Moderate Cosmetic Ingredient NOAEL Data

CI 42045 (Acid Blue 1 / D&C Blue No. 4)

Also known as: C.I. Food Blue 3, Patent Blue VF, Patent Blue Violet, C.I. Acid Blue 1, sodium salt, C.I. Acid Blue 1 (+15 more)

INCI: CI 42045

CI 42045 (Acid Blue 1 / D&C Blue No. 4) (CAS 129-17-9) is a cosmetic cosmetic ingredient functioning as Colorant. Synthetic triphenylmethane blue dye (Acid Blue 1, also known as D&C. Reported NOAEL =375 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: restricted, max No maximum concentration specified for permitted applications. Prohibited in hair dye products (Annex II/1355). Prohibited in products applied to mucous membranes (Annex IV restriction). Purity per EU standards required.. Industrial safety data is also available in the chemical safety database. Same-CAS

View industrial chemical safety profile for CAS 129-17-9 →

Auto-generated CPSR Part A draft with source citations
Function
Colorant. Synthetic triphenylmethane blue dye (Acid Blue 1, also known as D&C Blue No. 4, Food Blue 2). Imparts blue coloration to cosmetic and personal care products. Water-soluble anionic sulfonated triphenylmethane dye. Approved for limited cosmetic use under EU and US regulations, with key restrictions preventing use in hair dye products and limiting scope to non-mucosal applications.
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C27H31N2NaO6S2
MW
566.7 g/mol
EC Number
204-934-1
PubChem CID
8507
IUPAC Name
sodium 4-[[4-(diethylamino)phenyl]-(4-diethylazaniumylidenecyclohexa-2,5-dien-1-ylidene)methyl]benzene-1,3-disulfonate
InChIKey
SJEYSFABYSGQBG-UHFFFAOYSA-M

Regulatory Status

EU EU Status restricted
EU Max Conc. No maximum concentration specified for permitted applications. Prohibited in hair dye products (Annex II/1355). Prohibited in products applied to mucous membranes (Annex IV restriction). Purity per EU standards required.
US US Status permitted
US Notes FDA permanently listed as D&C Blue No. 4 (21 CFR 74.2104). Subject to mandatory FDA batch certification before US market distribution. Approved for externally applied cosmetics only. NOT permitted for use in the eye area, ingested products, injections, or surgical sutures per 21 CFR 74.2104 restrictions. External use only with batch 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 CI 42045 (Acid Blue 1 / D&C Blue No. 4).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for CI 42045 (Acid Blue 1 / D&C Blue No. 4). 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 =375 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID
NOAEL =500 mg/kg bw/day oral Mouse chronic ToxValDB_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: 1355
(EC) 2013/344
Annex IV — Permitted Colorants
Product type: Blue

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)
ASEAN Cosmetic Directive (II)
Ref: 1355
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
India: Permitted Colorant
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
CN permitted_colorant - Cosmetics except near eyes (Class 3)

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (2)
Carcinogen Classification
Blue VRS | 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)
Evidence for Carcinogenicity
No data are available in humans. Limited evidence of carcinogenicity in animals. OVERALL EVALUATION: Group 3: The agent is not classifiable as to its carcinogenicity to humans.
Source: Hazardous Substances Data Bank (HSDB)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (2)
EU Banned in Cosmetics EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for CI 42045 (Acid Blue 1 / D&C Blue No. 4).

Regulatory Flags

eu-annex-iv eu-mucous-membrane-prohibited eu-hair-dye-prohibited-annex-ii fda-d-and-c-blue-no-4 fda-batch-certification-required external-use-only-us no-eye-area-us triphenylmethane-dye water-soluble sulfonated eu_banned_cosmetics eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to CI 42045 (Acid Blue 1 / D&C Blue No. 4) by CAS number or substance name.

Studies
2
Lowest NOAEL
375 mg/kg bw/day
Highest NOAEL
500 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

C.I. Food Blue 3 Patent Blue VF Patent Blue Violet C.I. Acid Blue 1, sodium salt C.I. Acid Blue 1 Acid Blue V Acid Blue 1 Acid bright azure Z Acid Brilliant Blue Z Acid Brilliant Blue VF Acid Brilliant Sky Blue Z Acid Leather Blue V Aizen Brilliant Acid Pure Blue VH Alphazurine 2G Amacid Blue V Anhydro-4,4'-bis(diethylamino)triphenylmethanol-2',4''-disulphonic acid, monosodium salt Blue URS Blue VRS Brilliant Acid Blue A Export Brilliant Acid Blue V Extra

Chemical Function

Dye

Regulatory Lists

inert_ingredient; non_food_use; Pesticides banned; Europe; Personal care Canada; pharmaceutical

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
CHEMBL1731183
View full pharmaceutical profile →

Frequently Asked Questions

Is CI 42045 (Acid Blue 1 / D&C Blue No. 4) safe in cosmetics?

CI 42045 (Acid Blue 1 / D&C Blue No. 4) has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.

Is CI 42045 (Acid Blue 1 / D&C Blue No. 4) allowed in the EU?

CI 42045 (Acid Blue 1 / D&C Blue No. 4) EU regulatory status: restricted. Maximum allowed concentration: No maximum concentration specified for permitted applications. Prohibited in hair dye products (Annex II/1355). Prohibited in products applied to mucous membranes (Annex IV restriction). Purity per EU standards required.. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 42045 (Acid Blue 1 / D&C Blue No. 4) do in cosmetics?

CI 42045 (Acid Blue 1 / D&C Blue No. 4) functions as: Colorant. Synthetic triphenylmethane blue dye (Acid Blue 1, also known as D&C Blue No. 4, Food Blue 2). Imparts blue coloration to cosmetic and personal care products. Water-soluble anionic sulfonated triphenylmethane dye. Approved for limited cosmetic use under EU and US regulations, with key restrictions preventing use in hair dye products and limiting scope to non-mucosal applications.. It is classified as a cosmetic ingredient in our database. CAS number: 129-17-9.

What is the NOAEL for CI 42045 (Acid Blue 1 / D&C Blue No. 4)?

The NOAEL (No Observed Adverse Effect Level) for CI 42045 (Acid Blue 1 / D&C Blue No. 4) is =375 mg/kg bw/day based on a subchronic study via oral route in Rat. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is CI 42045 (Acid Blue 1 / D&C Blue No. 4) used outside cosmetics?

CI 42045 (Acid Blue 1 / D&C Blue No. 4) 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.

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