Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: vaseline
Concentration / amount:
Induction: 1 % (intradermal) in sesame oil and in adjuvant mixture; 10 % (epidermal) in vaseline
Challange: 1 % (epidermal) in vaseline
Challengeopen allclose all
Route:
other: epidermal
Vehicle:
other: vaseline
Concentration / amount:
Induction: 1 % (intradermal) in sesame oil and in adjuvant mixture; 10 % (epidermal) in vaseline
Challange: 1 % (epidermal) in vaseline
No. of animals per dose:
20 animals in test group
20 animals in negative control group

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Hours after challenge:
24
Group:
test group
Dose level:
1 %(epidermal) in vaseline
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
other: . Hours after challenge: 24.0. Group: test group. Dose level: 1 %(epidermal) in vaseline. No with. + reactions: 14.0. Total no. in groups: 20.0.
Hours after challenge:
48
Group:
test group
Dose level:
1 % (epidermal) in vaseline
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: . Hours after challenge: 48.0. Group: test group. Dose level: 1 % (epidermal) in vaseline. No with. + reactions: 10.0. Total no. in groups: 20.0.
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Data incomplete

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test material was a strong skin sensitiser in this test.