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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
according to internal standard method
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: NMRI-Wiga
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight males: 28.7 g, females: 28 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
The test substance was given as a 46.4 or 50% suspension with a 0.5% aqueous carboxymethyl cellulose solution
Doses:
10,000; 6,810; 4,640 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 9 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mortality was observed
Mortality:
2/5 males and 5/5 females treated with 10,000 mg/kg, and 1/5 females treated with 6,810 mg/kg died.
Clinical signs:
Dyspnea, apathy, unsteady gait and ruffled fur were reported until day 4 in mice given 10,000 and 6,810 mg/kg. Death occurred on day 2 and 3, bad general health until and including day 4. Mice given 4640 mg/kg showed dyspnea and ruffled fur only on the first day of treatment.
Gross pathology:
Diseased animals: intra-abdominal precipitation of the substance and coloration.
Euthanized animals: intra-abdominal precipitation of the substance and coloration, thickening of the edges of the liver.

Any other information on results incl. tables

In a pretest 2 male mice per dose group were treated with dose levels of 215, 1000 and 4640 mg/kg. No deaths occurred, animals of the high and medium dose showed dyspnea and ruffled fur on the first day of treatment.

Applicant's summary and conclusion