Registration Dossier

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: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: Borfluorid-Tetrahydrofuran
Batch number 5/93

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animal weight: 150 - 300 g
Individual identification of the rats using cage cards and group identification by tail marking.
The animals were housed in fully air-conditioned rooms with 20 - 24°C for temperature and 30 - 70% for relative humidity. The day/night rhythm was 12 h dark and 12 h light. The rats were singly hold in stainless steel wire mesh cages without beding. A standard diet and tap water were offered ad libitum per day.
The acclimatization period was at least 1 week. The animals were given no feed at least 16 hours before administration; water was available ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
200 mg/kg and 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (200 mg/kg); 0 days (2000 mg/kg)
- Frequency of observations and weighing: shortly before application, weekly thereafter and at the end of the study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Mortality:
200 mg/kg 0/3; 2000 mg/kg 3/3
Clinical signs:
200 mg/kg group: impaired general state and dyspnea.
2000 mg/kg group: poor general state, dyspnoea, apathy, abdominal position, staggering, ataxia, paresis, cyanosis
Gross pathology:
Animals that died: hemorrhage in the mucosa of the stomach and substance discoloration of the contents in the small intestines.
No abnormalities were found in sacrificed animals.

Applicant's summary and conclusion