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EC number: 267-744-8 | CAS number: 67914-60-7
- 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:
- 2016-09-20 to 2017-04-10
- 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:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I15FB3131
- Expiration date of the lot/batch: 2017-06-11 (retest date)
- Purity: 100% (based on base titration assay)
- Purity test date: 2015-09-04
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: no data - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
* For tier one, immediately after the preparation and on the fifth day
* For tier two, immediately after the preparation and several times later
- Sampling method: The samples were diluted in a 8:1:1 (v:v:v) ratio with 7.5% NH4Ac in water and 5% formic acid in methanol and analysed.
- Sampling intervals/times for pH measurements: at the beginning and end of the tests
- Sample storage conditions before analysis: at room temperature
- Buffers:
- - pH:
* Acetate buffer pH 4, 0.1 M: A solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. The buffer contained 0.0009% (w/v) sodium azide.
* Phosphate buffer pH 7, 0.1 M: A solution of 0.1 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 10 or 1 N sodium hydroxide. The buffer contained 0.0009% (w/v) sodium azide.
* Borate buffer pH 9, 0.1 M: A solution of 0.1 M boric acid in water and 0.1 M potassium chloride in water adjusted to pH 9 using 1or 10 N sodium hydroxide. The buffer contained 0.0009% (w/v) sodium azide. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: sterile vessel
- Sterilisation method: each solution was filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany) and transferred into a sterile vessel.
- Lighting: in the dark
- Measures taken to avoid photolytic effects: vessels placed in the dark
- Measures to exclude oxygen: Nitrogen was passed through the buffer solutions for about 5 minutes.
- If no traps were used, is the test system closed/open: under vacuum
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no
TEST MEDIUM
- Volume used/treatment: 6 mL
- Kind and purity of water: Tap water purified by a Milli-Q water purification system (Millipore, Bedford, MA, USA)
- Renewal of test solution: not applicable
- Identity and concentration of co-solvent: not applicable
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Dissolved oxygen: no data - Duration:
- 788.13 h
- pH:
- 4
- Temp.:
- 20 °C
- Initial conc. measured:
- 10.5 mg/L
- Duration:
- 644.48 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 9.77 mg/L
- Duration:
- 192.13 h
- pH:
- 4
- Temp.:
- 60 °C
- Initial conc. measured:
- ca. 9.93 mg/L
- Duration:
- 787.97 h
- pH:
- 7
- Temp.:
- 20 °C
- Initial conc. measured:
- 10.5 mg/L
- Duration:
- 143.62 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 10.1 mg/L
- Duration:
- 46.18 h
- pH:
- 7
- Temp.:
- 60 °C
- Initial conc. measured:
- 10 mg/L
- Duration:
- 28.12 h
- pH:
- 9
- Temp.:
- 20 °C
- Initial conc. measured:
- 10.3 mg/L
- Duration:
- 72.87
- pH:
- 9
- Temp.:
- 40 °C
- Initial conc. measured:
- ca. 10.05 mg/L
- Duration:
- 68.58 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 10.55 mg/L
- Number of replicates:
- Calibration solutions were injected in duplicate. Test samples were analysed by single injection.
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- No data
- Preliminary study:
- A degree of hydrolysis of ≥ 10% was observed at pH 4, pH 7 and pH 9 after 5 days. According to the guideline, the higher Tier test was required to determine the half-life time of the test item.
The mean recoveries of the test item containing buffer solutions at t=0 slightly exceeded the criterion range of 90-110% (i.e. 114, 116 and 113%). At all pH’s the degree of degradation clearly exceeded 10%. - Transformation products:
- not measured
- % Recovery:
- 105
- pH:
- 4
- Temp.:
- 20 °C
- Duration:
- 788.13 h
- % Recovery:
- 98
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 644.48 h
- % Recovery:
- 99
- pH:
- 4
- Temp.:
- 60 °C
- Duration:
- 192.13 h
- % Recovery:
- 105
- pH:
- 7
- Temp.:
- 20 °C
- Duration:
- 787.97 h
- % Recovery:
- 101
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 143.62 h
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 60 °C
- Duration:
- 46.18 h
- % Recovery:
- 103
- pH:
- 9
- Temp.:
- 20 °C
- Duration:
- 28.12 h
- % Recovery:
- 101
- pH:
- 9
- Temp.:
- 40
- Duration:
- 72.87 h
- % Recovery:
- 106
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 68.58 h
- pH:
- 4
- Temp.:
- 20 °C
- DT50:
- 335 d
- Key result
- pH:
- 7
- Temp.:
- 20 °C
- DT50:
- 9.1 d
- pH:
- 9
- Temp.:
- 20 °C
- DT50:
- 8 h
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the guideline study (OECD 111) performed for the test item JNJ 119379-AAA (T001141) to estimate the hydrolysis at pH values normally found in the environment (pH 4-9), it is concluded that the half-life at 20°C at pH 4, 7 and 9 respectively were 335 days, 9.1 days and 8.0 hours. The results of the study can be considered reliable without restriction.
Reference
The results of the hydrolysis as a function of pH of the test item are:
Parameter | Result |
Hydrolysis at pH 4 |
t½ = 335 days at 20°C t½ = 167 days at 25°C t½ = 7.1 days at 50°C t½ = 2.2 days at 60°C |
Hydrolysis at pH 7 |
t½ = 9.1 days at 20°C t½ = 6.5 days at 25°C t½ = 1.4 days at 50°C t½ = 0.57 days at 60°C |
Hydrolysis at pH 9 |
t½ = 8.0 hours at 20°C t½ = 5.2 hours at 25°C t½ = 1.6 hours at 40°C t½ = 0.55 hours at 50°C |
Description of key information
Based on the guideline study (Reingruber, 2017) performed for the test item JNJ 119379-AAA (T001141) to estimate the hydrolysis at pH values normally found in the environment (pH 4-9), it is concluded that the half-life at 20°C at pH 4, 7 and 9 respectively were 335 days, 9.1 days and 8.0 hours under the conditions of the test. Results of the study are reliable without restrictions.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 9.1 d
- at the temperature of:
- 20 °C
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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