Is Fast Green FCF safe in cosmetics?
Fast Green FCF has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Fast Green FCF
INCI: CI 42053
Fast Green FCF (CAS 2353-45-9) is a cosmetic colorant functioning as Colorant (green). NOAEL 16.25 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max Prohibited as hair dye (Annex II Entry 1357); no maximum concentration for general colorant use. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 2353-45-9 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant (green)
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
disodium;2-[[4-[ethyl-[(3-sulfonatophenyl)methyl]amino]phenyl]-[4-[ethyl-[(3-sulfonatophenyl)methyl]azaniumylidene]cyclohexa-2,5-dien-1-ylidene]methyl]-5-hydroxybenzenesulfonate
InChIKey
RZSYLLSAWYUBPE-UHFFFAOYSA-L
Regulatory Status
EU EU Status
restricted
EU Max Conc.
Prohibited as hair dye (Annex II Entry 1357); no maximum concentration for general colorant use
US US Status
permitted
US Notes
FD&C Green No. 3. Permitted in foods, drugs, and cosmetics generally. Certification required.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Fast Green FCF.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Fast Green FCF. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 500 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 992 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 1250 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 3000 mg/kg bw/day | oral | mouse | Chronic | COSMOS_DB |
| NOAEL | 3602 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | =500 mg/kg bw/day | oral | Dog | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =1321.43 mg/kg bw/day | oral | Mouse | chronic | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Fast Green FCF across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| ADI | <=25 mg/kg | Human | oral | - | WHO JECFA ADI |
| LOAEL | =48.75 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =2500 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1321.43 mg/kg-day | Mouse | oral | - | ECHA IUCLID |
| NOAEL | =1428.5 mg/kg-day | Mouse | dermal | chronic | ECHA IUCLID |
| NOAEL | =2500 mg/kg-day | Rat | oral | chronic | ECHA IUCLID |
| NOAEL | =7142.85 mg/kg-day | Mouse | oral | chronic | ECHA IUCLID |
| NOAEL | =500 mg/kg-day | Dog | oral | chronic | ECHA IUCLID |
| NOAEL | =2857 mg/kg-day | Mouse | oral | chronic | ECHA IUCLID |
| NOAEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
16, Sup 7
Evaluation Year
1987
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1357
(EC) 2013/344
Annex IV — Permitted Colorants
Product type: Green
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
India: Permitted Colorant
Additional Jurisdictional Restrictions (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_colorant | - | All cosmetics (Class 1) |
| BR | permitted_colorant | - | Column 2: All products except eye area |
| ASEAN | permitted_colorant | - | All products |
| ASEAN | permitted_colorant | - | All products |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (2)
Carcinogen Classification
3, not classifiable as to its carcinogenicity to humans. (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Fast Green FCF | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 16: (1978) Some Aromatic Amines and Related Nitro Compounds – Hair Dyes, Colouring Agents and Miscellaneous Industrial Chemicals | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print)
Source: International Agency for Research on Cancer (IARC)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Fragrance
Regulatory List Membership (6)
EU Banned in Cosmetics
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Fast Green FCF.
Regulatory Flags
Allergen
eu_banned_cosmetics
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Fast Green FCF by CAS number or substance name.
Studies
14
Lowest NOAEL
500 mg/kg bw/day
Highest NOAEL
7142.85 mg/kg bw/day
COSMOS_DB
ToxValDB_ECHA_IUCLID
Chemical Function
Dye
Fragrance
Regulatory Lists
banned; Europe; Personal care
IFRA Transparency
children; Europe; Personal care
children; Europe; Personal care - hair styling and care - shampoo
children; Europe; Personal care
children; Europe; Personal care
inert_ingredient; non_food_use; Pesticides
general_foods
pharmaceutical
Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
SCIL (9/2019)
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
ChEMBL ID
CHEMBL3188843
Frequently Asked Questions
Is Fast Green FCF allowed in the EU?
Fast Green FCF EU regulatory status: restricted. Maximum allowed concentration: Prohibited as hair dye (Annex II Entry 1357); no maximum concentration for general colorant use. This is based on EU Regulation 1223/2009 and its amendments.
What does Fast Green FCF do in cosmetics?
Fast Green FCF functions as: Colorant (green). It is classified as a Colorant in our database. CAS number: 2353-45-9.
What is the NOAEL for Fast Green FCF?
The NOAEL (No Observed Adverse Effect Level) for Fast Green FCF is 500 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is Fast Green FCF used outside cosmetics?
Fast Green FCF also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Fast Green FCF compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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Colorant (green triphenylmethane dye)
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Browse nearby
colorant
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Solvent
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