Is CI 16185 safe in cosmetics?
CI 16185 has a safety rating of "MODERATE" in our database. EU status: restricted. US status: prohibited. 10 toxicological study endpoint(s) are available in our database.
CI 16185
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)
CI 16185 (CAS 915-67-3) is a cosmetic cosmetic ingredient functioning as Colorant. NOAEL 47 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted. 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
Colorant
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
trisodium;3-hydroxy-4-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-2,7-disulfonate
InChIKey
WLDHEUZGFKACJH-UHFFFAOYSA-K
Regulatory Status
EU EU Status
restricted
US US Status
prohibited
US Notes
Delisted by FDA in February 1976 (FD&C Red No. 2); banned as suspected carcinogen after studies showed increased malignant tumors in female rats at high doses; 21 CFR 81.10 and 81.30
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 16185.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for CI 16185. 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 CI 16185 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 CI 16185.
Regulatory Flags
azo-dye
banned-in-us
eu-restricted
potential-carcinogen
not-for-hair-dye
synthetic-colorant
eu_children_restricted
eu_banned_cosmetics
fda_food_additive
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 16185 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 CI 16185 allowed in the EU?
CI 16185 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 16185 do in cosmetics?
CI 16185 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 915-67-3.
What is the NOAEL for CI 16185?
The NOAEL (No Observed Adverse Effect Level) for CI 16185 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 CI 16185 used outside cosmetics?
CI 16185 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 CI 16185 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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