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EC number: 609-099-0 | CAS number: 352303-67-4
- 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 September 2018 to 04 September 2018
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines on Pecticide Residue Trials. Second Edition No. 111 Hydrolysis of a Function of pH (MEP 2013)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2-fluoro-3-methoxyphenyl)boronic acid
- EC Number:
- 609-099-0
- Cas Number:
- 352303-67-4
- Molecular formula:
- FC6H3(OCH3)B(OH)2
- IUPAC Name:
- (2-fluoro-3-methoxyphenyl)boronic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Lot Number 18051400
Off White Powder
Purity 100.2%
Expiry Date 2019-03-14
Test item code 2018C021 - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on test conditions:
- Preparation of Standard Solution
The stock solution of 4000 mg/L was prepared by accurately weighing 0.3997 g of the test item into a 100 mL volumetric flask. Acetontrile was added to dissolve the test item and make up to the volume. The stock solution was diluted with acetonitrile to achieve the standard solutions at concentrations of 0.5 mg/L, 1mg/L, 2 mg/L, 5 mg/L, 10mg/L, 20 mg/L, 50 mg/L and I 00 mg/L. Method linearity was evaluated by analyzing calibration standards with the method and the plot of area versus concentration. The working standard
solutions were at least 5 concentration points. The LOD of the method was 0.5 mg/L. The solution was stored in the refrigerator in E 209,P-205(2-8 °C).
The stock solution of 4000 mg/L was prepared by accurately weighing 0.40009 g of the test item into a I 00 mL volumetric flask. Acetontrile was added to dissolve the test item and make up to the volume. The stock solution was diluted with acetonitrile to achieve the standard solutions at concentrations of 200 mg/L and 20 mg/L. The fresh and old solution with the concentration of 20 mg/L was injected for 6 times and the stability was determined.
Preparation of Buffer Solution
pH4.0: 500 mL 0.1 mol/L potassium dihydrogen citrate+ 90 mL 0.1 mol/L NaOH, Water was added to make up to the volume of 1000 mL.
pH7.0: 500 mL 0.1 mol/L KH2P04 + 296.0 mL 0.1 mol/L NaOH, Water was added to make up to the volume of 1000mL.
pH9.0: 500 mL 0.1 mol/L boracic acid ( dissolved in 0.1 mol/L KC!)+ 213 mLO. l mol/L NaOH, Water was added to make up to the volume of 1000mL. All the buffer solutions used in this study were sterilized beforehand under 121 °C for 20 min.
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 21.08
- Remarks:
- Preliminary study
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 20.77 mg/L
- Remarks:
- Preliminary study
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 19.7 mg/L
- Remarks:
- Preliminary study
- Number of replicates:
- Preliminary test - 5
Final Test - 2 - Negative controls:
- not specified
Results and discussion
- Preliminary study:
- Preliminary Test Result (Tier I): The test item was incubated in the sterilization buffer solution with pH4.0, pH7.0 and pH9.0 at constant temperature (50±0.5 °C) in darkness for 5 days and the hydrolysis rate was 8.1 %, 29.1 % and
46.3%, respectively. The initial concentration of the test item was 19.710mg/L,
20.770mg/L and 21.008mg/L, respectively. After 5 days dark culture, the final concentration of the different buffer solutions were 18.112 mg/L, 14.726 mg/L and 11.275 mg/L. The hydrolysis rate of the test item with the pH4.0 was less than I 0%. The test item with pH4.0 sterilization buffer solution is considered
hydrolytically stable and, no additional test was required according to "The guidelines of the testing of chemicals (Second edition) No.111: Hydrolysis as a Function ofpH (SEPA, 2013) ". On the other side, the test item with pH7.0 or pH9.0 sterilization buffer solution is not stable, and had to go to the next test. - Transformation products:
- not measured
Total recovery of test substance (in %)open allclose all
- % Recovery:
- > 94.1 - < 104.9
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- > 90.6 - < 101.1
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- > 94.4 - < 96.1
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
Dissipation DT50 of parent compoundopen allclose all
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- ca. 115.5
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Hydrolytically stable based on full study of 30 days
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- 115.5 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Hydrolytically stable based on full study of 30 days
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- 69.3 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Hydrolytically stable based on full study of 30 days
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- 77 d
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: Hydrolytically stable based on full study of 30 days
- Details on results:
- Standard solution
The following calibration samples were applied: 0.5, 1.0, 2.0, 5.0, 10.0, 20.0, 50.0 and 100 mg/L. The calibration graph was calculated applying weighted linear regression using l/concentration2 as weighting factor. The typical standard curve was: y=8.05e+004x-l.37e+003 and r=0.9993. The area deviation between old and fresh solution was 0.99% and the result indicated that the solution is stability during the study.
