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Toxicological information

Acute Toxicity: oral

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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:
2003

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

Constituent 1
Reference substance name:
Hydrazine monohydrate
IUPAC Name:
Hydrazine monohydrate
Constituent 2
Reference substance name:
7803-57-8
Cas Number:
7803-57-8
IUPAC Name:
7803-57-8
Details on test material:
IUCLID4 Test substance: other TS: Hydrazine monohydrate, purity: 100.15 %

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:
in all treatment groups:
hypoactivity, abnormal gait, salivation, adoption of a prone or lateral position, hair soiling amd wasting
Body weight:
body weight developmental data not given
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.