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EC number: 800-884-5 | CAS number: 1154308-86-7
- 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
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 August 2012 - 17 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 5, 1, 0.1 and 0 Days (staggered introduction to test so all samples analysed together)
- Sampling method: Dilution with acetonitrile
- Sampling intervals/times for pH measurements: At end of test
- Sampling intervals/times for sterility check: No sterility check, Tier 1 assessment only
- Sample storage conditions before analysis: ambient - samples vialled immediatly for analysis - Buffers:
- - pH: 4
- Type and final molarity and composition of buffer: Aqueous pH 4 buffer was prepared such that the final solution contained ca 9 mM sodium hydroxide and ca 50 mM monopotassium citrate in a 1 L flask. This was filtered through a 0.45 μm nylon filter. The pH of the buffer used was 4.01. This was purged with nitrogen gas to remove dissolved oxygen.
- pH: 7
- Type and final molarity and composition of buffer: Aqueous pH 7 buffer was prepared such that the final solution contained ca 35 mM sodium hydroxide and ca 50 mM monopotassium phosphate in a 1 L flask. This was filtered through a 0.45 μm nylon filter. The pH of the buffer used was 7.00. This was purged with nitrogen gas to remove dissolved oxygen.
- pH: 9
- Type and final molarity and composition of buffer: Aqueous pH 9 buffer was prepared such that the final solution contained ca 21 mM sodium hydroxide, ca 50 mM monopotassium chloride and ca 50 mM boric acid in a 1 L flask. This was filtered through a 0.45 μm nylon filter. The pH of the buffer used was 9.01. This was purged with nitrogen gas to remove dissolved oxygen. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 15 mL amber glass vessels
- Sterilisation method: filtration of buffer
- Lighting: None
- Measures taken to avoid photolytic effects: Physical covering of hydrolysis test
- Measures to exclude oxygen: headspace purged and minimised, vessels capped.
- If no traps were used, is the test system closed/open: Closed
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No
TEST MEDIUM
- Volume used/treatment: 10 mL
- Kind and purity of water: Milli_Q water, de-ionised reverse osmosis water
- Renewal of test solution: no renewal
- Identity and concentration of co-solvent: acetonitrile (0.25% v/v)
OTHER TEST CONDITIONS
- Adjustment of pH: Not required
- Dissolved oxygen: Not measured - Duration:
- 5 d
- pH:
- 4.01
- Initial conc. measured:
- ca. 0.223 g/L
- Duration:
- 5 d
- pH:
- 7
- Initial conc. measured:
- ca. 0.21 g/L
- Duration:
- 5 d
- pH:
- 9.01
- Initial conc. measured:
- ca. 0.243 g/L
- Number of replicates:
- 3 replicates at 4 timepoints
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- Mean % recoveries and difference in recovery from T0
Ln recovery regression - Preliminary study:
- After 5 days the substance coating additives test item was shown to have hydrolysed less than 10% compared to T0 in pH 4, 7 and 9 buffer at 50 ± 0.5 °C.
This indicates that the test item was hydrolytically stable at pH 4, 7 and 9, and significant hydrolysis did not occur. - Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- - Other: Significant hydrolysis not observed, no transformation products screened for
- % Recovery:
- ca. 98.6
- St. dev.:
- 2.97
- pH:
- 4.01
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- ca. 102.8
- St. dev.:
- 0.32
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- ca. 92.4
- St. dev.:
- 2.52
- pH:
- 9.01
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- Key result
- 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 hydrolysis of the substance coating additives was assessed in aqueous buffers at pH 4, 7 and 9 at 50 ± 0.5 °C. After 5 days at each pH, the substance coating additives were shown to have hydrolysed less than 10% compared to T0. This indicates that the substance coating additives was hydrolytically stable and significant hydrolysis did not occur at environmentally relevant pH values.
- Executive summary:
A study was conducted to determine the hydrolysis potential of the test substance according to OECD TG 111, in compliance with GLP. The hydrolysis of the test substance was assessed in aqueous buffers at pH 4, 7 and 9 at 50 ± 0.5 °C. After 5 days at each pH, the test substance was shown to have hydrolysed less than 10% compared to T0. Under the study conditions, since significant hydrolysis did not occur at environmentally relevant pH values and the test substance was considered to be hydrolytically stable (Browne, 2013).
Reference
Description of key information
The test substance was found to be hydrolytically stable at environmentally relevant pH values.
Key value for chemical safety assessment
Additional information
A study was conducted to determine the hydrolysis potential of the test substance according to OECD TG 111, in compliance with GLP. The hydrolysis of the test substance was assessed in aqueous buffers at pH 4, 7 and 9 at 50 ± 0.5 °C. After 5 days at each pH, the test substance was shown to have hydrolysed less than 10% compared to T0. Under the study conditions, since significant hydrolysis did not occur at environmentally relevant pH values and the test substance was considered to be hydrolytically stable (Browne, 2013).
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.
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