Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
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: crystalline

Results and discussion

Water solubilityopen allclose all
Key result
Water solubility:
>= 80 - < 84.7 other: g/100 g
Temp.:
23 °C
pH:
>= 2.9 - <= 3.7
Key result
Water solubility:
>= 80 - < 84.7 other: g/100 g
Temp.:
20 °C
pH:
>= 2.9 - <= 3.7

Any other information on results incl. tables

The following mixtures were prepared:

Weight of test item

 [g]

Amount of water added

[g]

Sample size

[g/100g]

Ratio

Observation

pH

1.04818

9.04834

10.38

1:9*

completely dissolved after shortly shaken by hand; clear, colorless, and homogeneous solution/mixture

3.7

3.49873

3.71491

48.50

1:1

completely dissolved afterrolling overnight; clear, colorless, and homogeneous solution/mixture

3.0

3.04100

2.0265

60.01

6:4

completely dissolved afterrolling overnight; clear, colorless, and homogeneous solution/mixture

3.0

3.54485

1.81586

66.13

65.35

completely dissolved afterrolling overnight; clear, colorless, and homogeneous solution/mixture

2.9

3.47862

1.48869

70.03

7:3

completely dissolved afterrolling overnight; clear, colorless, and homogeneous solution/mixture

2.9

3.75219

1.26808

74.74

75:25

completely dissolved afterrolling overnight; clear, colorless, and homogeneous solution/mixture

2.9

3.99565

0.99915

80.00

8:2

completely dissolved afterrolling overnight; clear, colorless, and homogeneous solution/mixture

2.9

4.28451

0.77213

84.73

85:15

not completely dissolved afterrolling overnight

**

4.51319

0.53138

89.47

9:1

not completely dissolved afterrolling for two days

**

 

 

 

 

Water used:

6.4

*Mixture from the pre-testing

** pH of these mixtures was not measureable.

Remark:

When mixing test item with water, cooling of the mixture was observed. The viscosity of the mixtures increased with increasing concentrations of test item.

The dissolved preparations (ratios 1 :9 - 8:2) were conditioned at 20 °C.

After conditioning over the weekend at 20.0 °C ± 0.5 °C, no changes were observed.

The undissolved preparations were heated overnight at 30 °C, then overnight at 50 °C and after that conditioned at 20 °C to investigate whether it is possible to produce saturated

solutions suitable for performing the flask method:

Ratio

Overnight at 30 °C

Overnight at 50 °C

Overnight at 20 °C

85:15

not completely

dissolved; supernatant liquid phase viscous

completely dissolved; mixture viscous

completely dissolved; mixture viscous

9:1

not completely

dissolved; supernatant liquid phase viscous

not completely

dissolved; undissolved amount decreased

undissolved, viscous mass without supernatant

Due to the fact that it was not possible to prepare samples with a liquid phase and a surplus of undissolved test item, the water solubility can only be estimated from the visual method.

The water solubility of the test item is > 80.0 g/100 g < 84.7 g/100 g (mtest item/ mmixture) at room temperature (T = 23 °C) and at T = 20.0 °C ± 0.5 °C.

Applicant's summary and conclusion