Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non-pathogen-free subjects used

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1992

Materials and methods

Principles of method if other than guideline:
Exposed to ca. 10% octafluoropropane in air for 10 days continuously.
GLP compliance:
no
Limit test:
yes

Test material

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

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
IR and GLC
Duration of treatment / exposure:
10 days
Frequency of treatment:
Continuous (24hr/day)
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Observed for bavioural and clinical symptoms daily, weighed at day 0, 5 and 10
Sacrifice and pathology:
All sacrificed, macroscopic examination

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
effects observed, non-treatment-related
Description (incidence and severity):
Ratio of liver and adrenal weight to body weight increased in females.
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
Interstitial pneumonitis found to be present in all control and test animals
Histopathological findings: neoplastic:
not specified

Effect levels

Key result
Dose descriptor:
conc. level:
Effect level:
ca. 113 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
behaviour (functional findings)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Non-pathogen-free subjects were used. Two males in the test group and one in the control were sacrificed on day 6 due to illness. All control and test subhjects were later found to have interstitial pneumonitis.

Applicant's summary and conclusion

Conclusions:
Material is not chronically toxic, even at high concentration.
Executive summary:

Material is not chronically toxic, even at high concentration.