Is CI 45350 safe in cosmetics?
CI 45350 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 4 toxicological study endpoint(s) are available in our database.
CI 45350
Also known as: C.I. Acid yellow 73, Spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one, 3',6'-dihydroxy-, disodium salt, Calcocid uranine B4315, 9-o-Carboxyphenyl-6-hydroxy-3-isoxanthone, disodium salt, Disodium 6-hydroxy-3-oxo-9-xanthene-o-benzoate (+12 more)
CI 45350 (CAS 518-47-8) is a cosmetic cosmetic ingredient functioning as Colorant. Reported NOAEL =250 mg/kg bw/day in Rabbit (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: permitted, max 6%. 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 518-47-8 →
Auto-generated CPSR Part A draft with source citations
Chemistry & Identifiers
IUPAC Name
disodium;2-(3-oxido-6-oxoxanthen-9-yl)benzoate
InChIKey
NJDNXYGOVLYJHP-UHFFFAOYSA-L
Regulatory Status
EU EU Status
permitted
EU Max Conc.
6%
US US Status
permitted
US Notes
Permitted as D&C Yellow No. 7 and D&C Yellow No. 8 (sodium salt) for externally applied cosmetics and drugs. Not permitted for use in eye-area products or ingested products.
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 45350.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for CI 45350. 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 | Rabbit | short-term | ToxValDB_ECHA_IUCLID |
| NOAEL | =500 mg/kg bw/day | oral | Rat | short-term | ToxValDB_ECHA_IUCLID |
| NOAEL | =1500 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =2241.4 mg/kg bw/day | injection | Rabbit | reproduction developmental | ToxValDB_ECHA_IUCLID |
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
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "D&C Yellow No. 8", "Chemical_Name": "Uranine", "CAS_Number": "518-47-8", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved 21 CFR 74.708", "Notes": "Sodium salt of fluorescein"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Skin Eye Respiratory Irritation
Eye, skin, ... and/or respiratory tract irritation.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (1)
EU Restricted for Children (Cosmetics)
Expert Verdict
Expert safety assessment and concern-level summary for CI 45350.
Regulatory Flags
max-6-percent-eu
not-for-eye-area
not-for-ingestion
fluorescent-dye
synthetic-dye
xanthene-dye
fda-d-and-c-yellow-7-8
eu_children_restricted
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 45350 by CAS number or substance name.
Studies
4
Lowest NOAEL
250 mg/kg bw/day
Highest NOAEL
2241.4 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
C.I. Acid yellow 73
Spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one, 3',6'-dihydroxy-, disodium salt
Calcocid uranine B4315
9-o-Carboxyphenyl-6-hydroxy-3-isoxanthone, disodium salt
Disodium 6-hydroxy-3-oxo-9-xanthene-o-benzoate
EINECS 208-253-0
Fluorescein, soluble
Fluor-I-strip A.T.
Funduscein
NCI-C54706
Sodium salt of hydroxy-o-carboxy-phenyl-fluorone
Soluble fluoresceine
Uranine Yellow
Japan Yellow 202(1)
Funduscein-25
Ak-Fluor
UNII-93X55PE38X
Chemical Function
Dye
Regulatory Lists
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care
children; Europe; Personal care
pharmaceutical
Personal care
CEDI
inert_ingredient; non_food_use; Pesticides
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.
Compound
FLUORESCEIN SODIUM
ChEMBL ID
CHEMBL1628233
Max Phase
4
Adverse Event Associations
31
Frequently Asked Questions
Is CI 45350 allowed in the EU?
CI 45350 EU regulatory status: permitted. Maximum allowed concentration: 6%. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 45350 do in cosmetics?
CI 45350 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 518-47-8.
What is the NOAEL for CI 45350?
The NOAEL (No Observed Adverse Effect Level) for CI 45350 is =250 mg/kg bw/day based on a short-term study via oral route in Rabbit. A total of 4 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is CI 45350 used outside cosmetics?
CI 45350 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 45350 compliance across multiple jurisdictions:
Ingredient Decoder
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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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Antioxidant
Acid Yellow 73 Sodium Salt
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Chemical family
Colorant / Hair dye
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