Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 January 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
other: Visual assessment
Key result
Water solubility:
< 1 mg/L
Conc. based on:
test mat.
Temp.:
22 °C
Remarks on result:
other: pH not recorded.
Details on results:
In each case, undissolved orange coloured parts from the test material was observed in the flasks. The aquatic phase did not appear orange at any concentration.
The feasibility limit of this method for this test material was found to be about 0.5 mg/L by visual assessment. The test material was not soluble at the lowest feasible nominal concentration (0.5 mg/L).
In the partition coefficient study using HPLC-UV (High Performance Liquid Chromatography with UV detection) for chemical analysis some water soluble minor fractions were detected. They did not have any orange colour and were not similar to the main substance of the test material. Hence only the main test material was evaluated in this water solubility assessment.
Conclusions:
Under the conditions of the study the water solubility of the test material was estimated to be < 1 mg/L by visual assessment.
Executive summary:

The water solubility of the test material was assessed according to the standardised guidelines OECD 105 and EU Method A.6 and in compliance with GLP. 

The test material could not be analysed for water solubility by a chemical analysis method due to the complex nature of the substance and the very low solubility. The water solubility of the test material was therefore estimated by visual assessment. 

Approximately 10 mg portions of the test material were weighed into glass stoppered graduated cylinders and ultrapure water was added in steps. After each addition of water, the mixtures were shaken vigorously and were visually checked for any undissolved parts of the test material. The test was repeated with about 5 mg of test material. In both series, the test material did not dissolve in water, but it stuck to the wall of the glass vessels.

Because the test material is strongly coloured, it was feasible to continue the test at lower nominal concentrations of 2.5 mg and 1.0 mg of pulverised test material weighed into 2000 mL flasks, separately. Both flasks contained a small orange ball of test material.

The flasks and cylinders were ultrasonicated for about 10 minutes, which can cause a slight increase of the temperature and facilitate the dissolution.

Undissolved test material was observed at the 0.5 and 1 mg/L nominal concentration levels. The water solubility of the test material was therefore estimated to be < 1 mg/L.

Description of key information

Under the conditions of the study the water solubility of the test material was estimated to be < 1 mg/L by visual assessment.

Key value for chemical safety assessment

Additional information

The water solubility of the test material was assessed according to the standardised guidelines OECD 105 and EU Method A.6 and in compliance with GLP.  The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The test material could not be analysed for water solubility by a chemical analysis method due to the complex nature of the substance and the very low solubility. The water solubility of the test material was therefore estimated by visual assessment. 

Approximately 10 mg portions of the test material were weighed into glass stoppered graduated cylinders and ultrapure water was added in steps. After each addition of water, the mixtures were shaken vigorously and were visually checked for any undissolved parts of the test material. The test was repeated with about 5 mg of test material.In both series, the test material did not dissolve in water, but it stuck to the wall of the glass vessels.

Because the test material is strongly coloured, it was feasible to continue the test at lower nominal concentrations of 2.5 mg and 1.0 mg of pulverised test material weighed into 2000 mL flasks, separately. Both flasks contained a small orange ball of test material.

The flasks and cylinders were ultrasonicated for about 10 minutes, which can cause a slight increase of the temperature and facilitate the dissolution.

Undissolved test material was observed at the 0.5 and 1 mg/L nominal concentration levels. The water solubility of the test material was therefore estimated to be < 1 mg/L.