Is Methenamine safe in cosmetics?
Methenamine has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 6 toxicological study endpoint(s) are available in our database.
Methenamine
Also known as: Urotropine, Hexamethylenetetramine, 1,3,5,7-Tetraazatricyclo[3.3.1.13,7]decane, Aminoformaldehyde, Ammonioformaldehyde (+15 more)
INCI: METHENAMINE
Methenamine (CAS 100-97-0) is a cosmetic cosmetic ingredient functioning as Preservative, Antimicrobial (formaldehyde releaser). NOAEL 25 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.16%. 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
Methenamine is classified GHS Danger (H228, H317, H334, H316, H320, H361, H372) in the chemicals database but is restricted in EU cosmetics at max 0.16%.
Source: Cosmetics: ingredients.eu status/eu max; Chemicals: ghs classifications.signal word/hazard statement code
Function
Preservative, Antimicrobial (formaldehyde releaser)
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
1,3,5,7-tetrazatricyclo[3.3.1.13,7]decane
InChIKey
VKYKSIONXSXAKP-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.16%
US US Status
permitted
US Notes
Allowed - No specific prohibition; subject to general safety requirements
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Methenamine.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
6 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 | =80 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =100 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =1130 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =1570 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =2500 mg/kg bw/day | oral | Mouse | chronic | ECHA |
| NOAEL | =12500 mg/kg bw/day | oral | Mouse | chronic | ECHA |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance is mildly irritating to the eyes and skin.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation may cause asthma.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Methenamine across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for Methenamine based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.5%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis
Source: FDA
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
FlammableHarmful / Irritant
Hazard Class and Category
Flam. Sol. 2; Skin Sens. 1
Hazard Statements
- H228 Flammable solid
- H317 May cause an allergic skin reaction
Inserted via ATP: ATP01
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex V — Permitted Preservatives
Max: 0.15%
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: 0.15%. —
SA Saudi SFDA (V - Preservatives)
Max: 0.0015.
BRIN Brazil/India Cosmetics
Brazil: Permitted Preservative · max 0,15%
India: Permitted Preservative · max 0.0015
Additional Jurisdictional Restrictions (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | banned | - | - |
| IN | permitted_preservative | 0.15 | all cosmetics |
| BR | permitted_preservative | 0.15 | - |
| ASEAN | permitted_preservative | 0.15% | All products |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (3)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
ICSC Safety Card
1228
Source: WHO/JECFA
Skin Eye Respiratory Irritation
An irritant to skin, eyes, and mucous membranes.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (2)
JECFA Evaluation
HEXAMETHYLENETETRAMINE | 1973 | 0-0.15 mg/kg bw | NMRS 53/TRS 539-JECFA 17/17 | FAS 5/NMRS 53A-JECFA 17/63
Source: WHO/JECFA
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Adhesion/cohesion promoter
Catalyst
Chemical reaction regulator
Dispersing agent
Preservative
Regulatory List Membership (3)
EU Regulated in Personal Care
FDA Indirect Food Contact Additives
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Methenamine — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
potential-allergen
preservative
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Methenamine by CAS number or substance name.
Studies
6
Lowest NOAEL
80 mg/kg bw/day
Highest NOAEL
1.250e+4 mg/kg bw/day
ECHA
Known Synonyms
Urotropine
Hexamethylenetetramine
1,3,5,7-Tetraazatricyclo[3.3.1.13,7]decane
Aminoformaldehyde
Ammonioformaldehyde
Caswell No. 482
Cystamin
EINECS 202-905-8
EPA Pesticide Chemical Code 045501
Hexaloids
Hexamethylenetetraamine
Hexamethylenetetraminum
Hexamethylentetramine
Hexilmethylenamine
Metramine
Resotropin
1,3,5,7-Tetraazatricyclo (3.3.1.1(3,7))decane
1,3,5,7-Tetraazatricyclo(3.3.1.1(sup 37))decane
Esametilentetramina
Methenaminum
Chemical Function
Preservative
Catalyst
Chemical reaction regulator
Dispersing agent
Adhesion/cohesion promoter
Regulatory Lists
Arts and crafts/Office supplies - fabric treatment and dye; detected; Europe
active_ingredient; Europe; Pesticides
drinking_water; Europe; manufacturing; plastic_additive
inert_ingredient; non_food_use; Pesticides
CEDI
Indirect additives food contact (10/2018)
Arts and crafts/Office supplies - fabric treatment and dye; detected
active_ingredient; Australia
Arts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; detected; Europe
Arts and crafts/Office supplies - home office - pens and markers; detected; Europe
pharmaceutical
Arts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; Europe
Canada; pharmaceutical
Europe; Personal care
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.
Compound
METHENAMINE
ChEMBL ID
CHEMBL1201270
Max Phase
4
Adverse Event Associations
177
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Hexamethylenetetramine
E Number
E239
ADI
0.15 mg/kg bw
Food Category
preservative
Frequently Asked Questions
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 NOAEL for Methenamine?
The NOAEL (No Observed Adverse Effect Level) for Methenamine is =80 mg/kg bw/day based on a chronic study via oral route in Rat. A total of 6 study endpoints are available. Source: ECHA.
Is Methenamine used outside cosmetics?
Methenamine 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 Methenamine have different safety status in cosmetics vs industrial chemicals?
Methenamine is classified GHS Danger (H228, H317, H334, H316, H320, H361, H372) in the chemicals database but is restricted in EU cosmetics at max 0.16%.
Compliance Tools
Check Methenamine compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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
Compare limits across jurisdictions
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