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EC number: 419-560-6 | CAS number: 4369-14-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 6th April 1994 - 9th June 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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
1
Method
- Target gene:
- histidine deficient S. typhimurium strains and tryptophan deficient E. coli strains
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- Source of S9: Phenobarbital (30 mg/kg x 1, 60 mg/kg x 3) and 5,6-benzoflavon (80 mg/kg x 1) induced rat liver S9 from Sprague-Dawley rats, male, 7 weeks old prepared by Hita Research Laboratories
- Method of preparation of S9 mix: In 1 mL of S9 mix, there was 8 µmol MgCl2, 33 µmol KCl, 5 µmol glucose-6-phosphate, 4 µmol NADPH, 4 µmol NADH, 100 µmol 0.2 M sodium phosphate buffer (pH 7.4), 0.1 mL S9
- Concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL of S9 mix - Test concentrations with justification for top dose:
- - Dose range-finding test: 5000, 2000, 1000, 500, 200, 100 and 50 µg/plate.
- Main test doses: The highest dose chosen for the main test 5000 µg/plate was based on the findings of the dose range-finding study and four more doses of 2500, 1250, 625 and 313 µg/plate were chosen by dilution with a geometric progression of two in two independent tests. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No denaturation of the test solution was observed until 2 hours after preparation which demonstrated that the test substance was stable within the solvent.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine (ICR-191)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Dose range-finding test was tested in triplicate for the negative control and in duplicate for the test and positive control groups; triplicate cultures were used for the main test.
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- The tests were carried out using the preincubation method
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes
- Exposure duration/duration of treatment: 48 hours
- Harvest time after the end of treatment (sampling/recovery times): After 48-hour incubation period.
FOR GENE MUTATION:
- Method used: Agar
METHODS FOR MEASUREMENT OF CYTOTOXICITY :
- Method: Background growth inhibition
- Rationale for test conditions:
- Based on a dose range-finding study.
- Evaluation criteria:
- The test substance was judged to be positive, when the number of revertant colonies is more than twice that of the negative control and a dose relationship and reproducibility are obtained.
- Statistics:
- Means with standard deviation, and statistical significance
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Cytotoxicity was seen at 5000 µg/plate without S9 mix; no increase in the number of revertants was seen.
STUDY RESULTS :
- Concurrent vehicle negative and positive control data : See attachment for study data tables. Positive and negative controls were within the range of the background data for the laboratory.
For all test methods and criteria for data analysis and interpretation:
- Concentration-response relationship where possible : There was no concentration driven increase in the number of revertants seen.
- Statistical analysis: Statistical analysis was performed but no statistically significant increase in the number of revertants was seen.
Ames test:
- Signs of toxicity : Yes, at 5000 µg/plate with and without S9 mix
- Individual plate counts : Yes, see attachment for study data tables
- Mean number of revertant colonies per plate and standard deviation : Yes, see attachment for study data tables
Applicant's summary and conclusion
- Conclusions:
- 3-(Trimethoxysilyl)propyl acrylate has been tested in a bacterial reverse mutation assay, conducted according to OECD Test Guideline 471 (1983) and in compliance with GLP, using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli WP2. No increase in the number of revertants was observed in any test strain, with or without metabolic activation, when tested up to cytotoxic concentration. Appropriate positive and solvent controls were added and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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