POOR Cosmetic Ingredient NOAEL Data

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 (ECHA); 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 and food safety data.

View industrial chemical safety profile for CAS 16423-68-0 →

CAS Number

16423-68-0

View industrial chemical safety profile →

Function

Colorant

Editorial assessment

POOR

Preliminary editorial note — not a computed safety verdict.

Chemistry & Identifiers

Formula

C20H8I4O5

835.9 g/mol

EC Number

240-474-8

PubChem CID

3259

IUPAC Name

3',6'-dihydroxy-2',4',5',7'-tetraiodospiro[2-benzofuran-3,9'-xanthene]-1-one

InChIKey

OALHHIHQOFIMEF-UHFFFAOYSA-N

ChEBI: CHEBI:61000 UNII: 8TL7LH93FM Wikidata: Q27888290

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	ECHA
NOAEL	=75 mg/kg bw/day	oral	Mouse	reproduction developmental	ECHA
NOAEL	=149 mg/kg bw/day	oral	Rat	reproduction developmental	ECHA
NOAEL	=251 mg/kg bw/day	oral	Rat	chronic	ECHA
NOAEL	=255 mg/kg bw/day	oral	Rat	reproduction developmental	ECHA
NOAEL	=472 mg/kg bw/day	oral	Rat	developmental	ECHA
NOAEL	=500 mg/kg bw/day	oral	Dog	chronic	ECHA
NOAEL	=641 mg/kg bw/day	oral	Rat	chronic	ECHA
NOAEL	=800 mg/kg bw/day	oral	Rat	reproduction developmental	ECHA
NOAEL	=1000 mg/kg bw/day	oral	Rat	reproduction developmental	ECHA

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
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
LD50	=7100 mg/kg	Rat	oral	-	ECHA
LD50	=1895 mg/kg	Rat	oral	-	ECHA
LD50	=1264 mg/kg	Mouse	oral	-	ECHA
LD50	=7400 mg/kg	Rat	oral	-	ECHA

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

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

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: WHO/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)

Editorial summary

Preliminary editorial summary for Erythrosin — not a computed safety verdict. See the sourced toxicological data above.

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

Lowest NOAEL

25 mg/kg bw/day

Highest NOAEL

4579 mg/kg bw/day

ECHA

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

Cross-Vertical Safety Context

Same-CAS public records found in food safety data.

SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name

Erythrosine (FD&C Red 3)

E Number

E127

ADI

0.1 mg/kg bw

Food Category

colorant

View full food safety profile →

Frequently Asked Questions

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.

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: ECHA.

Is Erythrosin used outside cosmetics?

Erythrosin also appears in industrial chemical safety and food 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

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82 Allergen Checker

Check for EU declarable fragrance allergens

Substance Compliance

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MoS Calculator

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Heavy Metal Limits

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ACID RED 51

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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