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EC number: 500-537-5 | CAS number: 161075-00-9
- 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 January 2013 to 28 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline-conform study conducted under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Water solubility:
- 466.6 mg/L
- Temp.:
- 20 °C
- pH:
- 8.6
- Remarks on result:
- other: The quality criteria of the A.6 method were verified (RSD% over three values is < 15%).
- Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of GALDEN LMW is 0.47 mg/L at 20°C. - Executive summary:
The study was conducted under GLP according to the OECD Test Guideline No. 105, flask method.
Six samples (about 2 g each) of test item were weighed into six 100 mL conical glass flasks, 100 mL of water analytical grade were added and each flask was closed with a polypropylene stopper. Two flasks, labelled “A” and “B”, were shaken at 30°C in a thermostatic mechanical shaker for 24 hours, two flasks, labelled “C” and “D”, were shaken at 30°C in a thermostatic mechanical shaker for 48 hours, two flasks, labelled “E” and “F”, were shaken at 30°C in a thermostatic mechanical shaker for 72 hours. Then all the flasks were allowed to stand at 20°C in a thermostatic oven for 24 hours.
The pH value of the sample solutions was determined by the pH meter equipped with a glass electrode.
The determination of the test item was performed by GC using an external standard and MS single Quadrupole triple axis detector.
Three working standard solutions of GALDEN LMW (WSS1 =0.05ng/mL, WSS2 =0.5ng/mL, WSS3 =5ng/mL) were used for linear calibration.
Preliminary non GLP tests on the test item were carried out to avoid any chromatographic peak of impurities or degradation products interfering with the test item peak and to determine the optimum chromatographic conditions.
From the obtained experimental data it can be concluded that the water solubility of GALDEN LMWis 0.47 mg/L at 20°C.
Reference
Galden Low Molecular Weight: details on water solubility test
Flask code |
As |
Cs (ng/mL) |
Ds* |
Water Solubility (ng/mL) |
Water Solubility (mg/L) |
A |
387819 |
2.42 |
200.0 |
484.62 |
0.485 |
B |
358311 |
2.24 |
200.0 |
448.01 |
0.448 |
C |
356243 |
2.23 |
200.0 |
445.44 |
0.445 |
D |
364186 |
2.28 |
200.0 |
455.30 |
0.455 |
E |
386592 |
2.42 |
200.0 |
483.09 |
0.483 |
F |
386589 |
2.42 |
200.0 |
483.09 |
0.483 |
Mean value : |
466.6 |
0.47 |
|||
Standard deviation (S.D.) : |
18.9 |
0.02 |
|||
Relative Standard Deviation (RSD%) : |
4.06% |
4.06% |
*The dilution step can be considered reliable since it was performed six times on six different sample aliquots, obtaining an acceptable relative standard deviation.
As = Peak area of the test item in the aqueous fractions
Ds = Dilution
Cs value is calculated from the As data using linear calibration curve obtained with Cstd and Astd data from injections of the working standard solutions for each reference material.
Description of key information
Water solubility of GALDEN LMW was experimetally determined to be 0.47 mg/L.
Key value for chemical safety assessment
- Water solubility:
- 0.47 mg/L
- at the temperature of:
- 20 °C
Additional information
The water solubility of GALDEN LMW was determined under a GLP study conducted according to the OECD Test Guideline No. 105, flask method, which was considered appropriate to test the substance.
According to the results, it can be concluded that the water solubility of GALDEN LMW is 0.47 mg/L at 20°C.
Galden is a multi-constituent substance consisting of low molecular weight perfluoropolyethers (PFPE). Perfluorinated substances typically have a low affinity for water. Two grades of Galden LMW are manufactured (Galden HT55 and Galden HT70), which contain the same perfluorinated constituents, but differ only in the relative concentration of the constituents.
As the two grades both contain only perfluorinated constituents (albeit in different relative concentrations), the water solubility of both Galden grades is very similar. The value of 0.47 mg/L therefore is representative for both grades.
A previous study, not conducted according to official guidelines was disregarded, since the method and the result cannot be considered reliable. According to that method, the water solubility of GALDEN LMW was determined to be 5 mg/L at 22 °C, value that markedly differs from the one obtained by the more recent study conducted under GLP and according to OECD Test Guideline No. 105.
Moreover due the lack of detailed information on the analytical method and its validation, the reliability of the analytical quantification cannot be defined.
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