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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 levelsopen allclose all
Sex:
male
Dose descriptor:
other: (approximate lethal concentration)ALC
Effect level:
10 000 ppm
Based on:
test mat.
Exp. duration:
4 h
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:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
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).