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:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
(2010)
GLP compliance:
yes (incl. certificate)
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:
Topical application: 25, 50 and 100% (w/v) in acetone/olive oil (4:1 v/v)
No. of animals per dose:
test group: 5 animals
control group: 5 animals

Results and discussion

In vivo (LLNA)

Results
Remarks on result:
other: see results in table 1, any other information on results incl. tables
Remarks:
see results in table 1, any other information on results incl. tables

Any other information on results incl. tables

Table 1: Summary of LLNA results

Concentration (% in w/v) in acetone/olive oil (4:1)

dpm/node

Stimulation index

Result

Vehicle

102.0

1.0

Negative

25

2763.4

27.1**

Positive

50

6236.5

61.1**

Positive

100

4634.0

45.4**

Positive

Positive control

1477.1

14.5**

Positive

** = Significant (p<0.01, Mann-Whitney U-test versus negative control)

dpm = disintegrations per node

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality or systemic toxicity was observed during the study. There were no indications of any irritancy at the site of application. Test item precipitate was observed on the ears of the animals in the 100 and 50% (w/v) dose groups on Days 1-6 and in the 25% (w/v) dose group on Days 2-3. Minimal alopecia was observed on Day 6 in the 100% (w/v) dose group for two animals. No treatment related effects were observed on animal body weights in any test item treated, negative and positive control groups. Appearance of the lymph nodes was normal in the negative control group. The stimulation index values were 45.4, 61.1 and 27.1 at concentrations of 100, 50 and 25 % (w/v), respectively. The resulted stimulation index values above the threshold limit of 3 observed at three examined concentrations indicates that the test material is a skin sensitizer.