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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Only 14 days of exposure instead of 28 days; Only 3 animals of each sex of the intermediate dose groups; actual concentration spaces are to narrow between the low and mid dose groups.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Gaitonde committee guidelines
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- only 3 animals of each sex of the intermediate dose groups; actual concentration spaces are to narrow between the low and mid dose groups, satellite group.
- GLP compliance:
- no
- Limit test:
- no
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 substance: Dormex (Hydrogen cyanamide, aqueous solution)
- Appearance: Light blue coloured, liquid
- Purity: 50 % w/w formulation
- Lot/Batch number: 507401
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- head only
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: Particles generated size: < 5 µm in diameter
- Details on inhalation exposure:
- The aerosol of the test substance was generated by infusing it through the nebulizer which generates particles less than 5 µm in diameter. During the exposure, samplings of the atmosphere from the inhalation chamber were done for the HPLC determination of actual concentrations of Hydrogen cyanamide.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- During the exposure, samplings of the atmosphere from the inhalation chamber were done for the HPLC determination of actual concentrations of Hydrogen cyanamide.
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- a daily treatment: 6 hours/ per day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.148 mg/L air (analytical)
- Remarks:
- range 0.0848-0.1916; nominal: 2.5 g/m³ of Hydrogen cyanamide
- Dose / conc.:
- 0.263 mg/L air (analytical)
- Remarks:
- range 0.1489-0.3270; nominal: 5 g/m³ of Hydrogen cyanamide
- Dose / conc.:
- 0.799 mg/L air (analytical)
- Remarks:
- range 0.4080-1.1184:; nominal: 9.375 g/m³ of Hydrogen cyanamide
- No. of animals per sex per dose:
- 10 rats (5 males and 5 females) were exposed to the low and high doses whereas 16 rats (8 males and 8 females) were exposed to the intermediate dose. An additional group of 8 males and 8 females served as the concurrent control group.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- On day 15 after start of the exposure 5 males and 5 females of each group were necropsied. The remaining animals (3 males and 3 females) of the control and intermediate dose group were maintained without any exposure for a further period of 2 weeks (satellite group, to investigate recovery).
- Positive control:
- No positive control
Examinations
- Observations and examinations performed and frequency:
- Animals were observed daily for mortality and/or moribundity and on hourly basis during exposure for toxic symptoms. Body weight and food consumption measurements were performed daily. Clinical pathology parameters (haematology and clinical chemistry) were determined in rats after 15 days of exposure in the main groups and after 29 days in the animals of the satellite group (control and intermediate dose).
- Sacrifice and pathology:
- On day 15 after start of the exposure 5 males and 5 females of each group were necropsied. The remaining animals (3 males and 3 females) of the control and intermediate dose group were maintained without any exposure for a further period of 2 weeks (satellite group, to investigate recovery). After the scheduled exposure regimen all animals of the low and high dose group and 5 males and 5 females each from the control and intermediate group and on day 29 the remaining animals were necropsied and the lesions were noted grossly. Organ weight evaluations (absolute and relative) and histopathological examination were performed on all animals. The same procedure was performed in the remaining animals at day 29.
- Statistics:
- The difference in body weight and organ weight between the animals of the control groups and the test substance treated groups was examined by the Student´s test criteria, p< 0.01 or p<0.05.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No mortality was observed in rats belonging to any of the groups throughout the study period. No clinical signs of toxicity were found in rats exposed to Hydrogen cyanamide.
Statistically significantly decreased body weight could be observed for all treatment groups. However, the reduction in the males showed no dose-response-relationship. The extent of body weight decrease was below 10 % for the low and high dose males as well as for the low dose females. Subsequently to a withdrawal period of another 14 days, the body weights of the satellite group (mid dose animals) were in the control range (5 % below the body weight of controls) indicating a clear recovery. Consequently, the findings in low and mid dose are considered to be not adverse.
Total food consumption was not mentioned. Clear substance-related effects were not seen in food consumption. No compound-related effects were found in haematological and blood chemistry parameters.
Several absolute and relative organ weights in all treated groups in males and females were statistical significant different from the control group.In the satellite group the absolute and relative liver and kidney was still increased in male animals. In female animals an increase in absolute and relative lung weight and an increase in relative kidney weight was obtained.
Gross pathological lesions were observed in animals of all dose groups including the controls.
Histopathological changes revealed consistent recurring lesions in the brain, liver, heart and lungs in the high dose group in both sexes.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.26 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- histopathology: non-neoplastic
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Conclusions:
- NOAEL (rat, inhalation): 0.26 mg/L / 0.2629 g/m³ (analytical concentration; active ingredient)
- Executive summary:
In a subacute inhalation study, Dormex (Hydrogen cyanamide, 50 % w/w formulation) was administered by inhalation (head only exposure) to male and female Wistar rats for 14 days. The nominal concentrations of the active ingredient, Hydrogen cyanamide were 2.5, 5 and 9.375 g/m³ to which the low, the intermediate and high dose group were exposed. 10 rats (5 males and 5 females) were exposed to the low and high doses whereas 16 rats (8 males and 8 females) were exposed to the intermediate dose. An additional group of 8 males and 8 females served as the concurrent control group. The aerosol of the test substance was generated by infusing it through the nebulizer which generates particles less than 5µm in diameter. During the exposure, samplings of the atmosphere from the inhalation chamber were done for the HPLC determination of actual concentrations of Hydrogen cyanamide. Animals were exposed for 6 hours per day, 5 days a week for 2 weeks. On day 15 after start of the exposure 5 males and 5 females of each group were necropsied. The remaining animals (3 males and 3 females) of the control and intermediate dose group were maintained without any exposure for a further period of 2 weeks (satellite group, to investigate recovery). After the scheduled exposure regimen all animals of the low and high dose group and 5 males and 5 females each from the control and intermediate group and on day 29 the remaining animals were necropsied and the lesions were noted grossly. Organ weight evaluations (absolute and relative) and histopathological examination were performed on all animals. The same procedure was performed in the remaining animals at day 29.
No mortality was observed in rats belonging to any of the groups throughout the study period. No clinical signs of toxicity were found in rats exposed to Hydrogen cyanamide.
Statistically significantly decreased body weight could be observed for all treatment groups. However, the reduction in the males showed no dose-response-relationship. The extent of body weight decrease was below 10 % for the low and high dose males as well as for the low dose females. Subsequently to a withdrawal period of another 14 days, the body weights of the satellite group (mid dose animals) were in the control range (5 % below the body weight of controls) indicating a clear recovery. Consequently, the findings in low and mid dose are considered to be not adverse.
Total food consumption was not mentioned. Clear substance-related effects were not seen in food consumption. No compound-related effects were found in haematological and blood chemistry parameters.
Several absolute and relative organ weights in all treated groups in males and females were statistical significant different from the control group.In the satellite group the absolute and relative liver and kidney was still increased in male animals. In female animals an increase in absolute and relative lung weight and an increase in relative kidney weight was obtained.
Gross pathological lesions were observed in animals of all dose groups including the controls.
Histopathological changes revealed consistent recurring lesions in the brain, liver, heart and lungs in the high dose group in both sexes.
Considering the lack of dose-response-relationship in the males and the recovery in the mid dose group, the NOAEL should be the mid dose, i.e. 0.26 mg/L.
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