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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:
29 January 2003 to 17 February 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed to GLP and in line with the standardised guidelines OECD 105, EU Method A.6 and EPA OPPTS 830.7840 with no deviations thought to impact the reliability of the presented results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Water solubility:
1.6 g/L
Temp.:
25 °C
pH:
>= 7.86 - <= 8.06
Details on results:
A comparison of the retention times of the test material in the reference solutions with those in the sample solutions indicated that the identity of the test material had not altered during the experiment.

Table 1: Results

Sample number

W1

W2

W5

W2

W4

W6

Amount of test item (g) dispersed in 12.5 mL of solvent

0.2273

0.2344

0.2147

0.2251

0.2195

0.2486

Number of days at 30.0 °C

3

2

1

3

2

1

Number of days at 25.0 °C

1

1

1

1

1

1

Centrifugation time (minutes)

40

40

40

40

40

40

Centrifugation speed (G value)

30000

30000

30000

50000

50000

50000

pH of aqueous solution

7.93

8.06

7.87

8.04

7.98

7.86

water solubility (g/L)

1st determination

1.651

1.721

1.565

1.683

1.558

1.532

2nd determination

1.663

1.724

1.586

1.690

1.573

1.536

average

1.657

1.723

1.576

1.687

1.566

1.534

average (g/L)

1.652

1.595

relative standard deviation (%)

4.02

4.53

final average (g/L)

1.6

final relative standard deviation (%)

4.5

Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
Under the conditions of the test, the solubility of the test material was determined, using the shake-flask method, to be 1.6 g/L in pure water at 25 ºC. The study is considered to be reliable, relevant and adequate for risk assessment purposes.
Executive summary:

The solubility of the test material was determined in accordance with the standardised guidelines OECD 105, EU Method A.6 and EPA OPPTS 830.7480 using the shake-flask method. The solutions were analysed using HPLC. Under the conditions of the test, the solubility of the test material was determined to be 1.6 g/L in pure water at 25 ºC.

Description of key information

1.6 g/L, 25 °C, OECD TG 105, EU Method A.6, Das 2003

Key value for chemical safety assessment

Water solubility:
1.6 g/L
at the temperature of:
25 °C

Additional information

The solubility of the test material was determined in accordance with the standardised guidelines OECD 105, EU Method A.6 and EPA OPPTS 830.7480 using the shake-flask method. The solutions were analysed using HPLC. Under the conditions of the test, the solubility of the test material was determined to be 1.6 g/L in pure water at 25 ºC. The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. The study was assigned a reliability score of Klimisch 1 and considered suitable for assessment as an accurate reflection of the test substance. The available data are considered complete and the result determined, 1.6 g/L at 25 °C, was taken forward for risk assessment.