Moderate Cosmetic Ingredient NOAEL Data

Acid Red 27 (Amaranth)

Also known as: FD & C Red No. 2, C.I. Acid Red 27, trisodium salt, 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-((4-sulfo-1-naphthyl)azo)-, trisodium salt, D and C Red 2, Acetacid Red 2BR (+15 more)

INCI: CI 16185

Acid Red 27 (Amaranth) (CAS 915-67-3) is a cosmetic cosmetic ingredient functioning as Cosmetic colorant. NOAEL 47 mg/kg bw/day (cross-referenced against 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 data.

View industrial chemical safety profile for CAS 915-67-3 →

Auto-generated CPSR Part A draft with source citations
Function
Cosmetic colorant
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C20H11N2Na3O10S3
MW
604.5 g/mol
EC Number
213-022-2
PubChem CID
13506
IUPAC Name
trisodium;3-hydroxy-4-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-2,7-disulfonate
InChIKey
WLDHEUZGFKACJH-UHFFFAOYSA-K

Regulatory Status

EU EU Status permitted
US US Status prohibited
US Notes Banned - FD&C Red No. 2 was banned by FDA in 1976 due to carcinogenicity concerns

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 27 (Amaranth).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Acid Red 27 (Amaranth). 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 =47 mg/kg bw/day oral Rat chronic ToxValDB_ECHA_IUCLID
NOAEL =50 mg/kg bw/day oral Mouse chronic ToxValDB_ECHA_IUCLID
NOAEL =100 mg/kg bw/day oral Mouse reproduction developmental ToxValDB_ECHA_IUCLID
NOAEL =150 mg/kg bw/day oral Rat reproduction developmental ToxValDB_ECHA_IUCLID
NOAEL =1250 mg/kg bw/day oral Rat chronic ToxValDB_ECHA_IUCLID
NOAEL =1260 mg/kg bw/day oral Rat chronic ToxValDB_ECHA_IUCLID
NOAEL =1850 mg/kg bw/day oral Mouse chronic ToxValDB_ECHA_IUCLID
NOAEL =2462 mg/kg bw/day oral Rat short-term ToxValDB_ECHA_IUCLID
NOAEL =3120 mg/kg bw/day oral Rat chronic ToxValDB_ECHA_IUCLID
NOAEL =3700 mg/kg bw/day oral Mouse chronic ToxValDB_ECHA_IUCLID

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Acid Red 27 (Amaranth) across SCCS product categories, with measured dermal absorption where available.

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
NOAEL =1250 mg/kg-day Rat oral chronic ECHA IUCLID
LD50 =6000 mg/kg Rat oral - ECHA IUCLID
LD50 >2000 mg/kg Mouse oral - ECHA IUCLID
LD50 >2000 mg/kg Mouse oral - ECHA IUCLID
LD50 >1000 mg/kg Rat oral - ECHA IUCLID
LD50 >10 mg/kg Mouse oral - ECHA IUCLID
LOEL =47 mg/kg-day Rat oral - ECHA IUCLID
LOEL =47 mg/kg-day Rat oral - ECHA IUCLID
NOAEL =1850 mg/kg-day Mouse oral - ECHA IUCLID
NOAEL =3120 mg/kg-day Rat oral - ECHA IUCLID

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
3
Volume
8, Sup 7
Evaluation Year
1987

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1350
(EC) 2013/344

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 (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1350
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
ASEAN permitted_colorant - All products

Additional Ingredient Properties

1 property record from structured ingredient metadata.

colorant
{"Common_Name": "FD&C Red No. 4", "Chemical_Name": "Ponceau SX", "CAS_Number": "4548-53-2", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "Not approved cosmetics", "EU_Status": "Not approved", "US_FDA_Status": "Not approved", "Notes": "Delisted 1976, historic only"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (4)
EU Banned in Cosmetics EU Restricted for Children (Cosmetics) FDA Substances Added to Food (EAFUS) EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Acid Red 27 (Amaranth).

Regulatory Flags

colorant eu_banned_cosmetics eu_children_restricted fda_food_additive eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Acid Red 27 (Amaranth) by CAS number or substance name.

Studies
10
Lowest NOAEL
47 mg/kg bw/day
Highest NOAEL
3700 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

FD & C Red No. 2 C.I. Acid Red 27, trisodium salt 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-((4-sulfo-1-naphthyl)azo)-, trisodium salt D and C Red 2 Acetacid Red 2BR Acid Leather Red I 2BW Acid Leather Rubine S Acilan Red SE Amaranth Extra Azo Rubine S.FQ Azorubine S Bordeaux S Extra Conc. A Export Bordeaux S Extra Pure A Calcocid Amaranth Cilefa Rubine 2B Dye FDC Red 2 EEC No. 123 EINECS 213-022-2 FD And C Red No. 2-Aluminium Lake Hexacol Amaranth B Extra

Chemical Function

Dye

Regulatory Lists

inert_ingredient; non_food_use; Pesticides children; Europe; Personal care children; Europe; Personal care - specialized bath products - bath salts children; Europe; Personal care - hair styling and care - shampoo children; Europe; Personal care - specialized bath products - bubble bath children; Europe; Personal care food_additive; Substances Added to Food (formerly EAFUS) (2/2019) banned; Europe; Personal care

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Acid Red 27 (Amaranth) safe in cosmetics?

Acid Red 27 (Amaranth) has a safety rating of "MODERATE" in our database. EU status: permitted. US status: prohibited. 10 toxicological study endpoint(s) are available in our database.

Is Acid Red 27 (Amaranth) allowed in the EU?

Acid Red 27 (Amaranth) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Acid Red 27 (Amaranth) do in cosmetics?

Acid Red 27 (Amaranth) functions as: Cosmetic colorant. It is classified as a cosmetic ingredient in our database. CAS number: 915-67-3.

What is the NOAEL for Acid Red 27 (Amaranth)?

The NOAEL (No Observed Adverse Effect Level) for Acid Red 27 (Amaranth) is =47 mg/kg bw/day based on a chronic study via oral route in Rat. A total of 10 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is Acid Red 27 (Amaranth) used outside cosmetics?

Acid Red 27 (Amaranth) also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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