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Diss Factsheets
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EC number: 947-263-6 | 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:
- 02 November 2017 to 08 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Incubated test solutions were run on a HPLC system to determine if any hydrolysis had occurred. A 5 mL volume of sample at pH 4 and 7 was extracted into
dichloromethane. The dichloromethane was transferred to a 7 mL vial and evaporated to dryness. An equal volume of mobile phase was added to the vial for
analysis. At pH 9, the sample could not be extracted and was diluted directly into methanol (0.45 mL sample and 4.5 mL methanol).
- A significant decrease in any chromatographic peak area would indicate breakdown of the test material. The chromatograms were also examined for the appearance of additional peaks that would provide confirmation that hydrolysis had occurred. - Buffers:
- The Buffers were prepared as follows:
- pH 4: 0.05M acetic acid adjusted with NaOH to pH 4 (pH: 4.01)
- pH 7: 500 mL 0.1M KH2PO4 + 296.3 mL 0.1N NaOH in 1 litre adjusted to pH 7 with HCl or NaOH (pH: 6.99)
- pH 9: 500 mL 0.1M H3BO3 in 0.1M KCl + 213 mL 0.1N NaOH in 1 litre adjusted to pH 9 with HCl (pH: 9.04)
- The pH of each solution was checked prior to use. Buffer solutions containing the test material are sterilised by passing sample through a sterilised 0.2 μm cellulose acetate syringe filter prior to incubation at test temperature. - Details on test conditions:
- SOLUTION PREPARATION
- Test Solutions were prepared by weighing approximately 0.06 g of test material into a 125 mL Erlenmeyer flask. The buffer (50 mL) was added to each flask and the solution was sonicated for 15 minutes to aid dissolution. Due to low solubility of the test material, a suspension was used rather than an aqueous half saturation solution. All solutions were cloudy after sonication. For pH 4 and 7, the supernatant was decanted and diluted by half. The solution at pH 9 was used undiluted. All pH’s were filtered through a 0.2 μm cellulose acetate filter to sterilise and the headspace blown off with nitrogen to limit the presence of oxygen. The solutions were not purged with nitrogen.
- 50 mL buffer was added for each solution.
- Incubated test solutions were run on a HPLC system to determine if any hydrolysis had occurred. A 5 mL volume of sample at pH 4 and 7 was extracted into dichloromethane. The dichloromethane was transferred to a 7 mL vial and evaporated to dryness. An equal volume of mobile phase was added to the vial for analysis. At pH 9, the sample could not be extracted and was diluted directly into methanol (0.45 mL sample and 4.5 mL methanol).
- A significant decrease in any chromatographic peak area would indicate breakdown of the test material. The chromatograms were also examined for the appearance of additional peaks that would provide confirmation that hydrolysis had occurred. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 other: %
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 other: %
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 other: %
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The test material concentrations after five days incubation at 50°C were:
- pH 4: 95.6 % (main peak @ 4.0 min.)
- pH 7: 100 % (main peak @ 4.0 min.)
- pH 9: 100 % (main peak @ 3.5 min.)
- There were no extraneous peaks in HPLC chromatogram
There was no other evidence of hydrolysis
- No hydrolysis occurred at pH 4, 7 or 9, therefore no further work was required - Test performance:
- A greater than 10 % drop in peak area indicates the test material is hydrolytically unstable at 50°C over a five day period and Tier 2 should be performed. The Test Material was hydrolytically stable at all 3 pH’s and Tier 2 was not required.
- Transformation products:
- not specified
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- A greater than 10% drop in peak area indicates the test material is hydrolytically unstable at 50°C over a five day period and Tier 2 should be performed. The Test Material was hydrolytically stable at all 3 pH’s and Tier 2 was not required.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this study, the test material was hydrolytically stable at pH 4, 7 and 9.
- Executive summary:
The hydrolysis of the test material was investigated in accordance with the standardised guideline OECD 111, under GLP conditions.
Samples of the test material at pH 4, 7 and 9 were incubated at 50°C for five days. Incubated test solutions were run on a HPLC system to determine if any hydrolysis had occurred. A 5 mL volume of sample at pH 4 and 7 was extracted into dichloromethane. The dichloromethane was transferred to a 7 mL vial and evaporated to dryness. An equal volume of mobile phase was added to the vial for analysis. At pH 9, the sample could not be extracted and was diluted directly into methanol (0.45 mL sample and 4.5 mL methanol).
A significant decrease in any chromatographic peak area would indicate breakdown of the test material. The chromatograms were also examined for the appearance of additional peaks that would provide confirmation that hydrolysis had occurred.
The test material concentrations after five days incubation at 50°C were: pH 4: 95.6 % (main peak at 4.0 min.), pH 7: 100% (main peak at 4.0 min.) and pH 9: 100% (main peak at 3.5 min.).
A greater than 10% drop in peak area indicates the test material is hydrolytically unstable at 50°C over a five day period and Tier 2 should be performed. The test material was hydrolytically stable at all 3 pH’s and Tier 2 was not required.
Under the conditions of this study, the test material was hydrolytically stable at pH 4, 7 and 9.
Reference
Description of key information
Under the conditions of this study, the test material was hydrolytically stable at pH 4, 7 and 9.
Key value for chemical safety assessment
Additional information
The hydrolysis of the test material was investigated in accordance with the standardised guideline OECD 111, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Samples of the test material at pH 4, 7 and 9 were incubated at 50°C for five days. Incubated test solutions were run on a HPLC system to determine if any hydrolysis had occurred. A 5 mL volume of sample at pH 4 and 7 was extracted into dichloromethane. The dichloromethane was transferred to a 7 mL vial and evaporated to dryness. An equal volume of mobile phase was added to the vial for analysis. At pH 9, the sample could not be extracted and was diluted directly into methanol (0.45 mL sample and 4.5 mL methanol).
A significant decrease in any chromatographic peak area would indicate breakdown of the test material. The chromatograms were also examined for the appearance of additional peaks that would provide confirmation that hydrolysis had occurred.
The test material concentrations after five days incubation at 50°C were: pH 4: 95.6 % (main peak at 4.0 min.), pH 7: 100% (main peak at 4.0 min.) and pH 9: 100% (main peak at 3.5 min.).
A greater than 10% drop in peak area indicates the test material is hydrolytically unstable at 50°C over a five day period and Tier 2 should be performed. The test material was hydrolytically stable at all 3 pH’s and Tier 2 was not required.
Under the conditions of this study, the test material was hydrolytically stable at pH 4, 7 and 9.
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