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)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
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:
NMRI
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
1 % solution in Acetone/Olive Oil (4:1) SI-Value 1.05
3 % solution in Acetone/Olive Oil (4:1) SI-Value 1.09
10 % solution in Acetone/Olive Oil (4:1) SI-Value 1.40
No. of animals per dose:
Test group: 18 animals
Control group: 6 animals

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: 1 % solution in Acetone/Olive Oil (4:1) SI-Value 1.05 3 % solution in Acetone/Olive Oil (4:1) SI-Value 1.09 10 % solution in Acetone/Olive Oil (4:1) SI-Value 1.40

Any other information on results incl. tables

RAC-BEPP dest. has a moderate sensitizing potential in mice after dermal application of a 10 % concentration. In addition, a pronounced non-specific (irritating) activation can not be exlcluded after application of a 10% concentration, which could have an impact on cell proliferation of the draining lymph nodes. The concentration of 3% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information