Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

In vivo test system

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals and environmental conditions:
SPF albino mice; strain: Crl:NMRI (Charles River Deutschland GmbH)

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
10%, 25%, 50%
No. of animals per dose:
6

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: 10%: 0.78 25%: 1.01 50%: 0.97

Any other information on results incl. tables

Treatment with the 10%, 25% and 50% test item did not cause a transgression of the positive threshold value concerning the lymph node cell count. Only at 50% test item, the positive threshold value concerning the index of the ear thickness was exceeded, however, a differentiation index of 0.00 was calculated. Therefore, no signs of an irritant and/or allergic effect were identified.

Applicant's summary and conclusion

Conclusions:
Neither a specific (sensitizing) nor a non-specific (irritant) stimulation potential shall be attributed to the test item.