Is Cetylpyridinium Chloride safe in cosmetics?
Cetylpyridinium Chloride has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Cetylpyridinium Chloride
Also known as: Pyridinium, 1-hexadecyl-, chloride, Caswell No. 166A, Ceeprin chloride, Cetyl pyridinium chloride, Cetylpyridini chloridum (+8 more)
INCI: CETYLPYRIDINIUM CHLORIDE
Cetylpyridinium Chloride (CAS 123-03-5) is a cosmetic cosmetic ingredient functioning as Preservative, antimicrobial, oral care agent. NOAEL 2.5 mg/kg bw/day (primary-source verified against the SCCS opinion); 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, pharmaceutical, and food safety data.
Cross-Vertical Regulatory Divergence
Cetylpyridinium Chloride is classified GHS Danger (H301, H302, H315, H318, H330, H335, H400, H410) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu status; Chemicals: ghs classifications.signal word/hazard statement code
Function
Preservative, antimicrobial, oral care agent
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
1-hexadecylpyridin-1-ium chloride
InChIKey
YMKDRGPMQRFJGP-UHFFFAOYSA-M
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA-approved as OTC active ingredient in oral antiseptic products; permitted in cosmetics with no specific restriction under 21 CFR
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Cetylpyridinium Chloride.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Cetylpyridinium Chloride. 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 | =2.5 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =2.5 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =2.5 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =2.5 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =15 mg/kg bw/day | - | - | NOAEL study | SCCS Opinion |
| NOAEL | =15 mg/kg/day | oral | rat | developmental toxicity | SCCS Opinion |
| NOAEL | =15 mg/kg bw/day | - | - | NOAEL study | SCCS Opinion |
| NOAEL | =15 mg/kg/day | oral | rat | developmental toxicity | SCCS Opinion |
| NOAEL | =15 mg/kg bw/day | - | - | NOAEL study | SCCS Opinion |
| NOAEL | =15 mg/kg/day | oral | rat | developmental toxicity | SCCS Opinion |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Cetylpyridinium Chloride across SCCS product categories, with measured dermal absorption where available.
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
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.
KR Korea MFDS Annex 2 (Restricted)
Category: Preservative. Max: 0.08%. —
JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 1.0
Japan (Restricted): max Wash-away: 5.0% | Leave-on: 1.0% | Mucosa: 0.010%
Korea (Restricted): max 0.08%
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 5.0% | Leave-on: 1.0% | Mucosa: 0.010% | Wash-away: 5.0% | Leave-on: 1.0% | Mucosa: 0.010% |
| AE | restricted | 0.1 | Oral hygiene / preservative applications |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (2 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_sccs_opinion | 10.0% | - | - | SCCS/1548/15 |
| measured_sccs_opinion | 100.0% | - | - | SCCS/1548/15 |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Skin Eye Respiratory Irritation
Mild skin irritation | A skin & eye irritant.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Biocide
Deodorizer
Emulsifier
Softener and conditioner
Surfactant (surface active agent)
Regulatory List Membership (1)
FDA Indirect Food Contact Additives
Editorial summary
Preliminary editorial summary for Cetylpyridinium Chloride — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
preservative
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Cetylpyridinium Chloride by CAS number or substance name.
Studies
38
Lowest NOAEL
2.5
Highest NOAEL
250
Units vary across source rows: mg/kg bw/day, mg/kg/day
SCCS Opinion
ECHA
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 10.0% | SCCS opinion extraction | - |
| 100.0% | SCCS PDF direct extraction | - |
Known Synonyms
Pyridinium, 1-hexadecyl-, chloride
Caswell No. 166A
Ceeprin chloride
Cetyl pyridinium chloride
Cetylpyridini chloridum
EINECS 204-593-9
EPA Pesticide Chemical Code 069160
NSC 14864
Swabettes Hoechst
Cetilpiridinio cloruro
Cetylpyridinii chloridum
UNII-6BR7T22E2S
cetylpyridinium chloride anhydrous
Chemical Function
Surfactant (surface active agent)
Biocide
Anti-static agent
Deodorizer
Emulsifier
Softener and conditioner
Regulatory Lists
pharmaceutical
CEDI
Indirect additives food contact (10/2018)
active_ingredient; Europe; 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
CHEMBL34833
SOURCE
EFSA / FDA GRAS
fda_gras_enriched
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Cetylpyridinium chloride
FDA GRAS
At the notifier's request, FDA ceased to evaluate this notice
GRN
31
Use on raw and fully cooked foods including, poultry, red meat, fish and shellfish, eggs, fruits, vegetables, cereal grains, nutmeats, and dairy products as an antimicrobial agent at levels not to exceed 1.0 percent
View full food safety profile →Frequently Asked Questions
Is Cetylpyridinium Chloride allowed in the EU?
Cetylpyridinium Chloride EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Cetylpyridinium Chloride do in cosmetics?
Cetylpyridinium Chloride functions as: Preservative, antimicrobial, oral care agent. It is classified as a cosmetic ingredient in our database. CAS number: 123-03-5.
What is the NOAEL for Cetylpyridinium Chloride?
The NOAEL (No Observed Adverse Effect Level) for Cetylpyridinium Chloride is =2.5 mg/kg bw/day based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.
Is Cetylpyridinium Chloride used outside cosmetics?
Cetylpyridinium Chloride 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.
Does Cetylpyridinium Chloride have different safety status in cosmetics vs industrial chemicals?
Cetylpyridinium Chloride is classified GHS Danger (H301, H302, H315, H318, H330, H335, H400, H410) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
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Ingredient Decoder
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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