Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-842-7 | CAS number: 2550-02-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sept. - Oct. 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Landesamt für Umwelt, wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz, Kaiser Friedrich Str. 7, 55116 Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triethoxypropylsilane
- EC Number:
- 219-842-7
- EC Name:
- Triethoxypropylsilane
- Cas Number:
- 2550-02-9
- Molecular formula:
- C9H22O3Si
- IUPAC Name:
- triethoxy(propyl)silane
1
Method
- Target gene:
- hisD6610 (frame shift), hisD3052 (frame shift), hisG46 (base pair substitution), hisG428 (base pair substitution) causing histidine deficiency
uvrB (deletion) causing UV sensitivity and biotine defiency, rfa (deletion) causing lipopolysaccharide side chain defiency, pKM101 (plasmide) causing ampillicine resistance, pAQ1 (plasmide) causing tetracycline resistance
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Additional strain / cell type characteristics:
- other: Mutations: hisD6610, uvrB, rfa, pKM101
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: Mutations: hisD3052, uvrB, rfa, pKM101
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: Mutations: hisG46, uvrB, rfa, pKM101
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: Mutations: hisG428, rfa, pKM101, pAQ1
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: Mutations: hisG46, uvrB, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (rat liver)
- Test concentrations with justification for top dose:
- first experiment: 5 concentrations: 1500/500/150/50/15 µg/plate (plate incorporation method)
second experiment: 6 different concentrations:1500/750/375/188/94/47 µg/plate (pre-incubation method) - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 4-nitro-1,2-phenylene Diamine and Sodium azide without metabolic activation, 2-Amino-Anthracene and Benzo-a-Pyrene with metabolic activation
- Details on test system and experimental conditions:
- First experiment: plate incorporation method, 1500-15µg/plate, 48h, 37°C, with and without S9-mix, 3 plates per strain and dose
Second experiment: pre-incubation method, 1500-47µg/plate, 48h, 37°C, with and without S9-mix, 3 plates per strain and dose
For the solvent control (with and without S9-mix) and the positive controls, 4 plates were used
Genotype Confirmation, toxicity control and sterility controls were performed - Rationale for test conditions:
- Guideline
- Evaluation criteria:
- The colonies were counted visually, the numbers were recorded. An increase of revertant colonies iper plate in at least one strain or a concentration related increase over the range tested can be taken as a sign of mutagenicity.
- Statistics:
- mean values, standard deviations, increase factors (mean revertants divided by mean spontaneous revertants)
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: all tested strains (TA97a, TA98, TA100, TA102, TA1535)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Valid test according Guideline 471. No mutagenic potential found in this test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
