Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for Cetrimonium Bromide. 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 |
|---|---|---|---|---|---|
| LOAEL | 10 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| NOAEL | 50 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 10 mg/kg bw/day | oral | rat | oral | REACH |
Sensitization Profile
Contact sensitization data for Cetrimonium Bromide based on clinical patch test studies and IFRA standards.
Source: IVDK
Expert Verdict
Well-established cationic preservative and conditioner restricted in EU Annex V at 0.1% as preservative with higher limits for rinse-off and leave-on applications. SCCS margin of safety 192 for leave-on formulations. All mutagenicity assays negative.
Regulatory Flags
Frequently Asked Questions
Is Cetrimonium Bromide safe in cosmetics?
Well-established cationic preservative and conditioner restricted in EU Annex V at 0.1% as preservative with higher limits for rinse-off and leave-on applications. SCCS margin of safety 192 for leave-on formulations. All mutagenicity assays negative. The EU classifies Cetrimonium Bromide as "restricted". Safety rating: GOOD. 3 toxicological study endpoint(s) are available in our database.
Is Cetrimonium Bromide allowed in the EU?
Cetrimonium Bromide EU regulatory status: restricted. Maximum allowed concentration: 0.1% as preservative (Annex V Entry 44); rinse-off up to 2.5%; leave-on hair up to 1.0%; leave-on face up to 0.5%. This is based on EU Regulation 1223/2009 and its amendments.
What does Cetrimonium Bromide do in cosmetics?
Cetrimonium Bromide functions as: Preservative, Antistatic Agent, Surfactant, Hair Conditioning Agent. It is classified as a Preservative in our database. CAS number: 57-09-0.
What is the Margin of Safety for Cetrimonium Bromide?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Cetrimonium Bromide?
The NOAEL (No Observed Adverse Effect Level) for Cetrimonium Bromide is 10 mg/kg bw/day based on a dermal study via dermal route in code:3484. A total of 3 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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