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EC number: 938-828-8 | CAS number: 1463474-95-4
- 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:
- from 2020-03-05 to 2020-03-10
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation (EC) No. 440/2008, Method C.7 (2008)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch number FC-C 11140
CAS number 1463474-95-4
Purity (certified) 96.6% (UVCB)
Appearance Dark red-brown microgranules (solid)
Water solubility 50 – 100 g/L
pH 7 – 9 (1% in water)
Stability under test Not specified
conditions
Expiry date 2022-08-31
Recommended storage Keep in a dry place. Store at room temperature in the original container. Keep container tightly closed.
Receipt 2019-09-12
Identification parameters Name, batch number, state and color
Retention sample At least 1 g has been retained on 2019-09-16 and stored at 6 ± 2 °C.
Storage condition 18 – 25 °C, dark, in tightly closed original container - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- Type and Frequency of Measurements
Samples were taken at test start (0 h) and test end (120 h). All samples were analysed immediately (if possible, less than 30 min after sampling until start of analyses, but at least not more than 2.5% of the total study time) via HPLC-DAD as specified in Annex I of the report. The method was validated according to Annex II of the report.
The incubation temperature was checked automatically once per hour and at least once per day manually.
Preparation of the test samples After sampling, the samples were analysed directly. - Buffers:
- Buffer solution pH 4 0.18 g of sodium hydroxide and 5.7555 g of mono potassium citrate were dissolved in 500 mL purified water.
Buffer solution pH 7 3.854 g of ammonium acetate were dissolved in 500 mL purified water.
Buffer solution pH 9 0.426 g sodium hydroxide, 1.8638 g potassium chloride and 1.5458 g boric acid were dissolved in 500 mL purified water. - Details on test conditions:
- Replicates Duplicates per pH and sampling date, single injections
Test container (sterile) HPLC vials, brown glass, volume: 2 mL
Test volume 1 mL
Test concentration / solution 150 mg/L (pH 4, 7 and 9)
Application
The test solutions were prepared at test start by direct weighing.
The test item was dissolved in the respective buffer and sterilized by filtration through 0.20 µm sterile membrane filters. After sterilization of the test solutions only sterilized glassware and additional material was used.
After the vials were sealed they were transferred into the thermostat. The time between test item application and transfer to thermostat did not exceed 30 min.
Incubation time 120 h
Temperature 50 ± 0.5 °C
Light Photolytic effects were avoided by using an opaque water bath.
Samples were kept in the dark. - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 136 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 149 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 145 mg/L
- Number of replicates:
- Duplicates per pH and sampling date, single injections
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- Not applicable substance is hydrolytically stable.
- Preliminary study:
- Substance is hydrolytically stable
Hydrolysis Results
Summary of Hydrolysis Results for HBED-Fe at 50 °C
Mean concentration of duplicates at pH 4.0: at T0 = 145 mg/L and at T120h = 149 mg/L
Mean concentration of duplicates at pH 7.0: at T0 = 149 mg/L and at T120h = 151 mg/L
Mean concentration of duplicates at pH 9.0: at T0 = 145 mg/L and at T120h = 149 mg/L
[mg/L] Loss of
Test Item
[%]
0 1 136 136 -
2 135
120 1 138 139 0
2 139 - Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- Substance is hydrolytically stable. No transformation products are formed.
- % Recovery:
- > 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- > 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- > 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- Remarks on result:
- hydrolytically stable based on preliminary test
- 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
- Other kinetic parameters:
- not applicable substance is hydrolyticallly stable.
- Details on results:
- The validity criteria were fulfilled:
The test temperature was 50 ± 0.5°C.
The pH of the buffer solutions were in the range of ± 0.1 pH at test temperature.
The sensitivity of the analytical method was sufficient to analyse test item concentrations at least down to 90 % reduction of the initial concentration.
Loss of Test Item [% of applied] of HBED-Fe at 50 °C after 120 Hours
Hydrolysis Time
[Hours] Loss of Test Item [%]
pH 4 pH 7 pH 9
120 0 0 0 - Results with reference substance:
- -
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item HBED-Fe was concluded to be hydrolytically stable under all of the tested conditions .
- Executive summary:
Hydrolysis as a function of pH was determined according to OECD Guideline No. 111 and Council Regulation (EC) No. 440/2008, Method C.7 for the test item HBED-Fe (batch number: FC-C 11140) from 2020-03-05 to 2020-03-10 at Noack Laboratorien, 31157 Sarstedt, Germany.
Analyses of the test item HBED-Fe were performed via HPLC DAD on a reversed phase analytical column using the test item as external standard. The analytical method was validated with satisfactory results with regard to linearity, accuracy, precision and specificity.
The study was conducted with a test item concentration of 150 mg/L in buffer solutions at pH 4, 7 and 9 at a test temperature of 50 °C (preliminary test). Samples were taken at test start (0 hours) and test end (120 hours). Pure test systems (buffer solution pH 4, 7 and 9) were analysed at test start and test end and there was no analytical interference with the test item.
No significant transformation was observed and therefore, the test item was considered as hydrolytically stable under this condition and a half-life of > 1 year could be assumed for environmental typical temperatures.
Loss of Test Item [% of applied] of HBED-Fe at 50 °C after 120 Hours
Hydrolysis Time [Hours] pH 4 pH 7 pH 120 0 0 0
Reference
Hydrolysis Results for HBED-Fe at pH 4 and 50 °C
Hydrolysis Time [Hours] | Replicate | Concentration [mg/L] | Mean [mg/L] | Loss of test item % |
0 | 1 | 136 | 136 | - |
0 | 2 | 135 | ||
120 | 1 | 138 | 139 | 0 |
120 | 2 | 139 |
Hydrolysis Results for HBED-Fe at pH 7 and 50 °C
Hydrolysis Time [Hours] | Replicate | Concentration [mg/L] | Mean [mg/L] | Loss of test item % |
0 | 1 | 149 | 149 | - |
0 | 2 | 149 | ||
120 | 1 | 151 | 151 | 0 |
120 | 2 | 151 |
Hydrolysis Results for HBED-Fe at pH 9 and 50 °C
Hydrolysis Time [Hours] | Replicate | Concentration [mg/L] | Mean [mg/L] | Loss of test item % |
0 | 1 | 145 | 145 | - |
0 | 2 | 145 | ||
120 | 1 | 149 | 149 | 0 |
120 | 2 | 149 |
Description of key information
HBED is observed to be hydrolytically stable in a preliminary test performed according to OECD 111. Identical results were observed in the supporting study with the analogue substance EDDHMA-FeK.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 365 d
- at the temperature of:
- 12 °C
Additional information
No hydrolysis was observed for HBED-Fe. The half-life for hydrolysis at 12 deg C for the three pH's tested (4, 7 and 9) is > one year.
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