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 →

SOURCE noael studies public
NOAEL studies
38
SOURCE chemical inventory jurisdictions
Regulatory lists
13
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 16 fields
Name
FD&C Green No. 3
CAS Number
2353-45-9
DTXSID
DTXSID3020673
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
GroupMeaningEvaluatedVolume
Group 3Not classifiable198716, 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
ListKeywordSource
banned; Europe; Personal careEuropean CommissionCosIng
IFRA TransparencyIFRAIFRA
children; Europe; Personal careDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal care - hair styling and care - shampooDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal careDanish 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)
Personal careFDAUnited States Food and Drug Administration (FDA)
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)
SCIL (9/2019)USEPASafer Chemical Ingredients List
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 38 of 38 studies
ValueUnitEndpointRouteSpeciesSource
11.86188925uMAC50--NTP_ICE_endocrine
7.982783792uMACC--NTP_ICE_endocrine
<=25mg/kgADIoralHumanToxValDB_WHO_JECFA_ADI
-uL/min/10^6 cellsClint-HumanNTP_ICE_adme_parameters
=89.957mg/m3DNEL systemicinhalationHumanToxValDB_GESTIS_DNEL
3P3ONR6O1SUNIIFDA UNII substance identifier--openFDA substances
3P3ONR6O1SUNIIFDA UNII substance identifier--openFDA substances
3P3ONR6O1SUNIIFDA UNII substance identifier--openFDA substances
3P3ONR6O1SUNIIFDA UNII substance identifier--openFDA substances
9J3VQ0Y6BVUNIIFDA UNII substance identifier--openFDA substances
9J3VQ0Y6BVUNIIFDA UNII substance identifier--openFDA substances
9J3VQ0Y6BVUNIIFDA UNII substance identifier--openFDA substances
9J3VQ0Y6BVUNIIFDA UNII substance identifier--openFDA substances
0.0151fractionFu-HumanNTP_ICE_adme_parameters
3IARC groupIARC carcinogenicity classification--IARC Monographs
3IARC groupIARC carcinogenicity classification--IARC Monographs
3IARC groupIARC carcinogenicity classification--IARC Monographs
3unitlessIARC group--NTP_ICE_cancer
>2000mg/kg bwLD50oralRatNTP_ICE_acute_oral
=48.75mg/kg bw/dayLOAELoralRatToxValDB_ECHA_IUCLID
-unitlessModel Score--NTP_ICE_endocrine
0.209unitlessModel Score--NTP_ICE_endocrine
500mg/kg bw/dayNOAELoraldogCOSMOS_DB
=500mg/kg bw/dayNOAELoralDogToxValDB_ECHA_IUCLID
992mg/kg bw/dayNOAELoralmouseCOSMOS_DB
1000mg/kg bw/dayNOAELoralratCOSMOS_DB
=1000mg/kg bw/dayNOAELoralRatToxValDB_ECHA_IUCLID
1250mg/kg bw/dayNOAELoralrabbitCOSMOS_DB
=1321.43mg/kg bw/dayNOAELoralMouseToxValDB_ECHA_IUCLID
=1428.5mg/kg bw/dayNOAELdermalMouseToxValDB_ECHA_IUCLID
2000mg/kg bw/dayNOAELoralratCOSMOS_DB
2500mg/kg bw/dayNOAELoralratCOSMOS_DB
=2500mg/kg bw/dayNOAELoralRatToxValDB_ECHA_IUCLID
=2857mg/kg bw/dayNOAELoralMouseToxValDB_ECHA_IUCLID
3000mg/kg bw/dayNOAELoralmouseCOSMOS_DB
3602mg/kg bw/dayNOAELoralratCOSMOS_DB
=7142.85mg/kg bw/dayNOAELoralMouseToxValDB_ECHA_IUCLID
=2000mg/kg bw/dayNOELoralMouseToxValDB_ECOTOX

Showing 38 of 38 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA (EU) 1 records
StatusNameEC NumberLink
RegisteredDihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt219-091-5ECHA 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
Category
colorant
View full cosmetic safety profile →

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE EMBL-EBI ChEMBL CHEMBL3188843
ChEMBL Phase
Not listed
Adverse Events
0
Bioactivity
0
View full pharmaceutical profile →

Food Safety Data

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

SOURCE EFSA / FDA GRAS 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 38 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?

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.

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

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