Is CI 73015 safe in cosmetics?
CI 73015 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 9 toxicological study endpoint(s) are available in our database.
CI 73015
Also known as: Indigo carmine, FD & C Blue No. 2, Disodium 3-oxo-2-(3-oxo-5-sulfonato-1,3-dihydro-2H-indol-2-ylidene)-2,3-dihydro-1H-indole-5-sulfonate, 12070 Blue, 1311 Blue (+15 more)
CI 73015 (CAS 860-22-0) is a cosmetic cosmetic ingredient functioning as Colorant. NOAEL 250 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
View industrial chemical safety profile for CAS 860-22-0 →
Auto-generated CPSR Part A draft with source citations
Chemistry & Identifiers
IUPAC Name
disodium;2-(3-hydroxy-5-sulfonato-1H-indol-2-yl)-3-oxoindole-5-sulfonate
InChIKey
JFVXEJADITYJHK-UHFFFAOYSA-L
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA permanently listed as FD&C Blue No. 2 (21 CFR 74.102, 74.1102, 74.3102, 82.102); permitted for foods, ingested drugs, and cosmetics generally; batch certification required; cannot be used in the eye area unless explicitly specified; also permitted in nylon surgical sutures (NTE 1%) and bone cement aluminum lake (NTE 0.1%)
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 73015.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
9 study endpoints found for CI 73015. 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 | 250 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 1350 mg/kg bw/day | oral | swine | Subchronic | COSMOS_DB |
| NOAEL | 2400 mg/kg bw/day | oral | mouse | Chronic | COSMOS_DB |
| NOAEL | =250 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =1282 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =1592 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =8259 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =9456 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for CI 73015 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 | <=5 mg/kg | Human | oral | - | WHO JECFA ADI |
| NOAEL | =1592 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1592 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1282 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1282 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA IUCLID |
| NOAEL | =500 mg/kg-day | Rat | oral | chronic | EFSA |
| NOAEL | =500 mg/kg-day | Rat | oral | chronic | EFSA |
| LD50 | =2500 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | =2000 mg/kg | Rat | oral | - | ECHA IUCLID |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 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: 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 (IV - Colorants)
BRIN Brazil/India Cosmetics
India: Permitted Colorant
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_colorant | - | All cosmetics (Class 1) |
| BR | permitted_colorant | - | Column 2: All products except eye area |
| ASEAN | permitted_colorant | - | All products |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "Indigo", "Chemical_Name": "Indigotin (natural)", "CAS_Number": "482-89-3", "Colorant_Type": "Natural Colorant", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved", "Notes": "Blue from plants"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (1)
JECFA Evaluation
FD AND C BLUE No. 2 | 2018 | 0-5 mg/kg bw | JECFA considered the new data that had become available since the previous evaluation as well as previously evaluated studies and concluded that there are no reasons to revise the ADI and confirmed the previous ADI of 0–5 mg/kg bw. | ">TRS 1014-JECFA 86/34 | FAS 77 JECFA 86/161
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for CI 73015.
Regulatory Flags
fda-certified
water-soluble
not-for-eye-area
eu-annex-iv
food-grade-also
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 73015 by CAS number or substance name.
Studies
9
Lowest NOAEL
250 mg/kg bw/day
Highest NOAEL
9456 mg/kg bw/day
COSMOS_DB
ToxValDB_ECHA_IUCLID
Known Synonyms
Indigo carmine
FD & C Blue No. 2
Disodium 3-oxo-2-(3-oxo-5-sulfonato-1,3-dihydro-2H-indol-2-ylidene)-2,3-dihydro-1H-indole-5-sulfonate
12070 Blue
1311 Blue
Aniline Carmine Powder
Basovit Blue 665E
Blue 2
Blue No. 2
C.I. 73015
C.I. 75781
Carmine Blue
Carmine indigo
Cogilor Blue 511.11
FD & C Blue 2
FD & C Blue No 2-307045
FD and C Blue 2
FD&C Blue No. 2-37006
Food Blue 1
Food Blue 2
Chemical Function
Dye
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
inert_ingredient; Pesticides
general_foods
pharmaceutical
Medical/dental
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; consumer_product; Substances in Products - Canada (4/2014)
Canada; consumer_product; Substances in Products - Canada (4/2014)
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
INDIGOTINDISULFONATE SODIUM
ChEMBL ID
CHEMBL2105023
Max Phase
4
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Indigo Carmine / Indigotine (FD&C Blue 2)
E Number
E132
ADI
5 mg/kg bw
Food Category
colorant
Frequently Asked Questions
Is CI 73015 allowed in the EU?
CI 73015 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 73015 do in cosmetics?
CI 73015 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 860-22-0.
What is the NOAEL for CI 73015?
The NOAEL (No Observed Adverse Effect Level) for CI 73015 is 250 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS_DB.
Is CI 73015 used outside cosmetics?
CI 73015 also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check CI 73015 compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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