Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: public available literature (non GLP, no guideline)
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity of hexamethylenetetraamine.
- Author:
- Girmanova, I., Chalupa, I., Sekerka, V.
- Year:
- 1 991
- Bibliographic source:
- Biologia (Bratislava), 46, 11, 1009-1015
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Sister chromatid exchange was measured additionally
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
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
Method
- Target gene:
- not applicable, chromosome aberration test
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 0.1, 1, 10, 50 mmol/L
- Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- incubation time: 20 h (Chromosome aberration), 30 h (Sister chromatid exchanges)
- Evaluation criteria:
- 100 metaphases from two replicates were evaluated.
- Statistics:
- Student t-test
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- strong cytotoxic effect at a concentration of 50 mmol/L
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Chromosome aberrations:
In the highest analysable concentration of 10 mmol/l 7% aberrant cells (without gaps) were induced compared to 2% in control cultures. Higher doses were strongly cytotoxic.
Sister chromatid exchanges:
Slightly increased SCE frequencies were described after treatment of V79 cells with 10 and 50 mmol/l methenamine.
Historical control data and other critical parameters at high concentrations (osmolarity, pH) not reported.
Applicant's summary and conclusion
- Conclusions:
- Methenamine induced chromosome aberrations in the highest analysable concentration of 10 mmol/L. Slightly increased Sister Chromatid Exchange frequencies were also described after treatment of V79 cells with 10 and 50 mmol/L methenamine.
- Executive summary:
In a mammalian cell cytogenetics assay (Chromosome aberration (CA) and Sister Chromatid Exchanges (SCE)), V79 cell cultures were exposed to methenamine in water at concentrations of 0, 0.1, 1, 10, 50 mmol/L without metabolic activation.
Methenamine was tested up to cytotoxic concentration. In the highest analysable concentration of 10 mmol/l 7% aberrant cells (without gaps) were induced compared to 2% in control cultures. Higher doses were strongly cytotoxic. Only one experiment without S-9 mix was done. In the same publication slightly increased SCE frequencies were described after treatment of V79 cells with 10 and 50 mmol/l methenamine. Positive controls induced the appropriate response. There was a concentration related positive response of Chromosome aberration and SCE induced over background.
This study is classified as acceptable but due to missing data about cytotoxicity a final evaluation is difficult. This study satisfies the requirement for Test Guideline (OECD 473, EU B.10 and in vitro sister chromatid exchange assay in V79 cells) for in vitro cytogenetic mutagenicity data.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.