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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:
Experimental Starting Date: 17 May 2012, Experimental Completion Date: 03 July 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
30.5 g/L
Temp.:
20 °C
pH:
4.6
Remarks on result:
other: The water solubility of the test item, corrected for purity, has been determined to be 30.5 g/L of solution at 20.0 ± 0.5 °C.

    

Results

Preliminary test:

The preliminary estimate of water solubility was 35.1 g/L at 20.0 ± 0.5 °C.

Definitive test :

Please see Attachment 1 (attached background material) for the Typical Chromatography.

The mean peak areas relating to the standard and sample solutions are shown in the following table:

 

Table 3.15

 

Solution

Mean PeakArea

Standard 50.3 mg/L

8.9266 x 107

Standard 50.3 mg/L

8.9753 x 107

Sample 1A

6.0302 x 107

Sample 1B

6.0372 x 107

Sample 2A

5.9132 x 107

Sample 3A

6.0619 x 107

Standard 50.3 mg/L

8.9696 x 107

Standard 50.3 mg/L

9.0255 x 107

Sample 2B

6.0211 x 107

Sample 3B

6.0116 x 107

 

No peak was observed in the chromatography of the matrix blanks at the retention time of the test item.

 

The concentration (g/L) of test item in the sample solutions is shown in the following table:

 

Table 3.16

 

Sample Number

Time Shaken at

~ 30 ºC (hours)

Time Equilibrated at 20 ºC (hours)

Concentration (g/L)

Solution pH

Analyzed

Corrected for purity

1

24

24

33.9

30.7

4.6

2

48

24

33.4

30.3

4.6

3

72

24

33.8

30.6

4.7

 

Mean corrected concentration:          30.5 g/L at 20.0 ± 0.5 ºC
Range:                                               30.3 to 30.7 g/L

 

Validation

The linearity of the detector response with respect to concentration was assessed over the concentration range of 0 to 101 mg/L. This was satisfactory with a correlation coefficient (r2) of 1.000 being obtained.

Conclusions:
Very soluble (> 10000 mg/L)
The water solubility of the test item, corrected for purity, has been determined to be 30.5 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

Water solubilty

Method

The determination was carried out using the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995 and Method 830.7840 of the OPPTS Guidelines.

The test system consists of glass double-distilled water.

Conclusion

The water solubility of the test item, corrected for purity, has been determined to be 30.5 g/L of solution at 20.0 ± 0.5 °C.

Description of key information


The water solubility of the test item, corrected for purity, has been determined to be 30.5 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:
30.5 g/L
at the temperature of:
20 °C

Additional information

The determination was carried out using the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995 and Method 830.7840 of the OPPTS Guidelines.

The test system consists of glass double-distilled water.

The water solubility of the test item, corrected for purity, has been determined to be 30.5 g/L of solution at 20.0 ± 0.5 °C.