Registration Dossier
Registration Dossier
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EC number: 810-432-9 | CAS number: 1487263-87-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,3-bis(acetyloxy)propyl 8-(3-octyloxiran-2-yl)octanoate
- Cas Number:
- 1487263-87-5
- Molecular formula:
- C25H44O7
- IUPAC Name:
- 2,3-bis(acetyloxy)propyl 8-(3-octyloxiran-2-yl)octanoate
- Test material form:
- other: oily liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1% on three consecutive days
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- None of the three tested concentrations of the test item reached the stimulation index of3. The stimulation index at a concentration of 25% was 0.8 The stimulation index at a concentration of 50% was 0.8 The stimulation index at a concentration of 100% was 1.3
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
The results of radioactivity determination were supported by the means of the ear thickness per group, which showed no relevant difference compared to the negative control.
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