Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study under GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
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:
- 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:
- TEST ANIMALS
- Housing: premating period in groups of of the same sex; mating in cages suitable for this purpose, pregnant females individually
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- oral administration by gavage
- Details on mating procedure:
- according to the respective guideline
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure period: males: 48 d; females: from 14 days before mating to day 3 of lactation
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: males: 49 days, females: day 4 post partum - Frequency of treatment:
- daily
- Details on study schedule:
- Dosing of both sexes should begin at least 2 weeks prior to mating, after they havbe been acclimated for at least 5 days.
Dosing is continued in both sexes during the mating period
Daily dosing of parental females should continue throughout pregnanty and at least up to including day 3 post partum
Males should further be dosed after the mating periond and then killed
Dams with offspring should be klled on day 4 post partum
The day of birth is defined as day 0 post partum
Femaeles showing no evidence of copulation are killed 24-26 days after the last day of the mating period
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2, 6, 18 mg/kg bw/day dissolved in water
Basis:
other: with respect to hydrazine: 0, 1.28 - 11.52 mg/kg bw/day
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- see section any other information on material and methods
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS:
CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations:
males weekly,
females during pregnancy day 0, 7, 14, and 20
and within 24 hours of partuition and day 4 post partum
FOOD CONSUMPTION yes
WATER CONSUMPTION No data
- Oestrous cyclicity (parental animals):
- yes
- Sperm parameters (parental animals):
- no data
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, no data
GROSS EXAMINATION OF DEAD PUPS:
no data - Postmortem examinations (parental animals):
- see section any other information on material and methods
GROSS NECROPSY
yes
ORGAN WEIGHTS
- Male animals:
absolute and relative organ weights: thymus, liver, spleen, kidneys, adrenals, testes, epididymides
- Maternal animals:
absolute and relative organ weights: thymus, liver, spleen, kidneys, adrenals, ovaries
HISTOPATHOLOGY
-Male animals
heart, spleen, thymus, liver, kidney, testis, epididymis, prostate, thyroid gland, adrenal gland skin
- Female animals
spleen, thymus, liver, kidney, uterus, vagina, skin - Postmortem examinations (offspring):
- no data
- Statistics:
- Bartlett's test of homogeneity of variance one-way analysis of variance. Dunnett's test the Kruskal-Wallis test Mann-Whitney U-test Fisher's exact test
- Reproductive indices:
- Copulation index
Fertility index
Gestation index
Implantation index
Delivery Index - Offspring viability indices:
- live birth index
viability index on day 4
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
males and females, 18 and 6 mg/kg bw-group: salivation
females, 18 mg/kg bw-group: lacrimation
AND MORTALITY (PARENTAL ANIMALS)
Males,18 mg/kg b-group: 2/12
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Males, 18 mg/kg bw-group: decrease in body weight and lowered food consumption in the early stage of the administration period
Males, 18 mg/kg bw-group: suppression of body weight gain
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
Irregular cycle: 2 mg/kg bw-group: 1/12; 6 mg/kg bw-group: 0/12; 18 mg/kg bw-group 3/12 versus control: 0/12
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
no data
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
Copulation indices and fertility indeces showed no significant difference to the conurrent control
ORGAN WEIGHTS (PARENTAL ANIMALS, only significant changes)
18 mg/kg bw-group, males:
increase in relative liver weight (3.7 g% vs. 3.3 g% of control)
and kidney weight (0.76 g% vs. 0.65 g%)
18 mg/kg bw-group, female:
no data
6 mg/kg bw -group female:
elevated relative liver weights (4.1 g% vs. 3.9 g%), spleen weight (0.23 g% vs. 0.18 g%) and kidney weights (0.7 g% vs. 0.6 g%)
GROSS PATHOLOGY AND HISTOPATHOLOGY (PARENTAL ANIMALS)
18 mg/kg bw (males and females), 6 mg/kg bw (males): pale liver, fatty changes, pigmentation of the spleen
OTHER FINDINGS:
Duration of gestation did not differ from the respective control group
Implantation Index (%):
2 mg/kg bw-group: 85; 6 mg/kg bw-group: 90; 18 mg/kg bw-group 69; versus 80 of control
Gestation Index (%)
2 mg/kg bw-group: 100; 6 mg/kg bw-group: 100; 18 mg/kg bw-group: 0.0% (sign. p<=0.01) versus 100 % of control
Effect levels (P0)
open allclose all
- Dose descriptor:
- other: NOAEL (female reproductive tox)
- Effect level:
- 6 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: (with respect to hydrazine:3.84 mg/kg bw/day) in females of the 18 mg-group lethal actions on the embryos were observed
- Remarks on result:
- other: Generation not specified (migrated information)
- Dose descriptor:
- other: NOAEL (male reproductive tox)
- Effect level:
- 18 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: (with respect to hydrazine: 11.52 mg/kg bw/day) The test substance had no effects on reproduction
- Remarks on result:
- other: Generation not specified (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: (with respect to hydrazine: 1.28 mg/kg bw/day) general toxicity: based on clinical signs including salivation and lacrimation, body weight development, and histopathological changes in liver kidneys and spleen
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings:
- not specified
Details on results (F1)
Viability index on day 4 (%).
