Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 26 October 2009 and 19 November 2009.
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:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 19-08-2008 Date of Signature: 04-09-2009
Type of method:
flask method
Remarks:
The determination was carried out using the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.

Test material

Constituent 1
Reference substance name:
DMH
IUPAC Name:
DMH
Details on test material:
Sponsor's identification: DMH
Description: white crystalline solid
Batch number: N5439431
Date received: 24 February 2006
Storage conditions: room temperature in the dark

Results and discussion

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

Any other information on results incl. tables

Results

Preliminary test

The preliminary estimate of water solubility was 142 g/l

Definitive test

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

Table8.2

Solution

Mean Area

Standard 103 mg/l

1.097 x 103

Standard 100 mg/l

1.062 x 103

Matrix Blank

0.000

Sample 1A

991.688

Sample 1B

987.426

Sample 2A

1.006 x 103

Sample 2B

960.461

Sample 3A

1.012 x 103

Sample 3B

991.473

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

Table 8.3

Sample Number

Time Shaken at

~ 30ºC (hours)

Time Equilibrated at 20ºC (hours)

Concentration (g/l)

Solution pH

1

24

24

140

5.6

2

48

24

139

5.6

3

72

24

142

5.6

Mean concentration:          140 g/l at 20.0 ± 0.5ºC
Range:                                  139 to 142 g/l

Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 200 mg/l. This was satisfactory with a correlation coefficient of 1.000 being obtained.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of the test material has been determined to be 140 g/l of solution at 20.0 ± 0.5°C.
Executive summary:

Method

The determination was carried out using the flask method, Method A6 Water Solubility ofCommissionRegulation (EC) No 440/2008 of 30 May 2008.

Conclusion

The water solubility of the test material has been determined to be 140 g/l of solution at 20.0 ± 0.5°C.