Registration Dossier

Toxicological information

Skin sensitisation

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 group
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 group
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:
other: No positive control
Hours after challenge:
0
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Remarks on result:
not measured/tested

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.