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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:
05 December 2019
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:
(see "Principles of method if other than guideline" for details)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
30 May 2008
Deviations:
yes
Remarks:
(see "Principles of method if other than guideline" for details)
Principles of method if other than guideline:
Due to the test material characteristics, the exact guideline text could not be followed; but the main objectives were met.
Because the test material is unstable in ultrapure water and the estimated water solubility is low (around 1 mg/L), an UV absorption method (using spectrophotometer) was used for the determination of the water solubility rapidly after mixing, to reduce the impact of degradation on the result.
GLP compliance:
yes (incl. QA statement)
Type of method:
other: UV absorption method
Specific details on test material used for the study:
No correction for purity of the test material was applied.
Key result
Water solubility:
> 1 - < 10 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
other: Information on pH not reported.
Details on results:
- Results of the Method Validation
Selectivity: No interfering component was observed.
Repeatability: RSD = 1.5 %
Linera range: 0.01 – 2 µg/mL
Limit of Quantification: 0.01 µg/mL
Recovery of the test material from ultrapure water (1 mg/L): 89 %
Precision in ultrapure water medium (1 mg/L): 1.3 %
Stability of the test material in ultrapure water (2 and 3 days, saturated solution), Recovery %: 67 and 50 % - therefore unstable.
Stability of the samples: At least 32 hours in the autosampler.
Stock solution stability at 5 ± 3 °C: Prepare fresh daily.

Main study results
The approximate water solubility was determined based on the above method.
In case of the reference solutions, clear solutions were detected in each case (before and after filtration). During the visual checking by a Tyndall beam laser, there were no remaining particles.
In case of the test material solutions, the laser beam was visible before filtration, indicating the test material was not totally dissolved. However, clear solutions were detected after filtration when checking by Tyndall beam, there were no remaining particles.
The recorded spectra of the formulations within 190 – 600 nm wavelength range showed that the water solubility was clearly a lot less than 10 mg/L and slightly higher than 1 mg/L.
Conclusions:
The water solubility of the test material was determined to be less than 10 mg/L and higher than 1 mg/L at approximately 20 °C using a UV absorption method.
Executive summary:

The water solublity of the test material was investigated under GLP conditions, using an UV absorption method.

Under the conditions of the study, the water solubility of the test material was determined to be less than 10 mg/L and higher than 1 mg/L at approximately 20 °C.

Description of key information

The water solublity of the test material was investigated under GLP conditions, using an UV absorption method.


 


Under the conditions of the study, the water solubility of the test material was determined to be less than 10 mg/L and higher than 1 mg/L at approximately 20 °C.

Key value for chemical safety assessment

Water solubility:
1 mg/L
at the temperature of:
20 °C

Additional information