Registration Dossier
Registration Dossier
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EC number: 206-114-9 | CAS number: 302-01-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study, GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Hydrazine monohydrate
- IUPAC Name:
- Hydrazine monohydrate
- Reference substance name:
- hydrazine monohydrate
- Cas Number:
- 7803-57-8
- Molecular formula:
- H4N2*H2O
- IUPAC Name:
- hydrazine monohydrate
- 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:
- TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: males 151-176 g; females: 126-145 g
- Fasting period before study: yes
- Housing: group-caged by sex
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 30-70
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- single oral application by gavage and a 14-day observation period
- Doses:
- 0, 100, 130, 169, 220, 286 mg/kg bw hydrazine monohydrate (corresponds to 0, 64-183 mg/kg bw hydrazine)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no data
-necropsy of the dead animals: yes
Other examinations performed: clinical signs, body weight, histopathology, - Statistics:
- Method of Bliss 1938, Litchfield and Wilcoxon 1949, Finney1971, Weil 1952 Thompson1947, Miller and Tainter1944
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 262 mg/kg bw
- 95% CL:
- >= 165 - <= 903
- Remarks on result:
- other: corresponding to 173 mg/kg bw hydrazine
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 165 - < 220 mg/kg bw
- Remarks on result:
- other: corresponding to 108-141 mg/kg bw hydrazine
- Mortality:
- 169 mg/kg bw 2 males and 2 females
220 mg/kg bw 1 male and 5 females
286 mg/kg bw 3 males and 5 females - Clinical signs:
- other: in all treatment groups: hypoactivity, abnormal gait, salivation, adoption of a prone or lateral position, hair soiling amd wasting
- Gross pathology:
- red patches/zones in the lungs, nasal hemorrhage and black patches/zones in the glandular stomach
- Other findings:
- no further details reported
Any other information on results incl. tables
No mortality males,females: 100 mg/kg bw group and 130 mg/kg bw-group.
Mortality occurred in the
169 mg/kg bw group: 2/5 males and 2/5 females
220 mg/kg bw group: 1/5 male and 5/5 females
286 mg/kg bw group: 3/5 males and 5/5 females
These animals died within 24 hours after treatment.
Clinical signs in all treatment groups:
hypoactivity, abnormal gait, salivation, adoption of a prone or lateral
position, hair soiling and waisting.
LD50 (males) 262 mg/kg bw.
LD50 (females) 169-220 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Executive summary:
Acute oral toxicity was tested with hydrazine monohydrate in male and female rats according to OECD TG 401 (gavage, 100-286 mg/kg bw) and resulted in the death of some animals within 24 hours after treatment. All animals displayed clinical signs including hypoactivity, abnormal gait, salivation, adoption of a prone or lateral position, hair soiling amd wasting. LD50(male) : 269 mg/kg bw and LD50(female): 169 -220 mg/kg bw (MHLW 2003). Assuming that hydrazine monohydrate solution contains 64 % hydrazine unaqueous, the respective LD50 (rat, oral) is 173 mg/kg bw for males and ranges between 108 and 141 mg/kg bw for females.
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