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EC number: 485-350-6 | CAS number: 405095-33-2
- 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:
- April - October 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5375 (In Vitro Mammalian Chromosome Aberration)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes
- Remarks:
- This study has been performed in compliance with GLP in Switzerland, Procedures and Principles, March 1986, issued by the Swiss federal Department of the Interior and the Intercantonal Office for the Control of Medicaments.
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 485-350-6
- EC Name:
- -
- Cas Number:
- 405095-33-2
- Molecular formula:
- C15H20N6O3
- IUPAC Name:
- Carbonic acid - 1-phenylguanidine (1:2)
- Test material form:
- solid: bulk
Constituent 1
Method
- Target gene:
- not applicable, examination of metaphase cells for the presence of structural chromosome aberrations
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Cell line: CHO CCL 61
- Type and identity of media: supplemented nutrient mixture F-12
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Post mitochondrial fraction S9 from Aroclor 1254 induced rat liver.
- Test concentrations with justification for top dose:
- - Original study, first experiment, without metabolic activation: 8 concentrations, range: 25.78 - 3300 µg/ml
- Original study, second experiment, with metabolic activation: 8 concentrations, range: 25.78 - 3300 µg/ml
- Confirmatory study, first experiment, without metabolic activation: 5 concentrations, range: 25.78 - 412.5 µg/ml
- Confirmatory study, second experiment, with metabolic activation: 5 concentrations, range: 103.13 - 1650 µg/ml
- Confirmatory study, third experiment, without metabolic activation: 10 concentrations, range: 6.45 - 3300 µg/ml
- Confirmatory study, fourth experiment, with metabolic activation: 8 concentrations, range: 25.78 - 3300 µg/ml
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- two in each experiment: one supplemented with vehicle, one without any additions
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: ASTA-Werke, Germany, 20 µg/ml; with S9
- Untreated negative controls:
- yes
- Remarks:
- two in each experiment: one supplemented with vehicle, one without any additions
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: KYOWA HAKKO KOGYO Ltd., Japan, 0.2 µg/ml; without S9
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- experiments without S9: cytotoxicity with final concentrations > 412.5 or 206.5 µg/ml of culture medium, cytotoxicity; experiments with S9: cytotoxicity with final concentrations > 1650 µg/ml of culture medium
- Vehicle controls validity:
- not applicable
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
It is concluded that under the given experimental conditions no evidence of clastogenic effects was obtained in Chinese hamster ovary cells in vitro treated with CA 1139 A. - Executive summary:
CA 1139 A (Intermediate of CGA 219417), identified as a light beige crystalline powder, 76.2 % purity, batch no. P.201025, was investigated for clastogenic (chromosome-damaging) effects on Chinese Hamster ovary cells in vitro with and without extrinsic metabolic activation (S9). The compound was dissolved in culture medium (without metabolic activation) or in nutrient mixture F-12 (with metabolic activation) and tested at each of the following conditions:
Experiment without metabolic activation:
- 18 hours treatment time:
original experiment: 103.13, 206.25 and 412.5 µg/ml
confirmatory experiment: 103.13, 206.25 and 412.5 µg/ml
- 42 hours incubation time: 51.56, 103.13 and 206.65 µg/ml
Final concentrations higher than 412.5 or 206.65 µg/ml of culture medium could not be scored due to cytotoxicity. Cytotoxicity was observed at concentrations of 412.5 µg/ml and higher. Mitomycin C (0.2 µg/ml) was used as a positive control in the 18 hours experiments.
Experiment with metabolic activation:
- 3 hours treatment followed by 15 hours recovery period:
original experiment: 412.5, 825 and 1650 µg/ml;
confirmatory experiment: 412.5, 825 and 1650 µg/ml.
- 3 hours incubation followed by 39 hours recovery period: 825, 1650 and 3300 µg/ml.
Final concentrations greater than 3300 µg/ml of culture medium could not be achieved due to solubility limitations. In the 3h/15h experiments, concentrations greater than 1650 µg/ml of culture medium could not be scored due to cytotoxicity. Cyclophosphamide (20.0 µg/ml) was used as a positive control in the 3h/15h experiments.
In both the experiments performed according to OECD Guideline 473 without and with metabolic activation CA 1139 A did not induce a biologically significant increase in the number of metaphases containing specific chromosomal aberrations.
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