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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07.01.2019 - 21.01.2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was performed in compliance with the Principle of Good Laboratory Practice, confirmed by Statement of GLP Compliance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Principles of method if other than guideline:
No deviations from the guidelines were observed.
GLP compliance:
yes (incl. QA statement)
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
flask method

Test material

1
Reference substance name:
Rhatany, Krameria triandra, ext.
EC Number:
283-919-1
EC Name:
Rhatany, Krameria triandra, ext.
Cas Number:
84775-95-1
Molecular formula:
not available
IUPAC Name:
Rhatany, Krameria triandra, ext.
Test material form:
liquid: viscous
Specific details on test material used for the study:
Name Krameria triandra extract obtained from Rhatany root by hydroalcoholic extraction
Batch no. PES180014
Appearance reddish brown viscous substance
Composition Krameria triandra extract obtained from Rhatany root by hydroalcoholic extraction
CAS No. 84775-95-1
EINECS-No. 283-919-1
Molecular weight not applicable, UVCB
Purity not applicable, UVCB
Homogeneity inhomogenous (warm up to 60 °C and stir)
Production date Jan. 2018
Expiry date Jan. 2019
Storage Fridge (2 - 8 °C)

Results and discussion

Water solubility
Key result
Water solubility:
>= 35.5 - <= 258.1 mg/L
Conc. based on:
element
Loading of aqueous phase:
33 other: % w/w
Incubation duration:
ca. 24 h
Temp.:
20 °C
pH:
>= 5.09 - <= 5.58
Remarks on result:
other: 20°C +- 0.5 °C
Details on results:
As the solubility was dependent on the nominal concentration, no exact value for the sol-ubility of the test item in water can be stated.

Therefore, the concentration of the test item in water was stated in the range of

35.5– 258.1 mg/L at 20.0 ± 0.5 °C
35.5– 258.1 * 10-3 kg/m3 (SI units)

for the following nominal concentration range of the test item in water: 101 – 1004 mg/L, corresponding to a dissolved part of 33 % of the test item (mean value) relating to the nominal concentration of the test item.

Applicant's summary and conclusion

Conclusions:
The solubility of Krameria triandra extract obtained from Rhatany root by hydroalcoholic extraction in water was determined from the measured concentrations of DOC in the filtrated test solutions. The carbon content of the test item 50.51 % was used in the calculation of the test item concentration from the measured DOC concentration.
In the main test, six different loading rates in the range of 100 – 1000 mg/L were chosen in order to determine the dependency of the water solubility on the amount of the test item added. A dependency of the solubility on the amount of the test item (nominal load) was perceived in flasks 1 – 6. Therefore, no exact value for the solubility of the test item in water can be stated. The solubility range for the tested nominal concentration 101 – 1004 mg/L is 35.5 – 258.1 mg/L, corresponding to 33 % of the test item (mean value) relating to the nominal concentration of the test item.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.
Executive summary:

This study was performed in order to determine the water solubility of Krameria triandra extract obtained from Rhatany root by hydroalcoholic extractionvia measurement of DOC concentration per TOC analyser. The concentration of the test item was calculated from the DOC concentrations and the carbon content in the test item.

Determination of the water solubility of Krameria triandra extract obtained from Rhatany root by hydroalcoholic extractionwas performed as follows (flask method):

The quantity of test item necessary to saturate the desired volume of water was estimated from the preliminary test. As the measured solubility may be dependent on the amount of the test item which is added to the flasks, different loading rates were chosen to study the effect of loading rate on the measured water solubility. Measurements of three replicates were performed until equilibrium was reached. Then, all other replicates were sampled and analysed. The solubility range for the tested nominal concentration 101 – 1004 mg/L is 35.5 – 258.1 mg/L, corresponding to 33 % of the test item (mean value) relating to the nominal concentration of the test item.

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