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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
A single deviation ocurred during the study. No animals (test or control) were weighed on Day 3 of the observation period. The report states that this deviation does not affect the scientific integrity of the study.
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report: PERFLUOROKETONE; T7-7479;L-15566
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: Clear, colorles liquid
- Analytical purity: 100%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers compositon:
- Purity test date:
- Lot/batch no.:
- Expiration date of the lot/batch: 30 June 2001
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: In the dark at room temperature ( ca 20 C)
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Limited, Kent England
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 200 to 250 g
- Fasting period before study:
- Housing:- Diet (e.g. ad libitum): ad libitum (SDS rate and mice diet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 plus/minus 3 degrees C
- Humidity (%) 50% plus minus 20%:
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From:22 June 2002 To: 6 July 2000

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Vapor generator
- Exposure chamber volume:
- Method of holding animals in test chamber: Separate restraining tubes
- Source and rate of air: 5 liters per minute
- Method of conditioning air:
- System of generating particulates/aerosols:
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure: Temperature was measured using an alcohol in glass thermometer adn humidity was measured using a Casella type T6900 relative humidity meter.
TEST ATMOSPHERE
- Brief description of analytical method used: eight samples of chamger air were removed from the exposure chamger for determination of the test substance by infra-red analysis. Six samples were obtained during the first two hours of exposure with 2 further samples obtained at approximately 1 hour intervals.
- Samples taken from breathing zone: yes/no Yes
VEHICLE
- Composition of vehicle (if applicable):
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:
TEST ATMOSPHERE (if not tabulated) Terget concentration 100,000 ppm; Time weighted average concentration was 98,658 ppm
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Infra-red analysis of samples withdrawn from the exposure chamber. See Table 1. Analytical Concentrations by Timepoints
Duration of exposure:
ca. 4 h
Concentrations:
Time weighted concentration is approxicmately 98,568 ppm
No. of animals per sex per dose:
5 animals/per sex/per dose. Only one dose level was tested
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All cages were checked twice daily for dead or moribund animals. The rats were observed intermittently for signs of reaction to the test substance during exposure and twice daily during the observation period. Animals were weighed daily commencing 5 days prior to exposure, daily during the observation period and on the day of necropsy
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: animals were observed twice daily for clinical signs. At necropsy, all animals were subjected to a detailed macroscopic examination. The lungs (including the larynx and trachea) were removed, dissected clear of surrounding tissue, weighed and weights recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 98 658 ppm
Exp. duration:
4 h
Remarks on result:
other: There were no treatment related effects
Mortality:
There were no unscheduled deaths
Clinical signs:
Exaggerated breathing was evident in the test animals from 30 minutes into the exposure. Soiling of the fur with excreta was observed in control and test rats from 30 minutes into exposure and was considered to be associated with the method of restraint. Exaggerated breathing was seen in all test rats following exposure and lasting for at least two hours post exposure. All rats were of normal appearance and behavior from Day 2 of the observation perioid.
Body weight:
No treatment related effects.
Gross pathology:
No treatment related findings. No treatment related effects were seen in the lung weights.
Other findings:
A small dark focus was noted on the lungs of a male control and test rat.

Any other information on results incl. tables

Table 2 : Clinical Signs during exposure

Group

Signs

Number showing signs

 

 

Time

 

 

0

0.25

0.5

1

2

3

4

1 Males

Normal

5

5

5

 

 

 

 

Control

Fur Soiled with excreta

 

 

 

5

5

5

5

 

 

 

 

 

 

 

 

 

 

Normal

5

5

2

 

 

 

 

2 Males

Exaggerated breathing

 

 

2

5

5

5

5

Test

Fur Soiled with excreta

 

 

1

5

5

5

5

 

 

 

 

 

 

 

 

 

1 Females

Normal

5

5

2

 

 

 

 

Control

Fur Soiled with excreta

 

 

3

5

5

5

5

 

 

 

 

 

 

 

 

 

 

Normal

5

5

1

 

 

 

 

2 Females

Exaggerated breathing

 

 

3

5

5

5

5

 

Fur Soiled with excreta

 

 

3

5

5

5

5

 

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Executive summary:

Acute inhalation toxicity was assessed by exposing 1 group of male and female rats, for a period of 4 hours, to a vapor generated from the test substance at a target concentration of 100,000 ppm. A measured TWA concentration of 98,568 ppm was calculated. A second group, acting as a control, was exposed to clean air only. The animals were observed for 14 day post exposure and then necropsied.

No unscheduled mortality was seen. No treatment related effects were seen in body weights, lung weights or clinical signs. The LC50 is greater than 98,568 ppm.