NOAEL Data IARC Group 3 REACH Registered Cosmetic Ingredient

FD&C Green No. 3

Also known as: FD & C green No. 3 (C.I. Food Green 3, disodium salt), Aizen Food Green No. 3, Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-C, EINECS 219-091-5, FD & C Green No. 3 (+5 more)

CAS 2353-45-9

FD&C Green No. 3 (CAS 2353-45-9) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: REACH registered, 13 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, IARC, ECHA REACH.

View cosmetic safety profile for Fast Green FCF →

Cross-Vertical Regulatory Divergence

FD&C Green No. 3 is classified GHS CMR hazard (H315, H319, H335, H341, H412) in the chemicals database but is restricted in EU cosmetics at max Prohibited as hair dye (Annex II Entry 1357); no maximum concentration for general colorant use.

SOURCE Cross-vertical comparison Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code

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 15 fields

Name

FD&C Green No. 3

CAS Number

2353-45-9

Molecular Formula

C37H36N2O10S3.2Na

InChI Key

RZSYLLSAWYUBPE-UHFFFAOYSA-L

Monoisotopic Mass

810.132747

Synonyms

FD & C green No. 3 (C.I. Food Green 3, disodium salt)Aizen Food Green No. 3Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-CEINECS 219-091-5FD & C Green No. 3Solid Green FCFZelen potravinarska 3Zelen Stala FCFUNII-3P3ONR6O1SC.I. 42053

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 13 records

DyeFragrance

Regulatory Lists

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

SOURCE EPA CPDat 13 records

List	Keyword	Source
banned; Europe; Personal care	European Commission	CosIng
IFRA Transparency	IFRA	IFRA
children; Europe; Personal care	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	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)
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
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)	FDA	United States Food and Drug Administration (FDA)

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 30 of 30 studies

Value	Unit	Endpoint	Route	Species	Source
11.86	uM	AC50	-	-	NTP ICE endocrine
7.983	uM	ACC	-	-	NTP ICE endocrine
<=25	mg/kg	ADI	oral	Human	WHO/JECFA
0	uL/min/10^6 cells	Clint	-	Human	NTP ICE adme parameters
=89.96	mg/m3	DNEL systemic	inhalation	Human	ToxValDB GESTIS DNEL
3P3ONR6O1S	UNII	FDA UNII substance identifier	-	-	openFDA substances
9J3VQ0Y6BV	UNII	FDA UNII substance identifier	-	-	openFDA substances
0.0151	fraction	Fu	-	Human	NTP ICE adme parameters
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
=48.75	mg/kg bw/day	LOAEL	oral	Rat	ECHA
0	unitless	Model Score	-	-	NTP ICE endocrine
0.209	unitless	Model Score	-	-	NTP ICE endocrine
500	mg/kg bw/day	NOAEL	oral	dog	COSMOS DB
=500	mg/kg bw/day	NOAEL	oral	Dog	ECHA
992	mg/kg bw/day	NOAEL	oral	mouse	COSMOS DB
1000	mg/kg bw/day	NOAEL	oral	rat	COSMOS DB
=1000	mg/kg bw/day	NOAEL	oral	Rat	ECHA
1250	mg/kg bw/day	NOAEL	oral	rabbit	COSMOS DB
=1321	mg/kg bw/day	NOAEL	oral	Mouse	ECHA
=1429	mg/kg bw/day	NOAEL	dermal	Mouse	ECHA
2000	mg/kg bw/day	NOAEL	oral	rat	COSMOS DB
2500	mg/kg bw/day	NOAEL	oral	rat	COSMOS DB
=2500	mg/kg bw/day	NOAEL	oral	Rat	ECHA
=2857	mg/kg bw/day	NOAEL	oral	Mouse	ECHA
3000	mg/kg bw/day	NOAEL	oral	mouse	COSMOS DB
3602	mg/kg bw/day	NOAEL	oral	rat	COSMOS DB
=7143	mg/kg bw/day	NOAEL	oral	Mouse	ECHA
=2000	mg/kg bw/day	NOEL	oral	Mouse	ToxValDB ECOTOX

Showing 30 of 30 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](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt	219-091-5	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

restricted

Max

Prohibited as hair dye (Annex II Entry 1357); no maximum concentration for general colorant use

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed CHEMBL3188843

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

E143 — ADI: 25 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 Green No. 3?

FD&C Green No. 3 has 30 NOAEL studies in the database. The lowest reported value is 0 uL/min/10^6 cells in Human. Source: NTP ICE adme parameters.

What regulatory lists include FD&C Green No. 3?

FD&C Green No. 3 appears on 10 regulatory/inventory lists including banned; Europe; Personal care, IFRA Transparency, children; Europe; Personal care, and 7 more. Source: EPA CPDat.

Is FD&C Green No. 3 a carcinogen according to IARC?

FD&C Green No. 3 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 Green No. 3 used in cosmetics?

Yes, FD&C Green No. 3 is also indexed as a cosmetic ingredient under the name Fast Green FCF. 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 Green No. 3 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.

Does FD&C Green No. 3 have different safety status in cosmetics vs industrial chemicals?

Is FD&C Green No. 3 used outside industrial chemicals?

FD&C Green No. 3 also appears in cosmetics, pharmaceutical, food safety, cannabis databases.