The following recovery samples were applied: 1 and 30 mg/L. The average recovery of test item was 10 I. I% and 90.6% and the variable coefficient was 11.3% and 2.6% with pH4 buffer solution. The average recovery of test item was 96.1 % and 94.4% and the variable coefficient was 7 .9% and I. I% with pH7 buffer solution. The average recovery of test item was I 04.9% and 94.1 % and the variable coefficient was 12.7% and 0.4% with pH9 buffer solution.
LOQ
The minimum concentration of the additive recovery was the limit of quantity (LOQ); the LOQ of FMPBA with the different buffer solutions (pH 4.0, 7 .0 and 9.0) were all 1.0 mg/L.
Preliminary Test (Tier I)
Preliminary Test Result (Tier I): The test item was incubated in the sterilization buffer solution with pH4.0, pH7.0 and pH9.0 at constant temperature (50±0.5 °C) in darkness for 5 days and the hydrolysis rate was 8.1 %, 29.1 % and 46.3%, respectively. The initial concentration of the test item was 19.710mg/L, 20.770mg/L and 21.008mg/L, respectively. After 5 days dark culture, the final concentration of the different buffer solutions were 18.112 mg/L, 14.726 mg/L and 11.275 mg/L. The hydrolysis rate of the test item with the pH4.0 was less than I 0%. The test item with pH4.0 sterilization buffer solution is considered hydrolytically stable and, no additional test was required according to "The guidelines of the testing of chemicals (Second edition) No.111: Hydrolysis as a Function ofpH (SEPA, 2013) ". On the other side, the test item with pH7.0 or pH9.0 sterilization buffer solution is not stable, and had to go to the next test.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The FMPBA testing for hydrolysis as a function of pH was assessed according to The guidelines of the testing of chemicals (Second edition) No.111: Hydrolysis as a Function of pH ( EP, 2013 ) .
The test item was incubated in the sterilization buffer solution with pH4.0 at constant temperature (50±0.5 °C) in darkness for 5 days and the hydrolysis rate was 8.1 % which was less than 10%. The test item with pH 4.0 sterilization buffer solution is considered hydrolytically stable.
The test item was incubated in the sterilization buffer solution with pH7.0 and pH9.0 at constant temperatures (50±0.5 °C, 25±0.5 °C, 15±0.5 °C) in darkness. The result showed that the half-life (to.s) of pH7.0 at constant temperature (50±0.5 °C, 25±0.5 °C, 15±0.5 °C) was 115.5 d, 77.0 d and 10.5 d, respectively. The half-life (to.s) of pH9.0 at constant temperature (50±0.5 °C,
25±0.5 °C, 15±0.5 °C) was 115.5 d, 69.3 d, and 5.2 d. - Executive summary:
The FMPBA testing for hydrolysis as a function of pH was assessed according to the guidelines of the testing of chemicals (Second edition) No. I I I: Hydrolysis as a Function ofpH (MEP, 2013). The High Performance Liquid Chromatography (HPLC) method was used to detect the test item. Chromatographic separation was carried out on an Agilent Eclipse XDB-C1s Sµm (4.6IDx250 mm) column with mobile phase consisting of acetonitrile and 0.1 % formic acid aqueous solution (30/70) at a flow rate of 0.8 mL/min, wavelength of 210 nm. The injector volume was 20 µL. The Average recovery was between 90.6%-104.9%. The minimum detected concentration of the method was 1.0 mg/L. Preliminary Test Result (Tier I): The test item was incubated in the sterilization buffer solution with pH4.0, pH7.0 and pH9.0 at constant temperature (50±0.5°C) in darkness for 5 days and the hydrolysis rate was 8.1%, 29.1% and 46.3%, respectively. The hydrolysis rate of the test item with the pH4.0 was less than I 0%. The test item with pH4.0 sterilization buffer solution is considered hydrolytically stable and, no additional test was required according to "The guidelines of the testing of chemicals (Second edition) No. I I I: Hydrolysis as a Function of pH (MEP, 2013) ". On the other side, the test item with pH7.0 or pH9.0 sterilization buffer solution is not stable, and had to go to the next test.
The test item was incubated in the sterilization buffer solution with pH7.0 and pH9.0 at constant temperatures (50±0.5 °C, 25±0.5 °C, 15±0.5 °C) in darkness for until 90% hydrolysis was observed or for 30 days whichever comes first. The result showed that the half-life (to.s) of pH7.0 at constant temperature(50±0.5 °C, 25±0.5 °C, 15±0.5 °C) was 115.5 d, 77.0 d and 10.5 d,respectively. The half-life (to.s) of pH9.0 at constant temperature (50±0.5 °C, 25±0.5 °C, 15±0.5 °C) were 115.5 d, 69.3 d, and 5.2 d.
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