Moderate Cosmetic Ingredient NOAEL Data

CI 42090

Also known as: FD & C Blue No. 1 (Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt), Aizen Food Blue No. 2, Brilliant Blue FCF Supra, Canacert Brilliant Blue FCF, Cosmetic Blue Lake (+15 more)

CI 42090 (CAS 3844-45-9) is a cosmetic cosmetic ingredient functioning as Colorant, Hair Dyeing. NOAEL 631 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max IV/63 (CI 42090) III/190 (Acid Blue 9; Acid Blue 9 Ammonium Salt; Acid Blue 9 Aluminum Lake). 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 3844-45-9 →

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

Chemistry & Identifiers

EC Number
223-339-8

Regulatory Status

EU EU Status restricted
EU Max Conc. IV/63 (CI 42090) III/190 (Acid Blue 9; Acid Blue 9 Ammonium Salt; Acid Blue 9 Aluminum Lake)
US US Status Not specifically regulated

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Toxicological Studies

10 study endpoints found for CI 42090. 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 200 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 250 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 1319 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 1500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL =50 mg/kg bw/day oral Human; Rat Reproductive toxicity INCHEM_WHO_jecfa_jecmono_v75je01
NOAEL =50 mg/kg bw/day oral Human; Rat Reproductive toxicity INCHEM_WHO_jecfa_jecmono_v75je01
NOAEL =50 mg/kg bw/day oral Human; Rat Reproductive toxicity INCHEM_WHO_jecfa_jecmono_v75je01
NOAEL =200 mg/kg bw/day - - Toxicology study INCHEM_WHO_jecfa_jecmono_v75je01

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for CI 42090 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 <=6 mg/kg Human oral - WHO JECFA ADI
NOAEL =631 mg/kg-day Rat oral - EFSA
NOAEL =631 mg/kg-day Rat oral chronic EFSA
NOEL =2000 mg/kg-day Mouse oral acute ECOTOX
NOEL =2 % diet Mouse oral chronic ECOTOX
NOEL =2 % diet Mouse oral chronic ECOTOX
NOEL =1 % diet Rat oral chronic ECOTOX
NOEL =2 % diet Rat oral chronic ECOTOX
LOEL =5 % Rat oral short-term ECOTOX
NOEL =5 % Rat oral short-term ECOTOX

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
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

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.

Additional Jurisdictional Restrictions (3)
Jurisdiction Status Max % Product Type
BR permitted_colorant - Column 2: All products except eye area
ASEAN restricted 0.5% Non-oxidative hair dye products only
ASEAN permitted_colorant - All products (0.5% limit in non-oxidative hair dye — Annex III)

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Shampoo 0.001–0.1 0.5 CIR/VCRP

Additional Ingredient Properties

2 property records from structured ingredient metadata.

colorant
{"Common_Name": "FD&C Blue No. 1", "Chemical_Name": "Brilliant Blue FCF", "CAS_Number": "3844-45-9", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved 21 CFR 74.101", "Notes": "Water-soluble, good stability"}
colorant_formulator
{"ci_number": "42090", "ci_name": "Pigment Blue 15", "color_category": "blue", "color_hex_code": "#1E90FF", "natural_or_synthetic": "synthetic", "organic_or_inorganic": "organic", "lake_or_dye": "pigment", "fda_approved_use": "general", "eu_approved_cosmetic": "yes", "japan_approved": "yes", "china_approved": "yes", "coverage_opacity": "transparent", "tinting_strength": "medium", "lightfastness_ra…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye Flavouring and nutrient Fragrance
Regulatory List Membership (5)
EU Regulated in Personal Care EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL) FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for CI 42090.

Regulatory Flags

cosing-sourced eu-restricted needs-enrichment eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to CI 42090 by CAS number or substance name.

Studies
91
Lowest NOAEL
0.414
Highest NOAEL
9000

Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg

COSMOS_DB INCHEM_WHO_jecfa_jecmono_v75je01 SCCNFP_vision_codex

Known Synonyms

FD & C Blue No. 1 (Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt) Aizen Food Blue No. 2 Brilliant Blue FCF Supra Canacert Brilliant Blue FCF Cosmetic Blue Lake EINECS 223-339-8 FD & C Blue No. 1 FDC Blue No. 1 Fenazo Blue XI Food Blue Dye No. 1 Hexacol Brilliant Blue A Intracid Pure Blue L Japan Blue 1 Japan Blue No. 1 Merantine Blue EG Usacert Blue No. 1 Usacert FD and C Blue No. 1 Modr Brilantni FCF Modr Kysela 9 Modr Potravinarska 2

Chemical Function

Dye

Regulatory Lists

Europe; Personal care - hair coloring Europe; Personal care - hair coloring IFRA Transparency inert_ingredient; non_food_use; Pesticides children; Europe; Personal care children; Europe; Personal care - specialized bath products - bath salts children; Europe; Personal care - body hygiene - body wash children; Europe; Personal care - hair styling and care - shampoo children; Europe; Personal care - specialized bath products - bubble bath children; Europe; Personal care - dental care - toothpaste children; Europe; Personal care children; Europe; Personal care Europe; Personal care Europe; Personal care Arts and crafts/Office supplies - body paint - tattoo ink; Europe general_foods pharmaceutical Personal care

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
CHEMBL3184128
View full pharmaceutical profile →

Frequently Asked Questions

Is CI 42090 safe in cosmetics?

CI 42090 has a safety rating of "MODERATE" in our database. EU status: restricted. 10 toxicological study endpoint(s) are available in our database.

Is CI 42090 allowed in the EU?

CI 42090 EU regulatory status: restricted. Maximum allowed concentration: IV/63 (CI 42090) III/190 (Acid Blue 9; Acid Blue 9 Ammonium Salt; Acid Blue 9 Aluminum Lake). This is based on EU Regulation 1223/2009 and its amendments.

What does CI 42090 do in cosmetics?

CI 42090 functions as: Colorant, Hair Dyeing. It is classified as a cosmetic ingredient in our database. CAS number: 3844-45-9.

What is the NOAEL for CI 42090?

The NOAEL (No Observed Adverse Effect Level) for CI 42090 is 200 mg/kg bw/day based on a Developmental study via oral route in rabbit. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is CI 42090 used outside cosmetics?

CI 42090 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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