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EC number: 947-903-4 | CAS number: -
- 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:
- 10 April 2017 - 13 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- July 27, 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- March 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- March 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Key result
- Water solubility:
- 93.39 g/L
- Conc. based on:
- test mat. (dissolved fraction)
- Incubation duration:
- >= 1 - <= 3 d
- Temp.:
- 20 °C
- pH:
- ca. 9.9
- Remarks on result:
- other: water solubility of one constituent
- Key result
- Remarks on result:
- other: It was concluded that no single water solubility for the test substance could be stated.
- Conclusions:
- The determination of the water solubility of the test item reveals different results for the individual constituents. For the constituent of the test item which was measured by the HPLC method it is concluded that the test item completely recovered. The water solubility of this constituent was determined to be 93.39 ± 1.45 g/L (95 % confidence interval) at 20 ± 0.5 °C using the shake-flask method for the performance of the main test.
During the preliminary test above 10 g/L concentration precipitate was observed. Thus, it was concluded that the water solubility of one constituent of the test item is 10 g/L. Based on these results, it was concluded that no single water solubility for the test item could be stated. - Executive summary:
A study according OECD TG 105, EU method A.6 and EPA OPPTS 830.7840 was conducted to evaluate the solubility ofthe test item in water at 20 ± 0.5 °C. A preliminary test for solubility was carried out as a range finding test for the decision whether the column elution method or the flask method has to be used for the performance of the main test. The solubility of the test item was higher than 10 mg/L. Therefore the shake-flask method was used for the main test. The determination of the water solubility of the test item reveals different results for the individual constituents. For the constituent of the test item which was measured by the previously validated HPLC method it is concluded that the test item completely recovered. The water solubility of this constituent was determined to be 93.39 ± 1.45 g/L (95 % confidence interval) at 20 ± 0.5 °C using the shake-flask method for the performance of the main test. During the preliminary test above 10 g/L concentration precipitate was observed. Thus, it was concluded that the water solubility of one constituent of the test item is 10 g/L. Based on these results, it was concluded that no single water solubility for the test item could be stated.
Reference
Preliminary test: The water solubility of the test item from saturated solution was estimated to be 20 g/L. After sonication the test item was observed to be dissolved completely, but after centrifugation there were undissolved parts remaining at the bottom of the centrifuge tube.
Calibration:
The calibration solutions were prepared in 0.2 - 20 μg/mL range. The calibration samples were analysed by HPLC with three parallel injections from each. The test items concentrations were calculated with the help of the calibration equation (see regression data).
Table 1. Data of the calibration on 13 April 2017 for the Preliminary Test
Concentration of the test item (µg/mL) | Mean of the Peak Areas of test item (n=3) | Accuracy (absolute value) % |
0.21 | 6950 | 14 |
0.52 | 17067 | 5 |
1.04 | 34191 | 2 |
2.1 | 68824 | 1 |
5.2 | 168668 | 0 |
10.4 | 341612 | 1 |
20.8 | 670861 | 0 |
Table 2. Data of the calibration on 21 April 2017 for the Main Test
Concentration of the test item (µg/mL) | Mean of the Peak Areas of test item (n=3) | Accuracy (absolute value) % |
0.21 | 7189 | 8 |
0.52 | 17737 | 2 |
1.04 | 34834 | 2 |
2.1 | 71072 | 2 |
5.2 | 172733 | 0 |
10.4 | 348406 | 1 |
20.8 | 690668 | 0 |
Table 3. Regression data
Analytical occasion | constant | X Coefficient | R.Squared |
13 April 2017 | 1169 | 32299 | 0.9999 |
21 April2017 | 861 | 33209 | 1.0000 |
Table 4. Results of the determination of water solubility of the test item
Pre-incubation period | Measured concentration of Retardan 200 P (g/L) | Measured pH | |
Test vessels | Mean | ||
24 h |
81.42 | *79.47 |
9.94 |
72.51 | 10.00 | ||
84.49 | 9.98 | ||
48 h | 93.91 | 93.62 | 9.96 |
91.44 | 9.97 | ||
95.51 | 9.89 | ||
72 h | 92.78 | 93.15 | 9.94 |
93.86 | 9.92 | ||
92.82 | 9.93 | ||
Solubility of the test item (g/L) | 93.39 | - | |
Confidence interval (95 %) | 1.45 | - | |
RSD% | 1 | - | |
Ultrapure water | - | 5.7 – 5.8 |
* Measured concentration between the 24 and 48 hour pre-incubation period samples differ by more than 15 %, therefore, the result of the 24 hour pre-incubation period was not used for the calculation.
Description of key information
The determination of the water solubility of the test item reveals different results for the individual constituents. For the constituent of the test item which was measured by the HPLC method it is concluded that the test item completely recovered. The water solubility of this constituent was determined to be 93.39 ± 1.45 g/L (95 % confidence interval) at 20 ± 0.5 °C using the shake-flask method for the performance of the main test.
During the preliminary test above 10 g/L concentration precipitate was observed. Thus, it was concluded that the water solubility of one constituent of the test item is 10 g/L. Based on these results, it was concluded that no single water solubility for the test item could be stated. A water solubility of 10 g/L was determined as key value as a worst case approach.
Key value for chemical safety assessment
- Water solubility:
- 10 g/L
- at the temperature of:
- 20 °C
Additional information
A study according OECD TG 105, EU method A.6 and EPA OPPTS 830.7840 was conducted to evaluate the solubility of the test item in water at 20 ± 0.5 °C. A preliminary test for solubility was carried out as a range finding test for the decision whether the column elution method or the flask method has to be used for the performance of the main test. The solubility of the test item was higher than 10 mg/L. Therefore the shake-flask method was used for the main test. The determination of the water solubility of the test item reveals different results for the individual constituents. For the constituent of the test item which was measured by the previously validated HPLC method it is concluded that the test item completely recovered. The water solubility of this constituent was determined to be 93.39 ± 1.45 g/L (95 % confidence interval) at 20 ± 0.5 °C using the shake-flask method for the performance of the main test. During the preliminary test above 10 g/L concentration precipitate was observed. Thus, it was concluded that the water solubility of one constituent of the test item is 10 g/L. Based on these results, it was concluded that no single water solubility for the test item could be stated. A water solubility of 10 g/L was determined as key value as a worst case approach.
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