NOAEL Data IARC Group 3 REACH Registered Cosmetic Ingredient

Azorubine

Also known as: C.I. food Red 3, C.I. Acid Red 14, disodium salt, C.I. 14720, 1-Naphthalenesulfonic acid, 4-hydroxy-3-[2-(4-sulfo-1-naphthalenyl)diazenyl]-, sodium salt (1:2), C.I. Acid Red No. 14 (+15 more)

CAS 3567-69-9

Azorubine (CAS 3567-69-9) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: REACH registered, 5 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, IARC, ECHA REACH.

View cosmetic safety profile for CI 14720 (Carmoisine / Azorubine) →

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

Azorubine

CAS Number

3567-69-9

DTXSID

DTXSID3021225

Molecular Formula

C20H14N2O7S2.2Na

InChI Key

YSVBPNGJESBVRM-UHFFFAOYSA-L

Monoisotopic Mass

504.003782

Synonyms

C.I. food Red 3C.I. Acid Red 14, disodium saltC.I. 147201-Naphthalenesulfonic acid, 4-hydroxy-3-[2-(4-sulfo-1-naphthalenyl)diazenyl]-, sodium salt (1:2)C.I. Acid Red No. 14omega Chrome Blue FBL. Red Z 3040Acetacid Red BAcid brilliant rubine 2gtAcid Brilliant Rubine 2GAcid Chrome Blue 2RAcid Chrome Blue BA

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 39 records

DyeFragrance

Regulatory Lists

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

SOURCE EPA CPDat 5 records

List	Keyword	Source
IFRA Transparency	IFRA	IFRA
inert_ingredient; non_food_use; Pesticides	EPA	CPCat
SCIL (9/2019)	USEPA	Safer Chemical Ingredients List
Europe; Personal care	European Commission	CosIng
SCIL (9/2019)	USEPA	Safer Chemical Ingredients List

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 28 of 28 studies

Value	Unit	Endpoint	Route	Species	Source
<=4	mg/kg	ADI	oral	Human	ToxValDB_WHO_JECFA_ADI
range:0-4.04	mg/kg bw/day	ADI	-	-	INCHEM_WHO_jecfa_jecmono_v18je03
<=4	mg/kg bw/day	ADI	-	Consumers	EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx
<=4	mg/kg bw/day	ADI	-	Consumers	EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx
range:0-4.04	mg/kg bw/day	ADI	-	-	INCHEM_WHO_jecfa_jecmono_v18je03
DR4641L47F	UNII	FDA UNII substance identifier	-	-	openFDA substances
DR4641L47F	UNII	FDA UNII substance identifier	-	-	openFDA substances
DR4641L47F	UNII	FDA UNII substance identifier	-	-	openFDA substances
DR4641L47F	UNII	FDA UNII substance identifier	-	-	openFDA substances
3	IARC group	IARC carcinogenicity classification	-	-	IARC Monographs
3	unitless	IARC group	-	-	NTP_ICE_cancer
>10000	mg/kg bw	LD50	oral	Rat	NTP_ICE_acute_oral
=375	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_EFSA
=375	mg/kg bw/day	NOAEL	-	Mouse	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=375	mg/kg bw/day	NOAEL	-	Mouse	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=400	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=400	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_EFSA
=400	mg/kg bw/day	NOAEL	-	Rat	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=400	mg/kg bw/day	NOAEL	-	Rat	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=486	mg/kg bw/day	NOAEL	dermal	Mouse	ToxValDB_ECHA_IUCLID
=625	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=1000	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
=1200	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=1250	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=1785.7	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
6000	ppm	Top dose	Dosed feed	Mouse	NTP_ICE_cancer
12500	ppm	Top dose	Dosed feed	Rat	NTP_ICE_cancer
25000	ppm	Top dose	Dosed feed	Rat	NTP_ICE_cancer

Showing 28 of 28 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA (EU) 1 records

Status	Name	EC Number	Link
Registered	Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate	222-657-4	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 EMBL-EBI ChEMBL AZORUBINE

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 / FDA GRAS 1 records

E122 — ADI: 4 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 Azorubine?

Azorubine has 28 NOAEL studies in the database. The lowest reported value is 4 mg/kg via oral in Human. Source: ToxValDB_WHO_JECFA_ADI.

What regulatory lists include Azorubine?

Azorubine appears on 4 regulatory/inventory lists including IFRA Transparency, inert_ingredient; non_food_use; Pesticides, SCIL (9/2019), and 1 more. Source: EPA CPDat.

Is Azorubine a carcinogen according to IARC?

Azorubine 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 Azorubine used in cosmetics?

Yes, Azorubine is also indexed as a cosmetic ingredient under the name CI 14720 (Carmoisine / Azorubine). 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 Azorubine 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 Azorubine used outside industrial chemicals?

Azorubine also appears in cosmetics, pharmaceutical, food safety, cannabis databases.