Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 Jan - 09 Feb 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The appearance of the test item is described in a reliable study report on the physical-chemical properties of the substance. Since no guideline was followed and no details on the methods are given, the description is considered as reliable with restrictions.
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The description of the physical state of the substance was based on a visual inspection of the substance at room temperature and normal pressure.
GLP compliance:
no
Physical state at 20°C and 1013 hPa:
solid
Form:
solid
Colour:
Yellowish
Substance type:
organic

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)
Deviations:
no
GLP compliance:
no
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
< 5 µg/L
Temp.:
20 °C
pH:
6.3

Any other information on results incl. tables

Working range

The calibration curve fitted over a range from 2.5µg/L and 49.3µg/L with r² = 1.000. Quadratic fit was used.

 

Recovery

In the course of the recovery experiment, an average recovery rate of 91.9% was determined.

 

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.

Volume of combined fractions

[mL]

Test Item**

 

[μg/L]

25.0

1 (1-2)

25

2.39*

 

2 (3-4)

25

2.10*

 

3 (5-6)

25

1.17*

 

4 (7-8)

25

1.82*

 

5 (9-10)

25

1.87*

 

6 (11-12)

25

2.59

 

7 (13-14)

25

0.96*

 

8 (15-16)

25

1.16*

 

 

 

 

12.5

1 (1-2)

25

1.53*

 

2 (3-4)

25

1.87*

 

3 (5-6)

25

2.11*

 

4 (7-8)

25

2.51

 

5 (9-10)

25

1.48*

 

6 (11-12)

25

2.01*

 

7 (13-14)

25

2.52

 

8 (15-16)

25

1.95*

* below LOQ, but it was decided to give the values.

** values of the main component (Octadecanoic acid, octyl ester).

 

The water solubility at both flow rates (25.0 mL/h and 12.5 mL/h) yielded values varying between 1.0 µg/L and 2.6 µg/L. The following value for water solubility of the test item can thus be reported as: < 5 µg/L

 

The water solubility was determined at 20 °C.

The pH value of the collected aqueous fractions was 6.3.

Applicant's summary and conclusion