Good Colorant NOAEL Data

Acid Red 92 (Phloxine B)

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)

INCI: CI 45410

Acid Red 92 (Phloxine B) (CAS 18472-87-2) is a cosmetic colorant functioning as Colorant (red/fluorescent pink), Hair dyeing. NOAEL 1 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 2.0% oxidative hair dye; 0.4% non-oxidative hair dye (Annex III). 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 (red/fluorescent pink), Hair dyeing
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
242-355-6

Regulatory Status

EU EU Status restricted
EU Max Conc. 2.0% oxidative hair dye; 0.4% non-oxidative hair dye (Annex III)
US US Status permitted
US Notes Permanently listed as D&C Red No. 27 (free acid) and D&C Red No. 28 (Na salt). Certification required.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Acid Red 92 (Phloxine B).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Acid Red 92 (Phloxine B). 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 Acid Red 92 (Phloxine B) 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

Additional Ingredient Properties

2 property records from structured ingredient metadata.

colorant
{"Common_Name": "Acid Red 92", "Chemical_Name": "Tetrachlorotetraiodofluorescein", "CAS_Number": "13473-26-2", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "External use", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved 21 CFR 74.302", "Notes": "Fluorescent pink/red"}
colorant_formulator
{"ci_number": "45410", "ci_name": "Pigment Red 95", "color_category": "red", "color_hex_code": "#FF1493", "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": "high", "lightfastness_rating…

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 Acid Red 92 (Phloxine B).

Regulatory Flags

eu_children_restricted eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Acid Red 92 (Phloxine B) 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
View full pharmaceutical profile →

Frequently Asked Questions

Is Acid Red 92 (Phloxine B) safe in cosmetics?

Acid Red 92 (Phloxine B) has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.

Is Acid Red 92 (Phloxine B) allowed in the EU?

Acid Red 92 (Phloxine B) EU regulatory status: restricted. Maximum allowed concentration: 2.0% oxidative hair dye; 0.4% non-oxidative hair dye (Annex III). This is based on EU Regulation 1223/2009 and its amendments.

What does Acid Red 92 (Phloxine B) do in cosmetics?

Acid Red 92 (Phloxine B) functions as: Colorant (red/fluorescent pink), Hair dyeing. It is classified as a Colorant in our database. CAS number: 18472-87-2.

What is the NOAEL for Acid Red 92 (Phloxine B)?

The NOAEL (No Observed Adverse Effect Level) for Acid Red 92 (Phloxine B) 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 Acid Red 92 (Phloxine B) used outside cosmetics?

Acid Red 92 (Phloxine B) 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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