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EC number: 606-195-4 | CAS number: 189956-45-4
- 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:
- 2016-06-14 to 2016-06-20
- 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)
- Deviations:
- no
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- See study report
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: M15GC2731
- Expiration date of the lot/batch: 2016-07-23 (retest date)
- Purity test date: 2015-03-29
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
* Tier 1: at the beginning and after 5 days
- Sampling method:
* Tier 1: Concentration of the test item in the test sample was determined immediately after preparation. The samples taken at t=5 days were cooled to room temperature using running tap water. - Buffers:
- - pH: 4.0, 7.0, 9.0
- Type and final molarity of buffer:
* Sodium hydroxide, 10 N 40 g of sodium hydroxide dissolved in 100 mL water
* Acetate buffer pH 4, 0.01 M solution of 16.7% 0.01 M sodium acetate in water and 83.3% 0.01 M acetic acid in water. The buffer contains 0.0009% (w/v) sodium azide.
* Phosphate buffer pH 7, 0.01 M solution of 0.01 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 1 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide.
* Borate buffer pH 9, 0.01 M solution of 0.01 M boric acid in water and 0.01 M potassium chloride in water adjusted to pH 9 using 1 N sodium hydroxide. The buffer contains 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.
- Temperature: 50.1°C ± 0.1°C.
- 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)
- Preparation of test medium: The test item was spiked to the solutions at a target concentration of 1.9 mg/L using a spiking solution in DMSO. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 49.9 °C
- Initial conc. measured:
- >= 1.95 - <= 1.96 mg/L
- Remarks:
- Final conc. 1.98 mg/L in both replicates
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 49.9 °C
- Initial conc. measured:
- >= 1.94 - <= 1.94 mg/L
- Remarks:
- Final conc. 1.96-1.97 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 49.9 °C
- Initial conc. measured:
- >= 1.96 - <= 1.97 mg/L
- Remarks:
- Final conc. 1.99-1.98 mg/L
- Number of replicates:
- 2 for each pH
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- no data
- Preliminary study:
- In the preliminary stiudies at t 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.
- Transformation products:
- no
- % Recovery:
- >= 1.95 - <= 1.96
- pH:
- 4
- Temp.:
- 49.9 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- ca. 1.94
- pH:
- 7
- Temp.:
- 49.9 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- >= 1.96 - <= 1.97
- pH:
- 9
- Temp.:
- 49.9 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Validity criteria fulfilled:
- yes
- Conclusions:
- The preliminary test (Tier 1) was performed according to OECD 111 for the determination of the rate of hydrolysis of JNJ-40370226-AAA (T002487) 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. 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. The results of the test can be considered reliable without restriction.
Reference
Description of key information
One study (Ciric, 2016) was performed according to OECD guideline 111 and regarded as a key study (Klimisch score of 1). A half-life time of > 1 year at 25 °C and pH 7 was determined for T002487.
Key value for chemical safety assessment
Additional information
The preliminary test (Tier 1) was performed according to OECD 111 for the determination of the rate of hydrolysis of JNJ-40370226-AAA (T002487) at pH values normally found in the environment (pH 4-9). 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.
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