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Diss Factsheets
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EC number: 210-283-4 | CAS number: 611-92-7
- 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
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Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.2.-3.3.2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable guideline study, tested with the source substance Ethyl centralite. According to the ECHA guidance “Practical guide 6" the reliability was changed to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See attached document in IUCLID Section 13 - RA Justification document.pdf
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached document in IUCLID Section 13 - RA Justification document.pdf
3. ANALOGUE APPROACH JUSTIFICATION
See attached document in IUCLID Section 13 - RA Justification document.pdf
4. DATA MATRIX
See attached document in IUCLID Section 13 - RA Justification document.pdf, Table 1: Data matrix - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Sample storage conditions before analysis: The volumetric flasks were placed in the thermostatic bath kept at a certain temperature. The body of each flask was wrapped in an aluminium foil and tightly closed with a stopper. At certain period of time, a portion of sample solution was transferred into a vial followed by a quick cooling to room temperature.
- Buffers:
- Buffered solutions were prepared in accordance with the Method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council Regulation (EC) No 440/2008, Appendix 3: Buffer Systems – Clark and Lubs:
- Buffer pH 4.0 - pH 3.97 (22.4°C)
- Buffer pH 7.0 - pH 7.12 (22.4°C)
- Buffer pH 9.0 - pH 8.96 (22.4°C) - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: volumetric flask, the body of each flask was wrapped in an aluminium foil and tightly closed
- Sterilisation method: all glassware, reagent-grade water and buffer solutions were sterilised by autoclave (121°C, 50 min)
TEST MEDIUM
- Kind and purity of water: deionized water
CALIBRATION SOLUTION
– Approx. 500 mg of test substance was dissolved and diluted with MeOH into a 100mL volumetric flask (CSS). This stock solution was diluted to 2 concentrations.
– Calibration Stock Solution 1 (CSS I): 10mL of CSS was pipetted into 100mL volumetric flask and the flask was filled up to the volume with MeOH.
– Calibration Stock Solution 2 (CSS II): 2mL of CSS was pipetted into 100mL volumetric flask and the flask was filled up to the volume with MeOH.
The stock solutions CSS I and CSS II were diluted with appropriate solvent to 5 more concentrations of calibration solutions.
SAMPLE SOLUTION
0.5 mL CSS I / 50 mL appropriate buffered solution of given pH (4.0, 7.1, and 9.0) - Duration:
- 5.1 d
- pH:
- 3.83
- Temp.:
- 50 °C
- Duration:
- 5.1 d
- pH:
- 7.07
- Temp.:
- 50 °C
- Duration:
- 5.1 d
- pH:
- 8.88
- Temp.:
- 50 °C
- Number of replicates:
- 2 replicates
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The preliminary test has shown that the test substance was rather stable at any of given pH of buffered solutions, i.e. 4.0, 7.1, and 9.0, during the whole period of 5 days.
- Transformation products:
- no
- % Recovery:
- > 90
- pH:
- 3.83
- Temp.:
- 50 °C
- Duration:
- 5.1 d
- % Recovery:
- > 90
- pH:
- 7.07
- Temp.:
- 50 °C
- Duration:
- 5.1 d
- % Recovery:
- > 90
- pH:
- 8.88
- Temp.:
- 50 °C
- Duration:
- 5.1 d
- Key result
- pH:
- 3.83
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7.07
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 8.88
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes - Validity criteria fulfilled:
- yes
- Conclusions:
- The preliminary test has shown that the test substance was rather stable at any of given pH of buffered solutions, i.e. 4.0, 7.1, and 9.0, during the whole period of 5 days.
The test substance is considered hydrolytically stable (t0.5, 25°C > 1 year) therefore no additional testing (Tier 2, Tier 3) is required. - Executive summary:
The procedure was performed according to Method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council regulation (EC) No 440/2008. Published in OJ No L 142/518 May 2008.
The preliminary test has shown that the test substance was rather stable at any of given pH of buffered solutions, i.e. 4.0, 7.1, and 9.0, during the whole period of 5 days.
The test substance is considered hydrolytically stable (t0.5, 25°C > 1 year) therefore no additional testing (Tier 2, Tier 3) is required.
Reference
Description of key information
The preliminary test has shown that the read-across test substance Ethyl centralite was rather stable at any of given pH of buffered solutions, i.e. 4.0, 7.1, and 9.0, during the whole period of 5 days.
The test substance is considered hydrolytically stable (t0.5, 25°C > 1 year) therefore no additional testing (Tier 2, Tier 3) is required.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
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.
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