Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-01-11 - 2010-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- Recombinant spider silk protein eADF4(C16) derived from E. Coli by fermentation
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Recombinant spider silk protein eADF4(C16) derived from E. Coli by fermentation
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 25%, 50% (diluted with DMSO) and 100%.
- No. of animals per dose:
- 3 test groups (3 different concentrations) and 1 negative control group (vehicle) were tested.
- Positive control substance(s):
- other: P-Phenylenediamine (CAS 106-50-3)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Variability:
- SD: 0.6
- Test group / Remarks:
- 100 %
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Variability:
- SD: 0.3
- Test group / Remarks:
- 50 %
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Variability:
- SD: 0.3
- Test group / Remarks:
- 25%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not a skin sensitiser under the test conditions of this study.
- Executive summary:
The test item was not a skin sensitiser under the test conditions of this study.
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