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 EU/OECD guideline.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0 (vehicle control), 3, 10 and 30%.
No. of animals per dose:
6 mice per group

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: The NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test substance.

Applicant's summary and conclusion

Interpretation of results:
other: irritant but not sensitising
Executive summary:

This study does point to a non-specific (irritant) irnmunostimulating potential of the test item.

 

This applies to NMRI mice, for weight and cell counts of the draining lymph nodes as well as ear swelling and ear weight indices evaluated after application of the test substance. The "positive level" of ear swelling which is 2x10-2mm increase, i.e. more than 10%

increase in index, has been exceeded in the high dose group. This increase is statistically significant compared to vehicle treated animals. An increase of the ear weights could also be determined in the animals of the high dose group compared to control animals.

Therefore, it must be concluded that the test item has an irritant potential at the highest concentration tested, i.e. 30%.

Taken together, no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 30% test substance by the method used. Therefore, the concentration of 30% turned out to be the NOEL for the

parameters investigated in this study with respect to skin sensitization.