Is CI 45370 safe in cosmetics?
CI 45370 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 3 toxicological study endpoint(s) are available in our database.
CI 45370
Also known as: Spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one,4',5'-dibromo-3',6'-dihydroxy-, Fluorescein, 4',5'-dibromo-, 4',5'-Dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one, D & C Orange 5, D and C Orange No. 5 (+15 more)
CI 45370 (CAS 596-03-2) is a cosmetic cosmetic ingredient functioning as Colorant (orange xanthene/fluorescein dye). Reported NOAEL =136.5 mg/kg bw/day in Mouse (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 596-03-2 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
CI 45370 is classified GHS Danger (H301, H412) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Colorant (orange xanthene/fluorescein dye)
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
4',5'-dibromo-3',6'-dihydroxyspiro[2-benzofuran-3,9'-xanthene]-1-one
InChIKey
ZDTNHRWWURISAA-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Safety Rating
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 45370.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for CI 45370. 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 | =136.5 mg/kg bw/day | dermal | Mouse | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =250 mg/kg bw/day | oral | Rabbit | short-term | ToxValDB_ECHA_IUCLID |
| NOAEL | =500 mg/kg bw/day | oral | Rat | short-term | ToxValDB_ECHA_IUCLID |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE
SVHC Candidate
No
Additional Ingredient Properties
2 property records from structured ingredient metadata.
colorant
{"Common_Name": "D&C Red No. 30", "Chemical_Name": "Helindone Pink CN", "CAS_Number": "2379-74-0", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "Lipstick, external cosmetics", "Max_Concentration_%": "3%", "EU_Status": "Not approved", "US_FDA_Status": "Approved 21 CFR 74.330 (restricted)", "Notes": "US only, restricted uses"}
colorant_formulator
{"ci_number": "45370", "ci_name": "Pigment Orange 20", "color_category": "orange", "color_hex_code": "#FF8C00", "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_…
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Expert Verdict
Expert safety assessment and concern-level summary for CI 45370.
Regulatory Flags
colorant
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 45370 by CAS number or substance name.
Studies
3
Lowest NOAEL
136.5 mg/kg bw/day
Highest NOAEL
500 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
Spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one,4',5'-dibromo-3',6'-dihydroxy-
Fluorescein, 4',5'-dibromo-
4',5'-Dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one
D & C Orange 5
D and C Orange No. 5
D&C Orange No. 5
Orange No. 201
Spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one, 4',5'-dibromo-3',6'-dihydroxy-
4',5'-Dibromo-3',6'-dihydroxyspiro(isobenzofuran-1(3H),9'-(9H)xanthene)-3-one
C.I. 45370:1
D & C Orange No. 5
5-19-06-00462
BRN 0057189
EINECS 209-876-0
Eosinic acid
Japan Orange 201
Japan Orange No. 201
Solvent Red 72
UNII-5P3H5X9X4Q
4',5'-Dibromofluorescein
Chemical Function
Dye
Regulatory Lists
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
CHEMBL3561473
Frequently Asked Questions
Is CI 45370 allowed in the EU?
CI 45370 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 45370 do in cosmetics?
CI 45370 functions as: Colorant (orange xanthene/fluorescein dye). It is classified as a cosmetic ingredient in our database. CAS number: 596-03-2.
What is the NOAEL for CI 45370?
The NOAEL (No Observed Adverse Effect Level) for CI 45370 is =136.5 mg/kg bw/day based on a chronic study via dermal route in Mouse. A total of 3 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is CI 45370 used outside cosmetics?
CI 45370 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.
Does CI 45370 have different safety status in cosmetics vs industrial chemicals?
CI 45370 is classified GHS Danger (H301, H412) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check CI 45370 compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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