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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 26 August 2010 and 27 October 2010.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
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 (incl. QA statement)
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
X-12764
IUPAC Name:
X-12764
Details on test material:
Sponsor's identification: X-12764
Description : Dark brown viscous liquid
Purity : approx. 50% w/w in mineral oil
Batch/Lot number: not supplied
Date received: 10 August 2010
Storage conditions: Room temperature in the dark
Expiry date : 06 August 2016


Results and discussion

Water solubility
Water solubility:
<= 0.002 g/L
Temp.:
20 °C
pH:
6 - 6.9

Any other information on results incl. tables

Results

Preliminary test

The preliminary estimate of water solubility was less than or equal to 6.8 x 10-4 g/l.

Definitive test

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

Table 8.3

Solution

Mean Area*

Standard 5.03 mg/l

1.261 x 106

Standard 4.02 mg/l

1.228 x 106

Standard 3.02 mg/l

6.976 x 105

Standard 2.01 mg/l

6.325 x 105

Standard 1.01 mg/l

2.893 x 105

Standard 0.503 mg/l

1.757 x 105

Standard 2.00 mg/l

5.871 x 105

Sample 1A

8.256 x 104

Sample 1B

9.580 x 104

Sample 2A

1.532 x 105

Sample 2B

1.653 x 105

Sample 3A

2.485 x 105

Sample 3B

2.809 x 105

Standard 2.01 mg/l

4.913 x 105

Standard 2.00 mg/l

4.332 x 105

*corrected for matrix blank

Table 8.3 (Continued)

Solution

Mean Area*

Standard 5.01 mg/l

1.296 x 106

Standard 4.00 mg/l

7.663 x 105

Standard 3.00 mg/l

6.306 x 105

Standard 2.00 mg/l

5.486 x 105

Standard 2.07 mg/l

4.951 x 105

Standard 1.00 mg/l

3.323 x 105

Standard 0.501 mg/l

2.715 x 105

Sample 4A

8.950 x 103

Sample 4B

7.050 x 103

Sample 5A

9.886 x 104

Sample 5B

8.147 x 104

Standard 2.00 mg/l

5.599 x 105

Standard 2.07 mg/l

5.541 x 105


*corrected for matrix blank

The calibration curves from which the sample concentrations were interpolated are presented in attachment "a6calcurves".

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

Table 8.4

Sample Number

Time Shaken at

~ 30ºC (hours)

Time Equilibrated at 20ºC (hours)

Concentration (g/l)

Solution pH

1

24

24

5.76 x 10-4

6.0

2

48

24

1.11 x 10-3

6.9

3

72

24

1.91 x 10-3

6.2

4

96

24

2.84 x 10-5

6.5

5

120

24

3.35 x 10-4

6.4

Overall concentration:          less than or equal to 1.91 x 10-3g/l at 20.0 ± 0.5ºC

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of the test item has been determined to be less than or equal to 1.91 x 10-3 g/l of solution at 20.0 ± 0.5°C.
Executive summary:

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 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 less than or equal to 1.91 x 10-3g/l of solution at 20.0 ± 0.5°C.