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Diss Factsheets
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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guidelinestudy under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 484 (Genetic Toxicology: Mouse Spot Test)
- GLP compliance:
- yes
- Type of assay:
- mouse spot test
Test material
- Reference substance name:
- hydrazine hydrate
- Cas Number:
- 10217-52-4
- Molecular formula:
- H4N2*xH2O
- IUPAC Name:
- hydrazine hydrate
- Reference substance name:
- hydrazine hydrate
- IUPAC Name:
- hydrazine hydrate
- Details on test material:
- IUCLID4 Test substance: other TS
: hydrazine hydrate 100% purity
containing 64 % hydrazine and 36 % water
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: females: 10 weeks
- Housing: females after mating: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 15-20 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- phosphate buffer pH = 7.4
- Details on exposure:
- single intraperitoneal injection
- Duration of treatment / exposure:
- once on gestation day 9
- Frequency of treatment:
- once
- Post exposure period:
- yes until birth of F1-generation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 80 mg/kg/bw
Basis:
analytical conc.
- No. of animals per sex per dose:
- 200 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 30 mg/kg bw ethylnitrosourea and historical control data
Examinations
- Tissues and cell types examined:
- fur of F1 animals were examined
- Details of tissue and slide preparation:
- fur of F1 animals were examied
- Evaluation criteria:
- At an age of 3 1/2 to 4 weeks the offsprings are observed for color spots: evaluation refering to spots of genetic relevance (SGR).
- Statistics:
- Fisher's exact one-tailed test
Results and discussion
Test results
- Sex:
- female
- Genotoxicity:
- other: non-significantly increased frequency of Spots of genetic relevance (SGR) but it was of biological relevance when compared to the historical control data of the performing institute
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- 80 mg/kg bw: all treated female mice died
Any other information on results incl. tables
RS-Freetext:
in a 1st trial with 80 mg/kg bw all mice died; at 40 mg/kg
8/173 mother animals died; compared to the concurrent
control groups (experiment in duplicate) the increase in the
frequency of Spots of Genetic Relevance (SGR): 2% versus 0.5% in
controls, was not statistically significant, but it was of biological
relevance when compared to historical controls of the same
institute.
The positive control ENU gave clearly positive results.
Applicant's summary and conclusion
- Executive summary:
In the mouse spot test according to OECD TG the single intraperitoneal injection of 40 and 80 mg/kg bw hydrazine hydrate into pregnant female mice resulted in an non-significantly increased frequency of Spots of Genetic Relevance(SGR) but it was of biological relevance when compared to the historical control data of the performing institute (Bayer AG 1989)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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