Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
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:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Version / remarks:
Testing done in 1988, and may reflect the guidelines of the time.
Deviations:
yes
Remarks:
A single dosage was used, due to known low toxicity of these materials. No observation period subsequent to the 28 days.
GLP compliance:
yes (incl. certificate)

Test material

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

Test animals

Species:
rat
Strain:
other: Charles River CD strain [Crl:CD(SD)BR]
Sex:
male/female
Details on test animals and environmental conditions:
Caged in groups of six, feee access to tap water and Labsure LAD 1 Diet. Mean temperature from 19.8°C to 21.7°C, 72.3% relative humidity, 15 air changes per hour, artificial lighting to give 12 hour days. There was a 7 dat acclimation period.
Water and food were tested analytically.

Administration / exposure

Route of administration:
oral: gavage
Details on route of administration:
Syringe and metal cannula.
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
28 days
Frequency of treatment:
Daily
Doses / concentrations
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
Observed daily for ill health, behavior changes or toxicosis. Furthe checks were made for dead or moribud animals.
Weighed prior, and weekly during the test.
Food consumption by cage was measured weekly.
Sacrifice and pathology:
All rats sacrificed, aAdrenals, kidneys, liver, ovaries, testes weighed.
Other examinations:
Blood samples taken at end of study.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Bodyweight in males was 5.8% less than in the control (females had no difference); this was considered insignificant.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
Slight reduction for males, corresponding to weight reduction.
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
Slightly lower glucose in males, but slightly higher in females. Sodium levels higher in females, but "considered to have arisen by chance". Decrease in cholesterol in females, but "insufficient to be toxicologically important".
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined

Effect levels

Dose descriptor:
NOEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
dermal irritation
body weight and weight gain
food consumption and compound intake
behaviour (functional findings)
gross pathology

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No changes were seen that were considered to be due to toxic effects of Flutec PP10 and in all respects, including general health, bodyweight, food consumption, haematology, biochemistry, organ weight analyss and both macroscopic and microscopic pathology, rats treated with Flutec PP10 were similar to controls.
Executive summary:

The test material showed no toxic effect at a dosage of 1000 mg/kg/day over 28 consecutive days.