Is Erythrosin safe in cosmetics?
Erythrosin has a safety rating of "POOR" in our database. EU status: restricted. US status: prohibited. 10 toxicological study endpoint(s) are available in our database.
Erythrosin
Also known as: Spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one,3',6'-dihydroxy-2',4',5',7'-tetraiodo-, disodium salt, Erythrosine B, Ceplac, E 127, Erythrosine 3 (+15 more)
INCI: CI 45430
Erythrosin (CAS 16423-68-0) is a cosmetic cosmetic ingredient functioning as Colorant. Reported NOAEL =25 mg/kg bw/day in Mouse (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: restricted, max 0.0025% in toothpaste only. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
View industrial chemical safety profile for CAS 16423-68-0 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
3',6'-dihydroxy-2',4',5',7'-tetraiodospiro[2-benzofuran-3,9'-xanthene]-1-one
InChIKey
OALHHIHQOFIMEF-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.0025% in toothpaste only
US US Status
prohibited
US Notes
FDA banned from cosmetics since 1990 due to thyroid tumor findings in rodent studies; not permitted in any US cosmetic product
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Erythrosin.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Erythrosin. 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 | =25 mg/kg bw/day | oral | Mouse | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =75 mg/kg bw/day | oral | Mouse | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =149 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =251 mg/kg bw/day | oral | Rat | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =255 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =472 mg/kg bw/day | oral | Rat | developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =500 mg/kg bw/day | oral | Dog | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =641 mg/kg bw/day | oral | Rat | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =800 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
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 | <=0.1 mg/kg | Human | oral | - | WHO JECFA ADI |
| NOAEL | =125 mg/kg-day | Rat | oral | - | EFSA |
| NOAEL | =1 mg/kg-day | Human | oral | short-term | EFSA |
| LOEL | =100 mg/kg-day | Mouse | oral | acute | ECOTOX |
| NOEL | =10 mg/kg-day | Mouse | oral | acute | ECOTOX |
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA IUCLID |
| LD50 | =7100 mg/kg | Rat | oral | - | ECHA IUCLID |
| LD50 | =1895 mg/kg | Rat | oral | - | ECHA IUCLID |
| LD50 | =1264 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | =7400 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
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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.
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_colorant | - | All cosmetics (Class 1) |
| ASEAN | permitted_colorant | - | All products |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "D&C Red No. 22", "Chemical_Name": "Eosin YS", "CAS_Number": "17372-87-1", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved 21 CFR 74.322", "Notes": "Yellowish red"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
Regulatory (2)
JECFA Evaluation
FD AND C RED No. 3 | 2018 | 0-0.1 mg/kg bw | The Committee concluded that the new data that have become available since the previous evaluation of erythrosine do not give reason to revise the ADI and confirmed the previous ADI of 0–0.1 mg/kg bw. | ">TRS 1014-JECFA 86/27 | FAS 77 JECFA 86/49
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Solvent
Regulatory List Membership (2)
EU Restricted for Children (Cosmetics)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Erythrosin.
Regulatory Flags
colorant
banned-US
restricted-EU
endocrine-concern
thyroid
eu_children_restricted
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Erythrosin by CAS number or substance name.
Studies
14
Lowest NOAEL
25 mg/kg bw/day
Highest NOAEL
4579 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
Spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one,3',6'-dihydroxy-2',4',5',7'-tetraiodo-, disodium salt
Erythrosine B
Ceplac
E 127
Erythrosine 3
Erythrosine E 127
Erythrosine Red 3
FDC Red 3
Food Red 3
Japan Food Red No. 3
Japan Red 3
Japan Red No. 3
Red 1799
Red 3
Red No. 3
C.I. ACID RED 51, (ERYTHROSIN B)
9-(o-Carboxyphenyl)-6-hydroxy-2,4,5,7-tetraiodo-3H-xanthene-3-one disodium salt monohydrate
Caswell No. 425AB
3',6-Dihydroxy-2',4',5',7'-tetraiodospiro(isobenzofuran-1(3H),9'(9H)xanthen)-one disodium salt
Disodium 9-(O-carboxyphenyl)-6-hydroxy-2,4,5,7-tetraiodo-3H-xanthen-3-one monohydrate
Chemical Function
Dye
Solvent
Regulatory Lists
Europe; Personal care - hair coloring
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - specialized bath products - bubble bath
children; Europe; Personal care - dental care - toothpaste
children; Europe; Personal care
inert_ingredient; non_food_use; Pesticides
general_foods
pharmaceutical
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; consumer_product; Substances in Products - Canada (4/2014)
Australian Status
AICIS status: listed
Frequently Asked Questions
Is Erythrosin allowed in the EU?
Erythrosin EU regulatory status: restricted. Maximum allowed concentration: 0.0025% in toothpaste only. This is based on EU Regulation 1223/2009 and its amendments.
What does Erythrosin do in cosmetics?
Erythrosin functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 16423-68-0.
What is the NOAEL for Erythrosin?
The NOAEL (No Observed Adverse Effect Level) for Erythrosin is =25 mg/kg bw/day based on a reproduction developmental study via oral route in Mouse. A total of 10 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Erythrosin used outside cosmetics?
Erythrosin also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Erythrosin 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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Moderate
Chemical family
Colorant, Hair Dyeing
Acid Red 51 (Erythrosine)
Moderate
Chemical family
Cosmetic colorant
CI 45430
Moderate
Chemical family
Colorant (red iodine-based xanthene dye)
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