Is CI 42640 (FD&C Violet No. 1) safe in cosmetics?
CI 42640 (FD&C Violet No. 1) has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited. 1 toxicological study endpoint(s) are available in our database.
CI 42640 (FD&C Violet No. 1)
Also known as: FD & C violet No. 1, C.I. Acid Violet 49, 11386 Violet, FD and C Violet No. 1, Benzenemethanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-3-sulfo-, hydroxide, inner salt, sodium salt (+15 more)
INCI: CI 42640
CI 42640 (FD&C Violet No. 1) (CAS 1694-09-3) is a cosmetic cosmetic ingredient functioning as Colorant. Formerly certified synthetic triphenylmethane violet dye. Once used. Reported NOAEL =500 mg/kg bw/day in Mouse (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database.
View industrial chemical safety profile for CAS 1694-09-3 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant. Formerly certified synthetic triphenylmethane violet dye. Once used as a food, drug, and cosmetic colorant. Now fully delisted and prohibited in the United States and not included in the EU Annex IV permitted colorants list.
Safety Rating
POOR
Chemistry & Identifiers
InChIKey
WTIXYDSCBZQJIC-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
prohibited
US Notes
Fully prohibited in the United States. FD&C Violet No. 1 was delisted by the FDA in 1973 (effective April 10, 1973) following Japanese studies linking the dye to carcinogenicity in female rats. The provisional listing for drug and cosmetic use was terminated. Delisted color additives are not permitted for any use in the US under 21 CFR 81.10. Any US cosmetic product containing CI 42640 would be considered adulterated under the FD&C Act.
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 42640 (FD&C Violet No. 1).
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint found for CI 42640 (FD&C Violet No. 1). 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 | Mouse | chronic | ToxValDB_ECHA_IUCLID |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
2B
Volume
16, Sup 7
Evaluation Year
1987
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
Health Hazard
Hazard Class and Category
Carc. 2
Hazard Statements
- H351 Suspected of causing cancer
Inserted via ATP: CLP00
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 386
(EC) 2009/1223
CMR: Carcinogenic Cat. 2()
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: 386
BRIN Brazil/India Cosmetics
Brazil: Prohibited
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CA | banned | - | - |
| KR | prohibited | - | - |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Evidence for Carcinogenicity
No data are available in humans. Sufficient evidence of carcinogenicity in animals. OVERALL EVALUATION: Group 2B: The agent is possibly carcinogenic to humans.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Regulatory List Membership (4)
California Proposition 65 (OEHHA)
EU Banned in Cosmetics
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for CI 42640 (FD&C Violet No. 1).
Regulatory Flags
fda-delisted-1973
fda-prohibited
not-in-eu-annex-iv
eu-prohibited-by-omission
carcinogenic-animal-studies
no-cosmetic-authorization
triphenylmethane-dye
adulterated-if-used-us
21-cfr-81-10
prop65
eu_banned_cosmetics
fda_food_additive
eu_cosing_listed
jecfa_concern
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 42640 (FD&C Violet No. 1) by CAS number or substance name.
Studies
1
Lowest NOAEL
500 mg/kg bw/day
Highest NOAEL
500 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
FD & C violet No. 1
C.I. Acid Violet 49
11386 Violet
FD and C Violet No. 1
Benzenemethanaminium, N-(4-((4-(dimethylamino)phenyl)(4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-3-sulfo-, hydroxide, inner salt, sodium salt
Ammonium, (4-(p-(dimethylamino)-alpha-(p-(ethyl(m-sulfobenzyl)amino)phenyl)benzylidene)-2,5-cyclohexadien-1-ylidene)ethyl(m-sulfobenzyl)-, hydroxide, inner salt, sodium salt
(4-((4-(Dimethylamino)phenyl)(4-(ethyl(3-sulphonatobenzyl)amino)phenyl)methylene)cyclohexa-2,5-dien-1-ylidene)(ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
Atlantic Acid Violet 4BNS
Benzenemethanaminium, N-[4-[[4-(dimethylamino)phenyl][4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-3-sulfo-, inner salt, sodium salt (1:1)
Acid Violet 5B
Benzenemethanaminium, N-[4-[[4-(dimethylamino)phenyl][4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-3-sulfo-, hydroxide, inner salt, sodium salt
C.I. Acid Violet 49, sodium salt
EC No.: 216-901-9
FD and C Violet 1
FD&C Violet No. 1
D and C Violet No. 1
C.I. Food Violet 2
A.F. Violet No. 1
Acid Fast Violet 5BN
Acid Violet S
Regulatory Lists
OEHHA Proposition 65 (3/2019)
OEHHA Proposition 65 (1/2023)
banned; Europe; Personal care
inert_ingredient; non_food_use; Pesticides
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Australian Status
AICIS status: listed
Frequently Asked Questions
Is CI 42640 (FD&C Violet No. 1) allowed in the EU?
CI 42640 (FD&C Violet No. 1) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 42640 (FD&C Violet No. 1) do in cosmetics?
CI 42640 (FD&C Violet No. 1) functions as: Colorant. Formerly certified synthetic triphenylmethane violet dye. Once used as a food, drug, and cosmetic colorant. Now fully delisted and prohibited in the United States and not included in the EU Annex IV permitted colorants list.. It is classified as a cosmetic ingredient in our database. CAS number: 1694-09-3.
What is the NOAEL for CI 42640 (FD&C Violet No. 1)?
The NOAEL (No Observed Adverse Effect Level) for CI 42640 (FD&C Violet No. 1) is =500 mg/kg bw/day based on a chronic study via oral route in Mouse. Source: ToxValDB_ECHA_IUCLID.
Compliance Tools
Check CI 42640 (FD&C Violet No. 1) compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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