Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%, 50% and 100%
No. of animals per dose:
5

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Test item: 0% S.I: 1.00 Test item: 25% S.I: 2.02 Test item: 50% S.I: 3.24 Test item: 100% S.I: 4.30
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Test item: 0% DPM: 917.8 Test item: 25% DPM: 1854.9 Test item: 50% DPM: 2975.9 Test item: 100% DPM: 3947.6

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be a skin sensitiser and an EC3 value of 45.1% (w/v) was derived