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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:
20 November 1995 to 08 December 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with OECD & EU test guidelines in compliance with GLP.
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes
Type of method:
column elution method
Water solubility:
< 0.59 mg/L
Temp.:
20 °C
pH:
7
Details on results:
Based on information supplied by the sponsor the water solubility was expected to be very low. Therefore, the column elution method was chosen for the performance of the water solubility study.
The HPLC method supplied by the sponsor was not suitable for the analysis of ADK STAB HP-10 in water (data not reported). In the chromatograms of the samples a lot of interfering peaks were observed with the same retention time as the test substance. Therefore, an UV/VIS spectrophotometric method was used for the analysis of ADK STAB HP-10 in water.

Extraction efficiency: No test substance was detected in the third extract of the sample which was extracted three times.
In the standard solution which was evaporated 98% of the original amount of test substance was found. Hence, no test substance was lost during the evaporation procedure.

Main study: The chromatograms of the samples taken from the blank column at 20.0 ± 0.5°C did not show a significant adsorbance between 260 and 280 nm.
The water solubility of the test substance was determined to be below the detection limit of column II.
In conclusion, the water solubility of ADK STAB HP-10 at 20.0 ± 0.5°C is <0.59 mg/l, using the column elution method.

Table 1 – Results of the water solubility of ADK STAB HP-10 at 20.0 ± 0.5°C (Column I)

Flow rate [ml/h]

Sample no

Concentration analysed [mg/l]

Mean1[g/l]

Mean2

[g/l]

pH

12

1

<0.71

<0.71

<0.71

7.3

2

<0.71

3

<0.71

4

<0.71

5

<0.71

6

<0.71

24

7

<0.71

<0.71

7.1

8

<0.71

9

<0.71

9

<0.71

11

<0.71

1Mean value of all concentrations analysed at one flow rate.

2Mean value of the water solubilities of both flow rates.

 

Table 2 – Results of the water solubility of ADK STAB HP-10 at 20.0 ± 0.5°C (Column II)

Flow rate [ml/h]

Sample no

Concentration analysed [mg/l]

Mean1[g/l]

(CV)

Mean2[g/l] (MD)

pH

12

12

<0.59

<0.59

<0.59

7.3

13

<0.59

14

<0.59

15

<0.59

16

<0.59

17

<0.59

24

18

<0.59

<0.59

6.7

19

<0.59

20

<0.59

21

<0.59

22

<0.59

1Mean value of all concentrations analysed at one flow rate.

2Mean value of the water solubilities of both flow rates.

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of ADK STAB HP-10 in distilled water at 20.0 ± 0.5°C is determined to be <0.59 mg/l, using the column elution method.
Executive summary:

The determination of the water solubility was based on the following guidelines:

OECD guideline for testing of chemicals no. 105: "Water solubility (column elution method - flask method)", Adopted May 12, 1981.

EEC Directive 92/69 EEC, Part A, Methods for the determination of physicochemical properties, A.6: "Water solubility". EEC Publication no. L383, December 1992.

 

The water solubility of ADK STAB HP-10 in distilled water at 20.0±0.5°C is determined to be <0.59 mg/l, using the column elution method.

Description of key information

Key value determined using EU Method A6 & OECD guideline 105.

Key value for chemical safety assessment

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

Additional information

The water solubility of ADK STAB HP-10 in distilled water at 20.0 ± 0.5°C is determined to be <0.59 mg/l, using the column elution method.