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Diss Factsheets
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EC number: 947-985-1 | CAS number: -
- 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
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-11-08 to 2018-04-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D26-3-3-1
- Expiration date of the lot/batch: 2018-12-01
- Purity test date: no data
- Purity: 47.4 wt%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: Duplicate sample solutions were taken initially and from the water bath at various time points. The pH of each solution recorded. The concentration of test item in the sample solutions was determined by flow ionization-mass spectrometry.
- Sampling method: An aliquot of each sample solution was diluted by a factor of 100 using mobile phase. - Buffers:
- - pH: 4.0, 7.0 and 9.0
- Type and final molarity of buffer:
pH Components Concentration (mol dm-3)
4 Citric acid 0.006
Sodium chloride 0.004
Sodium hydroxide 0.007
7 Disodium hydrogen orthophosphate (anhydrous) 0.003
Potassium dihydrogen orthophosphate 0.002
Sodium chloride 0.002
9 Disodium tetraborate 0.001
Sodium chloride 0.002
- The buffer solutions were passed through a 0.2 µm membrane filter to sterilize and subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: individual glass vessels, sealed with minimal headspace
- Sterilisation method: The buffer solutions were passed through a 0.2 μm membrane filter to sterilize and subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen.
- Lighting: These sample solutions were shielded from light whilst maintained at the test temperature.
- Measures taken to avoid photolytic effects: sample solutions were shielded from light
- Measures to exclude oxygen: degassing with nitrogen to minimize dissolved oxygen
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no
TEST MEDIUM
- Preparation of test medium: Stock solutions of test item were prepared at a nominal concentration of 1.0 mg/L in the three buffer solutions. The stock solutions were adjusted to the nominal pH of the relevant buffer solution and then split into individual glass vessels, sealed with minimal headspace, for each data point. These sample solutions were shielded from light whilst maintained at the test temperature.
- Renewal of test solution: not applicable
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Dissolved oxygen: no data - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 1 - <= 1 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 0.972 - <= 0.984 g/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 1.01 - <= 1.02 g/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- When the rate constant is known at two or more temperatures, the rate constant at other temperatures can be estimated using an Arrhenius plot. The natural logarithm of the rate constant and the reciprocal of the test temperature (K) for each individual determination were plotted for each pH, if relevant. From the regression line, the natural logarithm of the rate constant at 25 °C (1/T [K] = 3.354 x 10-3) was obtained and used to generate both the estimated rate constant and the half-life.
- Preliminary study:
- Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours.
Results from the Preliminary test/Tier 1 showed it was not necessary to undertake further testing at pH 4, 7 and 9. - Transformation products:
- no
- % Recovery:
- >= 99.1 - <= 99.7
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- >= 96.2 - <= 98.6
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- >= 99 - <= 99.8
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Validity criteria fulfilled:
- yes
- Remarks:
- No significant peaks were observed at the approximate retention time of the test item on analysis of any matrix blank solutions.
- Conclusions:
- According to OECD 111, the test substance was found to be hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0 with an estimated half-life time higher than 1 year at 25°C. Therefore, no further testing was performed. The results of the test can be considered reliable without restriction.
Reference
Description of key information
One study (Walker, 2019) was performed according to OECD guideline 111 and regarded as a key study (Klimisch score of 1). A half-life time of > 1 year at 25 °C and pH 7 was determined for the test substance.
Key value for chemical safety assessment
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.