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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
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:
Method not specified.
GLP compliance:
not specified

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
other: Full body exposure to the vapour
Vehicle:
other: Air
Details on exposure:
Animals exposed continuously to an atmosphere containing the test material.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
IR and GC
Duration of treatment / exposure:
Ten days
Frequency of treatment:
Continuous exposure (24hr/day)
Doses / concentrations
Dose / conc.:
10 other: %
Remarks:
Measured at 8.5% to 13.7%, mean 11.3%
No. of animals per sex per dose:
10
Control animals:
not specified

Examinations

Observations and examinations performed and frequency:
Animals were observed for behavioural or clinical symptoms daily during exposure. Body weights were recorded the day before exposure began (day 0), on day 5 and on day 10 at necropsy.
Sacrifice and pathology:
After sacrifice, tissues were examined macroscopically for gross abnormalities. Histopathological examination was carried out on the lungs, liver, adrenals, heart, kidneys, spleen and testes of half of the animals plus tissues showing gross abnormalities.
Lungs, adrenals, heart, kidneys, testes and liver were weighed and the organ weight body weight ratio calculated.
Other examinations:
Samples from 50% of the animals were taken for examination:
- haematology examinations; consisting of red blood cell count, white blood cell count, haemoglobin and haematocrit; and
- serum biochemistry; consisting of blood urea nitrogen, fasting blood sugar, alkaline phosphatase, SGOT and SGPT.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Weight gains were slightly depressed initially in the test group but were comparable to the control group over the last stages of the study.
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:
no effects observed
Description (incidence and severity):
Most females showed a slight increase in WBC count. Group means were increased for both sexes exposed to the notified gas but this was not statistically significant. The increase appeared to be due to two animals, one male and one female.
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, non-treatment-related
Description (incidence and severity):
At necropsy, four male and six female rats in the control group had red and brown discolouration of areas of the lungs; four males and nine females receiving perfluoropropane had areas of red, brown and grey discolouration of the lungs. (Rats in other test groups also had discolouration of the lungs at necropsy.)
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
Histopathology showed a high incidence of interstitial pneumonitis with perivascular and/or peribronchial infiltrate in control and in all test groups. There was an increased incidence of lymphocytic infiltrate in liver in the test group (from 7/10 to 10/10). Foci of necrosis were present in the liver of four test animals but not controls.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test material shows no signs of repeated dose dermal toxicity.
Executive summary:

The test material shows no signs of repeated dose dermal toxicity.