Registration Dossier
Registration Dossier
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EC number: 429-220-9 | CAS number: 132584-17-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF 59 NohSan No. 4200
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OPPTS 799.9510
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 429-220-9
- EC Name:
- -
- Cas Number:
- 132584-17-9
- Molecular formula:
- C17 H18 O4
- IUPAC Name:
- ethyl 2-hydroxy-2-(4-phenoxyphenyl)propanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: 73.5%
Batch: IN-JG303-7
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA97a, TA98, TA100, TA1535, E Coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor induced rat liver S-9 fraction
- Test concentrations with justification for top dose:
- Concentration range in the main test first trial: 10, 50, 100, 250, 500, 1000, 2500, 5000 µg/plate
Concentration range in the main test second trial: 10, 50, 100, 250, 500, 5000 µg/plate - Vehicle / solvent:
- Solvent: DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene, ICR 191 acridine mutagene
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 250 µg/platepo
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1000 µg/plate)
- Additional information on results:
- Observations:
Precipitation was observed levels over 250 µg/plate.
Toxicity was also apparent at the higher concentrations. - Remarks on result:
- other: preliminary test
Applicant's summary and conclusion
- Conclusions:
- negative with metabolic activation
negative without metabolic activation
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