Trifluoro(trifluoromethoxy)ethylene

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:

comparable to guideline study with acceptable restrictions

Remarks:

The study is not GLP, it is equivalent to OECD guideline 403, however a definitive LC50 value has been derived and the concentrations tested are much higher than that tested in the supporting study (1988) which may be the reason for toxic effects observed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trifluoro(trifluoromethoxy)ethylene

EC Number:

214-703-7

EC Name:

Trifluoro(trifluoromethoxy)ethylene

Cas Number:

1187-93-5

Molecular formula:

C3F6O

IUPAC Name:

1,1,2-trifluoro-2-(trifluoromethoxy)ethene

Test material form:

other: gas

Details on test material:

Name of the substance as cited in the report: perfluoromethylperfluorovinyl ether (PMVE)

Test animals

Species:

rat

Strain:

other: ChR-CD

Sex:

male

Administration / exposure

Route of administration:

inhalation: gas

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

A measured flow of the test gas and air were allowed to mix in a copper coil and flow into an 8-liter bell jar containing four ChR-CD male rats of initial body weight 250-304 grams.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

nominal concentration: 20000, 15000, 10000, 5000, 2500ppm

No. of animals per sex per dose:

4 male ChR-CD male rats were used.

Control animals:

no

Statistics:

no data

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

other: (approximate lethal concentration)ALC

Effect level:

10 000 ppm

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

> 10 000 - <= 15 000 ppm

Based on:

test mat.

Exp. duration:

4 h

Mortality:

At 20000 and 15000 ppm, mortality ratio is 4/4; at 10000 ppm, the ratio is 1/4; at 5000 and 2500ppm, the ratio is 0/4.

Clinical signs:

other: Lethal concentrations (20000, 15000, 10000 ppm) > mild polypnea followed by dyspnea with pumping respiration, inactivity, bloody discharge around nose and mouth, ruffled fur, unresponsiveness and lacrimation. Following exposure to lethal concentrations >

Body weight:

At lethal concentrations, animals showed large initial weight losses. Rats surviving lethal concentrations showed weight losses 2-6 days after exposure, but appeared normal thereafter. Animals exposed to sublethal concentrations showed larges initial weight losses 1-4 days after exposure at 5000 ppm. No weight loss was observed at the lowest concentration.

Gross pathology:

All rats that died had massive pulmonary edema and congestion. This was the probable cause of death. No other histological effects due to the exposures were observed in any of the survivors or in any of the other tissues examined. No liver weights were available.

Other findings:

no data

Any other information on results incl. tables

See results attached to the field "Attached background material".

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The perfluoromethyl ether used for studies is a pulmonary irritant with an approximate lethal concentration (ALC) of 10000 ppm (67893 mg/m3).

Executive summary:

Four male rats were used to investigate the acute inhalation toxicity of the test substance. The animals were exposed at five concentrations (20000, 15000, 10000, 5000, 2500 ppm) for 4 hour. During exposure, adverse clinical signs were observed. After exposure, the rats showed no clinical signs of toxicity. All rats that died showed massive pulmonary edema and congestion. Weight losses were observed at test concentrations except the lowest concentration. The approximate lethal concentration (ALC) of the test gas is 10000 ppm, which can be considered as a LOAEC. According to the test result, the LC50 can be deduced to be greater than 10000 ppm but lower than 15000 ppm. Test item can be classified as acute toxicity category 4 (via inhalation) according to CLP (Regulation EC No.1272/2008).