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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)
- Specific details on test material used for the study:
- Name: FAT 40875/A TE
Physical appearance: Dark red powder.
Purity: 86.4% all organic components
Batch No: BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured Date: December, 11th 2017
Expirty date: December, 11th 2022.
Recommended Storage Condition: Refrigeration (+2 to +8 °C), Protect from light. - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: Day 0 and Day 5.
- Sampling method: HPLC
- Sampling intervals/times for pH measurements: Day 0 and Day 5.
- Sampling intervals/times for sterility check: Start date and study termination dates.
- Sample storage conditions before analysis: Samples were analysed on the sampling day. - Buffers:
- - pH: 4
- Type and final molarity of buffer: Acetic acid solution, 0.2 M + Anhydrous sodium acetate solution 0.2 M.
- Composition of buffer: Acetic acid solution 205 mL + Anhydrous sodium acetate solution 45 mL. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 20 mL amber coloured vials.
- Sterilisation method: All glassware used was sterilised using autoclaved before use. All buffer solutions were sterilised by passing through 0.2 µm sterilised filter. The experiment was performed in laminar flow chamber under aseptic condition. Sterility of the samples was checked at experimental start date and at study termination for each of the test systems.
- 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.
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 1 and Day 5. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 mg/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- buffer solution
- Preliminary study:
- The hydrolysis of test item at 50 ± 0.5 °C after 5 days was found to be less than 10 % at pH 4.0. The test item was considered to be hydrolytically stable in pH 4.0 buffer (t1/2>1 Year).
- Transformation products:
- not specified
- % Recovery:
- 88.1
- St. dev.:
- 6.2
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- 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
- Anomalies or problems encountered (if yes): no - Validity criteria fulfilled:
- yes
- Conclusions:
- The test item was considered to be hydrolytically stable in pH 4.0 buffer (t1/2 >1 Year).
- Executive summary:
A study was performed as per OECD Guideline No. 111 to determine the rate of hydrolysis of the test item as a function of pH at pH 4 buffer and temperature.
Test item at nominal concentration of about 100 mg/L (100 µg/mL) in sterile buffer solutions of pH 4.0 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 6.8 % at pH 4.0. The hydrolysis of test item at 50 ± 0.5 °C after 5 days was found to be less than 10 % at pH 4.0. Hence, the test item was considered to be hydrolytically stable in pH 4.0 buffer (t1/2 >1 Year).
Reference
Limit of Detection (LOD) of the method was 0.77 µg/mL
Limit of Quantitation (LOQ) of the method was 5 µg/mL
Description of key information
FAT 40875/A was considered to be hydrolytically stable in pH 4.0 buffer (t1/2 >1 Year).
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
A study was performed as per OECD Guideline No. 111 to determine the rate of hydrolysis of the test item as a function of pH at pH 4 buffer and temperature. Test item at nominal concentration of about 100 mg/L (100 µg/mL) in sterile buffer solutions of pH 4.0 was incubated for 5 days at 50 ± 0.5 °C in the preliminary test.
The hydrolysis of test item after 5 days of incubation at 50 ± 0.5 °C was 6.8 % at pH 4.0. The hydrolysis of test item at 50 ± 0.5 °C after 5 days was found to be less than 10 % at pH 4.0. Hence, the test item was considered to be hydrolytically stable in pH 4.0 buffer (t1/2 >1 Year).
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