Registration Dossier
Registration Dossier
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EC number: 248-370-4 | CAS number: 27253-29-8
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed following appropriate testing guidelines, GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Neodecanoic acid
- EC Number:
- 248-093-9
- EC Name:
- Neodecanoic acid
- Cas Number:
- 26896-20-8
- Molecular formula:
- C10H20O2
- IUPAC Name:
- neodecanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Versatic 10
- Physical state: clear liquid
Constituent 1
Method
- Target gene:
- chromosome aberration
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 system - no further details
- Test concentrations with justification for top dose:
- Test #12500, 1250, 625, 500 micrograms/mlTest #21000, 800, 700, 600, 500, 400, 300, 200, 100 micrograms/ml
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: mitomycin C used in the absence of S9 metabolic activation system
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in cultureDURATION- Preincubation period: 3 hours- Exposure duration: 24 hoursSPINDLE INHIBITOR (cytogenetic assays): colcemidSTAIN (for cytogenetic assays): GiemsaNUMBER OF REPLICATIONS: two slides from each duplicate cultureNUMBER OF CELLS EVALUATED: At least 1000DETERMINATION OF CYTOTOXICITY - Method: mitotic index
- Evaluation criteria:
- For each selected treatment 200 well-spread metaphases containing 46 centromeres were analyzed by microscopic examination for a wide range of structural chromose and chromatid aberrations (gaps, breaks, fragments, dicentrics, rings, interchanges, intrachanges, and other anomalies such as interstital deletions and multiple aberrations.
- Statistics:
- Fisher's exact probability test
Results and discussion
Test results
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no statistical increases in the number of cells with chromosomal aberrations
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- only at the highest concentrations tested
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- Interpretation of results (migrated information):negativeVersatic 10 does not induce chromosome aberrations.
- Executive summary:
The test substance Versatic 10 (neodecanoic acid) was examined for its potential to induce structural chromosome aberrations in cultured human lymphocytes in both the absence and presence of a metabolic activation system (S9 mix), in compliance with OECD guideline 473.
Two independent chromosome aberration tests were conducted in both the absence and presence of S9. In the absence of S9, cells were exposed to the test substance continuously for 24 or 48 hours. In the presence of the S9, cells were exposed to the test substance for 3 hours and harvested at 24 or 48 hours later. The choice for the highest concentrations scored was based on toxicity. The test substance was dissolved in DMSO.
In neither chromosome aberration assay, Versatic 10 did not induce a statistically significant increase in the percentage of cells with structural chromosome aberrations at any of the concentrations and time points analyzed. The positive controls gave appropriate responses.
It is concluded that Versatic 10 is not clastogenic under the conditions used in this study.
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