Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 18- June 02, 2010
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids C10-20, reaction product with diethylenetriamine
EC Number:
940-308-0
IUPAC Name:
Fatty acids C10-20, reaction product with diethylenetriamine
Test material form:
liquid: viscous
Details on test material:
Test substance: Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Old name of the test material: MK195KSF
Sample description: orange/brown hazy solid
Volatile: no
Storage conditions: at room temperature

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
Based on the results observed in the preliminary test the following test item concentrations were selected for the main study: 12.5%, 25% and 50% (diuluent with DMSO).
The preparations were made immediately prior to each dosing.
No. of animals per dose:
5 mice /test group
3 mice/ preliminary test

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The stimulation index at a concentration of 12.5% was 16.0 The stimulation index at a concentration of 25% was 17.6 The stimulation index at a concentration of 50% was 21.0
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: The DPM at a concentration of 12.5% was 28581.8 The DPM at a concentration of 25% was 31382.4 The DPM at a concentration of 50% was 37610.0

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test item is expected to have sensiting properties and therefore, should be regarded as a dermal sensitiser.