Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
guinea pig
Strain:
other:
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
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:
0
Total no. in group:
20
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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:
0
Total no. in group:
10
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other:
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other:
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other:

Applicant's summary and conclusion