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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
May - June 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
no
Type of method:
flask method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: CG272
- Expiration date of the lot/batch: 11. July 2018
- Purity test date: not stated

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: to be established (solubility) and assumed stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Key result
Water solubility:
>= 66 - <= 70.6 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
2 000 mg/L
Incubation duration:
>= 1 - <= 3 d
Temp.:
20 °C
pH:
> 6 - < 7
Details on results:
Following Loading rates were analysed: 250, 500, 750, 1000, 1500, 2000 mg/L
Conclusions:
The water solubility of the test item was stated
as 68.3 mg/L with standard deviation of 2.3 mg/L, corresponding to a relative standard
deviation of 3.3 %.
Executive summary:

The solubility of the test item DENACOL EX-147 in water was determined by measurement

of the test item concentration via gas chromatography. Method and sample preparation

are fully described in validation report 16121602G926.

The preliminary test described in the guideline was not performed as the solubility of the

test item in water was estimated during the validation study as approx. 50 mg/L. According

to the guideline the flask method was used for the determination of the solubility of the test

item in water.

In the main test, six different loading rates of the test item were chosen to study the effect

of the loading rate on the measured water solubility: 250 mg/L (flask 2), 500 mg/L (flask 3),

750 mg/L (flasks 1A-1C), 1000 mg/L (flask 4), 1500 mg/L (flask 5) and 2000 mg/L (flask 6).

Three flasks 1A - C with the same loading rate (750 mg/L) were used during equilibration.

Six vessels (1C (for the sampling point 72 h) and 2 – 6) were set onto the shaking apparatus

immediately. After 24 hours, flask 1B (for the sampling point 48 h) and after 48

hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks were

shaken for further 24 hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C

were taken from the shaker, samples were taken, membrane filtered and analysed via

GC/FID after extraction. Because of a difference of less than 15 % in the concentrations

on days 2 and 3 and no upward tendency, the test was finished on day 3.

The final measurement was performed as determination from flasks 2 – 6. All filtrated test

solutions showed no Tyndall effect (i.e. a laser beam was not scattered when transmitted

through the liquid).

Dependency of solubility on amount of the test item (nominal load) was not perceived.

At the plateau, the concentration of DENACOL EX-147 in water had reached:

68.3 ± 2.3 mg/L at 20.0 ± 0.5 °C

68.3 ± 2.3 * 10-3 kg/m3 (SI units)

(mean value ± standard deviation of eight individual vessels)

Description of key information

one Guideline study available

Key value for chemical safety assessment

Water solubility:
68.3 mg/L
at the temperature of:
20 °C

Additional information