Moderate Cosmetic Ingredient NOAEL Data

CI 21108

Also known as: Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxo-, Disazo Yellow, Butanamide, 2,​2'-​[(3,​3'-​dichloro[1,​1'-​biphenyl]​-​4,​4'-​diyl)​bis(2,​1-​diazenediyl)​]​bis[N-​(4-​chloro-​2,​5-​dimethoxyphenyl)​-​3-​oxo-, Acetoacetanilide, 2,2''-[(3,3'-dichloro-4,4'-biphenylylene)bis(azo)]bis[4'-chloro-2',5'-dimethoxy-, 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(2,1-diazenediyl)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide] (+15 more)

CI 21108 (CAS 5567-15-7) is a cosmetic cosmetic ingredient functioning as Colorant. Reported NOAEL =555 mg/kg bw/day in Mouse (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: restricted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 5567-15-7 →

Auto-generated CPSR Part A draft with source citations
Function
Colorant
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C36H32Cl4N6O8
MW
818.5 g/mol
EC Number
226-939-8
PubChem CID
21733
IUPAC Name
2-[[2-chloro-4-[3-chloro-4-[[1-(4-chloro-2,5-dimethoxyanilino)-1,3-dioxobutan-2-yl]diazenyl]phenyl]phenyl]diazenyl]-N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide
InChIKey
NKXPXRNUMARIMZ-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
US US Status prohibited
US Notes Not listed as FDA-certified color additive for cosmetics; not in 21 CFR Part 74 or 82

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 21108.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for CI 21108. 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 =555 mg/kg bw/day oral Mouse chronic ToxValDB_ECHA_IUCLID
NOAEL =702 mg/kg bw/day oral Rat chronic ToxValDB_ECHA_IUCLID
NOAEL =1665 mg/kg bw/day oral Mouse chronic ToxValDB_ECHA_IUCLID

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex IV — Permitted Colorants
Product type: Yellow

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 (IV - Colorants)
Product type: Rinse-off products.
BRIN Brazil/India Cosmetics
India: Permitted Colorant

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Degradant/impurity Dye Pigment Processing aids not otherwise specified
Regulatory List Membership (2)
EU Regulated in Personal Care EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for CI 21108.

Regulatory Flags

azo-dye pigment diarylide rinse-off-only eu-annex-iv-restricted not-fda-approved dcb-concern eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to CI 21108 by CAS number or substance name.

Studies
3
Lowest NOAEL
555 mg/kg bw/day
Highest NOAEL
1665 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxo- Disazo Yellow Butanamide, 2,​2'-​[(3,​3'-​dichloro[1,​1'-​biphenyl]​-​4,​4'-​diyl)​bis(2,​1-​diazenediyl)​]​bis[N-​(4-​chloro-​2,​5-​dimethoxyphenyl)​-​3-​oxo- Acetoacetanilide, 2,2''-[(3,3'-dichloro-4,4'-biphenylylene)bis(azo)]bis[4'-chloro-2',5'-dimethoxy- 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(2,1-diazenediyl)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide] 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide Aquafine Yellow E 12 C.I. 21108 Chromofine Yellow 2700(L) Colanyl Yellow HRD FG 1842 Graphtol Yellow RCL HR 70 Yellow Helio Fast Yellow HRN Hostafine Yellow HR Hydrocolor Yellow Imperial yellow Imperon Gold Yellow K-RN Imperon Golden Yellow K-RN Irgalite Yellow B 3R

Chemical Function

Dye Pigment Degradant/impurity

Regulatory Lists

Europe; Personal care Arts and crafts/Office supplies - body paint - tattoo ink; Europe Arts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; Europe Arts and crafts/Office supplies - body paint - tattoo ink; Europe Europe; plastic_additive Europe Arts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; Europe Arts and crafts/Office supplies - body paint - tattoo ink; Europe

Australian Status

AICIS status: listed

Frequently Asked Questions

Is CI 21108 safe in cosmetics?

CI 21108 has a safety rating of "MODERATE" in our database. EU status: restricted. US status: prohibited. 3 toxicological study endpoint(s) are available in our database.

Is CI 21108 allowed in the EU?

CI 21108 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 21108 do in cosmetics?

CI 21108 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 5567-15-7.

What is the NOAEL for CI 21108?

The NOAEL (No Observed Adverse Effect Level) for CI 21108 is =555 mg/kg bw/day based on a chronic study via oral route in Mouse. A total of 3 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is CI 21108 used outside cosmetics?

CI 21108 also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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