Registration Dossier
Registration Dossier
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EC number: 940-308-0 | CAS number: -
Skin sensitisation
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:
- 2 010
- 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
- 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
Constituent 1
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.
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