1,1,2,2,3,3,4,5,5,6-decafluoro-4,6-bis(trifluoromethyl)cyclohexane

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Non-pathogen-free subjects used

Justification for type of information:

Saturated perfluorocarbons are well-established as a class of materials with essentially identical toxicological properties.

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

Test material information

Constituent 1

Reference substance name:

Octafluoropropane

EC Number:

200-941-9

EC Name:

Octafluoropropane

Cas Number:

76-19-7

Molecular formula:

C3F8

IUPAC Name:

1,1,1,2,2,3,3,3-Octafluoropropane

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:

behaviour (functional findings)

body weight and weight gain

clinical signs

mortality

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.