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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-05-11 - 2017-10-19 (experimental phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Remarks:
Partition coefficient
Reason / purpose for cross-reference:
reference to same study
Remarks:
Adsorption / Desorption
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
EC Guideline A.6. Water Solubility. March 19, 2014
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
OECD Guideline 105. Water Solubility. July 27, 1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
EPA Product Properties Test Guideline OPPTS 830.7840: Water Solubility: Column Elution Method; Shake Flask Method. March 1998
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Remarks:
slow-stirring
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sponsor

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In refrigerator (2-8°C)
Key result
Water solubility:
< 0 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
10 other: µl/l
Incubation duration:
>= 24 - <= 72 h
pH:
>= 7.3 - <= 7.4
Remarks on result:
other: water solubility is below the LOQ
Conclusions:
The study was performed according to OECD TG 105 under GLP on the substance to be registered itself, the test procedure is well documented and therefore reliability of Klimisch 1 has been assigned. The analytical method was properly established. The limit of quantification (LOQ) was assessed at a test item concentration of 10 µg/L in water. The response of the test samples was lower than the response of the lowest calibration solution (0.450 µg/L). The analyzed concentration in the test samples was determined to be < 4.5 µg/L taking a dilution factor of 10 into account. In conclusion it can only be stated that the water solubility of the test item at 20°C was < 4.5 * 10E-6 g/L, making a quantification in e.g. ecotoxicity test impossible as the test item must be regarded as practically insoluble in water.
Executive summary:

The water solubility of the test item was determined according to EC A.6, OECD 105, and OPPTS 830.7840 under GLP at 20°C by the slow-stirring flask method as < 4.5 x 10E-6 g/L.

Description of key information

Water solubility: < 4.5 x E-6 g/L at 20°C (EC A.6, OECD 105, OPPTS 830.7840, GLP, slow-stirring flask method)

Key value for chemical safety assessment

Water solubility:
0 g/L
at the temperature of:
20 °C

Additional information

It can only be stated that the water solubility of the test item at 20°C was < 4.5*10-6 g/L, making a quantification in e.g. ecotoxicity test impossible as the test item must be regarded as practically insoluble in water.