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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
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
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
not specified
Type of method:
other: increasing volumes of water in a glass-stoppered measuring cylinder

Test material

1
Reference substance name:
Silybum marianum extract
Molecular formula:
Not applicable
IUPAC Name:
Silybum marianum extract
Test material form:
liquid
Details on test material:
The test matérial contains 0.5% of tocophérol for stability

Results and discussion

Water solubility
Key result
Remarks on result:
not determinable
Details on results:
The sample remains undissolved after addition of 10 and 100 ml of water and long time of contact (96h).
Thereafter, the experiment is continued by placing 0.1 gram of sample in 1000 ml of water. After 96h of shaking, the substance is still not dissolved (formation of small droplets of insoluble oil). This indicate that the solubility of sample is less than 0.1 g/L.
As this experimental procedure is not suitable, the solubility of each of the constituents of this UVCB substance was estimated by a calculation method based on the use of software, the Estimation Programs Interface (EPI) SuiteTM.

Any other information on results incl. tables

The calculated water solubility of individual fatty acid ethyl esters constituting the sample are summarized in the table below:

- Palmitic acid ethyl ester ( 628-97-7) : 0.00381 mg/L

- Stearic acid ethyl ester ( 111-61-5) : 0.00035 mg/L

- Oleic acid ethyl ester ( 111-62-6) : 0.00078 mg/L

- Linoleic acid ethyl ester ( 544-35-4) : 0.00171 mg/L

- Arachidic acid ethyl ester ( 18281-05-5) : 0.00003 mg/L

- Eicosenoic acid ethyl ester (ND) : 0.00007 mg/L

- Behenic acid ethyl ester ( 5908-87-2) : 0.000003 mg/L

- Myristic acid ethyl ester ( 124-06-1) : 0.04075 mg/L

- Lignoceric Acid Ethyl Ester ( 24634-95-5) : 0.0000004 mg/L

- Linoleic acid ethyl ester ( 544-35-4) : 0.0017 mg/L

The Values of water solubility calculated for the sample constituents range from 0.0000004 to 0.04075 mg/L.

Applicant's summary and conclusion

Conclusions:
The experimental method based on OECD Guideline 105 is not suitable and does not allow to the determination of the solubility of MILK THISTLE LIPOLAMI® ER. Nevertheless, this method has allowed to estimate that the solubility of the sample is less than 0.1 g/L.
The solubility of each constituents of this UVCB substance was estimated by a calculation method based on the use of software, the Estimation Programs Interface (EPI) SuiteTM. The Values of water solubility calculated for the sample constituents range from 0.0000004 to 0.04075 mg/L.
Executive summary:

The experimental method based on OECD Guideline 105 is not suitable and does not allow to the determination of the solubility of MILK THISTLE LIPOLAMI® ER. Nevertheless, this method has allowed to estimate that the solubility of the sample is less than 0.1 g/L.

The solubility of each constituents of this UVCB substance was estimated by a calculation method based on the use of software, the Estimation Programs Interface (EPI) SuiteTM. The Values of water solubility calculated for the sample constituents range from 0.0000004 to 0.04075 mg/L.