Registration Dossier
Registration Dossier
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EC number: 220-985-2 | CAS number: 2958-36-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Oct 2004 - 03 Jan 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2005
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-amino-2',5-dichlorobenzophenone
- EC Number:
- 220-985-2
- EC Name:
- 2-amino-2',5-dichlorobenzophenone
- Cas Number:
- 2958-36-3
- Molecular formula:
- C13H9Cl2NO
- IUPAC Name:
- 4-chloro-2-(2-chlorobenzoyl)aniline
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:approximately 8 weeks
- Weight at study initiation: females 203.5g± 7.4g (3.6%) n=6
- Fasting period before study: overnight
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22 °C
- Humidity (%): 30 - 45 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % (m/v) solution of Tylose MH 1000 in deionised water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3 g test item filled up to 15 ml using a 0.5 % (m/v) solution of Tylose MH 1000 in deionised water
- Amount of vehicle (if gavage): 1 mL/100 g body weight
MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g body weight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at 1, 2 and 4 h after dosing and once daily thereafter
- Frequency of weighing: day of administration, day 7 and day 14
- Necropsy of survivors performed: yes
- All animals were examined externally. The cranial, thoracic and abdominal cavities were then opened and examined macroscopically.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the course of investigation.
- Clinical signs:
- other: Not any alterations of the general state of well-being were observed during the course of investigation.
- Gross pathology:
- No pathological findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 p.o. rat is > 2000 mg/kg bw.
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