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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: 25 April 2014 Experimental Completion Date: 03 June 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes
Type of method:
column elution method
Water solubility:
0 g/L
Temp.:
20 °C
pH:
>= 6.48 - <= 6.76
Details on results:
Please see section Remarks on results including tables and figures.

Results

Preliminary test

The preliminary estimate of water solubility was 1.21 x 10-4 g/L at 20.0 °C.

Definitive test

For typical chromatography see Appendix 3 - Attachment 1 of this Summary.

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

 

Table 3.9

 

Solution

Mean Peak Area

Standard 1.36 mg/L

4.2181 x 105

Standard 1.32 mg/L

4.1611 x 105

System A Sample 1

2.5442 x 105

System B Sample 1

3.6210 x 105

Standard 1.31 mg/L

3.7839 x 105

Standard 1.38 mg/L

4.1000 x 105

System A Sample 2

2.7656 x 105

System A Sample 3

2.4567 x 105

System B Sample 2

2.9698 x 105

System B Sample 3

4.5394 x 105

Standard 1.25 mg/L

3.6261 x 105

Standard 1.24 mg/L

3.6211 x 105

System A Sample 4

3.7949 x 105

System A Sample 5

2.8677 x 105

System B Sample 4

2.6134 x 105

System B Sample 5

3.4512 x 105

Standard 1.27 mg/L

3.7333 x 105

Standard 1.27 mg/L

3.7925 x 105

System A Sample 6

2.4740 x 105

System A Sample 7

1.9577 x 105

System B Sample 6

3.1709 x 105

System B Sample 7

2.5124 x 105

 

Table 3.9(continued)

 

Solution

Mean Peak Area

Standard 1.23 mg/L

3.8533 x 105

Standard 1.39 mg/L

4.4688 x 105

System A Sample 8

7.4505 x 105

System A Sample 9

4.3629 x 105

System B Sample 8

6.0472 x 105

System B Sample 9

3.4208 x 105

Standard 1.20 mg/L

3.7110 x 105

Standard 1.25 mg/L

3.6316 x 105

System A Sample 10

2.0472 x 105

System A Sample 11

2.5057 x 105

System B Sample 10

2.8447 x 105

System B Sample 11

2.2960 x 105

 

 

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

 

Table 3.10

 

Sample Number

Sampling Time (hour)

Concentration (g/L)

Solution pH

Determination A

Determination B

Determination A

Determination B

Determination A

Determination B

1

90.5

91.5

6.52 x 10-5

9.27 x 10-5

6.72

6.70

2

187.5

188.5

7.53 x 10-5

8.08 x 10-5

6.56

6.55

3

190.25

191.25

6.69 x 10-5

1.24 x 10-4

6.49

6.48

4

208.25

209.25

1.04 x 10-4

7.18 x 10-5

6.66

6.70

5

210.75

211.75

7.88 x 10-5

9.48 x 10-5

6.72

6.77

6

259

260

6.69 x 10-5

8.58 x 10-5

6.70

6.76

7

262

263

5.30 x 10-5

6.80 x 10-5

6.72

6.69

8

331.5

332.5

1.87 x 10-4

1.52 x 10-4

6.69

6.69

9

333.5

334.5

1.10 x 10-4

8.61 x 10-5

6.74

6.72

10

355.5

356.5

5.45 x 10-5

7.58 x 10-5

6.70

6.72

11

357.5

358.5

6.68 x 10-5

6.12 x 10-5

6.75

6.74

 

The overall results are shown in the following table:

 

Table 3.11

 

Determination

Mean Concentration (g/L)

Standard Deviation

A

8.44 x 10-5

3.87 x 10-5

B

9.02 x 10-5

2.64 x 10-5

Overall

8.73 x 10-5

-

Corrected Overall Result

1.05 x 10-4

-

 

Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0.293 to 5.86 mg/L. This was satisfactory with a correlation coefficient of 1.000 being obtained.

 

Recovery of analysis of the sample procedure was assessed and proved adequate for the test. At a nominal concentration of 0.1 mg/L, a mean percentage recovery of 83.2% was obtained (range 82.8 to 83.8%, relative standard deviation 0.629%).

 

The final result has been corrected for recovery of analysis.

 

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
Please see the Executive Summary below for the Conclusion.
Executive summary:

The determination was carried out using the column elution 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.

 

The test system consists of purified water.

Conclusion

The water solubility of the test item has been determined to be 1.05 x 10-4 g/L of solution at 20.0 ± 0.5 °C.

Description of key information

The determination was carried out using the column elution 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.

 

The test system consists of purified water.

The water solubility of the test item has been determined to be 1.05 x 10-4 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

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

Additional information