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Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-11-11 - 2005-12-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline comparable study; restriction: no data on control animals

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 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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 % ;
phaysical state: white powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: 
- Source: Animals Raising Lab. of Shanghai B.K. company; licence number SCXK(hu) 2003-0002
- Weight at study initiation: males 205 - 222 g, females 187 - 194 g
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 20 °C +/- 3° C
- Humidity (%): 55 % +/- 15 %
- Illumination: natural lights
- Number of animals: 5 per concentration and sex

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
- Exposure method: dynamic inhalation method
Mean chamber temperatur: 20 +/- 2°C;
Dust airflow rate: 10 L/min;
Sampling flow rate: 1.0 L/min;
Sampling volume: 5.0 L/per time;
Sampling frequency: one time/30 min;
Exposure duration: 4 hours

Ten rats (5 males and 5 females) were exposed to each concentration of the test material aerosol. Each rat was restrained in a single transparent polycrylic tube with adjustable unit. The exposure tubes were accomplished in the portholes of the inhalation chamber, and then the later was airproofed. The dust was generated from dust generation system and injected continouusly to the chamber with a dust injector at the top of chamber. The exhaust air was removed from the outlet at the bottom of the chamber to absorbing set. After exposure the animals were returned to their living cages, provided with diet and water ad libitum and observed for 2 weeks.

- Particle size analysis:
The particle sizes of test material were measured with the microscopic micro-marker method;
Result: < 5.0 µm 68%; 5.0 - 10 µm 31%

- Aerial concentration analysis:
The concentrations in the chamber were measured with a dust sampler in the following procedure. The sampler head was introduced into the chamber. The dust was collected with 2 layers of filter film (aperature 0f 0.1 µm) and weighted, and the concentration was calculated.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
single dose: 5050 mg/m3
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Post dose observation period: 14 days
- Observation of clinical signs:
Following exposure, the individual animal was observed at every hour until 6 hour after administration, at least twice daily thereafter in forenoon and afternoon. Individual body weights were recorded in 3, 7, and 14 days after exposure. Clinical symptoms and numbers of dead rats were recorded. The surviving animals were euthanized and examined for gross pathological changes.
- Disposal of Spare animals:
Spare animals were euthanized after observation period and the remain were burned with a specially designed furnace.
Statistics:
The estimation of the acute inhalation toxicity (LC50) for bis(4-fluorophenyl) ketone to rats was done using probit method.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 050 mg/m³ air
Exp. duration:
4 h
Remarks on result:
other: No deaths occurred
Mortality:
No deaths occurred.
Clinical signs:
other: After being exposed, all rats showed toxic signs such as nasal discharge, semi-closed eyelid. After 72 hours, the toxic signs disappeared and all the rats were in normal conditions.
Body weight:
Except of a few rats, all surviving males and females treated showed increase in body weight during the test.
Gross pathology:
No apparent changes were found in necropsy.
Other findings:
No other treatment related effects were observed within this study.

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 LC50 (inhalation, aerosol, 4 hrs) value in rats (male, female) was estimated to be > 5050 mg/m3. Therefore, under the conditions of this study the acute toxicity of the test substance after inhalation exposure is very low .
Executive summary:

The acute inhalation toxicity study of bis(4-fluorophenyl) ketone was conducted in male and female Sprague-Dawley rats. A single dose concentration of 5050 mg/m3 was selected for both sexes. Animals were exposed to the test substance for 4 hours and subsequently observed for clinical signs of toxicity and mortality for 14 days after dosing. No deaths were occurred. All rats showed toxic signs such as nasal discharge and semi-closed eyelid. After 72 hours, the toxic signs disappeared and all the rats were in normal conditions.

The LC50 (inhalation, aerosol, 4 hrs) value in rats (male, female) was estimated to be > 5050 mg/m3.

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