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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:
2015-08-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
119 mg/L
Conc. based on:
test mat.
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
6.7
Details on results:
The concentration measured did not differ for more than 15 % and Temperatures were kept constant within ± 0.5 °C. Thus, all validity criteria were fulfilled. No Tyndall-effect was observed in all replicates at all time points (24h, 48h, 72h).

pH-value of the Test Mixture

Test temperature

[°C]

Preincubation time [h]

Replicate

Measured pH

Mean value

20

24

1

6.351

7.3

2

6.479

48

1

6.545

2

6.733

72

1

6.989

2

7.142

Control

6.402

-

 

Check of the Tyndall-Effect

 Preincubation time

Replicate

Tyndall-Effect

24 h

1

negative

2

negative

48 h

1

negative

2

negative

72 h

1

negative

2

negative

Control

negative

 

 Water Solubility Results at 20 °C

Preincubation time

Replicate

No.

Concentration [mg/L]

Mean

24 h

1

120

120

2

120

48 h

1

119

119

2

118

72 h

1

120

117

2

115

Mean (24-72 h)

 

119

Deviation[%] (24-72 h)

2

 

 

Conclusions:
The solubility of the test item was determined to be 119 mg/L (pH 6.7) at 20 °C ± 0.5 °C.
Executive summary:

A study was conducted according to OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 440/2008, Method A.6 to determine the water solubility of the test item. In a non-GLP preliminary test the application dose for the main test was determined. As preliminary result a solubility range of 24.4 - 122 mg/L was determined. The analytical quantification of the test item was carried out via HPLC with DAD on a reversed phase analytical column. Method validation was performed according to SANCO 3029/99 rev.4 (2000) Repeatability and temperature as validity criteria. All validation criteria were fulfilled. The main test was conducted at 20 °C ± 0.5 °C. The test mixture replicates were preincubated at 30 ± 0.5 °C with constant stirring at 300 rpm for 72, 48 and 24 h, respectively. After preincubation, the temperature was reduced to the test temperature of 20 ± 0.5 °C for 24 h with stirring at 100 rpm. The samples were taken 24 h after reduction to the test temperature and the test item concentration was determined. The solubility of the test item was determined as mean of the 24-72 h time points to be 119 mg/L (pH 6.7) at 20 + 0.5 °C.

Description of key information

The water solubility of the test item was determined to be 119 mg/L (pH 6.7) at 20 °C ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:
119 mg/L
at the temperature of:
20 °C

Additional information

A study was conducted in accordance with OECD Guideline 105 and Council Regulation (EC) No. 440/2008, Method A.6 to determine the water solubility of the test item. The test was conducted at 20 °C ± 0.5 °C with preincubation at 30 °C ± 0.5 °C with constant stirring at 300 rpm for 72, 48 and 24 h. After preincubation, the temperature was reduced to the test temperature of 20 ± 0.5 °C for 24 h with stirring at 100 rpm. The samples were taken 24 h after reduction to the test temperature and the test item concentration was determined. The solubility of the test item was determined as mean of the 24 -72 h time points to be 119 mg/L at 20 ± 0.5 °C.