Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 February 2018 to 10 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
27 July 1995
Deviations:
no
Principles of method if other than guideline:
See method validation in "Any other information".
GLP compliance:
yes (incl. certificate)
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Details on test material:
Appearance: Straw to yellow syrup
Purity/Composition: Not indicated
Test item storage: At room temperature

Additional information
Test Facility test item number: 209099/A
Purity/Composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Specific details on test material used for the study:
Appearance: Straw to yellow syrup
Purity/Composition: Not indicated
Test item storage: At room temperature

Additional information
Test Facility test item number: 209099/A
Purity/Composition correction factor: No correction factor required
Test item handling: No specific handling conditions required

Results and discussion

Water solubility
Key result
Water solubility:
> 0.097 - < 0.11 mg/L
Conc. based on:
test mat.
Incubation duration:
ca. 168 h
Temp.:
293 K
pH:
> 5.8 - < 8.1

Any other information on results incl. tables

Preliminary test

The content of test item dissolved in the water sample was 2.53 mg/L.

Main study

The results for the samples at low nominal level taken at 24, 48, 72, 12, 144 and 168 hours are given in the first table below. The results for the samples at high nominal level taken at 24, 48, 72, 12, 144 and 168 hours are given in the second table below.

The maximum difference of the concentrations determined in the 24, 48 and 72 hour test samples was > 15%, and showed increase in the analysed concentration. Based on this, it was decided to prolong the stirring time for 96 hours. The maximum difference of the concentrations determined in the 120, 144 and 168 hour test samples was > 15%, due to decrease in concentration after 120 h. Based on this, the water solubility of the test item was given as the mean value of the 48- and 72-hour measurements.

No test item was detected in the pretreated sample from the blank water mixture.


Main study - water solubility of the test item at low nominal level

Stirring time [hours]

Analyzed concentration [g/L]

Mean [g/L]

Maximum difference [%]

pH

 

 

 

 

 

24

0.0000667

0.0000868

43

5.8

 

 

 

 

 

48

0.0000904

0.00009691

131

6.0

 

 

 

 

 

72

0.000103

 

 

6.0

 

 

 

 

 

120

0.000177

0.000139

42

8.1

 

 

 

 

 

144

0.000126

 

 

8.1

 

 

 

 

 

168

0.000115

 

 

8.1

 

 

 

 

 

1            the water solubility of the test item was given as the mean value of the 48- and 72-hour measurements.

  
Main study - water solubility of the test item at high nominal level

Stirring time [hours]

Analyzed concentration [g/L]

Mean [g/L]

Maximum difference [%]

pH

 

 

 

 

 

24

0.000106

0.000109

26

6.0

 

 

 

 

 

48

0.0000961

0.0001101

261

6.0

 

 

 

 

 

72

0.000125

 

 

6.1

 

 

 

 

 

120

0.000325

0.000213

70

8.1

 

 

 

 

 

144

0.000158

 

 

8.1

 

 

 

 

 

168

0.000156

 

 

8.1

 

 

 

 

 

1            the water solubility of the test item was given as the mean value of the 48- and 72-hour measurements.

Applicant's summary and conclusion

Conclusions:
The water solubility of the test substance was found to be in the range 0.0969 – 0.110 mg/L at 20 °C, under the conditions of the test.
The pH of the aqueous samples was 5.8 – 8.1.
Executive summary:

In this guideline (OECD 105) study, conducted with GLP certification, the water solubility of the test substance was found to be in the range 0.0969 – 0.110 mg/L at 20 °C, under the conditions of the test.

The pH of the aqueous samples was 5.8 – 8.1.