Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 Jan - 17 Jan 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)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
< 3 µg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.3

Any other information on results incl. tables

Study results

The concentrations of the test item in the different test solutions were calculated automatically using the equation of the calibration curve. The results for the duplicate analyses are listed in the following table:

Flow rate (mL/h)

Fraction No.

(combined aliquots)

Water Solubility [μg/L]

pH value

25.0

1 (11-12)

< 3

6.3

 

2 (13-14)

< 3

6.3

 

3 (15-16)

< 3

6.3

 

4 (17-18)

< 3

6.3

 

5 (19-20)

< 3

6.3

 

6 (21-22)

< 3

6.3

 

7 (23-24)

< 3

6.3

 

8 (25-26)

< 3

6.3

12.5

1 (11-12)

< 3

6.3

 

2 (13-14)

< 3

6.3

 

3 (15-16)

< 3

6.3

 

4 (17-18)

< 3

6.3

 

5 (19-20)

< 3

6.3

 

6 (21-22)

< 3

6.3

 

7 (23-24)

< 3

6.3

 

8 (25-26)

< 3

6.3

According the OECD 105, the water solubility at both flow rates yielded values below the limit of quantification (LOQ).

The water solubility of the test item was determined as < 3 μg/L.

The water solubility was determined at 20 °C. The pH value of the collected aqueous fractions was 6.3.

 

pH value of HPLC water: 6.3

Applicant's summary and conclusion