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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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: public available literature (non GLP, non guideline) but good documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Non-carcinogenicity of Methenamine in Mice and Rats.
- Author:
- Della Porta, G., Colnaghi, M.I., Parmiani, G.
- Year:
- 1 968
- Bibliographic source:
- Fd. Cosmet. Toxicol. 6, 707-715
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- only one single dose, limited number of parameters investigated
- Principles of method if other than guideline:
- Public avaialble literature. No guideline indicated. For details on method see 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:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 10 weeks old, outbread Wistar rats
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- Groups of 48 male and 48 female outbred Wistar rats (10 weeks old) received 0, or 1.0% methenamine in the drinking water for 104 weeks (calculated intake 2.0-1.5 g/kg bw/d in males and 2.5-2.0 g/kg bw/d in females).
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- no analytical measurement
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- continuous (drinking water ad libitum)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, or 1.0% methenamine (calculated intake 2.0-1.5 g/kg bw/d in males and 2.5-2.0 g/kg bw/d in females)
Basis:
nominal in water
- No. of animals per sex per dose:
- 48
- Control animals:
- yes, plain diet
- Details on study design:
- Groups of 48 male and 48 female outbred Wistar rats (10 weeks old) received 0, or 1.0% methenamine in the drinking water for 104 weeks (calculated intake 2.0-1.5 g/kg bw/d in males and 2.5-2.0 g/kg bw/d in females). After the termination of treatment rats were observed for a subsequent treatment-free period of up to 3 years of age.
- Positive control:
- no positive control.
Examinations
- Observations and examinations performed and frequency:
- Animals were inspected daily and weighted every two weeks. Water intake was determined periodically (no further information). There were no data on hematology and clinical biochemistry.
- Sacrifice and pathology:
- Necropsy and microscopic examination of organ samples were carried on animals dying during the study or were killed at the end of the study.
- Other examinations:
- no other examinations.
- Statistics:
- not indicated.
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):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- 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:
- Water intake was comparable in both control and methenamine treated test groups throughout the study. Body weights showed no significant differences between controls and methenamine treated groups. At the end of the second year 84% of survivors were noted in methenamine-treated and untreated animals. In all methenamine treated rats a yellow coloration of the coat was observed. At necropsy and microscopic examination no specific pathological lesions related to methenamine treatment were observed in rats which died during the study or were sacrificed at the end of the test.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 - 2 000 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: no treatment related effects observed.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 000 - 2 500 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: no treatment related effects observed.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, >= 1.0% (calculated intake >= 2.0-1.5 g/kg bw/d in males and >= 2.5- 2.0 g/kg bw/d in females) methenamine was established as no-toxic-effect-level (NOAELsys) for outbred Wistar rats.
- Executive summary:
Groups of 48 male and 48 female outbred Wistar rats (10 weeks old) received 0, or 1.0% methenamine in the drinking water for 104 weeks (calculated intake 2.0-1.5 g/kg bw/d in males and 2.5-2.0 g/kg bw/d in females). After the termination of treatment rats were observed for a subsequent treatment-free period of up to 3 years of age. Animals were inspected daily and weighted every two weeks. Water intake was determined periodically (no further information). There were no data on hematology and clinical biochemistry. Necropsy and microscopic examination of organ samples were carried on animals dying during the study or were killed at the end of the study. Water intake was comparable in both control and methenamine treated test groups throughout the study. Body weights showed no significant differences between controls and methenamine treated groups. At the end of the second year 84% of survivors were noted in methenamine-treated and untreated animals. In all methenamine treated rats a yellow coloration of the coat was observed. At necropsy and microscopic examination no specific pathological lesions related to methenamine treatment were observed in rats which died during the study or were sacrificed at the end of the test. Based on the results of the study, >=1.0% (calculated intake >=2.0-1.5 g/kg bw/d in males and >= 2.5- 2.0 g/kg bw/d in females) methenamine was established as no-toxic-effect-level (NOAELsys) for outbred Wistar rats.
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