Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 22, 1992 - December 30, 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-ET
- Appearance: Light yellow solid
- Storage condition of test material: At room temperature in the dark

Results and discussion

Water solubility
Water solubility:
< 2 µg/L
Temp.:
20 °C
pH:
6
Details on results:
- In most of the chromatograms of the water samples from both the preliminary test and the main study, no significant test substance peaks were observed. Hence, the water solubility of all the constituents and impurities of KY-ET was determined to be below the limit of detection.
- Using the standard solutions from the quantitative analyses, the limit of detection was determined on each day of analysis
- The limit of detection was determined to be < 2 µg/L
- The chromatograms of the samples taken from the blank column at 20 degrees Celsius did not show any peak with the same retention as the substance

Any other information on results incl. tables

Results of preliminary test

- The water solubility estimated from the preliminary test was < 1 µg/L at 20 degrees Celsius

Results of the main test: first experiment (Column 1)

Flowrate [mL/hour]

Sample no

Concentration [µg/L]

Mean at 1 flowrate [µg/L]

Mean [µg/L]

pH

24

1

4*

< 2

< 2

6.0

2

< 2

3

 < 2

4

< 2

5

< 2

6

< 2

7

< 2

12

1

2*

< 2

6.0

2

< 2

3

< 2

4

< 2

5

< 2

6

< 2

7

< 2

Results of the main test: second experiment (Column 2)

Flowrate [mL/hour]

Sample no

Concentration [µg/L]

Mean at 1 flowrate [µg/L]

Mean [µg/L]

pH

24

1

< 2

< 2

< 2

6.0

2

< 2

3

< 2

4

< 2

5

< 2

6

< 2

7

< 2

12

1

2

< 2

6.0

2

< 2

3

< 2

4

< 2

5

< 2

6

< 2

7

< 2

 

*Not taken into account as the value is out of range

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 < 2 µg/L at 20 degrees Celsius.