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EC number: 209-143-5 | CAS number: 556-88-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 November 2013 - 02 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1-nitroguanidine
- EC Number:
- 209-143-5
- EC Name:
- 1-nitroguanidine
- Cas Number:
- 556-88-7
- Molecular formula:
- CH4N4O2
- IUPAC Name:
- N-nitroguanidine
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- Na2O4S
- IUPAC Name:
- disodium sulfate
- Reference substance name:
- Sodium nitrate
- EC Number:
- 231-554-3
- EC Name:
- Sodium nitrate
- Cas Number:
- 7631-99-4
- Molecular formula:
- HNO3.Na
- IUPAC Name:
- sodium nitrate
- Reference substance name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- EC Number:
- 211-455-1
- EC Name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- Cas Number:
- 645-92-1
- Molecular formula:
- C3H5N5O
- IUPAC Name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- Reference substance name:
- 6-amino-1,3,5-triazine-2,4(1H,3H)-dione
- EC Number:
- 211-456-7
- EC Name:
- 6-amino-1,3,5-triazine-2,4(1H,3H)-dione
- Cas Number:
- 645-93-2
- Molecular formula:
- C3H4N4O2
- IUPAC Name:
- 6-amino-1,3,5-triazine-2,4(1H,3H)-dione
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
additive 1
- Specific details on test material used for the study:
- Test substance supplier NIgu Chemie GmbH
Los 3286
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human peripheral blood
- Details on mammalian cell type (if applicable):
- - collected from a single donor who was a healthy, non-smoking individual with no kown recent exposures to pharmaceuticals, genotoxic chemicals, or radiation
- drawn by venous puncture and collected in heparinized tubes
- blood was stored under sterile conditions at 4 derees C for a maximium of 4 hours
- whole blood samples treated with an anti-coagulant were pre-cultured in the presence of mitogen - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- without: EMS; with: CPA
- Test concentrations with justification for top dose:
- -Experiment 1: without metabolic activation - 15, 20, 180, 360, 750, 1250, 2500, 3000, 4000, 5000 ug/mL
-Experiment 1: with metabolic activation - 180, 360, 750, 1250, 2500, 3000, 3500, 4000, 5000 ug/mL
-Experiment 2: without metabolic activation - 750, 1250, 2500, 3000, 3500, 4000, 4500, 5000 ug/mL
-Experiment 2: with metabolic activation - 500, 1000, 2000, 3500, 4500, 5000 ug/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: RPMI + 0 % fetal bovine serum
- Justification for choice of solvent/vehicle: based on the results of the solubility test cell culture medium cell culture medium was used as a solvent
Controls
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Experiment 1: without and with metabolic activation, 4h treatment, 24h preparation interval - 1250, 2500, 5000 ug/mL
- Experiment 2: without metabolic activation, 24h treatment, 24h preparation interval - 1250, 2500, 5000 ug/mL
- Experiment 2: with metabolic activation, 4h treatment, 24h preparation interval - 1000, 2000, 5000 ug/mL
- at least 3 analysable concentratiosn of hte test item were used for the 24 h preparation
DETERMINATION OF CYTOTOXICITY
- Method: proliferation index, mitotic index - Evaluation criteria:
- The chromosomal aberration assay is considered acceptable if:
- The number of aberration found in the negative and/or solvent controls fall within the range of historical laboratory control data: 0-4 % (without and with metabolic activation)
- The positive control substance should produce biologically relevant increases in the number of cells with structural chromosome aberrations
Criteria for determining a positive result:
- A clear and dose-related increase in the number of cells with aberrations
- A biologically relevant response for at least one dose group, which is higher than the laboratory negative control range (0-4 % without and with metabolic activation) - Statistics:
- - Statistical significance (P < 0.05) was determined by Fischer's exact test
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: human peripheral blood
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- The test substance precipitates at 2 and 5 mg, therefore there is no genotoxicity up to the maximum solubility.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment 2, with and without metabolic activation, a biologically relevant decrease of the relative mitotic index was seen at 5000 ug/mL.
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Nitroguanidine did not induce structural chromosomal aberrations in human lymphocytes and is therefore considered non-clastogenic. Furthermore, the test substance precipitates at 2 and 5 mg, therefore there is no genotoxicity up to the maximum solubility.
- Executive summary:
In a mammalian cell cytogenetics chromosomal aberration assay primary human lymphocyte cultures were exposed to nitroguanidine at the following concentrations:
-Experiment 1: without metabolic activation - 15, 20, 180, 360, 750, 1250, 2500, 3000, 4000, 5000 µg/mL
-Experiment 1: with metabolic activation - 180, 360, 750, 1250, 2500, 3000, 3500, 4000, 5000 µg/mL
-Experiment 2: without metabolic activation - 750, 1250, 2500, 3000, 3500, 4000, 4500, 5000 µg/mL
-Experiment 2: with metabolic activation - 500, 1000, 2000, 3500, 4500, 5000 µg/mL
Nitroguanidine was tested up to 5000 µg/mL because the guideline recommends a maximum concentration of 5 mg/mL. Positive controls induced the appropriate response. There was no evidence of chromosomal aberration induced over background.
This study is classified as acceptable. This study satisfies the requirement of test guidelines OECD 473 (in vitro mammalian chromosome aberration test), EU method B.10 (mutagenicity - in vitro mammalian chromosome aberration test), and EPA OPPTS 870.5375 - in vitro mammalian chromosome aberration test for in vitro cytogenetic mutagenicity data.
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