Registration Dossier

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Toxicity of perfluorocarbons as a group has been established by decades of testing for many different medical applications.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: vapour

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Houses in plastic cages, free food and water (fasting overnight prior to expusure), observed for 1 week prior, kept in air conditioned room at 70-80°F 40-60% humidity.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
head only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
GC
Duration of exposure:
ca. 60 min
Concentrations:
8647 ppm (i.e., vapour pressure concentration)
No. of animals per sex per dose:
5 male, 5 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 8 647 ppm
Based on:
test mat.
Exp. duration:
60 min
Mortality:
None
Clinical signs:
other: None
Body weight:
Not altered
Gross pathology:
Nothing attributed to test material

Any other information on results incl. tables

"PFD exposure did not produce any toxic sign in rats during or after exposure. Body weights were not altered by exposure. ..."

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
"No toxicity could be demonstrated after exposure to 8647 ppm of perfluorodecalin."
Executive summary:

"No toxicity could be demonstrated after exposure to 8647 ppm of perfluorodecalin."