Registration Dossier

Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Concentration / amount:
Intradermal injection: 1 % w/v in 5 % Acetone in Alembicol D
Topical application: 80 % w/v in acetone
Challenge application: 80 and 40 % in acetone
Challengeopen allclose all
Route:
intradermal and epicutaneous
Concentration / amount:
Intradermal injection: 1 % w/v in 5 % Acetone in Alembicol D
Topical application: 80 % w/v in acetone
Challenge application: 80 and 40 % in acetone
No. of animals per dose:
10 test animals and 5 control guinea-pigs

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
40 % w/v in acetone
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 % w/v in acetone. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
40 % w/v in acetone
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 % w/v in acetone. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
80 % w/v in acetone
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 80 % w/v in acetone . No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
80 % w/v in acetone
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Clinical signs: No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 80 % w/v in acetone. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Clinical signs: No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 % w/v in acetone
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 % w/v in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
80 % w/v in acetone
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 80 % w/v in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information