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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
7 experimental animals, 3 control animals
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
7 experimental animals, 3 control animals
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The maximisation test was already available and therefore a LLNA test was considered unnecessary.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: 0.1N NaOH
Concentration / amount:
10% concentration intradermally injected,
50% concentration epidermally exposed
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other: 0.1N NaOH
Concentration / amount:
50% concentration
No. of animals per dose:
7
Details on study design:
Based on a test substance pretest, 0.1N NaOH was selected as the most suitable vehicle for V194024.
Test concentrations selected for the main study were based on the results of a preliminary study using four animals. In the main study, seven animals were intradermally injected with a 10% concentration and epidermally exposed to a 50% concentration, while three control animals were similarly treated, but with 0.1 N NaOH only. Since no signs of irritation were observed at the concentration selected for the epidermal induction, all animals were treated with 10% SDS approximately 24 hours before the epidermal induction.
Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and 0.1N NaOH. The challenge reactions were assessed 24 and 48 hours after bandage removal.
Challenge controls:
3 animals
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:
50% concentration
No. with + reactions:
0
Total no. in group:
7
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% concentration
No. with + reactions:
0
Total no. in group:
7
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1 N NaOH
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1 N NaOH
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No evidence was obtained that V194024 caused skin hypersensitivity in the guinea pig. This result lead to a sensitisation rate of 0%, indicating that V194024 need not be regarded as a potential skin sensitiser.