Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Principles of method if other than guideline:
0.1 mL water, type I, was added to 102.3 mg test item at room temperature. A slightly wet powder was obtained. Adding further 0.4 mL, a colloidal suspension with foam could be observed.
After the next steps, adding 0.5 mL, 1 mL and 8 mL, a visually clear liquid with pH 5 – 6 was obtained.
The result of the preliminary test is an approx. water solubility between 10- 50 g/L.
The check for Tyndall effect using a laser shows that it is also a colloidal solution.

The results were checked using the QSAR from ACD/Labs software.
GLP compliance:
no
Type of method:
flask method
Water solubility:
>= 10 - <= 50 g/L
Conc. based on:
test mat.
Temp.:
23 °C
pH:
>= 5 - <= 6
Remarks on result:
other: experimental result
Details on results:
0.1 mL water, type I, was added to 102.3 mg test item at room temperature. A slightly wet powder was obtained. Adding further 0.4 mL, a colloidal suspension with foam could be observed.
After the next steps, adding 0.5 mL, 1 mL and 8 mL, a visually clear liquid with pH 5 – 6 was obtained.
The result of the preliminary test is an approx. water solubility between 10- 50 g/L.
The check for Tyndall effect using a laser shows that it is also a colloidal solution.


The results were checked using the QSAR from ACD/Labs software. The results obtained for ecotoxicological pH-values were higher than the reuslts obtained by the experimental determination, e.g. ranged from 36.5 to 113 g/L for pH 4.6 to 6.
Conclusions:
water solubility 10-50 g/L
Executive summary:

In the non GLP Klimisch 1 key study from Keune (2017), the water solubility of Disodium 4-[1-methyl-2-[(1-oxooctadec-9-enyl)amino]ethyl] 2- sulphonatosuccinate was determined according to OECD 105 and EU method A.6.

0.1 mL water, type I, was added to 102.3 mg test item at room temperature. A slightly wet powder was obtained. Adding further 0.4 mL, a colloidal suspension with foam could be observed. After the next steps, adding 0.5 mL, 1 mL and 8 mL, a visually clear liquid with pH 5 – 6 was obtained. The result of the preliminary test is an approx. water solubility between 10- 50 g/L. The check for Tyndall effect using a laser shows that it is also a colloidal solution.

The results were checked using the QSAR from ACD/Labs software.

The results of 10 -50 g/L of this study are considered relevant and reliable for the risk assessment.

Description of key information

water solubility 10-50 g/L

Key value for chemical safety assessment

Water solubility:
10 g/L
at the temperature of:
23 °C

Additional information

In the non GLP Klimisch 1 key study from Keune (2017), the water solubility ofDisodium 4-[1-methyl-2-[(1-oxooctadec-9-enyl)amino]ethyl] 2- sulphonatosuccinatewas determined according to OECD 105 and EU method A.6.

0.1 mL water, type I, was added to 102.3 mg test item at room temperature. A slightly wet powder was obtained. Adding further 0.4 mL, a colloidal suspension with foam could be observed. After the next steps, adding 0.5 mL, 1 mL and 8 mL, a visually clear liquid with pH 5 – 6 was obtained. The result of the preliminary test is an approx. water solubility between 10- 50 g/L. The check for Tyndall effect using a laser shows that it is also a colloidal solution.

The results were checked using the QSAR from ACD/Labs software.

The results of 10 -50 g/L of this study are considered relevant and reliable for the risk assessment.