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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 March - 18 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
27 July 1995
Deviations:
yes
Remarks:
The standard EC A.6/OECD 105 methodology was considered not applicable to this test item due to the expected high saturation level. A range of sample concentrations were prepared to visually assess the point at which saturation was reached.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
30 May 2008
Deviations:
yes
Remarks:
The standard EC A.6/OECD 105 methodology was considered not applicable to this test item due to the expected high saturation level. A range of sample concentrations were prepared to visually assess the point at which saturation was reached.
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
Provided by lead regsitrant, no lot number.
- Expiration date of the lot/batch:
05 October 2018
- Purity test date:
no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Approximately 4 °C, in the dark
- Stability under test conditions:
stable
Key result
Water solubility:
> 37.9 - < 39.6 other: w/w
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
other: pH not measured
Details on results:
The water solubility of the test item has been determined to be in the range 37.9 to 39.6% w/w at 20.0 ± 0.5 °C.
Conclusions:
37.9 to 39.6% w/w at 20.0 ± 0.5 °C, by visual assessment using a modified flask method, designed to be compatible with Method A.6 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.

Description of key information

Key value for chemical safety assessment

Additional information

37.9 to 39.6% w/w at 20.0 ± 0.5 °C, by visual assessment using a modified flask method, designed to be compatible with Method A.6 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.