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Toxicological information

Acute Toxicity: oral

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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:
2006
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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
4,4'-Difluorobenzophenone
IUPAC Name:
4,4'-Difluorobenzophenone
Details on test material:
bis(4-fluorophenyl) ketone, purity 99 %

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.