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Diss Factsheets
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EC number: - | 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:
- 2018
- 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 (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- no
- Buffers:
- The test was carried out at three different pH values: 4, 7 and 9.
For this purpose, buffer solutions were prepared using reagent grade chemicals and double distilled water. Applicable buffer systems are described in the Appendix of EC method C.7 (92/69/EC), OECD guideline 111. The acetate buffer pH 4.0, the phosphate buffer pH 7.0 and the borate buffer pH 9.0 were prepared in a concentration of 0.02 M (for pH 4 and 7) and 0.01M for pH 9. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 100 mL volumetric flask
- Sterilisation method: All glassware used was sterilised using autoclave before use. All buffer solutions were sterilised by passing through 0.2 µm sterilised filters. The experiment was performed in laminar flow chamber under aseptic condition.
- Lighting: No lighting
- Measures taken to avoid photolytic effects: The prepared test item solutions taken in amber coloured vials were kept in a dark incubator in order to avoid photolytic effects.
- Measures to exclude oxygen: The buffer solutions were bubbled with nitrogen gas for approximately 5 minutes
TEST MEDIUM
- Volume used/treatment: 1000 µL
- Kind and purity of water: Double distilled water
OTHER TEST CONDITIONS
- Adjustment of pH: The pH of the buffered test item solutions during the reactions were measured after equilibrating the test samples at room temperature using a calibrated pH meter. The pH of the test item solutions was measured on Day 0 and Day 5. - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.5 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.5 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.5 mg/L
- Number of replicates:
- 2 at each pH-value
- Positive controls:
- no
- Negative controls:
- no
- Transformation products:
- not measured
- % Recovery:
- 87.9
- St. dev.:
- 5.2
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 98.6
- St. dev.:
- 5.3
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 82.8
- St. dev.:
- 0.9
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Details on results:
- Limit of Detection (LOD) of the method was 0.01 µg/mL
Limit of Quantitation (LOQ) of the method was 0.05 µg/mL - Validity criteria fulfilled:
- yes
- Conclusions:
- The test item was considered to be hydrolytically stable in pH 4.0, 7.0 and pH 9.0 buffers (t1/2>1 Year)
- Executive summary:
The study was performed as per OECD Guideline No. 111 (OECD, 2004) to determine the rate of hydrolysis of the test item FAT 41047/A as afunction of pH at different pH and temperature.
Test item at nominal concentration of about 0.5 mg/L (0.5 µg/mL) in sterile buffer solutions of pH 4.0, 7.0 and 9.0 was incubated for 5 days at 50 ± 0.5 °C in the preliminary test. Hydrolysis reactions were monitored by analyzing the test item concentration at set intervals using an in-house developed and validated HPLC method.
The hydrolysis of test item after 5 days of incubation at 50 ± 0.5°C was 2.6 %, 0.4 % and 7.2 % at pH 4.0, 7.0 and pH 9.0, respectively. The hydrolysis of test item at 50 ± 0.5°C after 5 days was found to be less than 10 % at pH 4.0, 7.0 and 9.0.
Hence the test item was considered to be hydrolytically stable in pH 4.0, 7.0 and pH 9.0 buffers (t1/2>1 Year).
Reference
Description of key information
The test item was considered to be hydrolytically stable in pH 4.0, 7.0 and 9.0 buffers (t 1/2 > 1 year).
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
The study was performed as per OECD Guideline No. 111 (OECD, 2004) to determine the rate of hydrolysis of the test item FAT 41047/A as afunction of pH at different pH and temperature.
Test item at nominal concentration of about 0.5 mg/L (0.5 µg/mL) in sterile buffer solutions of pH 4.0, 7.0 and 9.0 was incubated for 5 days at 50 ± 0.5°C in the preliminary test. Hydrolysis reactions were monitored by analyzing the test item concentration at set intervals using an in-house developed and validated HPLC method.
The hydrolysis of test item after 5 days of incubation at 50 ± 0.5°C was 2.6 %, 0.4 % and 7.2 % at pH 4.0, 7.0 and pH 9.0, respectively. The hydrolysis of test item at 50 ± 0.5°C after 5 days was found to be less than 10 % at pH 4.0, 7.0 and 9.0.
Hence the test item was considered to be hydrolytically stable in pH 4.0, 7.0 and pH 9.0 buffers (t1/2>1 Year).
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