Registration Dossier
Registration Dossier
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EC number: 206-466-3 | CAS number: 345-92-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-11-11 to 2005-12-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline comparable study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Bis(4-fluorophenyl) ketone
- EC Number:
- 206-466-3
- EC Name:
- Bis(4-fluorophenyl) ketone
- Cas Number:
- 345-92-6
- Molecular formula:
- C13H8F2O
- IUPAC Name:
- bis(4-fluorophenyl)methanone
- Reference substance name:
- 4,4'-Difluorobenzophenone
- IUPAC Name:
- 4,4'-Difluorobenzophenone
- Details on test material:
- bis(4-fluorophenyl) ketone, purity 99 %
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: SINO-BRITISH SIPPR/BK LAB ANIMAL LTD
- Weight at study initiation: 180 -210 g
- Fasting period before study: 16 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 20 °C +/- 2° C
- Humidity (%): 45 % - 65 %
- Air changes (per hr): 15 times
- Illumination: natural lights
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- soya oil
- Details on oral exposure:
- ADMINISTRATION:
- Doses: 464, 1000, 2150, 4640 mg/kg/bw
- Dosage preperation: test substance was mixed with soybean oil
- Volume administered or concentration: dose volume was calculated from body weight - Doses:
- 464, 1000, 2150, 4640 mg/kg/bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes continuously after exposure, then hourly for 6 hours after treatment administration, and at
least twice daily (forenoon and afternoon) thereafter
- Necropsy of survivors performed: all survived animals were necropsied
- Other examinations performed: clinical signs, body weight - Statistics:
- Statistical analysis was performed according to the Horns method.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- 24 hours after application in 2150 mg/kg group: 3/5 male and 3/5 female
24 hours after application in 4640 mg/kg group: 5/5 male and 5/5 female - Clinical signs:
- other: Hyporactivity was found from 3 hours after application in 4640mg/kg group and from 4 hours after application in 2150 mg/kg group. Other groups weren’t found obvious clinical signs.
- Gross pathology:
- No apparent changes were found in necropsy
- Other findings:
- no other findings
Any other information on results incl. tables
no other results
Applicant's summary and conclusion
- Interpretation of results:
- other: Harmful if swallowed
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The LD50 value (oral) of bis(4-fluorophenyl) ketone in female and male rats was estimated to be 2000 mg/kg bw. Hyporactivity was found from 3 hours after application in 4640mg/kg group and from 4 hours after application in 2150 mg/kg group. Other groups weren’t found obvious clinical signs. Therefore, under the conditions of this study the acute toxicity of the test substance after oral exposure in rats is moderate and bis(4-fluorophenyl) ketone has to be classified as harmful if swallowed.
- Executive summary:
The acute oral toxicity study of bis(4-fluorophenyl) ketone was conducted with 4 groups of SD rats for each sex. Each group consisted of ten rats, five male rats and five female rats. Both male and female rats were treated with 464, 1000, 2150 and 4640 mg/kg . Animals were observed for symptoms of clinical toxicity and mortality for 14 days after treatment. No apparent changes were found in body weight and necropsy. Results are summarized as follows: Approximate LD50 male rat: 2000 mg/kg（1370~2910) mg/kg bw; female rat: 2000 mg/kg（1370~2910) mg/kg bw.
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