NOAEL Data REACH Registered Cosmetic Ingredient

FD&C Blue No. 2 aluminum lake

Also known as: chemName:1H-Indole-5-sulfonic acid, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-, aluminum complex, synonym:Aluminum 3,3'-dioxo-(delta2,2-biindoline)-5,5'disulfonate, synonym:Aluminum, 2-(1,3-dihydro-, FD&C BLUE NO. 2, ALUMINUM LAKE, C.I. Acid Blue 74-aluminum lake (+15 more)

CAS 16521-38-3

FD&C Blue No. 2 aluminum lake (CAS 16521-38-3) is a chemical substance. Key regulatory status: REACH registered, 2 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, ECHA REACH.

View cosmetic safety profile for Acid Blue 74 Aluminum Lake →

SOURCE noael studies public
NOAEL studies
15
SOURCE chemical inventory jurisdictions
Regulatory lists
2
SOURCE eu clp annex vi
GHS signal
Not classified

Chemical Identity

CAS, identifiers, formula, and alternate names for the matched substance record.

SOURCE DSSTox identifiers 23 fields
Name
FD&C Blue No. 2 aluminum lake
CAS Number
16521-38-3
DTXSID
DTXSID6044224
Synonyms
chemName:1H-Indole-5-sulfonic acid, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-, aluminum complexsynonym:Aluminum 3,3'-dioxo-(delta2,2-biindoline)-5,5'disulfonatesynonym:Aluminum, 2-(1,3-dihydro-FD&C BLUE NO. 2, ALUMINUM LAKEC.I. Acid Blue 74-aluminum lakeC.I. 73015-Aluminum lakeC.I. Food Blue 1-aluminum lakeAcid Blue 74-aluminum lakeAluminum 3,3'-dioxo-(delta2,2-biindoline)-5,5'disulfonate(delta2,2-Biindoline)-5,5'-disulfonic acid, 3,3'-dioxo-, aluminum saltCertolake indigo carmineEINECS 240-589-3

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 3 records
Dye

Regulatory Lists

Inventory, screening, and regulatory list matches from public chemical databases.

SOURCE EPA CPDat 2 records
ListKeywordSource
CEDIFDAUnited States Food and Drug Administration (FDA)
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 15 of 15 studies
ValueUnitEndpointRouteSpeciesSource
4AQJ3LG584UNIIFDA UNII substance identifier--openFDA substances
4AQJ3LG584UNIIFDA UNII substance identifier--openFDA substances
4AQJ3LG584UNIIFDA UNII substance identifier--openFDA substances
4AQJ3LG584UNIIFDA UNII substance identifier--openFDA substances
conceptidentifierFDA UNII substance identifier--openFDA substances
conceptidentifierFDA UNII substance identifier--openFDA substances
conceptidentifierFDA UNII substance identifier--openFDA substances
conceptidentifierFDA UNII substance identifier--openFDA substances
250mg/kg bw/dayNOAELoralratCOSMOS_DB
500mg/kg bw/dayNOAELoraldogCOSMOS_DB
1000mg/kg bw/dayNOAELoralratCOSMOS_DB
1350mg/kg bw/dayNOAELoralswineCOSMOS_DB
2400mg/kg bw/dayNOAELoralmouseCOSMOS_DB
2500mg/kg bw/dayNOAELoralratCOSMOS_DB
7500mg/kg bw/dayNOAELoralmouseCOSMOS_DB

Showing 15 of 15 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA (EU) 1 records
StatusNameEC NumberLink
RegisteredAluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex240-589-3ECHA overview →

Australian Status (AICIS)

Australian industrial chemicals inventory status and applicable conditions.

SOURCE AICIS inventory 1 records
Inventory Status
listed

Cosmetic Safety Profile

Same-CAS cosmetic ingredient record for cross-vertical context.

SOURCE CosIng / Ingredients DB
EU Status
permitted
Max
-
Category
Colorant
View full cosmetic safety profile →

Food Safety Data

Same-CAS food additive, ADI, and GRAS records where available.

SOURCE EFSA / FDA GRAS 1 records

1 food-safety record found.

View full food safety profile →

Frequently Asked Questions

What is the NOAEL for FD&C Blue No. 2 aluminum lake?

FD&C Blue No. 2 aluminum lake has 15 NOAEL studies in the database. The lowest reported value is 4AQJ3LG584 UNII. Source: openFDA substances.

What regulatory lists include FD&C Blue No. 2 aluminum lake?

FD&C Blue No. 2 aluminum lake appears on 2 regulatory/inventory lists including CEDI, food_additive; Substances Added to Food (formerly EAFUS) (2/2019). Source: EPA CPDat.

Is FD&C Blue No. 2 aluminum lake used in cosmetics?

Yes, FD&C Blue No. 2 aluminum lake is also indexed as a cosmetic ingredient under the name Acid Blue 74 Aluminum Lake. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.

Where does the safety data for FD&C Blue No. 2 aluminum lake come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, ECHA REACH, CosIng / Ingredients DB, EFSA / FDA GRAS. All data traces to primary regulatory sources and is updated from official government databases.

Is FD&C Blue No. 2 aluminum lake used outside industrial chemicals?

FD&C Blue No. 2 aluminum lake also appears in cosmetics, food safety databases.