Is CI 16255 safe in cosmetics?
CI 16255 has a safety rating of "GOOD" in our database. EU status: permitted. US status: prohibited. 10 toxicological study endpoint(s) are available in our database.
CI 16255
Also known as: C.I. Acid Red 18, trisodium salt, Ponceau 4R, SX purple, C.I. Acid Red 28, Acilan Scarlet V3R (+15 more)
CI 16255 (CAS 2611-82-7) is a cosmetic cosmetic ingredient functioning as Colorant (red). Reported NOAEL =300 mg/kg bw/day in rat (SCCNFP_vision_codex); 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 and food safety data.
View industrial chemical safety profile for CAS 2611-82-7 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant (red)
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
trisodium;7-hydroxy-8-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-1,3-disulfonate
InChIKey
SWGJCIMEBVHMTA-UHFFFAOYSA-K
Regulatory Status
EU EU Status
permitted
US US Status
prohibited
US Notes
Not FDA-approved for cosmetics
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 16255.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for CI 16255. 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 | =300 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =300 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =300 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =300 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =500 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =500 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =500 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =500 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =1000 mg/kg | - | - | NOAEL study | SCCNFP_vision_codex |
| NOAEL | =1000 mg/kg | - | - | NOAEL study | SCCNFP_vision_codex |
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 | =70 mg/kg-day | Mouse | oral | chronic | EFSA |
| NOAEL | =1250 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1250 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1250 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1250 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| ADI | <=4 mg/kg | Human | oral | - | WHO JECFA ADI |
| NOAEL | =70 mg/kg-day | Mouse | oral | chronic | EFSA |
| LOEL | =10 mg/kg-day | Mouse | oral | acute | ECOTOX |
| NOEL | =1 mg/kg-day | Mouse | oral | acute | ECOTOX |
| LD50 | >8000 mg/kg | Rat | oral | - | ChemIDplus |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 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 (IV - Colorants)
BRIN Brazil/India Cosmetics
India: Permitted Colorant
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (1)
JECFA Evaluation
COCHINEAL RED A | 2011 | 0–4 mg/kg bw | The Committee concluded that new data do not indicate a need to revise the existing ADI of 0–4 mg/kg body weight and that dietary exposure to Ponceau 4R does not present a health concern. | TRS 966-JECFA 74/32 | FAS 18-JECFA 27/101
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (1)
EU Restricted for Children (Cosmetics)
Expert Verdict
Expert safety assessment and concern-level summary for CI 16255.
Regulatory Flags
colorant
eu_children_restricted
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 16255 by CAS number or substance name.
Studies
17
Lowest NOAEL
300
Highest NOAEL
1250
Units vary across source rows: mg/kg bw/day, mg/kg
SCCNFP_vision_codex
ToxValDB_ECHA_IUCLID
Known Synonyms
C.I. Acid Red 18, trisodium salt
Ponceau 4R
SX purple
C.I. Acid Red 28
Acilan Scarlet V3R
Crimson SX
Edicol Supra Ponceaux 4 RS
Edicol Supra Ponceaux 4RS
EINECS 220-036-2
New Coccine Extra Conc. A Export
New Coccine Extra Pure A
New Coccine Red No. 102
NSC 4301
Ponceau 4RE.FQ
Purple SX
Red Dye No. 102
1-(4-Sulpho-1-naphthylazo)-2-naphthol-6,8-disulphonic acid, trisodium salt
Zolfosol
Cerven kosenilova A
Cerven kysela 18
Chemical Function
Dye
Regulatory Lists
consumer_product; Europe
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
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 - specialized bath products - bubble bath
children; Europe; Personal care
children; Europe; Personal care
Europe; Personal care - hair styling and care - shampoo-dandruff
consumer_product; Europe
inert_ingredient; non_food_use; Pesticides
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
Ponceau 4R (Cochineal Red A)
E Number
E124
ADI
0.7 mg/kg bw
Food Category
colorant
Frequently Asked Questions
Is CI 16255 allowed in the EU?
CI 16255 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 16255 do in cosmetics?
CI 16255 functions as: Colorant (red). It is classified as a cosmetic ingredient in our database. CAS number: 2611-82-7.
What is the NOAEL for CI 16255?
The NOAEL (No Observed Adverse Effect Level) for CI 16255 is =300 mg/kg bw/day based on a repeated dose toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCNFP_vision_codex.
Is CI 16255 used outside cosmetics?
CI 16255 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 CI 16255 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
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