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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: public available literature (non GLP, non guideline)
Data source
Reference
- Reference Type:
- publication
- Title:
- The Chernoff-Kavlock Assay: Its Validation and Application in Rats.
- Author:
- Wickramaratne, G.A. de S.
- Year:
- 1 987
- Bibliographic source:
- Teratogenesis, Carcinogenesis, and Mutagenesis 7, 73-83
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- 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: Alpk:AP (Wistar -derived)
- Details on test animals or test system and environmental conditions:
- Housing was under SPF conditions, the dams being singly housed in mesh cages with potable water and food available ad libitum. From day 18 of gestation, the cages were fitted with solid bottoms, and the dams were provided with nesting material.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- Administration by gavage, the volume being adjusted to administer 10 mL/kg bodyweight on the daily bodyweight.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data on analytical verification of doses
- Details on mating procedure:
- Day 1 of gestation was defined as the day on which a sperm-positive vaginal smear was observed.
- Duration of treatment / exposure:
- Dosing was done over the period days 7-17 inclusive gestation.
- Frequency of treatment:
- daily
- Duration of test:
- Dams: 22 days (gestation)
Litters: 5 days
- No. of animals per sex per dose:
- 9 female rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- During validation of a Screening Assay (Chernoff-Kavlock Assay) modified for studies on rats methenamine was investigated with a group of 9 female rats treated orally (gavage) during gestation day 7 to 17 with daily doses of 1000 mg/kg bw.
Examinations
- Maternal examinations:
- - vaginal smear
- observation of body weight on day 1, 7-17 and 22
- Number of pregnant rats
- mortality - Ovaries and uterine content:
- not examined.
- Fetal examinations:
- - mean litter size
- total and mean number of live pups on day 1 and 5
- percentage survival
- Mean pup weight on day 1 and 5
- Mean weight gain per litter (days 1-5) - Statistics:
- standard deviation
Criteria for Assessment of results:
A set of three rules was drawn up on an empirical basis to assess the results. The rules are based on both the results of the validation phase and the background data on reproductive parameters for the strain. The rules are:
1) no effect on litter size, survival, or postnatal weight gain - negative
2) reduced litter size at birth (mean less than 8) or reduced postnatal survival (less than 80%)- potential teratogen
3) reduced postnatal weight gain (less than 30%) with no reduction in survival - potential foetotoxin - Indices:
- not calculated.
- Historical control data:
- No data available (validation of study).
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
In comparison to the concurrent control group a reduced weight gain was observed in treated maternal animals, indicating some toxicity or at least adverse effects of the treatment.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Basis for effect level:
- mortality
- Remarks on result:
- other: no data
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Compared with the controls, the 5 pregnant dams of the treated group showed no difference in mean litter size, survival of pups and pup postnatal weight gain. However, the number of dams for which offspring could be evaluated is poor, and it is not discussed and no information is given in this study to explain, why only 5 out of 9 sperm-positive dams produced litters in the test group.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: teratogenicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a Chernoff-Kavlock assay in rats methenamine was shown to be not teratogenic and not fetotoxic at a limit concentration of 1000 mg/kg bw/day, revealed some indication for systemic toxicity under the given test conditions in the dams.
- Executive summary:
During validation of a Screening Assay (Chernoff-Kavlock Assay) modified for studies on rats methenamine was investigated with a group of 9 female rats treated orally (gavage) during g.d. 7 to 17 with daily doses of 1000 mg/kg bw.
In comparison to the concurrent control group a reduced weight gain was observed in treated dams.
Compared with the controls, the 5 pregnant dams of the treated group showed no difference in mean litter size, survival of pups and pup postnatal weight gain. However, the number of dams for which offspring could be evaluated is poor, and it is not discussed and no information is given in this study to explain, why only 5 out of 9 sperm-positive dams produced litters.
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