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EC number: 202-905-8 | CAS number: 100-97-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1961
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: old public available literature (non GLP, non guideline). Route of exposure and dose regime not relevant.
Data source
Reference
- Reference Type:
- publication
- Title:
- Untersuchungen an Ratten zur Verträglichkeit von Hexamethylentetramin.
- Author:
- Brendel, R.
- Year:
- 1 964
- Bibliographic source:
- Arzneimittel-Forsch. 14, 51-53
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Public available literature. No guideline indicated. For details on method see IUCLID5 materials and methods section.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Methenamine
- EC Number:
- 202-905-8
- EC Name:
- Methenamine
- Cas Number:
- 100-97-0
- Molecular formula:
- C6H12N4
- IUPAC Name:
- 1,3,5,7-tetraazatricyclo[3.3.1.1³,⁷]decane
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: BD II (cPah)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Forschung. und Untersuchungsinstitut für Milchvitaminierung, Frankfurt am main, Germany
- Age at study initiation: 90 day study: 2-2.5 months; 333 day study: 6 weeks
- Housing: separated by sex
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- water
- Details on exposure:
- Each of 5 male and 5 female BD (cPah) rats received intramuscular injections of 0, or 200 mg/d methenamine for 90 days.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, or 200 mg/d methenamine (about 800 mg/kg bw/d in males and 1100 mg/kg bw/d in females, calculated on an assumed mean body weight of 250 g for male rats and 180 g for females)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Each of 5 male and 5 female BD (cPah) rats received intramuscular injections of 0, or 200 mg/d methenamine for 90 days (about 800 mg/kg bw/d in males and 1100 mg/kg bw/d in females, calculated on an assumed mean body weight of 250 g for male rats and 180 g for females, purity unspecified).
Examinations
- Observations and examinations performed and frequency:
- Parameters observed: mortality, clinical signs, behaviour, body weight gain and feed consumption
There were no data on hematology and clinical biochemistry. - Sacrifice and pathology:
- Macroscopic and histopathological observations
- Other examinations:
- none
- Statistics:
- none
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No differences from controls in behaviour, body weight gain and feed consumption in rats of both sexes were observed. The only clinical sign observed in animals of both sexes treated with methenamine was a citrus-yellow discoloration of the hair coat. No treatment-related macroscopic or histopathological findings were available.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: no adverse effects observed.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 100 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: no adverse effects observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, about 800 mg/kg bw/d in males and 1100 mg/kg bw/d in females are considered to be the no observed- adverse-effect-level (NOAELsys) for methenamine by intramuscular injection for 90 days.
- Executive summary:
Each of 5 male and 5 female BD (cPah) rats received intramuscular injections of 0, or 200 mg/d methenamine for 90 days (about 800 mg/kg bw/d in males and 1100 mg/kg bw/d in females, calculated on an assumed mean body weight of 250 g for male rats and 180 g for females, purity unspecified). There were no data on hematology and clinical biochemistry. No differences from controls in behaviour, body weight gain and feed consumption in rats of both sexes were observed. The only clinical sign observed in animals of both sexes treated with methenamine was a citrus-yellow discoloration of the hair coat. No treatment-related macroscopic or histopathological findings were available. Based on the results of this study, about 800 mg/kg bw/d in males and 1100 mg/kg bw/d in females are considered to be the no observed- adverse-effect-level (NOAELsys) for methenamine by intramuscular injection for 90 days.
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