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EC number: 206-992-3 | CAS number: 420-04-2
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Cyanamide
- EC Number:
- 206-992-3
- EC Name:
- Cyanamide
- Cas Number:
- 420-04-2
- Molecular formula:
- CH2N2
- IUPAC Name:
- cyanamide
- Test material form:
- other: aqueous solution
- Details on test material:
- - Test material: Hydrogen cyanamide in aqueous solution
- Appearance: Clear light yellow liquid
- Purity: 53 % w/v
- Lot/Batch number: 7/07/87
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Duration of treatment / exposure:
- Exposure for 24, 48 and 72 hours at all dose levels
- Frequency of treatment:
- Daily
- Post exposure period:
- No post exposure period
Doses / concentrationsopen allclose all
- Dose / conc.:
- 35 mg/kg bw/day (nominal)
- Remarks:
- the dosis analytical found was 31.44 mg/kg bw/day
- Dose / conc.:
- 175 mg/kg bw/day (nominal)
- Remarks:
- the dosis analytical found was 157.4 mg/ kg bw/day
- Dose / conc.:
- 350 mg/kg bw/day (nominal)
- Remarks:
- the dosis analytical found was 330.5 mg/kg bw/day
- No. of animals per sex per dose:
- Five mice/sex per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- A positive control triethylenemelamine
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes and normochromatic erythrocytes from the bone marrow
- Details of tissue and slide preparation:
- Bone marrow smear slides were prepared and stained. Approximately 1000 polychromatic erythrocytes (PCE’s) were examined for the presence of micronuclei. The ratio of poly- to normochromatic erythrocytes was determined to assess inhibition of erythropoesis.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- At the high dose group 3 male animals were found dead after 5 and 20 hours, respectively. All males at this dose level had ruffled coats throughout the duration of the study. All other animals were apparently healthy until the appropriate sacrifice time.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- A dose rangefinding study was carried out to assess toxicity with dose levels of 75, 150, 300, 450 and 600 mg/kg bw. Based upon the results of this trial the dose levels selected for the micronucleus assay were 35, 175 and 350 mg/kg bw.
The stability of the test substance throughout the study period was shown by reanalysis. The homogeneity was guaranteed by mixing before preparations of the test solutions. The stability of the test substance in water was verified analytically and the following concentrations were determined: 31.44, 157.4 and 330.5 mg/kg bw.
Applicant's summary and conclusion
- Conclusions:
- Hydrogen cyanamide did not induce micronuclei in polychromatic erythrocytes of mice when orally (by gavage) treated up to 350 mg/kg body weight.
- Executive summary:
The ability of hydrogen cyanamide to cause chromosomal damage in vivo was investigated in the mouse micronucleus assay. Male and female ICR mice were dosed orally by gavage with a aqueous solution of Hydrogen cyanamide. Based upon the results of the range finding trial the dose levels selected for the micronucleus assay were 35, 175 and 350 mg/kg bw. The vehicle control as well as the positive control triethylenemelamine were also tested. The stability of the test substance throughout the study period was shown by reanalysis. The homogeneity was guaranteed by mixing before preparations of the test solutions. The stability of the test substance in water was verified analytically and the following concentrations were determined: 31.44, 157.4 and 330.5 mg/kg.
Five mice/sex were exposed for 24, 48 and 72 hours at all dose levels. Only one sampling time, 24 hours after treatment, was performed with the negative and the positive control. A second group of animals was also assigned to the study and was dosed with the high dose of the test article. These animals were only used in the assay as replacements for any which died in the primary dose group.
Bone marrow smear slides were prepared and stained. Approximately 1000 polychromatic erythrocytes (PCE’s) were examined for the presence of micronuclei. The ratio of poly- to normochromatic erythrocytes was determined to assess inhibition of erythropoesis and all animals were examined after dosing and periodically throughout the duration of the study for toxic effects and/or mortalities.
At the high dose group 3 male animals were found dead after 5 and 20 hours, respectively. All males at this dose level had ruffled coats throughout the duration of the study. All other animals were apparently healthy until the appropriate sacrifice time. No significant changes in the ration of NCE´s to PCE´s were observed. The test substance, hydrogen cyanamide, induced no significant increases in micronucleated polychromatic erythrocytes over the levels observed in the negative controls in either sex or at any sampling interval. The positive control, triethylenmelamine, induced significant increases in micronucleated PCEs in both sexes.
It can be concluded that hydrogen cyanamide did not induce micronuclei in polychromatic erythrocytes of mice when orally (by gavage) treated up to 350 mg/kg body weight.
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