Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test item was not a skin sensitiser in an LLNA study.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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)
- Species:
- mouse
- Sex:
- female
- 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)
- 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%
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Based on the study data for skin sensitisation of the parent recombinant spider silk protein the substance is not to be classified for skin sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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