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EC number: 201-612-2 | CAS number: 85-52-9
- 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
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Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Dec 2018 to 25 Jan 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- March 04, 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- April 13, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- Version / remarks:
- October 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Appearance: Off-white powder
Purity/Composition: 98.8%
Test item storage: At room temperature - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Buffers:
- Acetate buffer pH 4, 0.1 M
Solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. Buffer contained 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.1 M
Solution of 0.1 M potassium di-hydrogen-phosphate in water adjusted to pH 7 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.1 M
Solution of 0.1 M boric acid in water and 0.1 M potassium chloride in water adjusted to pH 9 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide. - Estimation method (if used):
- The buffer solutions were filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany) and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes. The test item was spiked to the solutions at a target concentration of 20 mg/L using a spiking solution in DMSO. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in the dark in a temperature controlled environment at 50.0°C ± 0.1°C.
The spiking volume was < 1% of the sample volume. Nominal concentrations were not corrected for the spiking volume.
The concentration of the test item in the test samples was determined immediately after preparation (t=0) and after 2.4 hours and 5 days. The samples taken at t=2.4 hours and t=5 days were cooled to room temperature using running tap water.
The samples in buffer pH 4 were diluted in a 3:1 (v:v) ratio with acetonitrile and analysed. The samples in buffer pH 7 and pH 9 were diluted in a 3:1 (v:v) ratio with 1% formic acid in acetonitrile and analysed.
Blank buffer solutions containing a similar content of blank spiking solution were treated similarly as the test samples and analysed at t=0.
The pH of each of the test solutions (except for the blanks) was determined at each sampling time. - Details on test conditions:
- Preparation of Solutions:
Stock Solutions:
Stock solutions of the test item were prepared in DMSO at concentrations of 2000 and 5000 mg/L.
Calibration Solutions:
Five working solutions in the concentration range of 6 – 1500 mg/L were prepared in DMSO from two stock solutions. The solutions and the stock at concentration of 5000 mg/L were 100-fold diluted with 25/75 (v/v) acetonitrile/water to obtain six calibration solutions in the concentration range of 0.06 – 50 mg/L.
Sample Injections:
Calibration solutions were injected in duplicate. Test samples were analysed by single injection.
Calibration Curves:
Calibration curves were constructed using six concentration levels. For each level, duplicate responses were used. Linear regression analysis was performed using the least squares method with a 1/concentration2 weighting factor. If necessary, one data point was excluded from the curve since the back calculated accuracy was > 15% from the nominal concentration. The coefficient of correlation I was > 0.99 for each curve. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 25 °C
- Initial conc. measured:
- 22.9 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 25 °C
- Initial conc. measured:
- 22.9 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 25 °C
- Initial conc. measured:
- 22.7 mg/L
- Number of replicates:
- Two per pH
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The analytical results of the preliminary test are given in Table 10 and Table 11.
At pH 4, pH 7 and pH 9, a degree of hydrolysis of < 10% was observed after 5 days. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, no further tests were required.
No test item was detected in the blank buffer solutions.
The mean recoveries of the of the test item containing buffer solutions at t=0 fell above the criterion range of 90-110%, i.e. 114%. The slightly too high recovery did not hamper the conclusion that the test item had a half life time of more than 1 year at 25°C and was, therefore, considered not impacting the study results. - Transformation products:
- not specified
- % Recovery:
- >= 100
- pH:
- 4
- Temp.:
- 25 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- >= 100
- pH:
- 7
- Temp.:
- 25 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- >= 100
- pH:
- 9
- Temp.:
- 25 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- Remarks on result:
- hydrolytically stable based on preliminary test
- Remarks:
- At pH 4, pH 7 and pH 9, a degree of hydrolysis of < 10% was observed after 5 days. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, no further tests were required.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The preliminary test (Tier 1) was performed for the determination of the rate of hydrolysis of 2-Benzoylbenzoic acid at pH values normally found in the environment (pH 4-9).
At each pH value a degree of hydrolysis of < 10% was observed after 5 days. According to the guideline, performance of the main study (Tier 2) was not required.
The half-life times of the test item were as follows:
pH 4: Half life > 1 year @ 25 °C
pH 7: Half life > 1 year @ 25 °C
pH 9: Half life > 1 year @ 25 °C - Executive summary:
In this guideline (OECD 111) study conducted with GLP certification, the test material (EC 201 -612 -2) was determined to have the following hydrolysis half lifes at 25 °C:
pH 4 pH 7 pH 9 Temperature [°C] t½ Temperature [°C] t½ Temperature [°C] t½ 25 > 1 year 25 > 1 year 25 > 1 year
Reference
Table 10
Preliminary Test: Hydrolysis of the Test Item at pH 4, pH 7 and pH 9
pH code | Sampling time | Analyzed concentration [mg/L] | Degree of hydrolysis [%] | pH | |
Individual | Mean | ||||
pH 4 | 0 hours | 22.9 | 4 | ||
22.8 | 4 | ||||
2.4 hours | 22.9 | -0.18 | -0.19 | 4 | |
22.9 | -0.2 | 4 | |||
5 days | 21.6 | 5.3 | 5.2 | 4.1 | |
21.7 | 5.1 | 4.1 | |||
pH 7 | 0 hours | 22.9 | 7.1 | ||
22.7 | 7.1 | ||||
2.4 hours | 22.9 | -0.41 | -0.26 | 7.1 | |
22.9 | -0.11 | 7.1 | |||
5 days | 21.7 | 5 | 5.1 | 7.1 | |
21.7 | 5.1 | 7.1 | |||
pH 9 | 0 hours | 22.7 | 9 | ||
22.7 | 9 | ||||
2.4 hours | 22.9 | -0.78 | -0.76 | 9.1 | |
22.9 | -0.74 | 9 | |||
5 days | 21.6 | 4.8 | 4.8 | 9 | |
21.6 | 4.8 | 9 |
Table 11
Preliminary Test: Recoveries
pH code | Nominal concentration [mg/L] | Analyzed concentration [mg/L] | Recovery [%] | |
Individual | Mean | |||
pH 4 | 20 | 22.9 | 114 | 114 |
20 | 22.8 | 114 | ||
pH 7 | 20 | 22.9 | 115 | 114 |
20 | 22.7 | 114 | ||
pH 9 | 20 | 22.7 | 114 | 114 |
20 | 22.7 | 114 |
Description of key information
Study conducted to recognised testing guidelines with GLP certification.
Key value for chemical safety assessment
Additional information
pH 4 | pH 7 | pH 9 | |||
Temperature [°C] | t½ | Temperature [°C] | t½ | Temperature [°C] | t½ |
25 | > 1 year | 25 | > 1 year | 25 | > 1 year |
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