Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 14-17, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):diisopropylsuccinate
- Physical state: liquid

Results and discussion

Water solubilityopen allclose all
Water solubility:
3 637 mg/L
Temp.:
10 °C
pH:
4.5 - 4.6
Remarks on result:
other: standard deviation: 146, replicates of three days
Water solubility:
3 772 mg/L
Temp.:
20 °C
pH:
4.3 - 4.5
Remarks on result:
other: standard deviation: 116, replicates of three days
Details on results:
The temperature of the water bath was 10.0 °C respectively 20.0 °C.
The pH of the solutions were 4.5 to 4.6 at 10 °C and 4.3 to 4.5 at 20 °C.
The difference between the concentrations of the test substance of day 1 to 3 at 10 °C
and 20 °C was <15 % and the concentrations of the test substance showed no relevant tendency. Therefore the mean of day 1 - 3 was taken as the
solubility of the test substance at both temperatures, according to the guidelines.
As the temperature coefficient of the solubility of the test substance was <3 % per °C, the solubility was not determined at three temperatures, in
agreement with the guideline.

Any other information on results incl. tables

Table1: Water Solubility at 10 °C

Mass concentration of diisopropylsuccinate determined at different times of stirring, two solutions were used.

 

nominal temperature

equilibration time

pH of the solutions

concentration (mg/L)

deviation from the maximum concentration
(%)

1st

2nd

1st

2nd

mean

 

10 °C

1 day

4.6

4.6

3848

3751

3800

0.0

2 days

4.5

4.4

3604

3592

3598

-5.3

3 days

4.5

4.5

3534

3496

3515

-7.5

 

 

 

mean (day 1-3)

3637

 

 

 

 

SD

146

 

 

Table2: Water Solubility at 20 °C

Mass concentration of diisopropylsuccinate determined at different times of stirring, two solutions were used.

 

nominal temperature

equilibration time

pH of the solutions

concentration (mg/L)

deviation from the maximum concentration
(%)

1st

2nd

1st

2nd

mean

 

20 °C

1 day

4.4

4.5

3749

3955

3852

0.0

2 days

4.4

4.3

3881

3770

3825

-0.7

3 days

4.3

4.3

3640

3639

3640

-5.5

 

 

 

mean (day 1-3)

3772

 

 

 

 

SD

116

 

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
The water solubility of diisopropylsuccinate was determined to:
Mean: 3637 mg/L, standard deviation: 146, replicates of three days, temperature 10.0 °C.
Mean: 3772 mg/L, standard deviation: 116, replicates of three days, temperature 20.0 °C.
As the temperature coefficient of the solubility of the test substance was <3 % per °C, the solubility was not determined at three temperatures, in
agreement with the guideline.
Executive summary:

The flask method was used.

The water solubility of diisopropylsuccinate was determined to:
Mean: 3637 mg/L, standard deviation: 146, replicates of three days, temperature 10.0 °C.
Mean: 3772 mg/L, standard deviation: 116, replicates of three days, temperature 20.0 °C.

As the temperature coefficient of the solubility of the test substance was <3 % per °C, the solubility was not determined at three temperatures, in agreement with the guideline.