Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15th December 2009 to 23rd February 2010.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of GLP inspection: 15/09/09 Date of Signature on GLP: 26/11/09
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification : DVS005u (aka Weston 705)
Description : clear colourless viscous liquid
Batch number : MW9F23A901
Date received : 05 November 2009
Expiry date : 15 June 2010
Storage conditions : approximately 4°C in the dark, under nitrogen

Results and discussion

Water solubility
Water solubility:
< 0 g/L
Temp.:
20 °C
pH:
5.6

Any other information on results incl. tables

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

Solution

MeanArea

Standard 11.6 mg/l

732.983

Standard 12.7 mg/l

828.689

Sample 1A

ND

Sample 1B

ND

Sample 2A

ND

Sample 2B

ND

Sample 3A

ND

Sample 3B

ND

ND = none detected

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

Sample Number

Time Shaken at

~ 30ºC (hours)

Time Equilibrated at 20ºC (hours)

Concentration (g/l)*

Solution pH

1

24½

24¼

<1.0 x 10-4

3.6

2

48½

24¼

<1.0 x 10-4

3.6

3

72½

24¼

<1.0 x 10-4

3.7

Overall concentration:          <1.0 x 10-4 g/l at 20.0 ± 0.5ºC


Discussion:

The relatively large, unknown peaks in the sample chromatograms at approximately 1.5, 3.1 and 4.2 minutes were not seen during method validation. Thus, these peaks have been considered to be due to water-soluble, UV-absorbing impurities in the test material.

Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 250 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.

Recovery data is shown in the following table:

Nominal Concentration

(g/l)

Recovery(%)

Mean Recovery (%)

1.0 x 10-4

76.3 to 89.8

81.5

1.0 x 10-3

85.4 to 93.6

88.5

No test material was detected in any of the sample solutions; therefore, a limit value for these solutions was taken as 1.0 x 10-4g/l, i.e. the lowest nominal concentration used during method validation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of the test material has been determined to be less than 1.0 x 10-4 g/l of solution at 20.0 ± 0.5°C.
Executive summary:
Water Solubility:  Less than 1.0 x 10-4g/l of solution at 20.0 ± 0.5°C, using the flask method, 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.