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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: reporting suffers from deficiencies e.g. individual animals are not presented
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Reference Type:
- other: abstract
- Title:
- Comparison of the Embryotoxicity of Hydrazine and Monomethylhydrazine.
- Author:
- Keller WC et al. (1980).
- Year:
- 1 980
- Bibliographic source:
- Abstr. Pap. Soc. Toxicol. 19, A21.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guide for the care and use of laboratory animals, Inst. Lab. Animals Resources, National Res. Council
- Principles of method if other than guideline:
- Pregnant female rats were intraperitoneal injected according to different shemes (see section adional informations on remarks and results) and fetuses were evaluated after delivering on gestation day 20 up to postpartal day 21.
- GLP compliance:
- not specified
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: other TS : hydrazine; purity = 95%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet ad libitum
- Water ad libitu
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70-76
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Details on exposure:
- intraperitoneal injection
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- Length of cohabitation: overnight
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- trial 1: gestation day 6-15
trial 2: gestation days 7-9; days 10-12; days 13-15
trial 3. gestadion days 7-9 - Frequency of treatment:
- once daily
- Duration of test:
- trial 1: until gd 20
trial 2: until gd 20
trial 3: until postnaltal day 21
- No. of animals per sex per dose:
- no data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- see section addition information on material and methods
Examinations
- Maternal examinations:
- see section addition information on material and methods
- Ovaries and uterine content:
- see section addition information on material and methods
- Fetal examinations:
- see section addition information on material and methods
- Statistics:
- student's t method, , Fisher's exact test, Newman Keulls post test
- Indices:
- not given
- Historical control data:
- not given
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
see section remarks on results
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2.5 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 2.5 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
see section remarks on results
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 2.5 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext: trial 1:(significant changes only)
maternal body weight gain significantly reduced at 5.0 mg/kg
or more (only as graphic); number of resorptions per litter significantly
increased at 5 mg/kg bw/d: 3.3 and 10 mg/kg bw/d: 6.0 versus 1.5 in controls; 10 mg/kg bw/d: With the exception of one litter which had no resorptions and six viable fetuses, all litters were totally resorbed fetal body weight sign.decreased at 5.0 mg/kg: 2.9 g versus 3.1 g of control ; no significant increase in fetal
abnormalities trial 2: maternal body weight gain significantly reduced in dams treated gd7 -9(a), gd10 -12(b) and gd13 -15(c)(data not shown) during exposure period; the most susceptible period for the effects of hydrazine was during gestation days 7 through 9 (a)
number of resorptions per litter
significantly increased in (a)6.1 versus 1.5 of controls; fetal body
weight significantly decreased in a)2.7 g and c) 2.9g versus 3.1 g in
controls; significantly increase in fetal abnormalities in a) including
supernumerary ribs, moderate
hydronphrosis and moderate hydrocephalus. trial 3: No significant effects
reported in postnatal evaluation.
Applicant's summary and conclusion
- Executive summary:
Pregnant female rats were intraperitoneal injected with 0, 2.5, 5.0, 10.0 mg/kg/d once daily on gd 9 -16 and sacrificed on gd day 20. The NOAEL (maternal toxicity ) was determined 2.5 mg/kg bw/day based on reduced weight gain or weight loss during treatment from 5.0 mg/kg bw/d onwards; the NOAEL (developmental toxicity) was determined 2.5 mg/kg bw/day based on a dose-related embryolethality from 5.0 mg/kg bw/d onwards. Furthermore, treatmant of dams with 10 mg/kg bw on gd 7 -9 resulted in significantly increased number of resorptions per litter, significantly decreased fetal body weight and fetal abnormalities including supernumerary ribs, moderate hydronphrosis and moderate hydrocephalus (Keller 1982).
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