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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 10, 2016 - October 21, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC method MT 157
Deviations:
no
GLP compliance:
no
Type of method:
flask method
Specific details on test material used for the study:

Internal sample code: 2929564-001
Purity: 100.3% w/w
Batch number: 2510468
Key result
Water solubility:
> 2 500 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
100.9 mg/L
Incubation duration:
> 30 - < 1 440 min
Temp.:
20 °C
Remarks on result:
other: pH value is not available.
Remarks:
pH value is not available.

Results

Using the analytical balance, two amounts of test item, 100.9 mg and 105.4 mg respectively, were weighed into two test tubes and increasing measured volumes of waterat room temperature (ca.)were added, as reported in table below.

 

Delmopinolo HCl: Water solubility test.

 

Approximate solubility (g/L)

Total volume required for complete dissolution (mL)

Solubility

after 30 min.

> 1000

0.10

Complete

 

In order to obtain a more accurate value of water solubility a second test was performed.

Using the analytical balance, test item aliquots were weighed in duplicate and increasing measured volumes of waterat room temperature (ca.)were added to each aliquot as indicated in table below, until complete dissolution was obtained.

After each addition, the mixture was shaken and then stored at test temperature with intermittent shaking for 30 minutes. The contents of the test tube were visually checked after 30 minutes and after 24 hours.

 

The results of the water solubility test are reported in the following table:

 

Delmopinolo HCl: Water solubility test.

 

Solubility range

(g/L)

Weight

(g)

Test 1

Weight

(g)

Test 2

Volume of addition (mL)

Solubility

after 30 min.

Solubility

after 24 h

>1500

3.0027

3.0033

2.00

Complete

Complete

>2000

4.0061

4.0012

2.00

Complete

Complete

>2500

5.0021

5.0009

2.00

Complete

Complete

 

As the amount of test item dissolved in water increases, the solution viscosity increases as well. At a test item concentration of 2500 g/L the solution doesn’t present any undissolved matter but its viscosity is so high that it is quite solid.

The A.6 method in Council Regulation (EC) No 440/2008 of 30 May 2008 requires, for the “Flask Method” procedure, a test item amount of 5 times the saturation limit determined in the preliminary test.

The amount of test item required to proceed would adsorb all the water present and it would not be possible to filter the mixture to proceed with an analytical determination of the water solubility.

Therefore the experimental phase was stopped after the preliminary test.


 

 

Conclusions:
From the obtained experimental data according to OECD guideline No. 105, CIPAC MT 157 and A.6 method in Council Regulation (EC) No 440/2008 of 30 May 2008, it can be concluded that the water solubility of Delmopinolo HCl is estimated > 2500 g/L at 20°C.
Executive summary:

Water solubility of Delmopinolo HCl is estimated > 2500 g/L at at 20°C.

Description of key information

Water solubility of Delmopinolo HCl is estimated > 2500 g/L at at 20°C.

Key value for chemical safety assessment

Water solubility:
2 500 g/L
at the temperature of:
20 °C

Additional information

Water solubility of Delmopinolo HCl is estimated > 2500 g/L at at 20°C.