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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 as a class have near identical toxicological properties.
Note that the tox. testing dates from the '80s, pre-dating concerns about animal testing.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Testing pre-dates LLNA

Test material

Constituent 1
Chemical structure
Reference substance name:
Perfluoroperhydrophenanthrene
EC Number:
400-470-0
EC Name:
Perfluoroperhydrophenanthrene
Cas Number:
306-91-2
Molecular formula:
C14F24
IUPAC Name:
1,1,2,2,3,3,4,4,4a,4b,5,5,6,6,7,7,8,8,8a,9,9,10,10,10a-Tetracosafluorophenanthrene
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Housed in suspended cages, free access to water and vitamen-c enriched FDI, hay given weekly. Temperature was ca. 21degC, humidity 30 to 70%.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
75%
Day(s)/duration:
7
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Neat
Day(s)/duration:
2 (48 hours)
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
20% anterior and 10% posterior
Day(s)/duration:
1 (24 hours)
Adequacy of challenge:
not specified
No. of animals per dose:
20
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20% and 10%
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
Slight odema only
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Slight odema only
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20% and 10%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Slight odema only
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Slight odema only
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
No positove control used
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Remarks on result:
other: No positive control used
Remarks:
But IUCLID 6 demands an entry for it, so here it is!

Applicant's summary and conclusion

Conclusions:
From this and other similar testing we can be confident saturated perfluorocarbons do not cause skin sensitisation.
Executive summary:

From this and other similar testing we can be confident saturated perfluorocarbons do not cause skin sensitisation.