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EC number: 206-114-9 | CAS number: 302-01-2
- 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guidelinestudy, GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- a 14-day recovery period : control and high dose animals
- Principles of method if other than guideline:
- Guideline for the 28-day repeated dose toxicity test in mammalian species (Chemical Substances Control Law of Japan)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- hydrazine monohydrate
- Cas Number:
- 7803-57-8
- Molecular formula:
- H4N2*H2O
- IUPAC Name:
- hydrazine monohydrate
- Reference substance name:
- hydrazine hydrate
- IUPAC Name:
- hydrazine hydrate
- Details on test material:
- IUCLID4 Test substance: other TS: hydrazine monohydrate, purity: 100.15 %
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Crj: CD (SD)IGS
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- as required by guideline
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- After the 28 day treatment period a 14-day recovery period is reported for the control and the highest test group.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no given
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1, 3, 10, 30 mg/kg bw/day (corresponding to 0, 0.64-19.2 mg/kg bw/d hydrazine)
Basis:
- No. of animals per sex per dose:
- 5 males and 5 females/per dose group including control animals
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 14 d
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- clinical signs, food comsumption, body weight, hematology, blood chemistry, urinalysis
- Sacrifice and pathology:
- all animals were autopsied
rel and absolute organ weight, gross findings, histopathological findings - Other examinations:
- no further information
- Statistics:
- Appropriate statistical methods were used: eg. non-parametric analysis (no further information)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- see section remarks on results
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: (corresponding to 1.92 mg/kg bw/d) based on adverse effects from 10 mg/kg bw/d onwards including changes in hematology, blood chemistry and changes in liver, spleen and kidneys
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
CLINICAL OBSERVATIONS AND FREQUENCY:
-Mortality:
No deaths were observed
-Clinical signs:
30 mg/kg bw/d:
males+females: wasting, piloerection, salivation;
females: dirty nasal discharge
30 mg/kg bw/d (males and females):
-Body weight gain, food consumption, food efficiency suppressed,
reversable during recovery
--HEMATOLOGY (significant changes)
-------males, 30 mg/kg bw:
significant decrease:
HCT: 38.0 % vs 44.8 % of control; recovery in 14 d
HGB: 11.9 g/dL vs 15.1 g/dL of control; recovery in 14 d
MCV: 51.8 µm3 vs 57.3 µm3 of control; recovery in 14 d
MCH: 16.2 pg vs 19.6 pg of control; recovery in 14 d
MCHC: 31.3 % vs 34.2 % of control
PT: 14.4 sec vs 17.5 sec of control; recovery in 14 d
APTT: 19.6 sec 24.2 sec of control; recovery in 14 d
significant increase but recovery in 14 d:
Reticulocytes: 6.2 % vs 2.8 % of control;
Methemoglobin: 0.99 % vs 0.75 % of control;
PLT count: 1786 10³/mm3 vs 1304 10³/mm3 of control
------females,
---from 10 mg/kg bw onwards significant decrease but recovery in 14 d
HCT: 40.5 %, 34.7 % % vs 43.6 % of control;
HGB: 14.0 g/dL, 10.6 g/dL vs 15.3 g/dL of control;
MCH: 18.7 pg, 16.6 pg vs 19.7 pg of control;
---30 mg/kg bw significant dercrease
RBC: 6.43x10[exp6]/mm³ vs 7.77 x10[exp6]/mm³of control; recovery in 14 d
MCHC: 30.7 % vs 35.1 % of control
---30 mg/kg bw significant increase but recovery in 14 d:
Reticulocytes: 9.2 % vs 2.2 % of control;
Methemoglobin: 1.0 % vs 0.52 % of control
--CLINICAL CHEMISTRY (significant changes):
------Male, 30 mg/kg bw but recovery in 14 d
Glucose (mg/dL): 100 vs. 140 of control
BUN (mg/dL): 22.5 vs. 13.7 of control
Tbilirubin (mg/dL): 0.12 vs. 0.04 of control
Albumin (g/dL): 3.86 vs. 3.60 of control
A/G ratio : 2.37 vs. 1.80 of control
Chloride (mmol/L): 104.6 vs. 108 of control
Iphosphate (mg/dL): 9.54 vs. 8.05 of control
AST (U/L): 51 vs. 77 of control
ALT (U/L): 17 vs. 32 of control
------female, at 10 mg/kg bw but recovery in 14 d
AST (U/L): 62 vs. 73 of control
ALT (U/L): 17 vs. 25 of control
------female, 30 mg/kg bw but recovery in 14 d
Glucose (mg/dL): 83 vs. 114 of control
Tbilirubin (mg/dL): 0.11 vs. 0.03 of control
A/G ratio : 2.42 vs. 1.77 of control
Chloride (mmol/L): 102 vs. 108 of control
Calcium (mg/dL): 10.49 vs. 9.74 of control
Iphosphate (mg/dL): 9.81 vs. 7.56 of control
----------GROSS AND HISTOPATHOLOGY
---The absolute weights of
the kidneys were increased or tended to be increased in both sexes of
the 10 and 30 mg/kg bw groups; elevation of liver weights in females of
the 10 and 30 mg/kg bw groups and of spleen weights in 30 mg /kg bw
females was apparent.
---Relative weights of
the liver and kidneys were higher or tended to be higher in both sexes
of the 10 and 30 mg/kg bw groups than in controls. liver males:
3.01%,3.5% versus 2.7%, recovery in 14 d liver females: 3.2%,3.9% versus
2.7%, after 14d: 3.2% versus 2.7% kidneys males: 0.84%,1.04 versus
0.76%, recovery in 14 d kidneys females: 0.86%, 0.96% versus 0.79%,
after 14 d: 0.85% versus 0.75%
---Macroscopically,
pale colored livers were observed in both sexes of the 30 mg/kg bw group.
---Histopathologically,
fatty change of the hepathocytes was observed in males of the 10 and 30
mg/kg bw groups and in females of all groups including the controls.
Pigmentation of the spleen was observed in both sexes of the 30 mg/kg bw
group. A higher degree of extramedullary hematopoiesis than normal was
observed in both sexes of the 30 mg/kg bw group and in males of the 10
mg/kg bw group.
Applicant's summary and conclusion
- Executive summary:
In a subacute toxicity study according to OECD TG 407 hydrazine monohydrate was administered to male and female Crj:CD(SD)IGS rats by gavage at dose levels of 0, 1, 3, 10, 30 mg/kg bw/day diluted in water. Additionally, the control group and the highest dose group were observed during a 14-day recovery period (MHLW 2003). Based on adverse effects from 10 mg/kg bw/d onwards including changes in hematology, blood chemistry and changes in liver, spleen and kidneys the NOAEL is 3 mg/kg bw/day for male and female rats.
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