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Diss Factsheets
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EC number: 209-406-4 | CAS number: 577-11-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Remarks:
- The EC method A.6 requires a sequenced sampling after 1, 2 and 3 days of equilibration in order to check if saturation was achieved. Due to the long-term saturation period of 35 days sampling was done on day 35 only.
- Qualifier:
- according to guideline
- Guideline:
- other: Slow-stir method as referred in the ECHA document 'Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance' (May 2008)
- Deviations:
- no
- Principles of method if other than guideline:
- The test substance is a surfactant. The established methods for the determination of the water solubility as
described in EC A.6 and OECD 105 are not applicable to surfactants. Therefore a method variation of the equilibration
step based on the publication of D.J. Letinski et al. (Chemosphere 48 (2002), 257-265) was applied. - GLP compliance:
- no
- Type of method:
- flask method
- Water solubility:
- 8.17 g/L
- Temp.:
- 20 °C
- pH:
- 5
- Conclusions:
- Interpretation of results (migrated information): soluble (1000-10000 mg/L)
The water solubility is 8.17 g/L. - Executive summary:
The water solubility of Docusate Sodium at 20 °C was investigated by the slow-stir method as referred in the ECHA document 'Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance' (May 2008). Basic principles and requirements of the established method EC A.6 were followed. The concentration in the saturated solution was determined by XRF measurement to be 8.17 ± 0.16 g/l..
The results of this study are considered to be acceptable for the risk assessment.
Reference
In the following table raw data and measurement results of the saturated solutions after 35 days of slow stearing are given.
Parameter |
|
Solution I |
Solution II |
Solution III |
Weight of the test substance [g] |
|
1.903 |
2.064 |
1.965 |
Volume of double distilled water [mL] |
|
40 |
40 |
40 |
pH of clear saturated solution |
|
5.5 |
5.0 |
5.0 |
Concentration of saturated solution [g/L] |
Measurement I |
7.690 |
8.131 |
8.283 |
Measurement II |
7.757 |
8.094 |
8.190 |
From a statistical point of view (t-test, confidence level 95%) the results of solution I are outliers. Therefore they were discarded for further calculations. Results of solutions II and III were used for further calculations. The solubility of the test substance in water at 20 °C was obtained by calculating the mean value of solutions II and III. The mean value is 8.17 g/l. The most important contribution to the uncertainty of the result comes from the distribution of analytical measurements. The standard deviation of the results of solutions II and III was calculated to be 0.08 g/l, giving an expanded uncertainty of 0.16 g/l (coverage factor k=2).
An additional contribution to the uncertainty of the solubility arises from the fact that the test substance might be contaminated by sulfur containing compounds (see composition chap. 2.4). Unfortunately, there are to many unknown parameters related to this problem in order to discuss the contribution to the uncertainty on a theoretical basis. These parameters are for example the true content of each of these contaminations,
the solubility of the contaminations in the presence of the main component, the influence of the contaminations on the solubility of the main component etc.
Thus the final result for the water solubility of Docusate sodium at 20 °C is 8.17 ± 0.16 g/l.
Description of key information
8.17 g/L
Key value for chemical safety assessment
- Water solubility:
- 8.17 g/L
- at the temperature of:
- 20 °C
Additional information
For the determination of the water solubility of Docusate Sodium one Klimisch 1 key study is available (Redlich 2010). This study was performed using the internationally accepted slow stir method recommended for surface active substancesa and resulted in 8.17 +/- 0.16 g/L.
The experimentally determined water solubility of 8.17 g/L was considered as reliable and relevant for the further risk assessment.
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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