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EC number: 609-425-1 | CAS number: 374067-80-8
- 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:
- 2015-12-03 to 2016-03-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to standard test guidelines (OECD, EC) and conform GLP requirements. Temperature fluctuations were observed in Tier 1, Tier 2 (20°C) and Tier 2 (70°C).The study integrity was not adversely affected by the deviation. The results of the study can be considered reliable without restrictions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- yes
- Remarks:
- temperature variation in Tier 1, Tier 2 (20°C) and Tier 2 (70°C)
- 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:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- 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: I5CB0987
- Expiration date of the lot/batch: 2016-07-29 (retest date)
- Purity test date: 2016-02-26
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
* Tier 1: at the beginning and after 120 hours
* Tier 2: at the beginning and at several sampling points after t=0
- 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. The samples were diluted in a 9:1 (v:v) ratio with 50 mM ammonium acetate in 50/50 (v/v) acetonitrile/water and analysed.
* Tier 2: All sample were measured freshly.
- Sampling methods for the volatile compounds, if any: not applicable
- Sampling intervals/times for pH measurements: the pH of each test solutions was determined at least at the beginning and at the end of the test.
- Sampling intervals/times for sterility check: not applicable
- Sample storage conditions before analysis: samples at pH 4, 7 and 9 were not stable when stored in the freezer for 14 days. Samples at all pH's were measured freshly
- Other observation, if any: no data - Buffers:
- - pH:
* Tier 1: 4.0, 7.0, and 9.0
* Tier 2: 4.0, 7.0, and 9.0
- Type, final molarity and composition of buffer:
* buffer pH 4: solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. The buffer contains 0.0009% (w/v) sodium azide
* buffer pH 7: solution of 0.1 M potassium di-hydrogenophosphate in water adjusted to pH 7 using 10 N sodium hydroxide. The buffer contains 0.0009% (w/v) sodium azide.
* buffer pH 9: solution of 0.1 M boric acid in water and 0.1 M potassium chloride in water adjusted to pH 9 using 10 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: the buffer solutions were filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Wathman, 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.
- Details on test procedure for unstable compounds: no data
- Details of traps for volatile, if any: not applicable
- 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:
* Tier 1 and Tier 2 (20°C; 50°C): 6 mL
* Tier 2 (70°C): 10 mL
- Kind and purity of water: Milli-Q
- Preparation of test medium: The test item was spiked to the solutions at a targetconcentration of 3.005 mg/L using a spiking solution in dimethyl sulfoxide.
- 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:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 2.94 - <= 2.95 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 2.97 - <= 2.98 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 3.02 - <= 3.02 mg/L
- Duration:
- 720.83 h
- pH:
- 4
- Temp.:
- 20 °C
- Initial conc. measured:
- >= 2.96 - <= 2.97 mg/L
- Duration:
- 699.22 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 2.97 - <= 2.98 mg/L
- Duration:
- 95.05 h
- pH:
- 4
- Temp.:
- 70 °C
- Initial conc. measured:
- >= 3.03 - <= 3.03 mg/L
- Duration:
- 720.67 h
- pH:
- 7
- Temp.:
- 20 °C
- Initial conc. measured:
- >= 3.02 - <= 3.02 mg/L
- Duration:
- 722 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 3.02 - <= 3.03 mg/L
- Duration:
- 265.67 h
- pH:
- 7
- Temp.:
- 70 °C
- Initial conc. measured:
- >= 3.09 - <= 3.1 mg/L
- Duration:
- 720.33 h
- pH:
- 9
- Temp.:
- 20 °C
- Initial conc. measured:
- >= 3.05 - <= 3.05 mg/L
- Duration:
- 721.75 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 3.05 - <= 3.06 mg/L
- Duration:
- 380.22 h
- pH:
- 9
- Temp.:
- 70 °C
- Initial conc. measured:
- >= 3.12 - <= 3.13 mg/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- no data
- Preliminary study:
- The preliminary hydrolysis tests were performed at 50°C at pH 4.0, pH 7.0 and pH 9.0. Aliquots of each test solution were analyzed at the beginning and after 120 hours. Further hydrolysis tests were performed at 20°C, 50°C and 70°C in the buffered test solution at pH 4.0, 7.0 and 9.0, due to the instability of the test item found in the preliminary test at 50°C.
- Transformation products:
- not measured
- pH:
- 4
- Temp.:
- 20 °C
- DT50:
- 106 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- 58 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- 99 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 4
- Temp.:
- 70 °C
- DT50:
- 24 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 20 °C
- DT50:
- 186 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- 112 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- 282 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 70 °C
- DT50:
- 76 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 20 °C
- DT50:
- 266 d
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- 171 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- 525 h
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 70 °C
- DT50:
- 108 h
- Type:
- (pseudo-)first order (= half-life)
- Validity criteria fulfilled:
- yes
- Conclusions:
- T002326 was found to be hydrolytically not stable at pH 4.0, pH 7.0 and pH 9.0, therefore further testing was performed. Additional testing determined a half-life time of 58 days at 25°C at pH 4.0, a half time of 112 days at 25°C at pH 7.0 and a half life of 171 days at 25°C at pH 9.0. The results of the test can be considered reliable without restriction.
Reference
Description of key information
One study (Reingruber, 2016) was performed according to the OECD guideline 111 and regarded as a key study (Klimisch score of 1). A half-life time of 112 days at 25 °C and pH 7 was determined for T002326.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 112 d
- at the temperature of:
- 25 °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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.