Registration Dossier
Registration Dossier
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EC number: 203-012-6 | CAS number: 102-19-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed reports
Data source
Reference
- Reference Type:
- publication
- Title:
- effect of test chemical on the genotoxicity
- Author:
- Adams, T.B.et. al
- Year:
- 2 005
- Bibliographic source:
- Food and Chemical Toxicology,2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: REC assay
- Principles of method if other than guideline:
- To evaluate the genotoxicity of the test chemical in Bacillus subtilis strain H17 (rec+) and M45 (rec-) by REC assay
- GLP compliance:
- not specified
- Type of assay:
- Bacillus subtilis recombination assay
Test material
- Reference substance name:
- Isopentyl phenylacetate
- EC Number:
- 203-012-6
- EC Name:
- Isopentyl phenylacetate
- Cas Number:
- 102-19-2
- Molecular formula:
- C13H18O2
- IUPAC Name:
- isopentyl phenylacetate
- Details on test material:
- - Name of test material: Isoamyl phenylacetate
- Molecular formula: C13H18O2
- Molecular weight: 206.283g/mol
- Substance type: Organic
- Physical state: Organic
- Purity: No data available
- Impurities (identity and concentrations): No data available.
Constituent 1
Method
- Target gene:
- Rec gene
Species / strain
- Species / strain / cell type:
- bacteria, other: Bacillus Subtilis H17 and M45
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- not specified
- Metabolic activation system:
- No data
- Test concentrations with justification for top dose:
- 20 μl/disk
- Vehicle / solvent:
- No data available.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate) : no data available
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): no data available
- Test substance added in medium: in agar
METHODS FOR MEASUREMENTS OF GENOTOXICITY : The difference in zone of inhibition (>8mm) between 2 strains was reported as positive indication of mutagenicity. - Rationale for test conditions:
- No data available
- Evaluation criteria:
- The difference in zone of inhibition (>8mm) between 2 strains was reported as positive indication of mutagenicity.
- Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- bacteria, other: Bacillus. Subtilis strain : H17 (rec+) and M45 (rec-)
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- STUDY RESULTS:
No Zone of inhibition was observed when 20 μl/disk of the test chemical was incubated with the Bacillus subtilis strains H17 (rec+) and M45 (rec-) in the Rec assay. - Remarks on result:
- other: No mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- No Zone of inhibition was observed when 20 μl/disk of the test chemical was incubated with the Bacillus subtilis strains H17 (rec+) and M45 (rec-) in the Rec assay. Hence, the test chemical can be considered to be non-mutagenic
- Executive summary:
DNA damage and/or repair study was performed to determine the genetic toxicity for test chemical using Bacillus subtilis strains H17(rec+) and M45 (rec-) by Rec assay. The test chemical was used at the concentration of 20 μl/disk. No Zone of inhibition was observed when 20 μl/disk of the test chemical was incubated with the Bacillus subtilis strains H17 (rec+) and M45 (rec-) in the Rec assay. Hence, the test chemical can be considered to be non-mutagenic
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