Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
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 %, 100 %
No. of animals per dose:
4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Test group 25 % 26.79 Test group 50 % 28.78 Testgroup 100 % 30.53
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: DPM per lymph node: Control group 447.1 Test group 25 % 11978.2 Test group 50 % 12864.8 Test group 100 % 13650.7

Any other information on results incl. tables

The EC 3 value could not be calculated, since all S.I. are above 3.

Viability / Mortality: No deaths occurred during the study period.

Clinical signs: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.

Body weight: The body weight of the animals, recorded prior to the first application and prior to treatment with ³HTdR, was within the range commonly recorded for animals of this strain and age. The individual body weight values are included in Annex 1 of the study report.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
In the study Simulation Indices of 26.79, 28.78 and 30.53 were determined with the test item B 1061 at concentrations of 25, 50 and 100 % in acetone:olive oil (4+1). The EC3 value could not be calculated, since all obtained S.I. were above 3.
The test item B 1061 was found to be a skin sensitiser under the described conditions.
Executive summary:

In the study the test item B 1061 dissolved in acetone:olive oil (4 +1) was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed using test item concentrations of 25, 50 and 100 %.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

In this study Stimulation Indices (S.I.) of 26.79, 28.78 and 30.53 were determined with the test item at concentrations of 25, 50 and 100 % in acetone:olive oil (4 +1), respectively.

The test item B 1061 was a skin sensitiser in this assay.