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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:
from 2017-11-08 to 2017-11-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
see 'Principles of method if other than guideline'
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
see 'Principles of method if other than guideline'
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
yes
Remarks:
see 'Principles of method if other than guideline'
Principles of method if other than guideline:
A miscibility test was carried out to evaluate the solubility of Test Item in water. This procedure deviates from the guideline but is considered scientifically valid.
GLP compliance:
yes (incl. QA statement)
Type of method:
other: miscibility test with visual inspection
Key result
pH:
>= 7.98 - <= 9.03
Remarks on result:
completely miscible

Table 1. Water solubility test

Test Item, (g)

Water, (g)

Observation

pH value

1.0073

9.01052

clear, homogeneous single-phase liquid

8.01

1.0080

9.00270

clear, homogeneous single-phase liquid

7.98

1.0055

1.00589

clear, homogeneous single-phase liquid

8.40

1.0283

1.00410

clear, homogeneous single-phase liquid

8.40

4.5197

0.50749

clear, homogeneous single-phase liquid

8.93

4.5121

0.50984

clear, homogeneous single-phase liquid

9.03

 

Conclusions:
The test item is miscible with water at room temperature.
Executive summary:

The water solubility was determined according to OECD 105, Regulation (EC) No. 440/2008 method A.6 and OPPTS 830.7840. In a preliminary test no saturated solution of the test item could be prepared, therefore, the standard methods for determination of the water solubility are technically not feasible. Therefore, the water solubility of the test item was determined using the miscibility test with visual detection. The test item was mixed with ultrapure water in rations 1 :1, 1 : 9 and 9 : 1. After sonication and vigorous shaking the solubility was visually detected. The pH of each sample was recorded. The the test substance was determined to be miscible with water at room temperature (pH 7.98 - 9.03).

Description of key information

The test item is miscible with water at room temperature. For further risk assessment a default maximum value of 100000 mg/L was used.

Key value for chemical safety assessment

Water solubility:
100 000 mg/L
at the temperature of:
20 °C

Additional information

The water solubility was determined according to OECD 105, Regulation (EC) No. 440/2008 method A.6 and OPPTS 830.7840. In a preliminary test no saturated solution of the test item could be prepared, therefore, the standard methods for determination of the water solubility are technically not feasible. Therefore, the water solubility of the test item was determined using the miscibility test with visual detection. The test item was mixed with ultrapure water in rations 1 :1, 1 : 9 and 9 : 1. After sonication and vigorous shaking the solubility was visually detected. The pH of each sample was recorded. The the test substance was determined to be miscible with water at room temperature (pH 7.98 - 9.03).

For further risk assessment a default maximum value of 100000 mg/L was used.