Registration Dossier
Registration Dossier
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EC number: 455-040-5 | CAS number: 3789-59-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 06.06.03-19.01.05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Details on test material:
- - Name of test material: (S)-1-Phenylpropylamin (CAS 3789-59-1)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
Results and discussion
Test results
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- The test material induced statistically significant dose-related increases in the frequency of cells with chromosome aberrations in the absence of a liver enzyme metabolising system after 24 hours continuous exposure. The test material was therefore considered to be clastogenic to human lymphocytes in vitro. There was also some evidence that the test material could induce polyploidy, which is considered to be a marker for aneugenicity.
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