Registration Dossier
Registration Dossier
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EC number: 456-160-0 | CAS number: 73942-87-7
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)
- Rationale for reliability incl. deficiencies:
- other: GLP. Guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- -
- EC Number:
- 456-160-0
- EC Name:
- -
- Cas Number:
- 73942-87-7
- Molecular formula:
- C12H13NO3
- IUPAC Name:
- 7,8-dimethoxy-2,3-dihydro-1H-3-benzazepin-2-one
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Vehicle:
- DMSO
Challenge
- Vehicle:
- DMSO
- No. of animals per dose:
- 4 females for the preliminary test and 28 females for the main test
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
Results and discussion
Any other information on results incl. tables
No clinical signs and no mortality were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions, Veralactame does not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay
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