Registration Dossier
Registration Dossier
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EC number: 216-437-7 | CAS number: 1584-62-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.01.-13.05.2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 2-bromo-4'-chloro-2'-(o-fluorobenzoyl)acetanilide
- EC Number:
- 216-437-7
- EC Name:
- 2-bromo-4'-chloro-2'-(o-fluorobenzoyl)acetanilide
- Cas Number:
- 1584-62-9
- Molecular formula:
- C15H10BrClFNO2
- IUPAC Name:
- 2-bromo-4'-chloro-2'-(o-fluorobenzoyl)acetanilide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 199-211 g (f), 318-335 g (m)
- Fasting period before study: max. 20 h
- Housing: 3 animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany)
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet (Altromin (code VRF1)), ad libitum
- Water (e.g. ad libitum): tap-water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at the test facility.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/viability: twice daily; Body weights: Days 1, 8 and 15; Clinical signs: at periodic intervals on Day 1, and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Restless behaviour, lethargy, hunched posture, uncoordinated movements and/or quick breathing were noted among the majority of animals. The animals had recovered from the symptoms between days 2 and 7.
- Gross pathology:
- No abnormalities were found at macroscopic post martern examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of BFB in male and female Wistar rats was established to exceed 2000 mg/kg body weight.
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