Registration Dossier

Administrative data

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.
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Jan - 21 Feb 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
column elution method
Water solubility:
< 5 µg/L
Temp.:
20 °C
pH:
6.3

Working range

The calibration curve fitted over a range from 2.3µg/L and 115.4µg/L with r² = 1.000. A quadratic fit was used.

 

Recovery

In the course of the recovery experiment, an average recovery rate of 82.2% 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

2.78

 

2 (3-4)

25

2.03*

 

3 (5-6)

25

0.00*

 

4 (7-8)

25

2.36*

 

5 (9-10)

25

2.09*

 

6 (11-12)

25

3.12

 

7 (13-14)

25

2.11*

 

8 (15-16)

25

2.62

 

 

 

 

12.5

1 (1-2)

25

2.16*

 

2 (3-4)

25

1.86*

 

3 (5-6)

25

2.32

 

4 (7-8)

25

2.64

 

5 (9-10)

25

1.68*

 

6 (11-12)

25

2.23*

 

7 (13-14)

25

1.71*

 

8 (15-16)

25

2.31*

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

 

The water solubility at both flow rates (25.0 mL/h and 12.5 mL/h) yielded values varying between not detectable (< 0.7 µg/L) and 3.1 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.

Data source

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

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Fatty acids, soya, iso-Pr esters
EC Number:
305-857-7
EC Name:
Fatty acids, soya, iso-Pr esters
Cas Number:
95193-46-7
Molecular formula:
not applicable, the substance is UVCB
IUPAC Name:
Fatty acids, soya, isopropyl esters

Results and discussion

Physical state at 20°C and 1013 hPa:
liquid
Form / colour / odour
Form:
liquid
Colour:
Yellow
Substance type:
organic

Applicant's summary and conclusion