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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: public available study ( non GLP, non guideline)
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmacokinetics of methenamine in healthy volunteers.
- Author:
- Klinge, E., Männistö, P., Mäntylä, R., Lamminsivu, U., Ottoila, P.
- Year:
- 1 982
- Bibliographic source:
- J. Antimicrobial. Chemotherapy 9, 209-216
Materials and methods
- Objective of study:
- absorption
- excretion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Public available literature. No guideline indicated. For details on method see materials and methods section.
- GLP compliance:
- not specified
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
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Ten healthy volunteers participated in the study. Six of them were women (mean age 30 years, range 24-42, mean weight 57 kg, range 50-65) and four men (mean age 27 years, range 21-34; mean weight 67 kg, range 59-79).
Administration / exposure
- Route of administration:
- other: oral: tablets
- Vehicle:
- not specified
- Details on exposure:
- Subjects received methenamine hippurate via tablet.
- Duration and frequency of treatment / exposure:
- The study consisted of two eight-day periods between which there was an interval of a week. The subjects took in a cross-over design, one tablet at 8 a.m. on the first morning, and from the second morning onwards one tablet at 8 a.m. and 8 p.m. The last tablet was taken on the 7th day at 8 a.m.. On the 1st, 6th and 7th morning the tablet was taken on an empty stomach after night of fasting and eating was not permitted until 10 a.m., but the subjects drank 250 mL water at 7 a.m. and 200 mL at 8, 9, 10 and 12 a.m. There were no dietary restrictions on the other days.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg methenamine hippurate per dose (see above).
- No. of animals per sex per dose / concentration:
- 6 females and 4 males
- Control animals:
- no
- Positive control reference chemical:
- no positive control
- Details on study design:
- see above
- Details on dosing and sampling:
- On the 1st, 6th and 7th day blood samples were withdrawn 0.25, 0.5, 1, 2, 4, 6, 8 and 12 h after ingestion of the tablet. Urine was collected on the 1st and 7th day in fractions of 0-2, 2-4, 4-6,6-12 and 12-24 h. On the 6th day the first fraction was omitted. The pH of the fractions was determined.
Methenamine itself was determined by gas chromatography from serum and urine samples. - Statistics:
- Students t-test
Results and discussion
- Preliminary studies:
- no preliminary study
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The mean halflife in blood was reported as 4.3 h (range 2.8 - 6.0 h). The distribution volume was 0.56 l/kg.
- Details on excretion:
- On successive daily application approximately 90% of the dose was excreted in the urine during each 12 h dosing interval.
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 4.3 h
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: 183 mg/L * h
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- not examined.
Applicant's summary and conclusion
- Conclusions:
- no bioaccumulation potential based on study results
Methenamine is excreted very fast. No bioaccumulation is expected. - Executive summary:
In a well documented pharmacokinetic study, ten healthy volunteers, 6 women and 4 men, were given two formulations of methenamine hippurate as a single dose (1 g, about 450 mg base) on the first day and thereafter 1 g twice daily for 8 d, and - after a treatment-free period of one week - the second formulation was administered for another 8 d. After a single dose maximum serum concentration was achieved in about 1 h. The mean half life in blood was reported as 4.3 h. The distribution volume was 0.56 l/kg. On successive daily application approximately 90% of the dose was excreted in the urine during each 12 h dosing interval. Methenamine itself was determined by gas chromatography from serum and urine samples.
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