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EC number: 278-169-7 | CAS number: 75277-39-3
- 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:
- from 2012-11-09 to 2013-12-18
- 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)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: day 0 and day 5
- Sampling intervals/times for pH measurements: day 0 and day 5 - Buffers:
- - pH: 4, 7, 9
- Type and final molarity of buffer: Composition was taken from the annex of the OECD method (buffer solutions 7 and 9) resp. Küster et al. (buffer solution 4). All chemicals used were of analytical grade. The pH was measured with a pH-meter with an uncertainty of 0.01 units and pH was adjusted to the nominal pH value ± 0.02 units.
The buffer solutions were filtrated (0.45 µm) after preparation, resulting in sterile solutions.
- Composition of buffer:
Buffer-Solution, pH 4
CH3COOH, 2-m: 160 mL
CH3COONa, 1-m: 80 mL
Water: ad 2000 mL
Buffer-Solution, pH 7
KH2PO4: 17.4171 g
Water: 500 mL
NaOH, 2-m: 29.8 mL
Water: ad 2000 mL
Buffer-Solution, pH 9
H3BO3: 6.1863 g
KCl: 7.4579 g
Water: 1000 mL
NaOH, 2-m: 21.5 mL
Water: ad 2000 mL - Details on test conditions:
- TEST SYSTEM
- Test flaks: Test tubes
- Sterilisation method: filters
- Measures taken to avoid photolytic effects: incubation chamber
- Measures to exclude oxygen: teflon seals
- If no traps were used, is the test system closed: yes
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No
TEST MEDIUM
- Volume used/treatment: 1.5 mL
- Kind and purity of water: Deionised water from an ion exchanger with TOC < 1 ppm and conductivity below 0.1 µS/cm
- Preparation of test medium: A solution of the test item was prepared by dissolving 200 mg with 50 mL of water by means of an ultrasonic bath (resulting concentration 4000 mg/L). This solution was mixed 1:1 with the appropriate buffer solution, giving a nominal concentration of 2000 mg/L and filtrated using sterilised 0.2 µm filters. - Duration:
- 5 d
- Temp.:
- 50 °C
- Initial conc. measured:
- > 1 707 - < 1 815 mg/L
- Number of replicates:
- 3
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- none
- Preliminary study:
- The preliminary study indicates that the substance is hydrolytically stable and no further studies need to be conducted.
- Test performance:
- The validity criteria were met.
- Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- At pHs 4, 7 and 9, no signs of hydrolysis were observed in the preliminary study (tier 1). Therefore, the test item can be considered as hydrolytically stable at these pH values.
- % Recovery:
- > 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- > 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- > 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes - Validity criteria fulfilled:
- yes
- Conclusions:
- The assessment of hydrolytic stability of the test substance was carried out according to OECD 111 (2004). The test item was determined to be hydrolytically stable (t1/2 > 1 year at 25 °C) at pH 4, 7 and 9.
- Executive summary:
The assessment of hydrolytic stability of the test substance was carried out according to OECD 111 (2004) under GLP conditions. A solution of the test substance in demineralized water was mixed with buffer solutions (pH values: 4, 7 and 9). The resulting solutions were sterilized by filtration using sterile 0.2 µm filters and stored at 50 °C for a period of five days. Samples were taken at the beginning and after five days. The analysis of the samples (performed with HPLC/UVD) showed no decrease of the concentration of the test item within five days. At pHs 4, 7 and 9, no signs of hydrolysis were observed in the preliminary study. Therefore the test item was determined to be hydrolytically stable (t1/2 > 1 year at 25 °C) at pH 4, 7 and 9.
- Endpoint:
- hydrolysis
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the attached read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Transformation products:
- not measured
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- hydrolytically stable based on preliminary test
Referenceopen allclose all
Measured Values
| pH 4.0 | pH 7.0 | pH 9.0 |
Concentration mg/L d = 0 Replicate 1 | 1797.66 | 1777.21* | 1722.36 |
Concentration mg/L d = 0 Replicate 2 | 1781.90 | 1814.82* | 1742.25 |
Concentration mg/L d = 0 Replicate 3 | 1792.32 | 1707.72* | 1712.84 |
Concentration mg/L d = 5 Replicate 1 | 2032.37 | 1885.36** | 1929.37 |
Concentration mg/L d = 5 Replicate 2 | 1946.19 | 1857.97** | 1877.85 |
Concentration mg/L d = 5 Replicate 3 | 2002.28 | 1829.14** | 1882.00 |
Concentration blank mg/L d = 5 | < 200 | < 200 | < 200 |
* Concentrations in the test item solutions pH 7 were calculated after baseline subtraction of the blank pH 7 (automatically performed by evaluation software Chromeleon), measured on day 0, because the blank at pH 7 gave a disturbing signal on day 0. This may have been caused by change in column properties, compared with the column properties during validation.
** Because the recovery of the QC-samples was 104.9 % (mean), the measured concentrations were divided through 1.049.
Mean Concentrations and recoveries
| pH 4.0 | pH 7.0 | pH 9.0 |
Mean Concentration mg/L d = 0 | 1790.63 | 1766.58 | 1725.82 |
Mean Concentration mg/L d = 5 | 1993.61 | 1857.49 | 1896.41 |
Recovery after 5 days | 111.3 % | 105.1 % | 109.9 % |
Description of key information
The assessment of hydrolytic stability of the read-across source substance was carried out according to OECD 111 (2004), (reference 5.1.2-1). The source substance was determined to be hydrolytically stable (t1/2 > 1 year at 25 °C) at pH 4, 7 and 9.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
No experimental data on the hydrolysis of the registration substance is available, but information of a GLP-compliant guideline study with the read-across source substance HEPES (CAS no. 7365-45-9).
The assessment of hydrolytic stability of the read-across source substance was carried out according to OECD 111 (2004) under GLP conditions. A solution of the test substance in demineralized water was mixed with buffer solutions (pH values: 4, 7, and 9). The resulting solutions were sterilized by filtration using sterile 0.2 µm filters and stored at 50 °C for a period of five days. Samples were taken at the beginning and after five days. The analysis of the samples (performed with HPLC/UVD) showed no decrease of the concentration of the test item within five days. At pHs 4, 7 and 9, no signs of hydrolysis were observed in the preliminary study. Therefore the read across source substance was determined to be hydrolytically stable (t1/2 > 1 year at 25 °C) at pH 4, 7 and 9.
Conclusion
Based on reliable data for the read-across source substance the target substance is considered to be hydrolytically stable (t1/2 > 1 year at 25 °C) at pH 4, 7 and 9.
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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