Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 april 2013 to 07 may 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
radio-labelled thymidine: 3H-methyl thymidine)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epidermal topical application
Vehicle:
other: ethanol/water (3+7 v/v)
Concentration / amount:
5; 10 and 20 %
Challenge
Concentration / amount:
5; 10 and 20 %
No. of animals per dose:
4

Study design: in vivo (LLNA)

Vehicle:
other: ethanol/water (3+7, v/v)
Concentration:
5, 10 and 25 % (w/w)
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 1.0 1.2 1.0 2.9
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 112.2 129.1 116.2 323.7

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was not a skin sensitiser under the test conditions of this study.