5,5-dimethylhydantoin

Water solubility

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

Test material information

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 10^3
Standard 100 mg/l	1.062 x 10^3
Matrix Blank	0.000
Sample 1A	991.688
Sample 1B	987.426
Sample 2A	1.006 x 10^3
Sample 2B	960.461
Sample 3A	1.012 x 10^3
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.