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Diss Factsheets

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
Study period:
1976-no details
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
- Principle of test: the test consists in determining the concentration expected to cause death in 50% of the treated animals.
- Short description of test conditions: 7 groups of rats were exposed to a single exposure of carbonyl fluoride at increasing concentrations for 4 hours to determine the LC50.
- Parameters analysed / observed: mortality, clinical signs, gross pathology
GLP compliance:
not specified
Test type:
traditional method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Carbonyl difluoride
EC Number:
206-534-2
EC Name:
Carbonyl difluoride
Cas Number:
353-50-4
Molecular formula:
CF2O
IUPAC Name:
carbonyl difluoride
Test material form:
gas
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: In-house source, Batch No. 9990
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: no data

Test animals

Species:
rat
Strain:
other: ChR-CD
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 240-260g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: not specified

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical (12" diameter) Plexiglass chamber
- Exposure chamber volume: 20-liter
- Source and rate of air: 20-liter/minute
- System of generating atmosphere: test atmosphere was generated by syringe driving COF2 into a dilution air stream passing through a Teflon line, and introduced through the top of the 20-liter cylindrical chamber and exhausted through a hole in the bottom of the chamber.
- Treatment of exhaust air: vacuum exhaust, no further details
- Temperature, humidity, pressure in air chamber: 45% humidity (average)

TEST ATMOSPHERE
- Brief description of analytical method used: Infra-red analysis using Miran IR analyser. The method can discriminate HF from COF2, thus allowing to assess the extent of hydrolysis of COF2 to HF.
- Samples taken from breathing zone: no information

VEHICLE
- Composition of vehicle (if applicable): air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
measured concentrations: 26.7 to 47.6 ppm (v/v) (see result table)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: not specified
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes, gross pathology on 3 rats (basis of selection not provided)
- Other examinations performed: clinical signs
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
34.3 ppm
Based on:
test mat.
95% CL:
>= 23.3 - <= 40.4
Exp. duration:
4 h
Mortality:
Reported in the table
Clinical signs:
other: Few clinical signs were observed. Rapid shallow to convulsive respiration occurred, varying with exposure concentration.
Gross pathology:
Examination of 3 rats (no details on corresponding concentration, and whether they were among the surviving animals):
Observation of white plaques, red focal spots, consolidation and edema of the lungs. Liver congestion and bright red spleens.

Any other information on results incl. tables

Analysis of chamber samples by infrared analysis to discriminate HF from COF2 indicated an average concentration of 48.8 ppm of COF2, with no detection of HF. The rate of hydrolysis to HF was negligible under the test conditions. Thus the acute inhalation toxicity cannot only be attributed to the formation of hydrogen fluoride.

Results :

 analytical concentration (TWA)

(ppm COF2, v/v)

 sd 

(ppm COF2, v/v)

 mortality observed

(number of dead animals/total in test group)

 26.7 4.1   5/10
 30.8  3.3  3/10
 32.7  1.7  3/10
 41.3  6.7  6/10
 44.7  6.2  8/10
 47.2  4.6  9/10
 47.6  6.8  6/10

Applicant's summary and conclusion

Interpretation of results:
Category 1 based on GHS criteria
Conclusions:
The 4-hour acute LC50 for gaseous carbonyl fluoride was determined to be 34.3 ppm (v/v) in air.
Executive summary:

Carbonyl fluoride was assessed in an acute inhalation toxicity study in rats. Seven groups of 10 males and 10 females were exposed for 4 hours (whole body) to increasing concentrations (26.7 to 47.6 ppm v/v) of carbonyl fluoride to determine the LC50.

Animals were observed for mortality, clinical signs. The gross pathology examination performed on 3 rats (no details on corresponding concentration, and whether they were among the surviving animals) showed white plaques, red focal spots, consolidation and edema of the lungs, liver congestion and bright red spleens.

The LC50 was determined to be 34.3 ppm (v/v) in air.