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EC number: 700-182-8 | CAS number: 134652-60-1
- 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
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 June to 10 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent study conducted by a GLP certified laboratory in accordance with a suitable study guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- and OECD Guideline No. 111, ”Hydrolysis as a Function of pH”
- Deviations:
- yes
- Remarks:
- The reaction solutions were not thermostated, because rapid degradation of TIS-M did not permit incubation of the test solutions. The test was carried out at room temperature. Sterility confirmation test was disregarded because of rapid hydrolysis.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tripropan-2-ylsilyl 2-methylprop-2-enoate
- EC Number:
- 700-182-8
- Cas Number:
- 134652-60-1
- Molecular formula:
- C13 H26 O2 Si
- IUPAC Name:
- Tripropan-2-ylsilyl 2-methylprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): TIS-M
- Lot/batch No.: 9925
- Expiration date of the lot/batch: 2 December 2010
- Storage condition of test material: Under nitrogen at room temperature, continuously protected form all light.
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
None - Radiolabelling:
- not specified
Study design
- Analytical monitoring:
- yes
- Details on sampling:
Sampling:
Samples stored in the autosampler were injected consecutively every 9 minutes.
Analysis of the samples: Samples were analysed with the above presented HPLC method below
Sterility confirmation
Sterility confirmation test was disregarded because of the fast reaction.- Buffers:
- pH 4.0: 0.2 ml 0.2 M Sodium hydroxide and 25 ml 0.2 M Potassium hydrogen phthalate will be diluted to 100 ml with ultra-pure water.
pH 7.0: 14.8 ml 0.2M Sodium hydroxide and 25 ml 0.2 M Potassium dihydrogen phosphate will be diluted to 100 ml with ultra-pure water.
pH 9.0: 10.7 ml 0.2 M Sodium hydroxide and 25 ml 0.2 M Boric acid and Potassium chloride will be diluted to 100 ml with ultra-pure water. - Estimation method (if used):
- Not applicable.
- Details on test conditions:
- TEST CONDITIONS
Test temperature: room temperature
As the reaction is very fast, it is impossible to regulate the test temperature
pH: 4.0, 7.0, 9.0
Buffer solutions:
pH 4.0: 0.2 ml 0.2 M Sodium hydroxide and 25 ml 0.2 M Potassium hydrogen phthalate will be diluted to 100 ml with ultra-pure water
pH 7.0: 14.8 ml 0.2M Sodium hydroxide and 25 ml 0.2 M Potassium dihydrogen phosphate will be diluted to 100 ml with ultra-pure water
pH 9.0: 10.7 ml 0.2 M Sodium hydroxide and 25 ml 0.2 M Boric acid and Potassium chloride will be diluted to 100 ml with ultra-pure water
Light: The hydrolysis reaction was carried out using dark HPLC vials to avoid photolytic effects.
Oxygen: Nitrogen was bubbled into the water before the preparation of the solution in order to exclude oxygen.
PERFORMANCE OF THE TEST
Test solution:
25 ml sterile solutions were prepared. The nominal test item concentration in the buffer solution was 5 μg/ml. The pH of the solution was checked with a calibrated pH meter.
Storage of the solutions:
Test solution was transferred into 1.5 ml HPLC vials. The vials were entirely filled with the solution.
7 vials of test solution and 1vial of control buffer were placed in the autosampler of the HPLC, in the dark.
Sampling:
Samples stored in the autosampler were injected consecutively every 9 minutes.
Analysis of the samples: Samples were analysed with the above presented HPLC method.
Sterility confirmation
Sterility confirmation test was disregarded because of the fast reaction.
- Measures taken to avoid photolytic effects: The hydrolysis reaction was carried out using dark HPLC vials to avoid photolytic effects.
- Measures to exclude oxygen: Nitrogen was bubbled into the water before the preparation of the solution in order to exclude oxygen.
-Temperature: Room temperature. As the reaction is very fast, it is impossible to regulate the test temperature
Duration of testopen allclose all
- Duration:
- 54 min
- pH:
- 4
- Temp.:
- 25 °C
- Initial conc. measured:
- 5 other: μg/ml
- Duration:
- 54 min
- pH:
- 7
- Temp.:
- 25 °C
- Initial conc. measured:
- 5 other: μg/ml
- Duration:
- 54 min
- pH:
- 9
- Temp.:
- 25 °C
- Initial conc. measured:
- 5 other: μg/ml
- Number of replicates:
- 2
- Positive controls:
- not specified
- Negative controls:
- not specified
- Statistical methods:
Evaluation:
The chromatograms were evaluated with the help of “LaChrom Chromatogram Processor".
