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Diss Factsheets
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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
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 January 2011 to 26 January 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU & OECD test guidance in compliance with GLP and reported with a valid GLP certificate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- yes
- Principles of method if other than guideline:
- The guideline specifies that the test item in excess should be added to water however the physical properties of Reactive Orange F08-0314 do not permit this. Due to the high solubility, five times the visually estimated quantity cannot be stirred. The study method therefore deviates from the guideline but is considered scientifically valid.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Details on test material:
- Name: Reactive Orange F08-0314
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- > 417 g/L
- Temp.:
- 20 °C
- pH:
- > 5.02 - < 5.05
- Details on results:
- Calibration: Six concentration levels were used: 0.2, 0.5, 1, 2, 5 and 10 µg/ml. The calibration graph was calculated applying linear regression.
Results of the Shake Flask Method: pH of the samples varied in the range of 5.02 – 5.05. Samples were analysed with the HPLC method. Based on the measured concentrations the test mixtures were homogeneous and the whole amount of the added test substance was dissolved.
Justification Measurement: Into a single flask 12.0 g Reactive Orange F08-0314 was weighed. After addition of 20 ml water, the mixture was agitated at 30 °C for three days. After the re-equilibration at 20 °C for 24 hours the sample was centrifuged, filtered, diluted and analysed by HPLC like the other samples.
Concentration measured for this sample was 463 mg/ml.
Any other information on results incl. tables
Table 1: Summary of Standard Curve Parameters
Date |
Intercept |
Slope |
Correlation Coefficient. |
24 January 2011 |
419 |
19196.4 |
1.000 |
25 January 2011 |
-11 |
19229.5 |
1.000 |
26 January 2011 |
111 |
18552.5 |
1.000 |
Table 2: Results of the determination of Reactive Orange F08-0314 concentrations
Equilibration at 30°C |
pH |
Measured concentration [g/l] |
Mean |
[%] of theoretical concentration |
24 hours |
5.05 |
411 |
409 |
98 |
5.05 |
406 |
|||
5.04 |
410 |
|||
48 hours |
5.03 |
405 |
409 |
98 |
5.04 |
414 |
|||
5.03 |
408 |
|||
72 hours |
5.03 |
417 |
416 |
100 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): very soluble (> 10000 mg/L)
As the measured concentrations correspond to the total dissolution of the test substance, and also based on the justification measurement, water solubility of Reactive Orange F08-0314 is higher than 417 g/l at 20 °C. - Executive summary:
Study performed to Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Part A, A.6 Water Solubility and Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Guideline No. 105, "Water Solubility", adopted July 27, 1995. This study is compliant with the Principles of Good Laboratory Practice (GLP) and reported with a valid GLP certificate.
The purpose of this study was to determine the water solubility of Reactive Orange F08-0314 which is specified by the saturation mass concentration of the test item in water at 20 ±1°C.
As the expected water solubility was above 10-2 g/l, the flask method was applied.
Water solubility of Reactive Orange F08-0314 is higher than 417 g/lat 20°C.
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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