Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Water solubility
Key result
Water solubility:
44.2 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
1.85

Any other information on results incl. tables

Table1:      Preliminary Test Results

Test Item

[mg]

total volume of ultra-pure water
[mL]

time of shaking

[min]

remarks

Approximate solubility

[g/L]

 

0.5

26

not dissolved completely

200 - 1000

99.0

1

14

not dissolved completely

100 - 200

 

2

10

not dissolved completely

50 - 100

 

10

23

 dissolved completely

10 - 50

Table2:      Results of the water solubility of test item

time of shaking

Analyte concentration Flask 1

Analyte concentration Flask 2

pH value

[h]

[g/L]

[g/L]

 

23

43.3

45.6

1.86

47

43.4

45.8

1.85

71

42.5

44.6

1.84

Mean:

43.1

45.3

1.85

SD:

0.493

0.643

0.01

RSD [%]:

1.1

1.4

0.5

Overall mean:

 

44.2

 

 AD:

 

2.2

 

 RD [%]:

 

5.0

 

SD: standard deviation; RSD: relative standard deviation; AD: absolute deviation; RD: relative deviation

 

The results indicate the required reproducibility of relative standard deviation below 15 % of the last three sampling dates. Also the concentrations between the last two sampling dates for each vessel do not differ by more than 15%. There is no tendency to increasing values, when the shaking time was prolonged.

 

Applicant's summary and conclusion

Conclusions:
The solubility of the test item was determined in ultra-pure water in equilibrium with atmospheric carbon dioxide at a temperature of 20 ± 0.5 °C.
The results are presented in the following table:

Table 3: Solubility of the test item in ultra-pure water saturated with carbon dioxide at 20 ± 0.5 °C

Determined pH value 1.85
Mean solubility [g/L] 44.2