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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Test methods and performance uncertain, limited documentation available.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Age at study initiation: at 7 weeks of age
Weight at study initiation: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2°C
- Humidity (%): 55±5 °C
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Administration / exposure

Route of administration:
intravenous
Vehicle:
physiological saline
Details on exposure:
Manufacture, supplier, source of supply: Iwai Chemicals Co.
Lot/batch No.: no data
Doses:
more than 4 doses (unspecified)
No. of animals per sex per dose:
5 - 10 animals/dose
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 7 days
Frequency of observations and weighing: No data
Necropsy of survivors performed: yes
Other examinations performed: clinical signs
Statistics:
Litchfield-Wilcoxon method

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
2 600 mg/kg bw
95% CL:
> 2 396 - < 2 821
Sex:
male
Dose descriptor:
LD50
Effect level:
2 600 mg/kg bw
95% CL:
> 2 396 - < 2 821
Mortality:
no data
Clinical signs:
Immediately after dosing, female and male rats showed clonic convulsion, exophthalmos, cyanosis and dyspnea and then, the breath stopped during convulsion.
Body weight:
no data
Gross pathology:
Congestion in lungs and dot hemorrhage in glandular stomach were observed in some animals. No abnormal gross findings in the other organs were observed.
Other findings:
Organ weights: No data
Histopathology: No data
Potential target organs: No data
Other observations: No data

Applicant's summary and conclusion