Registration Dossier

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

Data source

Reference
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Challenge
Route:
epicutaneous, occlusive

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
12
Total no. in group:
20
Remarks on result:
other:
Reading:
1st reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other:
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other:
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
No. with + reactions:
15
Total no. in group:
15
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
No. with + reactions:
13
Total no. in group:
15
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion