Fluoroethylene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Principles of method if other than guideline:

Five male and five female rats were exposed to the test material at a concentration of 100000 ppm, seven hours per day, five days per week for a total of 30 exposures. Observations were conducted for clinical signs, body weight gain, gross and micropathology, and organ weights.

GLP compliance:

no

Test type:

other: subchronic (inhalation gas) (whole body)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fluoroethylene

EC Number:

200-832-6

EC Name:

Fluoroethylene

Cas Number:

75-02-5

Molecular formula:

C2H3F

IUPAC Name:

fluoroethene

Details on test material:

- Purity: ≤100%

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:

inhalation: gas

Type of inhalation exposure:

whole body

Vehicle:

other: air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 12-liter bell jars; 5 males in one bell jar and 5 females in another bell jar
- Method of holding animals in test chamber: No data
- Source and rate of air: No data
- Method of conditioning air: No data
- System of generating test atmosphere: The test substance and air were metered into a 5-gallon mixing carboy at flow rates calculated to give a concentration of 100000 ppm of test substance. The air-gas mixture was then divided equally between two 12-liter bell jars so that the flow to each was at the rate of 2.5 L/min.
- Temperature, humidity, pressure in air chamber: No data
- Treatment of exhaust air: No data

TEST ATMOSPHERE
- Brief description of analytical method used: No data
- Samples taken from breathing zone: No

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Remarks on duration:

per day, 5 days per week for a total of 30 exposures.

Concentrations:

100000 ppm (nominal)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Dose selection rationale: Reported low toxicity; exposure to 80% by volume (20% oxygen) for 12.5 hours was nonlethal to rats.
- Duration of observation period following administration: Cage side observations were performed, but time schedule was not reported.
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: yes, one day after the final exposure
- Other examinations performed: clinical signs, body weights, organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 100 000 ppm

Exp. duration:

4 h

Remarks on result:

other: At 100000 ppm: Slight reversible nasal irritation after exposure, otherwise no clinical signs, normal weight gains, no gross or micropathology findings, organ weights in normal range.

Clinical signs:

other: One of the five male and one of the five female rats showed slight nasal irritation after the 7-hour exposure period, but the irritation cleared up by the following morning.

Body weight:

Weight gains were normal.

Gross pathology:

No gross pathology attributable to the test substance was observed.

Other findings:

- Organ weights: Organ weights were in the normal range for both males and females.
- Histopathology: No micropathology attributable to the test substance was observed.

Applicant's summary and conclusion

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). Exposure of rats to 100000 ppm for 30 exposures resulted in slight reversible nasal irritation after exposure; otherwise, there were no clinical signs, normal weight gains, no gross or micropathology findings, and organ weights in normal range. The 4-hour LC50 is >100000 ppm.

Executive summary:

Five male and five female rats were exposed to the test substance at a concentration of 100000 ppm, seven hours per day, five days per week for a total of 30 exposures. Exposure resulted in slight reversible nasal irritation after exposure; otherwise, there were no clinical signs, normal weight gains, no gross or micropathology findings, and organ weights were in normal range. The 4-hour LC₅₀ is >100000 ppm.