Is CI 45405 safe in cosmetics?
CI 45405 has a safety rating of "GOOD" in our database. EU status: permitted. US status: prohibited. 10 toxicological study endpoint(s) are available in our database.
CI 45405
Also known as: Phloxine B, Fluorescein, 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-, disodium salt, EINECS 242-355-6, Food Dye Red No. 104, Japan Red 104 (+2 more)
CI 45405 (CAS 18472-87-2) is a cosmetic cosmetic ingredient functioning as Colorant. NOAEL 1 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 and pharmaceutical data.
View industrial chemical safety profile for CAS 18472-87-2 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
prohibited
US Notes
Not listed as an approved FDA D&C or FD&C color additive for cosmetics in the US. Closely related CI 45410 (Phloxine B) is approved as D&C Red No. 28.
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 45405.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for CI 45405. 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 | =50 mg/kg bw/day | dermal | - | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =50 mg/kg bw/day | dermal | - | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =50 mg/kg bw/day | dermal | - | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =50 mg/kg bw/day | dermal | - | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =0.14 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =0.14 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =0.14 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =0.14 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =50 mg/kg bw/d | - | - | genotoxicity | SCCS_vision_codex |
| NOAEL | =50 mg/kg bw/day | - | - | reproductive toxicity | SCCS_vision_codex |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for CI 45405 across SCCS product categories, with measured dermal absorption where available.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 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: Red
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 (III - Restricted)
Product type: (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products. Max: (b) 0,4 %.
BRIN Brazil/India Cosmetics
India: Restricted · max (b) 0,4 %
India: Permitted Colorant
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| ASEAN | permitted_colorant | - | All products |
| ASEAN | permitted_colorant | - | All products |
| ASEAN | permitted_colorant | - | All products |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_sccs_opinion | 14.58% | - | - | 2012-03-27 |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (2)
EU Restricted for Children (Cosmetics)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for CI 45405.
Regulatory Flags
not-for-eye-products
not-fda-approved
synthetic-dye
xanthene-dye
halogenated-fluorescein
acid-red-98
eu_children_restricted
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 45405 by CAS number or substance name.
Studies
21
Lowest NOAEL
0.14
Highest NOAEL
2000
Units vary across source rows: mg/kg bw/day, mg/kg bw/d
ToxValDB_ECHA_IUCLID
SCCS_vision_codex
SCCNFP_vision_codex
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 14.58% | SCCS opinion extraction | - |
Known Synonyms
Phloxine B
Fluorescein, 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-, disodium salt
EINECS 242-355-6
Food Dye Red No. 104
Japan Red 104
Japan Red 104-1
Red No. 104-1
Chemical Function
Dye
Regulatory Lists
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bubble bath
children; Europe; Personal care - dental care - toothpaste
children; Europe; Personal care
children; Europe; Personal care
pharmaceutical
Personal care
Europe; Personal care; restricted
inert_ingredient; non_food_use; Pesticides
Canada; pharmaceutical
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 data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
ChEMBL ID
CHEMBL61441
Frequently Asked Questions
Is CI 45405 allowed in the EU?
CI 45405 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 45405 do in cosmetics?
CI 45405 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 18472-87-2.
What is the NOAEL for CI 45405?
The NOAEL (No Observed Adverse Effect Level) for CI 45405 is =50 mg/kg bw/day based on a repeated dose toxicity study via dermal route in rat. A total of 10 study endpoints are available. Source: SCCNFP_vision_codex.
Is CI 45405 used outside cosmetics?
CI 45405 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.
Compliance Tools
Check CI 45405 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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