Is CI 16035 (Allura Red AC) safe in cosmetics?
CI 16035 (Allura Red AC) has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
CI 16035 (Allura Red AC)
Also known as: 2-Naphthalenesulfonic acid, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-, disodium salt, FD&C Red no.40, C.I. Food Red 17, C. I. 16035, Allura Red AC Dye (+7 more)
INCI: CI 16035
CI 16035 (Allura Red AC) (CAS 25956-17-6) is a cosmetic colorant functioning as Colorant, Hair Dyeing Agent. NOAEL 7300 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.4% (hair dye use only). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
View industrial chemical safety profile for CAS 25956-17-6 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant, Hair Dyeing Agent
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
disodium;6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
InChIKey
CEZCCHQBSQPRMU-UHFFFAOYSA-L
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.4% (hair dye use only)
US US Status
permitted
US Notes
Listed as FD&C Red No. 40. Permanently listed color additive. FDA batch certification required for each lot. Permitted in foods, drugs, and cosmetics generally, including eye area and lip products (aluminum lake form also permitted for eye area). Separate from EU nomenclature — labeling must use CI 16035 in EU, FD&C Red No. 40 in US context.
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 16035 (Allura Red AC).
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for CI 16035 (Allura Red AC). 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 | 125 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
| NOAEL | 200 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 250 mg/kg bw/day | oral | dog | Short Term Toxicity | COSMOS_DB |
| NOAEL | 700 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 939.3 mg/kg bw/day | oral | rat | Reproductive-developmental | COSMOS_DB |
| NOAEL | 1500 mg/kg bw/day | oral | swine | Short Term Toxicity | COSMOS_DB |
| NOAEL | =10 mg/kg bw/day | oral: feed | Mouse | reproduction toxicity | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
| NOAEL | =10 mg/kg bw/day | oral: feed | Mouse | reproduction toxicity | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
| NOAEL | =7 mg/kg bw/day | oral | - | carcinogenicity | SCCNFP_vision_codex |
| NOAEL | =7 mg/kg bw/day | oral | - | carcinogenicity | SCCNFP_vision_codex |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for CI 16035 (Allura Red AC) 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 | =901 mg/kg-day | Rat | oral | chronic | ECHA IUCLID |
| NOAEL | =2829 mg/kg-day | Rat | oral | chronic | ECHA IUCLID |
| LD50 | >10000 mg/kg | Rabbit | dermal | - | ECHA IUCLID |
| LD50 | >10000 mg/kg | Rabbit | dermal | - | ECHA IUCLID |
| NOAEL | =260.2 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =260.2 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =200 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =200 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =260.2 mg/kg-day | Rat | oral | short-term | ECHA IUCLID |
| NOAEL | =200 mg/kg-day | 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
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex IV — Permitted Colorants
Product type: Red
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 (III - Restricted)
Product type: Hair dye substance in non-oxidative hair dye products. Max: 0.004.
BRIN Brazil/India Cosmetics
India: Restricted · max 0.004
India: Permitted Colorant
Additional Jurisdictional Restrictions (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_colorant | - | All cosmetics (Class 1) |
| BR | permitted_colorant | - | Column 2: All products except eye area |
| ASEAN | restricted | 0.4% | Non-oxidative hair dye products only |
| ASEAN | permitted_colorant | - | All products (non-oxidative hair dye limit 0.4% Annex III) |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "FD&C Red No. 40", "Chemical_Name": "Allura Red AC", "CAS_Number": "25956-17-6", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved 21 CFR 74.340", "Notes": "Water-soluble, excellent stability"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Flavouring and nutrient
Fragrance
Regulatory List Membership (5)
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for CI 16035 (Allura Red AC).
Regulatory Flags
no-accepted-mos
genotoxicity-signal
azo-dye
dual-annex-listing
fda-batch-certification-required
contamination-risk
hair-dye-restricted-0.4pct
leave-on-risk-assessment-required
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 16035 (Allura Red AC) by CAS number or substance name.
Studies
38
Lowest NOAEL
7
Highest NOAEL
3750
Units vary across source rows: mg/kg bw/day, mg/kg
SCCNFP_vision_codex
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
COSMOS_DB
ToxValDB_ECHA_IUCLID
Known Synonyms
2-Naphthalenesulfonic acid, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-, disodium salt
FD&C Red no.40
C.I. Food Red 17
C. I. 16035
Allura Red AC Dye
Disodium 6-hydroxy-5-((2-methoxy-5-methyl-4-sulfophenyl)azo)-2-naphthalenesulfonate
Disodium 6-hydroxy-5-((6-methoxy-4-sulfo-m-tolyl)azo)-2-naphthalenesulfonate
EINECS 247-368-0
UNII-WZB9127XOA
Fancy Red
Japan Food Red No. 40
Japan Red 40
Chemical Function
Dye
Regulatory Lists
Europe; Personal care - hair coloring
IFRA Transparency
inert_ingredient; non_food_use; Pesticides
Arts and crafts/Office supplies - body paint - tattoo ink; Europe
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - body hygiene - body wash
children; Europe; Personal care - hair styling and care - shampoo
children; Europe; Personal care - specialized bath products - bubble bath
children; Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
Europe; Personal care; restricted
SCIL (9/2019)
inert_ingredient; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
ChEMBL ID
CHEMBL3188816
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Allura Red AC (FD&C Red 40)
E Number
E129
ADI
7 mg/kg bw
Food Category
colorant
Frequently Asked Questions
Is CI 16035 (Allura Red AC) allowed in the EU?
CI 16035 (Allura Red AC) EU regulatory status: restricted. Maximum allowed concentration: 0.4% (hair dye use only). This is based on EU Regulation 1223/2009 and its amendments.
What does CI 16035 (Allura Red AC) do in cosmetics?
CI 16035 (Allura Red AC) functions as: Colorant, Hair Dyeing Agent. It is classified as a Colorant in our database. CAS number: 25956-17-6.
What is the NOAEL for CI 16035 (Allura Red AC)?
The NOAEL (No Observed Adverse Effect Level) for CI 16035 (Allura Red AC) is 125 mg/kg bw/day based on a Subchronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is CI 16035 (Allura Red AC) used outside cosmetics?
CI 16035 (Allura Red AC) also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check CI 16035 (Allura Red AC) 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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