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: guideline study in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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 lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Powder (grey)
- Storage condition of test material: Room temperature and humidity.

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Jackson Laboratories, ME, USA.
- Age at study initiation: ca 2 months.
- Weight at study initiation: 18.3 - 23.4 g.
- Housing: 1 per cage.
- Diet (e.g. ad libitum): PMI diet, ad lbitum.
- Water (e.g. ad libitum): Ad lbitum.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified, but controlled.
- Humidity (%): Not specified, but controlled.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.

IN-LIFE DATES: From: April 22, 2009 To: May 5, 2009.

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
10%
No. of animals per dose:
One group of 5 females.
Details on study design:
As per OECD 429.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Students' t-Test

Results and discussion

Positive control results:
The SI (Stimulation Index) of the positive control, 25% HCA, was 26.7.

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
The SI value for the test article at a concentration of 10% in DMSO was 2.3. In conclusion, topical application of the test article at 25% in DMSO resulted in an SI value of < 3. Therefore, the test article was considered not to be a skin sensitizer in this study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, topical application of the test article at 10% in DMSO resulted in an SI value of 2.3. Therefore, the test article was considered not to be a skin sensitizer in this study.
Executive summary:

The test article was evaluated at a concentration of 10% in DMSO, with DMSO as the vehicle control and 25% HCA as the positive control.

All animals survived the in-life phase of the study and were observed to be normal. Ear thickness measurements and clinical observations indicated that treatment with the test article did not result in dermal irritation.

The SI (Stimulation Index) of the positive control, 25% HCA, was 26.7. The SI value for the test article at a concentration of 10% in DMSO was 2.3.

In conclusion, topical application of the test article at 25% in DMSO resulted in an SI value of < 3. Therefore, the test article was considered not to be a skin sensitizer in this study.