Calculations were carried out using “EXCEL for Windows". The calibration curves were constructed with “STATISTICA for Windows" using weighted linear regression. The factor was 1/concentration.
Results and discussion
- Preliminary study:
- No data.
- Test performance:
- Based on the measured concentrations (see Table 3 below) decomposition of TIS-M proved to be very fast. Compared to the start concentration 10 % or less was measured in the vials after nine minutes.
Half lives of the reactions can not be calculated, it is estimated to be less than 9 minutes. - Transformation products:
- not specified
- Details on hydrolysis and appearance of transformation product(s):
- Not measured
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- < 9 min
- Type:
- other: estimate
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- < 9 min
- Type:
- other: estimate
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- < 9 min
- Type:
- other: estimate
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
Based on the measured concentrations decomposition of TIS-M proved to be very fast. Compared to the start concentration 10 % or less was measured in the vials after nine minutes. Half lives of the reactions can not be calculated, it is estimated to be less than 9 minutes.
Any other information on results incl. tables
Table 1.: Results of the Method Validation (Study Code: 09/285-316AN)
Selectivity |
No interfering component was observed |
Reinjection repeatability (7 injections) |
Coefficient of Variation < 1.5 % |
Linear range |
0.2-10ug/ml |
Limit of Detection |
0.1 ug/ml |
Limit of Quantification |
0.2 ug/ml |
Recovery from sunflower oil |
81 % (1 mg/ml) 108 % (20 mg/ml) 110 % (600 mg/ml) |
Recovery from aqueous test media |
51-62% (1 ug/ml) |
Stability of the samples |
At least 21 hours in the autosampler |
Stock solution stability |
At least seven days at 5 ± 3 °C |
Stability of the test item in dried sunflower oil |
At least 24 hours at room temperature At least 120 hours at 5 ± 3 °C days |
Stability of the test item in Water |
Less than 30 minutes |
Table 2.: Regression data from calibration series.
Analytical occasion |
Intercept |
Slope |
Correlation Coefficient. |
07 June 2010 |
-4832 |
34674 |
0.999 |
10 June 2010 |
-1277 |
35946 |
0.998 |
Table 3.: Measured pH values
Nominal pH |
Control |
Replicate 1 |
Replicate 2 |
4 |
4.02 |
4.27 |
4.25 |
7 |
7.00 |
7.25 |
7.25 |
9 |
9.00 |
9.33 |
9.31 |
Table 4.: Measured data
|
Time |
TIS-M concentration |
|
pH |
minutes |
replicate 1 |
replicate 2 |
|
|
[j,g/ml |
[j,g/ml |
|
Start |
2.6 |
2.0 |
|
9 |
0.26 |
n.d. |
|
18 |
< 0.2 |
n.d. |
4 |
27 |
n.d. |
n.d. |
|
36 |
n.d. |
n.d. |
|
45 |
n.d. |
n.d. |
|
54 |
n.d. |
n.d. |
|
Start |
2.1 |
1.8 |
|
9 |
n.d. |
n.d. |
|
18 |
n.d. |
n.d. |
7 |
27 |
n.d. |
n.d. |
|
36 |
n.d. |
n.d. |
|
45 |
n.d. |
n.d. |
|
54 |
n.d. |
n.d. |
|
Start |
0.5 |
2.6 |
|
9 |
n.d. |
< 0.2 |
|
18 |
n.d. |
n.d. |
9 |
27 |
n.d. |
n.d. |
|
36 |
n.d. |
n.d. |
|
45 |
n.d. |
n.d. |
|
54 |
n.d. |
n.d. |
n.d. stands for "not detected"
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- The study deviated from the Guidelines in that the reaction solutions were not thermostated, because rapid degradation of TIS-M did not permit incubation of the test solutions. The test was carried out at room temperature. Sterility confirmation test was
- Conclusions:
- Decomposition of the substance proved to be very fast, so the half lives of the reactions could not be calculated. The half life is estimated to be less than 9 minutes.
- Executive summary:
The hydrolysis of the registered substance was assessed according to EC C.7 using a HPLC method. It was calibrated using the following concentrations of calibration samples: 0.2, 0.5, 1, 2, 5 and 10 μg/ml. The half life of the registered substance was estimated to be less than 9 minutes.
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