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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 28, 2016 to July 07, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
Type of method:
flask method
Remarks:
Measurement of DOC concentration using TOC analyser
Specific details on test material used for the study:
Purity: 100%
Highly viscous liquid
Key result
Water solubility:
10.2 mg/L
Conc. based on:
test mat.
Remarks:
nominal concentration
Loading of aqueous phase:
1 024 mg/L
Incubation duration:
72 h
Temp.:
20 °C
pH:
6.37
Key result
Water solubility:
29 mg/L
Conc. based on:
test mat.
Remarks:
nominal concentration
Loading of aqueous phase:
10 137 mg/L
Incubation duration:
72 h
Temp.:
20 °C
pH:
6.47
Details on results:
As solubility was dependent on nominal concentration, no exact value for the solubility of the test substance in water can be stated. The solubility range for the tested nominal concentration 1024 – 10137 mg/L is 10.2 – 29.0 mg/L at 20.0 ± 0.5 °C, corresponding to 0.3 – 1.0 % of the test substance relating to the nominal concentration of the test substance. Dependency of pH value on amount of the test substance (nominal load) was not perceived.
Conclusions:
Under the study conditions, the solubility range for the tested nominal concentrations of 1024 – 10137 mg/L was 10.2 – 29.0 mg/L at 20.0 ± 0.5 °C, corresponding to 0.3 – 0.5 % of the test substance relating to its nominal concentration. The test substance can be regarded as highly insoluble in water.
Executive summary:

A study was conducted to determine the water solubility of the test substance according to OECD Guideline 105 and EU Method A.6. The flask method was used for this experiment. The concentration of the test substance in the aqueous samples was determined by the analysis of total organic carbon (TOC). Each sample was measured at least in duplicate. From the measured TOC values, the concentration of the test substance was calculated from the content of total carbon of the test substance (68.75%). In order to determine the dependency of the water solubility on the amount of the test substance added, 6 different loading rates were chosen. As the concentrations of DOC in the preliminary test lay in the low calibration range (< 7 mg/L) for the nominal concentration of the test substance in water 1000 mg/L, the range 1 – 10 g/L was chosen for the test. The samples were analysed after 24, 48, and 72 hours at room temperature (20.0 ± 0.5 °C). Flasks were taken from the shaker, samples were taken, membrane filtrated and measured for DOC. DOC was measured in the saturated aqueous solutions. All filtrated test solutions showed no Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid). As solubility was dependent on nominal concentration, no exact value for the solubility of the test substance in water can be stated. The solubility range for the tested nominal concentrations of 1024 – 10137 mg/L was 10.2 – 29.0 mg/L at 20.0 ± 0.5 °C, corresponding to 0.3 – 0.5 % of the test substance relating to its nominal concentration. Dependency of pH value on amount of the test item (nominal load) was not perceived (Affolter, 2016).

 

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion