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EC number: - | 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
Partition coefficient
Administrative data
Link to relevant study record(s)
- Endpoint:
- partition coefficient
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the substance is inorganic
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 20 March 2017 to 01 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Deviations:
- yes
- Remarks:
- guideline demonstrated to be not applicable
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient - HPLC Method)
- Deviations:
- yes
- Remarks:
- guideline demonstrated to be not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
- Analytical method:
- high-performance liquid chromatography
- Remarks on result:
- other: guideline demonstrated to be not applicable
- Details on results:
- RESULTS
- Results demonstrated that the active ingredient precipitated out of water saturated octanol stock solution.
- The filtered stock had an observed Tyndall beam effect which suggested some fine precipitate still remained; if this had been filtered out then the filtered results may have been even lower.
- Furthermore, the stock solution was observed again after being left undisturbed for two weeks; the solution was cloudy with a large amount of an off-white precipitate. This suggested even more had dropped out of solution. - Conclusions:
- The partition coefficient test by the flask-shake method was not applicable. As the test item was inorganic based, preparing a stock solution in octanol saturated water was not feasible either.
- Executive summary:
GUIDELINE
The partition coefficient of the test item was not determined, using a procedure designed to be compatible with Method A.8 Partition Coefficient of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 117 of the OECD Guidelines for Testing of Chemicals, 13 April 2004, as the test guideline was demonstrated to be not applicable.
METHODS
The partition coefficient of inorganic substances, as is the active ingredient of the test item, is not usually required. However, the Sponsor requested the endpoint to be determined, as in this case, the inorganic active was suspended in an organic medium. This may then have significantly affected its bioaccumulation potential. The flask-shake method was therefore attempted. The HPLC method to determine partition coefficient would not be applicable for pure inorganic substances or those in an organic medium.
A stock solution of the test item was prepared at approximately 4 g/L in water saturated octanol. This was observed to be a clear brown solution but with a Tyndall beam effect after ultrasonication. However, it was decided to still validate the microwave digestion procedure which removes the octanol and creates an acidic aqueous media so that analysis by Inductively-Coupled Plasma-Mass Spectrometry could be performed. The stock solution was left overnight to allow any precipitation to settle out. Observing the solution it had become cloudier and was filtered through a 0.45 μm membrane. The filtrate was a clear, very light brown solution with a strong Tyndall beam effect and was treated similarly by microwave digestion and analysed.
RESULTS
Results demonstrated that the active ingredient precipitated out of water saturated octanol stock solution. The filtered stock had an observed Tyndall beam effect which suggested some fine precipitate still remained; if this had been filtered out then the filtered results may have been even lower. Furthermore, the stock solution was observed again after being left undisturbed for two weeks; the solution was cloudy with a large amount of an off-white precipitate. This suggested even more had dropped out of solution.
CONCLUSION
The partition coefficient test by the flask-shake method was not applicable. As the test item was inorganic based, preparing a stock solution in octanol saturated water was not feasible either.
Referenceopen allclose all
TABLE 16 – MEAN RESULTS FROM QUADRUPLE UNFILTERED STOCK AND FILTERED STOCK
Solution |
Concentration calcium (mg/L) |
Concentration boron (mg/L) |
Unfiltered stock |
12.7 |
2.07 |
Filtered stock |
8.49 |
1.50 |
Matrix banks |
≤ 0.69 |
≤ 0.02 |
Description of key information
The study does not need to be conducted because the substance is inorganic.
Key value for chemical safety assessment
Additional information
GUIDELINE
The partition coefficient of the test item was not determined, using a procedure designed to be compatible with Method A.8 Partition Coefficient of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 117 of the OECD Guidelines for Testing of Chemicals, 13 April 2004, as the test guideline was demonstrated to be not applicable.
METHODS
The partition coefficient of inorganic substances, as is the active ingredient of the test item, is not usually required. However, the Sponsor requested the endpoint to be determined, as in this case, the inorganic active was suspended in an organic medium. This may then have significantly affected its bioaccumulation potential. The flask-shake method was therefore attempted. The HPLC method to determine partition coefficient would not be applicable for pure inorganic substances or those in an organic medium.
A stock solution of the test item was prepared at approximately 4 g/L in water saturated octanol. This was observed to be a clear brown solution but with a Tyndall beam effect after ultrasonication. However, it was decided to still validate the microwave digestion procedure which removes the octanol and creates an acidic aqueous media so that analysis by Inductively-Coupled Plasma-Mass Spectrometry could be performed. The stock solution was left overnight to allow any precipitation to settle out. Observing the solution it had become cloudier and was filtered through a 0.45 μm membrane. The filtrate was a clear, very light brown solution with a strong Tyndall beam effect and was treated similarly by microwave digestion and analysed.
RESULTS
Results demonstrated that the active ingredient precipitated out of water saturated octanol stock solution. The filtered stock had an observed Tyndall beam effect which suggested some fine precipitate still remained; if this had been filtered out then the filtered results may have been even lower. Furthermore, the stock solution was observed again after being left undisturbed for two weeks; the solution was cloudy with a large amount of an off-white precipitate. This suggested even more had dropped out of solution.
CONCLUSION
The partition coefficient test by the flask-shake method was not applicable. As the test item was inorganic based, preparing a stock solution in octanol saturated water was not feasible either.
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