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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
no detailed information on conduct of the study available; purity of the test substance not specified

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The test substance was applied via stomach intubation (single dose). No further details on the conduct of the study available.
- Short description of test conditions: no information availble
- Parameters analysed / observed: mortality, clinical signs, body weight changes, gross pathology of died animals and survivors
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No. of test material: 03788

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: testing facility
- Age at study initiation: 3 - 4 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: no
- Diet: Wayne diet, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 8 mL/kg bodyweight
Doses:
8, 4 and 2 mL/kg body weight (corresponding to approx. 9264, 4632 and 2316 mg/kg body weight; based on a density of 1.158 g/mL (lit.))
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: not specified
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes + necropsy of died animals

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4.92 mL/kg bw
Remarks on result:
other: corresponding to approx. 5697 mg/kg bodyweight (based on the density of 1.158 g/mL (lit.))
Mortality:
- in the 8 mL/kg bw group 5/5 animals died (4 on 1st day and 1 after 5 days)
- in the 4 mL/kg bw group 1/5 animals died (on 1st day)
- in the 2 mL/kg bw group no mortality was observed
Clinical signs:
- 8 mL/kg bw group: sluggish, slow breathing 15 min; prostrate 1.5 h
- 4 mL/kg bw group: sluggish, slow breathing 30 min; piloerection, legs stiffened within 2 h; prostrate at 2.5 h; convulsions, foaming at mouth at 4 h
- 2 mL/kg bw group: sluggish, slow breathing 30 min; prostrate 3 h
Body weight:
- decrease of 6,7 - 15 % in the 4 mL/kg bw group and 2.2 - 3.3 % in the 2 mL/kg bw group
- bodyweight changes in the 8 mL/kg bw group could not be determined due to the death of all animals
Gross pathology:
- in died animals petechial hemorrhages and congestion in the lungs; livers burned; livers, spleens and kidneys mottled; kidneys pale; adrenals congested; stomachs distended, containing a hard mass, opaque and gas-filled; intestines opaque, gas-filled and yellow
- nothing remarkable in survivors

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met