Registration Dossier
Registration Dossier
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EC number: 419-560-6 | CAS number: 4369-14-6
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:
- other: The study was conducted according to standard OECD method and under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 419-560-6
- EC Name:
- -
- Cas Number:
- 4369-14-6
- Molecular formula:
- C9H18O5Si
- IUPAC Name:
- 3-(trimethoxysilyl)propyl prop-2-enoate
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from rat liver indiced with phenobarbital
- Test concentrations with justification for top dose:
- concentration range in the main test with and without metabolic activation: 313 to 5000µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- no data
- Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- There were no increase in the number of the revertant colonies over twice compared with the solvent control in any test conditions
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No precipitation was noted
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
negative with and without metabolic activation - Executive summary:
Under the performed test according to OECD 471 and 472 under GLP, acryloxypropyltrimethoxysilane showed no gen mutation.
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