Methenamine
INCI: METHENAMINE
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
10 study endpoints found for Methenamine. 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 | >=1500 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 800 mg/kg bw/day | 2010 | rat | other | REACH |
| NOAEL | >=1.3 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| NOAEL | >=50 mg/kg bw/day | 2400 | code:1342 | other | REACH |
| NOAEL | >=80 mg/kg bw/day | oral | rat | oral | REACH |
| LOAEL | 5000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | >=60.65 mg/kg bw/day | oral | cat | oral | REACH |
| NOAEL | >=732 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | >=1250 mg/kg bw/day | oral | dog | oral | REACH |
| NOAEL | >=100 mg/kg bw/day | oral | rat | 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 Methenamine based on clinical patch test studies and IFRA standards.
Source: ESSCA 2019/20; IVDK; FDA
Expert Verdict
Formaldehyde releaser; formaldehyde is a known sensitizer (contact eczema) and classified carcinogen; however, expert committees (European, Danish, American) consider the low released amounts safe. Releases formaldehyde gradually in aqueous environments; release increases with higher temperature, longer storage, and varies by pH; releases less formaldehyde than diazolidinyl urea or DMDM hydantoin
Regulatory Flags
Frequently Asked Questions
Is Methenamine safe in cosmetics?
Formaldehyde releaser; formaldehyde is a known sensitizer (contact eczema) and classified carcinogen; however, expert committees (European, Danish, American) consider the low released amounts safe. Releases formaldehyde gradually in aqueous environments; release increases with higher temperature, longer storage, and varies by pH; releases less formaldehyde than diazolidinyl urea or DMDM hydantoin The EU classifies Methenamine as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.
Is Methenamine allowed in the EU?
Methenamine EU regulatory status: restricted. Maximum allowed concentration: 0.16%. This is based on EU Regulation 1223/2009 and its amendments.
What does Methenamine do in cosmetics?
Methenamine functions as: Preservative, Antimicrobial (formaldehyde releaser). It is classified as a cosmetic ingredient in our database. CAS number: 100-97-0.
What is the Margin of Safety for Methenamine?
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 Methenamine?
The NOAEL (No Observed Adverse Effect Level) for Methenamine is >=1500 mg/kg bw/day based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.
Compliance Tools
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