Phytosteryl Macadamiate

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-09-26 - 2001-01-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP-study was conducted according an internationally accepted guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

column elution method

Test material

Test material information

Constituent 1

Test material form:

other: solid

Details on test material:

Purity: 100%

Results and discussion

Water solubility

Water solubility:

0.8 mg/L

Temp.:

20 °C

pH:

7.1

Any other information on results incl. tables

Sample	Value	Cone.	Cone.	Calculated	Water	pH
No.	measured by	analysed	calculated	solubility with	solubility	value
	TOC[mg/l]	[mg/l]	[mg/l]	83 % C-content [mg/l]	mean [mg/l]
1	0.676	2.704	0.660	0.795		7.1
2	0.666	2.664	0.620	0.747		7.1
3	0.761	3.044	1.000	1.205		7.0
4	0.856*	3.424	1.380	1.663		7.0
5	0.652	2.608	0.564	0.680		7.1
6	0.741	2.964	0.920	1.108		7.1
7	0.674	2.696	0.652	0.786		7.0
8	6.562*	26.248	24.204	29.161		7.0
9	0.647	2.588	0.544	0.655		7.2
10	0.651	2.604	0.560	0.675		7.1
11	0.665	2.660	0.616	0.742	0.77	7.2
12	0.567	2.268	0.224	0.270	SD=±0.26	7.2

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of YOFCO MAS at 20 °C ± 0.5 °C was determined to be 0.8 mg/l ( ± 0.3 mg/l).

Executive summary:

The determination of the water solubility of YOFCO MAS was performed according to the EEC Directive 92/69, A.6 "Water Solubility" (1992) and the OECD guideline No. 105, "Water Solubility" (adopted July 27, 1995).

During the preliminary test the water solubility of YOFCO MAS at room temperature was estimated by a simplified fiask method to be about 1 mg/l. Therefore the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 ml/min) and five samples during the second run (0.26 ml/min), each with a sampling interval of one hour. Total elution time was 67.5 hours. The quantification was performed using a TOC analyser.

The amount of test item present was calculated based on the molecular formula and the carbon content of the test item. The measured results differ by about 30 %. The larger deviation than usual is caused by the analytical method used. The carbon measurement is very sensitive to contamination.

The water solubility of YOFCO MAS at 20 °C ± 0.5 °C was determined to be 0.8 mg/l ( ± 0.3 mg/l).