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
9 study endpoints found for Bronopol. 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 | 0.2 other | dermal | code:3484 | dermal | REACH |
| NOAEL | 7 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 0.2 other | dermal | code:3543 | dermal | REACH |
| NOAEL | 20 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 250 ppm | oral | rat | oral | REACH |
| LOAEL | 0.15 other | oral | rat | oral | REACH |
| NOAEL | 8 mg/kg bw/day | oral | dog | oral | REACH |
| NOEL | 0.05 other | oral | dog | oral | REACH |
| NOEL | 0.05 other | oral | dog | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Sensitization Profile
Contact sensitization data for Bronopol based on clinical patch test studies and IFRA standards.
Source: ESSCA 2019/20; IVDK; FDA
Expert Verdict
Restricted preservative with dual carcinogenic hazards: formaldehyde release and nitrosamine formation. EU limits to 0.1% with age restrictions; Washington State bans as of January 2027. Complex safety profile requires formulation-specific nitrosamine management and warrants consideration of safer alternatives.
Regulatory Flags
Frequently Asked Questions
Is Bronopol safe in cosmetics?
Restricted preservative with dual carcinogenic hazards: formaldehyde release and nitrosamine formation. EU limits to 0.1% with age restrictions; Washington State bans as of January 2027. Complex safety profile requires formulation-specific nitrosamine management and warrants consideration of safer alternatives. The EU classifies Bronopol as "restricted". Safety rating: MODERATE. 9 toxicological study endpoint(s) are available in our database.
Is Bronopol allowed in the EU?
Bronopol EU regulatory status: restricted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Bronopol do in cosmetics?
Bronopol functions as: Preservative. It is classified as a Preservative in our database. CAS number: 52-51-7.
What is the Margin of Safety for Bronopol?
not established 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 Bronopol?
The NOAEL (No Observed Adverse Effect Level) for Bronopol is 0.2 other based on a dermal study via dermal route in code:3484. A total of 9 study endpoints are available. Source: REACH.
Is Bronopol classified as hazardous under GHS?
Bronopol carries a GHS signal word of "DANGER". Hazard statements: Flammable solid Harmful if swallowed or in contact with skin Causes skin irritation Causes serious eye damage May cause respiratory irritation Very toxic to aquatic life with long lasting effects. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Compliance Tools
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Related Ingredients
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