Glycerides, C16-22

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Feb. 15, 2010 to Mar. 31, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to standard guidelines in compliance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Type of method:

column elution method

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-22

EC Number:

268-083-8

EC Name:

Glycerides, C16-22

Cas Number:

68002-70-0

Molecular formula:

Triglyceride containing a glycerol backbone esterified to fatty acids with a chain length varying from C16 to C22

IUPAC Name:

Tri (C16-22 fatty acyl) glycerol

Details on test material:

- Name of test material (as cited in study report): Fully hydrogenated high erucic acid rapeseed oil (CAS N° 84681-71-0, EC N° 283-532-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-22’
- Physical state: Solid (white yellow)
- Expiration date of the lot/batch: July 8, 2010
- Storage condition of test material: In original container, at room temperature (10-30 °C), in the dark

Results and discussion

Water solubility

Water solubility:

< 6.2 mg/L

Temp.:

20 °C

pH:

>= 6.9 - <= 7.2

Remarks on result:

other: The water solubility was estimated to be below the limit of quantification of the analytical method

Details on results:

- Calibration range: 1 to 50 mg carbon/L pure water in the case of TC-calibration; 1 to 40 mg carbon/L pure water in the case of IC-calibration.
- Regression coefficient (r²): At least 0.999 in the case of TC; At least 0.998 in the case of IC.
- Typical calibration curve: y = 4.1007* x + 0.5893 in the case of TC; y = 4.0637* x – 1.7556 in the case of IC
- Limit of detection: LOD TC: 1.0446 mg carbon/L; LOD IC: 3.3632 mg carbon/L
- Limit of quantification: LOQ TC: 3.6606 mg carbon/L; LOQ IC: 11.3819 mg carbon/L
- LOQ TOC: 5 mg carbon/L
- Mean recovery in the fortified samples: 96 % (n = 9, RSD 1 %)

Any other information on results incl. tables

For more information on the results see table 1 - 2 and figure 1 - 2 under 'attached background material'.

Applicant's summary and conclusion

Conclusions:

The water solubility of fully hydrogenated high erucic acid rapeseed oil was estimated to be below the limit of quantification of the analytical method and was determined to be < 6.2 mg/L at 20 ± 2 °C.

Executive summary:

The water solubility of fully hydrogenated high erucic acid rapeseed oil was determined using the coloumn elution method according to OECD Guideline 105 and EU Method A.6.

The test flasks, containing carrier material loaded with fully hydrogenated high erucic acid rapeseed oil + tetrahydrofuran (which was later removed by rotary evaporator) were stored in darkness for for 3 d until the test was started. the carrier material was later pourd into a coloumn (togeather with the distilled water) which was connected to a pump. In the first experiment the coloumn flow was adjusted to 0.4 mL/min and in asecond and third experiment the flow rate was adjusted to 0.2 and 0.1 mL/min, respectively.

The saturation concentration was estimated using the TOC-method.

The water solubility of fully hydrogenated high erucic acid rapeseed oil at 20 ± 2 °C was estimated to be < 6.2 mg/L.