Is CI 42053 safe in cosmetics?
CI 42053 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
CI 42053
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)
CI 42053 (CAS 2353-45-9) is a cosmetic cosmetic ingredient functioning as Colorant (green triphenylmethane dye). NOAEL 16.25 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 2353-45-9 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
CI 42053 is classified GHS CMR hazard (H315, H319, H335, H341, H412) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Colorant (green triphenylmethane dye)
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
permitted
US US Status
permitted
US Notes
Permitted — FD&C Green No. 3; permanently listed, certification required; eye area (incl. Al lake), lips, and external use
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for CI 42053.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for CI 42053. 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 CI 42053 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 CI 42053.
Regulatory Flags
colorant
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 CI 42053 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
Known Synonyms
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
Solid Green FCF
Zelen potravinarska 3
Zelen Stala FCF
UNII-3P3ONR6O1S
C.I. 42053
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 CI 42053 allowed in the EU?
CI 42053 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 42053 do in cosmetics?
CI 42053 functions as: Colorant (green triphenylmethane dye). It is classified as a cosmetic ingredient in our database. CAS number: 2353-45-9.
What is the NOAEL for CI 42053?
The NOAEL (No Observed Adverse Effect Level) for CI 42053 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 CI 42053 used outside cosmetics?
CI 42053 also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does CI 42053 have different safety status in cosmetics vs industrial chemicals?
CI 42053 is classified GHS CMR hazard (H315, H319, H335, H341, H412) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check CI 42053 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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