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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:
Between 15 February and 03 March 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
- 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 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Remarks:
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 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
Water solubility:
0.011 g/L
Temp.:
20 °C
Remarks on result:
other: pH not reported
Details on results:
Due to the tabular nature of this information & to retain the integrity & coherence of the original Harlan Laboratories Ltd. Study report please see section “Any other information on results incl. tables”

Results

Preliminary test

The preliminary estimate of water solubility was 1.7 x 10-2 g/L at 20 °C.

Definitive test

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

  Table 3.9

Solution

Mean PeakArea

Standard 10.3 mg/L

1.4598 x 106

Standard 10.0 mg/L

1.4425 x 106

Matrix blank

None detected

Sample 1A

8.3487 x 105

Sample 1B

8.2671 x 105

Sample 2A

8.2333 x 105

Sample 2B

8.2384 x 105

Sample 3A

8.1298 x 105

Sample 3B

8.1857 x 105

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

 

Table 3.10 

Sample Number

Time Shaken at

~ 30 ºC (hours)

Time Equilibrated at 20 ºC (hours)

Concentration (g/L)

Solution pH

1

24

26

1.16 x 10-2

6.0

2

48

26

1.15 x 10-2

5.8

3

72

26

1.14 x 10-2

5.8

 

Mean concentration:  1.15 x 10-2 g/L at 20.0 ± 0.5 ºC
Range:                        1.14 x 10-2 to 1.16 x 10-2g/L

Validation

The linearity of the detector response with respect to concentration was assessed over the concentration range of 0 to 20.0 mg/L. This was satisfactory with a correlation coefficient (r2) of 0.999 being obtained.

Conclusions:
Interpretation of results: slightly soluble (0.1-100 mg/L)
The water solubility of the test item has been determined to be 1.15 x 10-2 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

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 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

Conclusion

The water solubility of the test item has been determined to be 1.15 x 10-2 g/L of solution at 20.0 ± 0.5 °C.

Description of key information

The water solubility of the test item has been determined to be 1.15 x 10-2 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

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

Additional information