total:
2 mg/kg bw-group: 99; 6 mg/kg bw-group: 89 (sign p<=0.05); 18 mg/kg bw-group: no data versus 99 % of control
There was no abnormality consedered to be the effect of the test substance on external observation of pups of the 6 mg7kg bw-group but body weights and the viability inded on day 4 of lactation tended to be lower in males and females (no further data available)
There were no gross abnormalities considered to be the effect of the test substance in dead fetuses or offspring necropsied (no further data available).
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 2 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: (with respect of hydrazine: 1.28 mg/kg bw/day) offspring: from 6 mg/kg group viablity index on day 4 and latation tended to be lower in males and females
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
------REPEATED DOSE TOXICITY:
MORTALITY:
18 mg-group: 2/12 males died
CLINCAL SIGNS:
6 mg-group and higher dose groups: salivation in males and females
18 mg-group, females: lacrimation
BODY WEIGHT AND FOOD CONSUMPTION:
Significant decrease in body weight and lowered food consumption were
observed in males of the 18 mg group in the early stage of the
administration period.
18 mg group, males: significant suppression of body weight
GROSS AND HISTOPATHOLOGICAL EXAMINATION:
18 mg-group, males:
increase in relative liver weight (3.7 g% vs. 3.3 g% of control) and
kidney weight (0.76 g% vs. 0.65 g%)
6 mg-group female:
elevated relative liver weights (4.1 g% vs. 3.9 g%), spleen weight (0.23
g% vs. 0.18 g%) and kidney weights (0.7 g% vs. 0.6 g%)
18 mg/kg bw (males and females), 6 mg/kg bw (males): pale liver, fatty
changes, pigmentation of the spleen
------REPRODUCTIVE andDEVELOPMENTAL TOXICITY
The test substance had no effect on either copulation or fertility
ability.
18 mg-group, dams:
GESTATION INDEX: 0 % vs. 100 % of control;
LIVE BIRTH INDEX: 0 % vs. 97.9 % of control
--- pup data:
6 mg-group:
VIABILITY INDEX ON DAY 4 (males and females):
88.6 % vs. 98.6 % of controls
Applicant's summary and conclusion
- Executive summary:
In a preliminary reproduction toxicity study according to OECD TG 421, male and female rats received orally by gavage 0, 2, 6, or 18 mg/kg bw/day hydrazine monohydrate. The NOAEL (general toxicity) is 2 mg/kg bw/d based on clinical signs including salivation and lacrimation, body weight development, and histopathological changes in liver kidneys and spleen. The NOAELs for reproductive and developmental toxicity are considered to be 18 mg/kg bw/d for males because reproductive performance and fertility was not affected by treatment, for females the NOAEL is 6 mg/kg bw/day based on lethal actions on the embryos of the 18 mg/kg bw females; the NOAEL offspring is 2 mg/kg bw/day based on body weight development , viablity index of day 4 of lactation tended to be lower in males and females from 6 mg -group onwards.
Assuming that the hydrazine monohydrate contains 64% hydrazine unhydrous the respective values for hydrazine are
NOAEL (general toxicity): 1.28 mg/kg bw/day
NOAEL (male fertility): 11.52 mg/kg bw/day
NOAEL (female fertility): 3.84 mg/kg bw/day
NOAEL (offspring): 1.28 mg/kg bw/day
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.