Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1, 1992 - December 24, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD 105 (1981), EU Method A.6 (1984) and according to GLP principles. Limited information available to verify the composition of the used test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(1984)
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KY-MA
- Physical state: Light yellow solid
- Storage condition of test material: At room temperature in the dark

Results and discussion

Water solubility
Water solubility:
6 µg/L
Temp.:
20 °C
pH:
6
Remarks on result:
other: Mean of 2 experiments
Details on results:
- The test substance consists of 4 components. Only the concentration of 1 component in the waterphase was above the limit of detection; only the concentration of this component was used for the calculation of the water solubility of the substance (a reaction mass of several constituents).
- The chromatograms of the samples taken from the blank column at 20 degrees Celsius did not show any significant peaks with the same retention as the substance

Any other information on results incl. tables

Results of preliminary test 1

- The mean value of all measurements was 50 µg/L

- No significant differences were observed between the concentrations analysed after the 2nd and 3rd centrifugation step

Results of preliminary test 2

- The water solubility estimated from preliminary test 2 was 8 µg/L at 20 degrees Celsius

Results of the first experiment (Column 1)

Flowrate [mL/hour]

Sample no

Concentration [µg/L]

Mean at 1 flowrate [µg/L]

Mean [µg/L]

(MD)

pH

24

1

11.3*

5.8

 

(5%)**

5.8

(2%)

6.0

2

5.8

3

6.0

4

5.5

5

5.6

6

6.0

7

6.1

12

1

6.8*

5.7

 

(4%)**

6.0

2

12.3*

3

5.6

4

5.6

5

5.5

6

5.6

7

6.1

Results of the second experiment (Column 2)

Flowrate [mL/hour]

Sample no

Concentration [µg/L]

Mean at 1 flowrate [µg/L]

Mean [µg/L]

pH

24

1

6.6

6.7

 

(5%)**

6.3

(11%)

6.0

2

7.2

3

7.1

4

6.6

5

6.4

6

6.6

7

6.2

12

1

6.2

6.0

 

(6%)**

6.0

2

6.2

3

6.2

4

6.2

5

6.2

6

5.5

7

5.5

 

*Not used for the calculations

**Coefficient of variation

MD = maximum deviation

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
Using the column elution method the water solubility of the substance was determined in accordance with OECD 105 (1981), EU Method A.6 (1984) and according to GLP principles. The water solubility of the substance was determined to be 6 µg/L at 20 degrees Celsius.