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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:
23 April 2002 to 27 April 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
yes
Remarks:
Due to the test item properties it was impossible to load the test item to a carrier material as demanded by the guidelines. Therefore the study was conducted with the flask method regardless to the supposed water solubility of < 10 mg/L..
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
1992
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
0.088 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
225.25 mg/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
7
Details on results:
The measured concentration in at least two of the last test vessels did not differ by more than 15% (actual = 12.0%) and the temperatures were kept constant within ± 0.5°C; all validity criteria were met.

The analytical system gave linear response in the range of 0.097 - 0.582 mg/L. The precision of the method was tested using 5 replicates at rates of 0.097 and 0.582 mg/L. The coefficient of variation was 2.5% at 0.097 mg/L and 1.2% at 0.582 mg/L. The peak symmetry of the active ingredient was 1.0. Recovery was tested using a fortified sample at 0.097 mg/L. The coefficient of variation (n=5) was 7.5%. The limit of detection (LOD) was 0.047 mg/L and the limit of quantification (LOQ) was 0.070 mg/L.

Table 1. Solubility results

 Sample  Test item concentration (mg/L)  Measured pH value
 24 h  < LOQ  7.02
 48 h  0.093  7.00
 72 h  0.083  7.01
 Mean (1)  0.088  -
 Deviation (%)  12.0  -

(1) Mean value of the 48 and 72 h sample

LOQ = 0.070 mg test item/L

Conclusions:
The water solubility was determined to be 0.088 mg/L at 20°C and pH 7.0.
Executive summary:

The water solubility was tested according to OECD TG 105. This study is assigned a reliability of 1 (reliable without restrictions) as it followed an accepted guideline and was GLP-compliant. The water solubility was determined to be 0.088 mg/L at 20°C and pH 7.0.

Description of key information

The water solubility was determined to be 0.088 mg/L at 20°C and pH 7.0.

Key value for chemical safety assessment

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

Additional information

Water solubility was tested using the flask method according to OECD TG 105. This study is assigned a reliability score of 1 as it followed an accepted guideline and was GLP-compliant. The water solubility of the test item was determined to be 0.088 mg/L at 20°C and pH 7.0.

A supporting study is available using a common approach for preparation of ecotoxicological test media of poorly soluble test items (2017). The maximum solubility was achieved after 96 hours with 0.094 mg/L in ultrapure water at room temperature, as determined by the slow-stirring experiment. This value is nearly identical and also comparable to the water solubility of 0.088 mg/L according to OECD 105.

This solubility determination study is assigned a reliability of 2 (reliable with restrictions) as it is not GLP-compliant and did not follow a guideline. However the experimental design and results are adequate and well-reported.