Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to EU / OECd guideline.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
0.25, 0.5 and 1% in DMSO
No. of animals per dose:
5 animals per group and dose
Details on study design:
The test substance and the vehicle were applied on external surfaces of each ear (25 μl/ear) for three consecutive days (Days 0, 1 and 2) at the appropriate concentrations. On Day 5, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated thymidine and the obtained values were used to calculate proliferation indices.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The proliferation index values of the test substance were 6.8, 13.2 and 17.8 at treatment concentrations of 0.25, 0.5 and 1%, respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: test substance concentration: 0.25 % DPM: 40907 test substance concentration: 0.5 % DPM: 79761 test substance concentration: 1 % DPM: 107501

Any other information on results incl. tables

No mortality and no clinical signs were observed during the study. No cutaneous reactions were observed in the vehicle, reference control or treated groups.

Group Number Test Group Name  DPM  Nodes  DPM/nodes Stimulation Index Values
   
1 Vehicle control DMSO 6030 10 603.0  
2 Test substance at 0.25% in DMSO 40907 10 4090.7 6.8
3 Test substance at 0.5% in DMSO 79761  10  7976.1  13.2
4 Test substance at 1% in DMSO 107501  10  10750.1  17.8

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was found to be a sensitizing formulation in the Local Lymph Node Assay at all concentrations tested.