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EC number: 947-990-9 | 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:
- other: expert statement supported by experimental data
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- Regulation (EC) No 440/2008
- Deviations:
- no
- Principles of method if other than guideline:
- A determination of the water solubility of Yoghurt powder according to the OECD 105 protocol is not possible, because the test item seems to degrade during the test and therefore, its water solubility cannot be determined this way.
- GLP compliance:
- no
- Type of method:
- flask method
- Specific details on test material used for the study:
- Form: solid, powder
Lot No: 1:1:1 (weight) mixture of the three charges 107298, 106156 and 104439
Purity: 100%
Expiry date: Charge 107298: 2 May 2018 / Charge 106156: 10 October 2018 / Charge 104439: 24 May 2018
Storage: at room temperature, protected from light - Key result
- Water solubility:
- >= 1 - <= 10 g/L
- Conc. based on:
- test mat. (dissolved fraction)
- Loading of aqueous phase:
- 10 g/L
- Incubation duration:
- ca. 24 h
- Remarks on result:
- other: based on the results of the preliminary test
- Remarks:
- test conducted at room temperature
- Details on results:
- Preliminary test
The approximate solubility is given as a function of the water volume under which complete dissolution of the sample occurs (see table in the next section). No dissolution of ca. 0.1 g test item was observed up to a volume of 100 mL using the setup described above. However, after 24 hours of stirring, the test item solution was clear and the test item seemed to be dissolved. Therefore, this preliminary test indicated a water solubility of 1 to 10 g/L.
Main test
Upon opening of the test assays for sampling purposes, the following observations were made:
- The colour of the test assay had changed from the initial milky white to a murky brown
- The initial neutral smell of the test solution had changed to a pervasive smell reminiscent of fermented milk
The same observations were made for test vessels two and three after stirring for 48 h and 72 h at about 30 °C, respectively, before 24 h of equilibration at about 20 °C with stirring.
These observations indicate that the test item had begun to degrade since the start of the test. This hypothesis seems very likely considering that the test item should be ready bioavailable based on its origin (this was confirmed in the ready biodegradation study, see cross-ref.) and contains viable bacterial cells according to sponsor information. Furthermore, the incubation temperatures of this test, especially the initial saturation at about 30 °C are ideal for bacterial growth. Due to these observations, further testing was stopped. - Conclusions:
- A determination of the water solubility of Yoghurt powder (EC 917-734-0) according to the OECD 105 protocol is not possible, because the test item seems to degrade during the test and therefore, its water solubility cannot be determined this way.
Based on the results of the preliminary test, where no degradation was apparent (test lasted only for about 24 hours and was conducted at room temperature), the water solubility can be given as 1 to 10 g/L at room temperature. - Executive summary:
It was the aim of this expert statement to assess the water solubility of Yoghurt powder (EC 917-734-0) according to TG OECD 105.
The preliminary test according to the guideline showed that the test item could be dissolved in 100 mL of ultra-pure water after about 24 hours of stirring at room temperature.
In the definitive test, several test vessels containing ultra-pure water mixed with test item in great excess (initial amount of test item about 50 g per liter water), were incubated and stirred for different periods of time at about 30°C (saturation phase), and then transferred to about 20°C for 24 h (equilibration phase).
Upon opening of the test assays for sampling purposes, a color change from milky white to murky brown was apparent as well as a pervasive smell reminiscent of fermenting milk, which was not the case at the start of the test. Both observations, which were made for three different test assays, are indicative of a test item degradation. This hypothesis seems very likely considering that the test item should be ready bioavailable based on its origin and contains viable bacterial cells according to sponsor information. Furthermore, the incubation temperatures of this test, especially the initial saturation at about 30°C are ideal for bacterial growth. Due to these observations, further testing was stopped.
A determination of the water solubility of Yoghurt powder according to the OECD 105 protocol is not possible, because the test item seems to degrade during the test and therefore, its water solubility cannot be determined this way.
Based on the results of the preliminary test, where no degradation was apparent (test lasted only for about 24 hours and was conducted at room temperature), the water solubility can be given as 1 to 10 g/L at room temperature.
Reference
Testing scheme to determine the approximate water solubility in the preliminary test:
mL of water for 0.1 g test item | 0.1 | 0.5 | 1 | 2 | 10 | 100 | >100 |
Approximate solubility in g/L | >1000 | 1000 to 200 | 200 to 100 | 100 to 50 | 50 to 10 | 10 to 1 | <1 |
Description of key information
It was the aim of this expert statement to assess the water solubility of Yoghurt powder (EC 917-734-0) according to TG OECD 105. A determination of the water solubility according to the OECD 105 protocol is not possible, because the test item seems to degrade during the test and therefore, its water solubility cannot be determined this way.
Based on the results of the preliminary test, where no degradation was apparent (test lasted only for about 24 hours and was conducted at room temperature), the water solubility can be given as 1 to 10 g/L at room temperature.
Key value for chemical safety assessment
- Water solubility:
- 10 g/L
- at the temperature of:
- 25 °C
Additional information
Based on the results of the preliminary test, where no degradation was apparent (test lasted only for about 24 hours and was conducted at room temperature), the water solubility can be given as 1 to 10 g/L at room temperature.
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