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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27.08.1997 - 10.09.1997
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: Body weight variation did not exceed + / - 20% of the sex mean
- Fasting period before study:
- Housing: 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: At least 5 days befor start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light / 12 hours dark per day
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 animals
3 rats male
3 rats female
Control animals:
no
Details on study design:
- Duration of observation period following administration: Days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: The method used is not intended to allow the calculation of a precise LD50 value
Mortality:
No mortality ocurred
Clinical signs:
other: Lethargy, hunced posture, ventro-lateral recumbency, uncoordinated movements and piloerection were observed in the majority of animals between days 1 and 2. Rales were noted in one animal on day 3. One male showed scabs in the neck on day 2 and alopecia i
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results according to the EC criteria for classification and labelling requirements for dangerous and preparations (93/21/EEC), VBE doesnot have to be classied and has no obligatory labelling requirements for oral toxicity
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification