)
SCIL (9/2019)	USEPA	Safer Chemical Ingredients List
Arts and crafts/Office supplies - body paint - tattoo ink; Europe	Danish Environmental Protection Agency	Danish EPA

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 41 of 41 studies

Value	Unit	Endpoint	Route	Species	Source
=0.414	mg/kg	-	-	rat	Regulatory source
9000	mg/kg bw/day	-	oral	rat	Regulatory source
12.79	uM	AC50	-	-	NTP ICE endocrine
15.17	uM	ACC	-	-	NTP ICE endocrine
range:0-55	mg/kg bw/day	ADI	oral	Human; Rat	WHO/JECFA
<=6	mg/kg	ADI	oral	Human	WHO/JECFA
range:0-66	mg/kg bw/day	ADI	-	-	WHO/JECFA
=6	mg/kg bw/day	ADI	-	Consumers	EFSA
=12	mg/kg bw/day	ADI	oral	-	WHO/JECFA
range:0-12.512.5	mg/kg bw/day	ADI	oral	Rat	WHO/JECFA
range:0-2525	mg/kg bw/day	ADI	-	Rat	WHO/JECFA
range:0-3030	mg/kg bw/day	ADI	-	-	WHO/JECFA
=100	mg/L	ADI	oral	-	WHO/JECFA
=106	mg/m3	DNEL systemic	inhalation	Human	ToxValDB GESTIS DNEL
H3R47K3TBD	UNII	FDA UNII substance identifier	-	-	openFDA substances
PPQ093M8HR	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
=5	%	LOEL	oral	Rat	ToxValDB ECOTOX
0	unitless	Model Score	-	-	NTP ICE endocrine
0.107	unitless	Model Score	-	-	NTP ICE endocrine
=0.414	mg/kg	NOAEL	-	rat	SCCNFP Opinion
=5	%	NOAEL	oral	rat	SCCNFP Opinion
=50	mg/kg bw/day	NOAEL	oral	Human; Rat	WHO/JECFA
200	mg/kg bw/day	NOAEL	oral	rabbit	COSMOS DB
=200	mg/kg bw/day	NOAEL	-	-	WHO/JECFA
250	mg/kg bw/day	NOAEL	oral	mouse	COSMOS DB
=300	mg/kg bw/d	NOAEL	-	rat	SCCNFP Opinion
=330	mg/kg bw/day	NOAEL	-	Dog	WHO/JECFA
=338	mg/kg bw/day	NOAEL	-	-	WHO/JECFA
=600	mg/kg bw/day	NOAEL	oral	-	WHO/JECFA
=630	mg/kg bw/day	NOAEL	oral	rat	SCCNFP Opinion
=631	mg/kg bw/day	NOAEL	oral	Rat	EFSA
=631	mg/kg bw/day	NOAEL	oral: feed	Rat	EFSA
=631	mg/kg bw/day	NOAEL	-	Rat	WHO/JECFA
=631	mg/kg bw/day	NOAEL	oral	rat	SCCNFP Opinion
=631	mg/kg	NOAEL	oral	rat	SCCNFP Opinion
=647	mg/kg bw/day	NOAEL	-	Rat	WHO/JECFA
=691	mg/kg bw/day	NOAEL	oral	-	WHO/JECFA
=696	mg/kg bw/day	NOAEL	-	-	WHO/JECFA

Showing 41 of 41 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA 1 records

Status	Name	EC Number	Link
Registered	Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt	223-339-8	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

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed CHEMBL3184128

ChEMBL Phase

Not listed

Adverse Events

Bioactivity

View full pharmaceutical profile →

Food Safety Data

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

SOURCE EFSA 1 records

E133 — ADI: 6 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 Blue No. 1?

FD&C Blue No. 1 has 41 NOAEL studies in the database. The lowest reported value is 0 unitless. Source: NTP ICE endocrine.

What regulatory lists include FD&C Blue No. 1?

FD&C Blue No. 1 appears on 16 regulatory/inventory lists including Europe; Personal care - hair coloring, IFRA Transparency, inert_ingredient; non_food_use; Pesticides, and 13 more. Source: EPA CPDat.

Is FD&C Blue No. 1 a carcinogen according to IARC?

FD&C Blue No. 1 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 Blue No. 1 used in cosmetics?

Yes, FD&C Blue No. 1 is also indexed as a cosmetic ingredient under the name FD&C Blue No. 1 (CI 42090). 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 Blue No. 1 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, ChEMBL / DailyMed, EFSA / FDA GRAS, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.

Is FD&C Blue No. 1 used outside industrial chemicals?

FD&C Blue No. 1 also appears in cosmetics, pharmaceutical, food safety, cannabis databases.