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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:
4 May 2017 to 5 May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
> 1 000 g/L
Conc. based on:
test mat.
Temp.:
21.4 °C
pH:
6
Details on results:
PRELIMINARY TEST RESULTS
- An aliquot of 0.5069 g of test material was dispensed and 0.50 mL of water was added. The test was done at room temperature (21.4 °C). The test material dissolved into a slightly cloudy solution. The resulting solution was pH 6.

DEFINITIVE TEST RESULTS
- No definitive test was required since the test material was completely soluble at 1000 g/L.

OBSERVATIONS
- The test material formed a slightly cloudy solution when combined with water at a ratio of 1000 g /L water. The cloudiness could be removed by syringe filtering the sample with a 0.2 μm cellulose acetate filter. A quantitative UV absorbance comparison was made between the filtered and unfiltered solutions by diluting both solutions in methanol (methanol:water 50:50), which fully dissolved the cloudiness of the unfiltered solution. Both were tested using a UV spectrophotometer at 196 nm. The absorbances of the filtered and non-filtered solutions differed by less than 3 %. The solution was still cloudy at the 500 g/L level indicating there is an impurity present in the test material that does not dissolve at greater 500 g/L. This confirmed that the test material was fully soluble at 1000 g/L, with the solids confirmed as an insoluble impurity. No chemical instability was observed during the test.

- The test material had a water solubility of greater than 1000 g/ L at 21.4 °C as determined by OECD Test No. 105.
Conclusions:
Under the conditions of this study, the test material had a water solubility of greater than 1000 g/ L at 21.4 °C.
Executive summary:

The water solubility of the test material was investigated in accordance with the standardised guideline OECD 105, under GLP conditions.

The test material formed a slightly cloudy solution when combined with water at a ratio of 1000 g /L water. The cloudiness could be removed by syringe filtering the sample with a 0.2 μm cellulose acetate filter. A quantitative UV absorbance comparison was made between the filtered and unfiltered solutions by diluting both solutions in methanol (methanol:water 50:50), which fully dissolved the cloudiness of the unfiltered solution. The absorbances of the filtered and non-filtered solutions differed by less than 3 %. The solution was still cloudy at the 500 g/L level indicating there is an impurity present in the test material that does not dissolve at greater 500 g/L.

Under the conditions of this study, the test material had a water solubility of greater than 1000 g/ L at 21.4 °C.

Description of key information

Under the conditions of the study, the test material had a water solubility of greater than 1000 g/ L at 21.4 °C.

Key value for chemical safety assessment

Water solubility:
1 000 g/L
at the temperature of:
21.4 °C

Additional information

The water solubility of the test material was investigated in accordance with the standardised guideline OECD 105, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The test material formed a slightly cloudy solution when combined with water at a ratio of 1000 g /L water. The cloudiness could be removed by syringe filtering the sample with a 0.2 μm cellulose acetate filter. A quantitative UV absorbance comparison was made between the filtered and unfiltered solutions by diluting both solutions in methanol (methanol:water 50:50), which fully dissolved the cloudiness of the unfiltered solution. The absorbances of the filtered and non-filtered solutions differed by less than 3%. The solution was still cloudy at the 500 g/L level indicating there is an impurity present in the test material that does not dissolve at greater 500 g/L.

Under the conditions of this study, the test material had a water solubility of greater than 1000 g/ L at 21.4°C.