Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 15 February and 03 March 2012
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:
2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
- 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.
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Remarks:
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: BMS-589154-01
Description: Off white powder
Batch: 1M49303NA
Purity: Not supplied
Expiry / Retest Date: Not supplied
Storage Conditions: Room temperature in the dark

Results and discussion

Water solubility
Water solubility:
0.011 g/L
Temp.:
20 °C
Remarks on result:
other: pH not reported
Details on results:
Due to the tabular nature of this information & to retain the integrity & coherence of the original Harlan Laboratories Ltd. Study report please see section “Any other information on results incl. tables”

Any other information on results incl. tables

Results

Preliminary test

The preliminary estimate of water solubility was 1.7 x 10-2 g/L at 20 °C.

Definitive test

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

  Table 3.9

Solution

Mean PeakArea

Standard 10.3 mg/L

1.4598 x 106

Standard 10.0 mg/L

1.4425 x 106

Matrix blank

None detected

Sample 1A

8.3487 x 105

Sample 1B

8.2671 x 105

Sample 2A

8.2333 x 105

Sample 2B

8.2384 x 105

Sample 3A

8.1298 x 105

Sample 3B

8.1857 x 105

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

 

Table 3.10 

Sample Number

Time Shaken at

~ 30 ºC (hours)

Time Equilibrated at 20 ºC (hours)

Concentration (g/L)

Solution pH

1

24

26

1.16 x 10-2

6.0

2

48

26

1.15 x 10-2

5.8

3

72

26

1.14 x 10-2

5.8

 

Mean concentration:  1.15 x 10-2 g/L at 20.0 ± 0.5 ºC
Range:                        1.14 x 10-2 to 1.16 x 10-2g/L

Validation

The linearity of the detector response with respect to concentration was assessed over the concentration range of 0 to 20.0 mg/L. This was satisfactory with a correlation coefficient (r2) of 0.999 being obtained.

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 1.15 x 10-2 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:
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 1.15 x 10-2 g/L of solution at 20.0 ± 0.5 °C.