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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: inhalation
Administrative data
- Endpoint:
- repeated dose toxicity: inhalation
- Remarks:
- other: 1 Year exposure and add observation period lifelong
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: evaluation of histopatological changes only
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Long-Term Inhalation Toxicity of Hydrazine.
- Author:
- Vernot EH, MacEwen JD, Bruner RH, Haun CC, Kinkead ER, Prentice DE, Hall A, Schmidt RE, Eason RL, Hubbard GB, Young JT . (1985).
- Year:
- 1 985
- Bibliographic source:
- Fundam. Appl. Toxicol. 5, 1050-1064
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Reference Type:
- other: abstract
- Title:
- Chronic inhalation toxicity of hydrazine. Oncogenic effects
- Author:
- MacEwen, JD, Vernot ER, Haun CC
- Year:
- 1 980
- Bibliographic source:
- Proc. Am. Ass. Cancer Res. 21, 74
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
- Reference Type:
- other: Review
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Method: exposure of rat, mouse, hamster, dog for 1 year and post exposure observation for 18 months (rat), 15 months (mouse), 12 months (hamster) and 38 months (dog), respectively.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hydrazine
- EC Number:
- 206-114-9
- EC Name:
- Hydrazine
- Cas Number:
- 302-01-2
- Molecular formula:
- H4N2
- IUPAC Name:
- hydrazine
- Details on test material:
- IUCLID4 Test substance: hydrazine
purity= 97% nominal
Constituent 1
Test animals
- Species:
- other: rat, mouse, hamster, dog
- Strain:
- other: F344 rat; C57BL/6 mouse, Golden Syrian hamster, Beagle dogs
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
-
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- inhalation exposures were conducted 6 hr/day, 5 days/week for 1 year without exposures on weekend and holidays
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Technico Autoanalyser proportioning pump and colorimeter
- Duration of treatment / exposure:
- 12 mo
- Frequency of treatment:
- 6 h per d, 5 d a week, not during holidays (not specified)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.05 - 5.0 ppm (0, 0.066-6.65 mg/m³)
Basis:
- No. of animals per sex per dose:
- 100 male and 100 female rats/conc. 0.066, 0.33, 1.33, 6.65 mg/m³: post exposure observation: 18 months
400 female mice/conc.0.066, 0.33, 1.33 mg/m³; post exposure observation: 15 months
200 male hamsters/conc. 0.33, 1.33, 6.65 mg/m³ post exposure observation: 12 months
4 males and 4 female dogs/conc. 0.33. 1.33 mg/m³ post exposure observation: 38 months - Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: 12 mo hamsters, 18 mo rats, 15 mo mice, 38 mo dogs
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- clinical signs of toxicology body weight development biweekly (10 mice/cage as cage groups),
hematology and clinical chemistry of dogs biweekly, - Sacrifice and pathology:
- all animals that died or were killed during the study were necropsied: external examination and complete histopathological examination
- Other examinations:
- no further data
- Statistics:
- yes: t-test, Fisher's exact test,
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):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- see remarks on results
Effect levels
open allclose all
- Dose descriptor:
- LOAEC
- Effect level:
- 0.066 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: Rat: based on inflammatory changes and squamous metaplasia in the nose, larynx and trachea most prominent at the highest test dose
- Dose descriptor:
- LOAEC
- Effect level:
- 0.33 mg/m³ air
- Sex:
- male
- Basis for effect level:
- other: hamster: based on generalized amyloidosis in the liver, kidneys, thyroid and adrenal glands significantly greater frequency than in control animals
- Dose descriptor:
- NOAEC
- Effect level:
- 0.33 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: dog: based on focal areas of highly vacuolated liver cells and a corresponding elevation in SGPT (data not shown)
- Dose descriptor:
- NOAEC
- Effect level:
- 6.65 mg/m³ air
- Sex:
- female
- Basis for effect level:
- other: mouse: no non-neoplastic lesions
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Variance in exposure concentration mainly +/-10%; neoplastic lesions see
chapter carcinogenicity; significantly reduced body weight gain in male
and female rats (but not dose-dependent), most
significant in male rats at 5 ppm, in male hamsters at all doses during
exposure (only at 5 ppm in the final mo); no effects on weight gain in
female mice; mortality in mice and rats not significant different from
controls, in unexposed hamsters lowered number of deaths during exposure
compared to all treated hamsters (no data about significance);
histopathology of rodents found dead or sacrified at termination of post
exposure period (10% of surviving rats were nercopsied after 12 mo post
exposure period) showed following alterations, significantly different
from controls:
hamsters: liver amyloidosis and hemosiderosis, bile duct
hyperplasia, spleen amyloidosis, lymphadenitis, kidney interstitial and
glomerular amyloidosis, adrenal amyloidosis, senile atrophy of the
testis;
female rats: tracheal inflammation, hepatic hyperplasia at 1 and
5 ppm; only significant in high dose group: nasal squamous and
epithelial metaplasia, inflammation and squamous metaplasia of the
larynx, tracheal squamous metaplasia, lymph node hyperplasia,
glomerulonephritis, cystic endometrial hyperplasia, endometritis,
salpingitis, atrophy of ovar;
male rats: myocardial degeneration; only significant in high dose
group: nasal meta- and hyperplasia, laryngeal squamous metaplasia,
interstitial hyperplasia of the testis; no significant histopathological
alterations in mice and dogs; no further treatment
related, significant effects in dogs.
Applicant's summary and conclusion
- Executive summary:
There is a longterm study on rats, mice, hamsters and dogs which is reported in brief. The used concentration for rats ranged between 0.05 and 5 ppm (0.066 -6.65 mg/m³) hydrazine, for mice between 0.05 and 1.0 ppm (0.066-1.33 mg/m³) and for hamsters between 0.25 and 5.0 ppm (0.33-6.65 mg/m³) The exposure period was 6 h per day, 5 days per week for 1 year (but not during holidays, not specified) followed by a lifelong post exposure observation period (MacEwen 1981, Vernot 1985). With respect to the non-neoplastic lesions
in rats the LOAEC is 0.066 mg/m³ based on dose-dependent increase in inflammatory changes and
squamous metaplasia in the nose, larynx and trachea
in hamster the LOAEC is 0.33 mg/m³ based on generalized amyloidosis in the liverm , kidneys,thyroid and adrenal glands significantly greater frequency than in control animals
in dogs the NOAEC is 0.33 mg/m³ based on focal areas of highly vacuolated liver cells and a corresponding elevation in SGPT (data not shown)
in mouse the NOAEC is 6.65 mg/m³ because no non-neoplasic lesions were reported
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