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Water solubility

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Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
no
Type of method:
column elution method
Key result
Water solubility:
> 0.02 - < 0.1 mg/L
Conc. based on:
test mat. (total fraction)
Temp.:
20 °C
pH:
6.9
Remarks on result:
other: pH value of Millipore water:

The limit of detection refered to addendum: statement to the final report, dated 05.06.2014

Conclusions:
The water solubility of test substance was determined to be >0.02 to < 0.1 mg/L at 20°C and at pH 6.9.
Endpoint:
water solubility
Type of information:
other: statement
Adequacy of study:
weight of evidence
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Statement to the Final Report "Determination of Water Solubility of test item, report no 09-16759/1-1"
Principles of method if other than guideline:
Statement to the final report "Determination of Water Solubility of Test Item, study number 09-16759/1-1"
GLP compliance:
no
Type of method:
other: statement
Key result
Water solubility:
> 0.02 - < 0.1 mg/L
Conc. based on:
test mat. (total fraction)
Temp.:
20 °C
pH:
6.9
Remarks on result:
other: pH value Millipore water:
Details on results:
A detection limit test (R. 7 .1. 7 .4) calculated on the basis of the listed data yields to a lower limit of 0.02 mg/L.
Therefore it is possible to report as upper limit for the water solubility of the test item, the limit of determination of 0.1 mg/L and as lower limit the limit of detection of 0.02 mg/L.
Conclusions:
A detection limit test (R. 7 .1. 7 .4) calculated on the basis of the listed data yields to a lower limit of 0.02 mg/L.
Therefore it is possible to report as upper limit for the water solubility of the test item, the limit of determination of 0.1 mg/L and as lower limit the limit of detection of 0.02 mg/L.

Description of key information

> 0.02 < 0.1 mg/L at 20°C and at pH 6.9

Key value for chemical safety assessment

Additional information

The determination was conducted by column elution method to test procedure VTA34N00003.01, which complies with EU test method L383 A/54-62 (EEC A.6). The concentration was quantified by UPLC-ESI-MS.

The water solubility of test item was found beneath the limit of quantification of 0.1 mg/L and above the limit of detection of 0.02 mg/L.