Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (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
Test material form:
other: solid
Details on test material:
Batch# 967734
Purity: 99.1 %

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
The animals were individually housed in suspended solid-floor polypropylene cages
furnished with softwood woodflakes. Free access to mains tap water and food (2014C
Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was
allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of
19 to 25°C and 30 to 70%, respectively. Any occasional deviations from these targets
were considered not to have affected the purpose or integrity of the study. The rate of
air exchange was approximately fifteen changes per hour and the lighting was controlledby a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered
not to contain any contaminant of a level that might have affected the purpose or integrity
of the study.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
50%
25%
10%
No. of animals per dose:
5 mice
Details on study design:
The mice were treated by daily application of 25 μl of the
appropriate concentration of the test item to the dorsal surface of each ear for three
consecutive days (Days 1, 2, 3). The test item formulation was administered using an
automatic micropipette and spread over the dorsal surface of the ear using the tip of the
pipette.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
alpha-Hexylcinnamaldehyde, 85% was considered to be a sensitiser under the conditions of the test.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 10%: 1.67 25%: 2.76 50%: 3.69
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Vehicle: 1817.54 (+/- 657.13) dpm/Animal 10%: 3037.60 (+/-1145.05) dpm/Animal 25%: 5009.25 (+/-639.45) dpm/Animal 50%: 6698.23 (+/-2082.90) dpm/Animal

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was considered to be a sensitiser under the conditions of the test.
Executive summary:

The test item was considered to be a sensitiser under the conditions of the test.