Registration Dossier
Registration Dossier
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EC number: 700-677-9 | CAS number: 19190-61-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Count of disintegrations per minutes for max 5 minutes instead of 10 min. Deviations from optimal range for relative humidity.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 661476-43-3
- Cas Number:
- 661476-43-3
- IUPAC Name:
- 661476-43-3
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10%, 25%
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- stimulation index: 4
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: 10% group: 3,5 25% group: 2.7
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The supporting substance is the homopolymer of the substance to be registered. The supporting substance is classified as skin sensitizer. It is assumed that the monomer shows the same potential to cause skin sensitiations as the reaction product after polymerization.
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