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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 September to 7 October 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
modified according to Letinski et al. (2002) and OECD 123 (2006)
GLP compliance:
yes (incl. QA statement)
Remarks:
Staatliches Gewerbeaufsichtsamt Hildesheim
Type of method:
flask method
Remarks:
slow stirring approach
Key result
Water solubility:
2 mg/L
Temp.:
20 °C
pH:
5.8

Results

The method showed acceptable results for linearity, accuracy, precision and specificity according to SANCO 3029/99 rev.4 (2000) and fulfilled all study plan requirements.

The intended temperature (20.0 ± 0.5 °C) was respected during the study and a mean pH of 5.8 was measured.

All samples were checked negative for a Tyndall effect verifying the absence of colloidal dispersed matter.

The results of the water solubility sampling are reported in the table below.

 

Sampling of equilibrium

Incubation time (1)

[h]

Calculated Concentration (2)

[mg/L]

 

 

 

Replicate 1

Replicate 2

 

1 (5)

116.02

1.52

1.49

 

2

118.02

2.10

1.95

 

3

120.02

1.99

1.92

 

4

139.80

2.07

2.07

 

5

141.97

2.06

2.06

 

6

144.40

1.88

1.89

Overall

 

Mean

2.02

1.98

2.00

 

Deviation [%]

11.7 (3)

9.6 (3)

2.1 (4)

(1) Time after application

(2) Dilution factor of and exact weight of the external standard taken into account

(3) Calculation according to formula

(4) Calculation according to formula

(5) Not taken into account, as equilibrium was not achieved

 

Conclusions

The water solubility of the test item was determined at 20 °C and pH 5.8 to be 2.00 mg/L.

Conclusions:
A water solubility value of 2.00 mg/L (at 20 °C, pH = 5.8) was determined for the test substance according to OECD 105.
Executive summary:

The water solubility of the test item was determined according to OECD 105 (1995) using a slow stirring method. The test was performed under GLP. The concentrations were analyzed via GC-MS after reaching equilibration state. The water solubility of the test item was determined to be 2.00 mg/L at 20 °C and pH 5.8.

Description of key information

Water solubility: 2.00 mg/L at 20 °C, pH = 5.8 (OECD 105, slow stirring method)

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item was determined according to OECD 105 (1995) using a slow stirring method. The test was performed under GLP. The concentrations were analyzed via GC-MS after reaching equilibration state. The water solubility of the test item was determined to be 2.00 mg/L at 20 °C and pH 5.8.