Bis(4-fluorophenyl) ketone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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 %,
physical state: white powder,
storage conditions: test substance was stored in the refrigator of sample room and kept only in the original container

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 in Shanghai
- Age at administration: 6 weeks
- Body weight at study initiation: 180 -200 g
- 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
- Cages: 32 x 32 x 50 cm

Administration / exposure

Type of coverage:

occlusive

Vehicle:

soya oil

Details on dermal exposure:

Animals were shaved on the back part about an area of 5 x 8 cm2. The animals were observed for 24 hours and animals without any injury for study were used. The dose volume was calculated from body weight just before adiminstration. Prescribed amount of the substance was mixed with soybean oil and was applied directly to the sheared area and smeared it evenly. Then the application sites were covered with one layer of plastic film and four layers of gauze. The gauze layers were fixed with adhesive tape tightly to the animals. Twenty-four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water.

Duration of exposure:

24 hours

Doses:

one dose level: 2500 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

The limit test at one dose level of 2500 mg/kg bw was carried out in a group of 5 males and 5 females using the procedures described above.
All animals were observed 30 minutes continuously after exposure, then hourly for 6 hours after treatment administration, and at least twice daily (forenoon and afternoon) thereafter. Clinical symptoms were recorded. The animals were observed for 14 days after treatment. Each animal was weighed on days 1, 7 and 14 during the observation period and in case of dead animals being found. At the end of the observation period, all survived animals were necropsied.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths occurred.

Mortality:

No mortalities were observed.

Clinical signs:

other: No apparent abnormalities were found at 2500 mg/kg bw of both sexes.

Gross pathology:

no data

Other findings:

No apparent changes were found in necropsy

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The LD50 value (dermal) of bis(4-fluorophenyl) ketone in male and female rats was estimated to be > 2500 mg/kg bw. No mortalities and no clinical signs were observed. Therefore, under the conditions of this study the acute toxicity of bis(4-fluorophenyl) ketone after dermal exposure is very low.

Executive summary:

The acute dermal toxicity study of bis(4-fluorophenyl) ketone was conducted with one group of Sprague-Dawley rats for each sex. Each group consited of 5 rats. The male and female rats were treated with 2500 mg/kg bw. 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: > 2500 mg/kg bw, LD₅₀ female rat: > 2500 mg/kg bw.