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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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:
guideline study
Justification for type of information:
Saturated perfluorocarbons are well established as a class of compounds with very similar toxicological properties.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
S1178B

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Equal numbers of male and female HC/CFY 9remote Sprague-Dawley) rats, in a weight range 202 to 248 g, approximately 6 to 8 weeks old, all acclimated for a minimum of five days.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Hair removed from dorso-lumber by electric clippers. Test mateerial spread over prepared skin, then covered with gauze, held with an impermeable dressing.
Duration of exposure:
24 hours
Doses:
Equivalent to 10% of the total body surface.
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
None
Clinical signs:
None
Body weight:
Body weights were recorded, but not commented on and no figures for a control were given. All rats gained body weight in the two weeks subsequent to treatment.
Gross pathology:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal dermal dose to rats of Flutec PP10 [perfluoroperhydrofluorene] was found to be greater than 2.0 g/kg bodyweight.
Executive summary:

Material is essentially non-toxic.