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Diss Factsheets
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EC number: 264-935-8 | CAS number: 64519-44-4
- 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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 - 16 April 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted according to an internationally recognised method, and under GLP. Significant variability was observed in the results. The substance is considered to be adequately characterised. Therefore validation with restrictions applies.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- adopted 27. Jul. 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- Commission Regulation (EU) No 260/2014 amending Regulation (EC) No 440/2008 adopted 24 January 2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP certificate (inspected on 15 to 16 November 2017 / signed on 15 May 2018)
- Type of method:
- flask method
- Remarks:
- with slow-stirring adaptation (as recommended in ECHA guidance and Letinski publication)
- Key result
- Water solubility:
- 622.5 mg/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 10 g/L
- Incubation duration:
- >= 1 - <= 6 d
- Temp.:
- 20 °C
- pH:
- >= 5.88 - <= 7
- Remarks on result:
- other:
- Remarks:
- loading rate tested between 4 and 14 g/L without dependency of solubility perceived
- Executive summary:
The water solubility of the test substance was measured, under GLP, according OECD 105/ EU A6 guideline, flask method with slow-stirring adaptation.
Samples were extracted and filtered. Analysis was performed using a fully validated GC-FID method.
In a first assay, equilibrium time was measured and considered to be reached after 24 hours stirring, based on 4 measurements on day 1, 2, 3 and 4 and using a loading rate of 10 g/L.
A second assay was performed with longer stirring times (6 days) using loading rates between 4 and 14 g/L. No significant loading-rate- dependency was observed.
The maximum difference calculated from the concentrations measured in all the samples was below 15%. Therefore the water solubility of the test substance was given as the mean value of all the measurements.
Finally, the water solubility of the test substance is 622.5 g/L at 20 °C, pH 5.8 -7.
Reference
The solubility of the test item in water was determined from the measured concentrations of the test item in the filtrated test solutions after extraction procedure. They are calculated following the equation cited above.
Measurements during Equilibration
The data which was acquired during equilibration time (flask 1A-C, days 1 – 4) was presented in the following table:
Table 4.8/1: Equilibration:
Day | Temperature [°C] | pH (via pH paper) |
Measured (without taking into account all recovery rates and dilution factor) |
Concentration Mean [mg/L] |
Difference to previous sample [%] |
1 | 20,5 | 6 - 7 | 135,1 | 751,6 | - |
130,06 | |||||
2 | 20,5 | 6 - 7 | 121,18 | 707,7 | -5,8 |
128,49 | |||||
3 | 20,5 | 6 - 7 | 106,17 | 586,5 | -17,1 |
100,74 | |||||
4 | 20,5 | 6 - 7 | 112,71 | 663,6 | 13,1 |
112,93 |
During the equilibration time downward tendency was observed during the first 3 days and the difference of more than 15 % was observed in the concentrations on days 2 and 3.
Therefore, the test was prolonged and the flask 1A was further measured corresponding to the value of day 4. Due to a difference of less than 15 % in the concentrations on days 3 and 4 and no upward tendency, the test was finished and the flasks 2 – 6 were analysed in the same way.
Measurements day 6, in the flasks 2 - 6:
Table 4.8/2: Results flasks 2 - 6:
Flask | Temperature [°C] | pH (via pH meter) |
Measured Concentration [mg/L] (without taking into account all recovery rates and dilution factor) |
Concentration Mean [mg/L] |
2 | 20,5 | 6,32 | 109,11 | 591,8 |
92,13 | ||||
3 | 20,5 | 5,88 | 82,17 | 499 |
87,51 | ||||
4 | 20,5 | 6,11 | 124,27 | 712,7 |
118,05 | ||||
5 | 20,5 | 6,36 | 116,48 | 684,4 |
116,23 | ||||
6 | 20,5 | 6,11 | 97,38 | 569,8 |
96,35 |
Considering the concentration means obtained on flasks 2 – 6, a standard deviation of 87.1 mg/L was calculated, giving a relative standard deviation of 14.2 %.
Dependency of solubility on amount of the test item (nominal load) was not perceived.
Finally, considering that the RSD of all replicates (including results obtained on flasks 1A – 1C and 2 - 6), was lower than 15 % (13.2 %),
the equilibration time can be considered as approximately 1 day and all measurements were included in the calculation to determine the water solubility of the substance.
Note that even if the RSD of all replicates was lower than 15 %, a significant variation of the concentrations obtained in flasks 1A-C and 2-6 was observed, which may be due to micro emulsion. However, no Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid) could be observed indicating that no colloidal dispersed particles or micells should be present.
Therefore, the water solubility of the test item was stated as 622.5 ± 82.4 mg/L corresponding to a relative standard deviation of 13.2 %.
Description of key information
Considered moderately soluble, with equilibrium reached at 24h. pH of saturated solution: between 5.8 and 7.
Key value for chemical safety assessment
- Water solubility:
- 622.5 mg/L
- at the temperature of:
- 20 °C
Additional information
A reliable experimental study, conducted according to a recognized OECD/EC optimised method, and under GLP, is available. Despite restrictions, it is considered as a key study. The result is retained as key data.
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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