Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Jul - 16 Aug 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Standard EC method A6 and OECD method 105 was not applicable to this test item due to the high indeterminable saturation levels produced

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
adopted in 2008
Deviations:
yes
Remarks:
Standard EC method A6 and OECD method 105 was not applicable to this test item due to the high indeterminable saturation levels produced
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted in 1995
Deviations:
yes
Remarks:
Standard EC method A6 and OECD method 105 was not applicable to this test item due to the high indeterminable saturation levels produced
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health, London, UK
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Storage conditions: room temperature in the dark

Results and discussion

Water solubility
Key result
Water solubility:
>= 667.53 - <= 814.97 g/L
Conc. based on:
test mat.
Incubation duration:
3 d
Temp.:
20 °C
pH:
>= 9.4 - <= 10
Remarks on result:
other:
Remarks:
Water solubility determined based on visual inspection
Details on results:
The standard EC method A6 and OECD method 105 was not applicable to this test item due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guidelines. No analysis could be performed due to the high solubility producing unfilterable mixtures.
Therefore the water solubility was determined based on visual inspection.

Any other information on results incl. tables

Preliminary test

Results of the preliminary estimate of water solubility are shown in the following table.

Table 3

Concentration

[% w/w]

Observation

pH

10.0

Dark yellow/brown solution with no excess test item present

8.6

30.0

Dark yellow/brown solution with no excess test item present

9.6

50.0

Dark yellow/brown solution with excess test item present

9.6

74.9

Yellow/brown wet looking solid

-

80.0

Yellow/brown solid, no liquid present

-

90.0

Yellow/brown solid, no liquid present

-

 

Preliminary test result: water solubility in the range 30.0 to 50.0% w/w at 20.0 ± 0.5 °C.

 

Definitive test

The results of the definitive test for the water solubility are shown in the following table.

Table 4

Concentration

[% w/w]

Observation

pH

35.1

Dark yellow/brown solution, no excess test item visible

9.1

40.0

Dark yellow/brown solution, no excess test item visible

9.4

44.9

Dark yellow/brown solution, with small amount of undissolved test item

floating within the solution

10.0

 

Water solubility in the range 40.0 to 44.9% w/w at 20.0 ± 0.5 °C. This corresponds to 667,53 to 814,97 g/L.

 

Discussion

The standard EC method A6 and OECD method 105 was not applicable to this test item due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guidelines. No analysis could be performed due to the high solubility producing unfilterable mixtures.

Therefore the water solubility was determined based on visual inspection.

Conclusion

The water solubility of the test item has been determined to be in the range of 40.0 to 44.9% w/w of solution at 20.0 ± 0.5 °C.

Applicant's summary and conclusion