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
Study period:
22.-28.09.2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
no
Type of method:
column elution method
Key result
Water solubility:
< 0.182 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
5.8

Preliminary test


Three preliminary tests were carried out with specified amounts of the test item and 100 ml and 500 ml demineralized water, respectively. After each addition of an amount of water, the mixture was stirred for at least 24 hours, and visually checked for any undissolved particles.


Table 1: Results of the preliminary test


























Amount of test item /mg



Total volume of demineralized water / mL



Appearance of mixture



7.1



100



Not dissolved



16.2



500



Not dissolved



4.3



500



Not dissolved



 


The preliminary test showed that the water solubility of the test item is < 10 mg/L. According to the preliminary test the water solubility was determined by the column elution method in the main test.


 


Column elution method


102.9 mg of the test item were dissolved in 100 mL in acetone. For charging the columns in each case 25 mL of the test item solution was added to about 3 g of sea sand and the mixtures were shaken. The solvent was then removed under reduced pressure using a rotary evaporator (40 °C, approx. 20 mbar). The dry residues were placed into the columns of the test apparatus, which have afterwards been filled with water (test temperature: 20 °C; water pH at 24 °C: 5.8). After a swelling time of 2 h pumps were started to rinse the test item coated sand with demineralized water. At the end of the study it was confirmed that residual test item remained on the columns. The residual test item was eluted with 50 mL acetone. As blank value the used demineralized water was tested. Shortly before the peak of the test item another peak was detected. This peak did not affect the final result. The concentration of the test item was quantified by HPLC.


Column 1:


Rotation period of the fraction collector:          90 min per fraction


Duration of sampling:                           about 48 h (32 fractions)


 


Table 2: Column elution method, column 1 (approx. 12.5 mL/h)










































Fraction no



V / mL



pH



Water solubility / mg/L



21



18.0



6.4



< 0.182



22



18.0



6.5



< 0.182



23



18.0



6.5



< 0.182



24


18.0

7.0



< 0.182



25



18.0



6.7



< 0.182



 


The water solubility was found to be below the quantification limit of 0.182 mg/l.


 


Column 2:


Rotation period of the fraction collector:          45 min per fraction


Duration of sampling:                           about 47 h (63 fractions)


 


Table 3: Column elution method, column 2 (approx. 25.0 mL/h)










































Fraction no



V / mL



pH



Water solubility / mg/L



49



17.0



6.7



< 0.182



50



17.0



6.7



< 0.182



51



17.0



6.6



< 0.182



52



17.0



6.5



< 0.182



53



17.0



6.4



< 0.182



The water solubility was found to be below the quantification limit of 0.182 mg/l.


 


In both columns the concentration of five consecutive fractions was constant within ± 30 %. No increasing or decreasing tendency was observed.


 


Table 4: Coating check
























 



Amount of test item


used for coating /mg



Measured concentration of


 test item in eluate /mg/L



Amount of test item


 eluated /mg



Column 12.5 mL/h



25.7



0.823 / 0.706



19.1



Column 25.0 mL/h



25.7



0.638 / 0.644



16.0



 


The coating check was successful. Enough test item remained on the columns. 


The water solubility cs of the test item was found to be below the quantification limit of 0.182 mg/l (mean value of the columns).

Conclusions:
The water solubility cs of the test item at a temperature of 20 °C was determined according to the column elution method. It was found to be below the quantification limit: cs < 0.182 mg/L.
Executive summary:

The water solubility was determined according to OECD 105 using the column elution method. The preliminary test showed that the water solubility of the test item is < 10 mg/L. The column elution method showed a solubility: cs < 0.182 mg/L.

Description of key information

The water solubility cs of the test item at a temperature of 20°C was determined according to the column elution method was found to be cs < 0.182 mg/L.

Key value for chemical safety assessment

Additional information

The water solubility was determined according to OECD 105 using the column elution method. The preliminary test showed that the water solubility of the test item is < 10 mg/L. The column elution method showed a solubility: cs < 0.182 mg/L.

Categories Display