acetalization product between glucose and C16-18(even numbered)- alcohol

Water solubility

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 26th 2019 to August 01st 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

OECD 105 guideline adapted with the OECD 123 guideline using the slow stirring method

Deviations:

yes

Remarks:

The flask method and column elution method described in the OECD 105 guideline were not be used in this study. To verify the specificity of the analytical method, twice an analysis of the matrix (ultra-pure water) instead of once.

GLP compliance:

yes (incl. QA statement)

Type of method:

other: The guideline OECD 105 was adapted by using a slow-stirring method described in guideline OECD 123 “Partition Coefficient (1-Octanol/Water): Slow-Stirring Method (23 March 2006).

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 18082014099
- Expiration date of the lot/batch: July 25, 2021
- Purity test date: > 99% dry matter

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (20 ± 5°C) and keep away from direct sunlight

Key result

Water solubility:

< 0.13 mg/L

Conc. based on:

test mat.

Incubation duration:

ca. 24 h

Temp.:

20 °C

pH:

>= 5 - <= 6

Conclusions:

The water solubility of the test item “Acetalization product between glucose and C16-18 (even numbered)-alcohol ” was determined to be lower than 0.13 mg/L.

Executive summary:

The aim of this study was to determine experimentally the water solubility on the test item ” Acetalization product between glucose and C16-18 (even numbered)-alcohol “ according to the OECD 105 guideline adapted with the OECD 123 guideline using the slow stirring method.

 

The study was carried out in accordance with the study plan No.19/1035Fa dated June 13, 2019

There was one deviation and no amendment during this study.

The results of this study are summarized below:

 

Two independent experiments and blank vessel were carried out. Concentration of the test item was regularly measured by GC/FID (Gas chromatography with Flame Ionization Detector).

  

The water solubility of the test item “Acetalization product between glucose and C16-18 (even numbered)-alcohol ” was determined to be lower than 0.13 mg/L.

Reference 2

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

01 February 2008 to 07 August 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

OECD Guideline No. 105 (1995)

Deviations:

no

Remarks:

-The sand was washed only one time with acetone instead of two times as described in the corresponding procedure.- The pH of the collected fraction after the column elution was not taken.Not considered to have affected the results quality/ interpretations

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:

column elution method

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. LCE07099
- Expiration date of the lot/batch:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in darkness at room temperature

Key result

Water solubility:

<= 1 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

10 mg/L

Incubation duration:

ca. 25 h

Temp.:

20 °C

Remarks on result:

other: pH was not mesured (See deviations)

Details on results:

The sand was washed only one time with acetone instead of two times as
described in the corresponding procedure.
- The pH of the collected fraction after the column elution was not taken.
These deviations were not considered to have affected the quality or the interpretation
of the results obtained.

Conclusions:

Interpretation of results: slightly soluble (0.1-100 mg/L)
Water solubility was determined to be equal or lower than 1 mg/l according to the OECD guideline n°105

Executive summary:

As the preliminary test showed a hydrosolubility lower than 10 mg/L, the column elution

method was taken to determine the hydrosolubility of the test item.

The alcohols (C16 and C18), the main substances of the test item were analysed as silyl

derivatives by gas chromatography using a FID detector.

The limit of quantification of the alcohols was 1 mg/L.

The analysis of the alcohols in the fractions obtained at elution flow rates of 12.5 and

25 mL/h showed that the hydrosolubility of the alcohols is lower than 1.0 mg/L.

The hydrosolubility of the test item is equal or lower than 1 mg/L.

Description of key information

In compliance with Commission Directive 92/69/EEC - A6 method (1992) OECD Guideline No. 105 (1995) a solubility test was performed to assess the hydrosolubility of the test item.

As the preliminary test showed a hydrosolubility lower than 10 mg/L, the column elution method was used to determine the hydrosolubility of the test item.

The alcohols (C20 and C22), the main substances of the test item were analysed as silyl

derivatives by gas chromatography using a FID detector. The limit of quantification of the alcohols was 0.5 mg/L.

The analysis of the alcohols in the fractions obtained at elution flow rates of 12.5 and

25 mL/h showed that the hydrosolubility of the alcohols is lower than 0.5 mg/L.

In conclusion the hydrosolubility of the test item was determined to be equal or lower than 1 mg/L.

In order to refine the water solubility of the test item, a second solubility test was performed according to OECD 105 guideline adapted with the OECD 123 using the slow stirring method in order to improve the limits of quantification and detection of the test item. Two independent experiments and blank vessel were carried out. Concentration of the test item was regularly measured by GC/FID (Gas chromatography with Flame Ionization Detector).

  

The water solubility of the test item “Acetalization product between glucose and C16-18 (even numbered)-alcohol ” was determined to be lower than 0.13 mg/L.

Key value for chemical safety assessment

Water solubility:

0.13 mg/L

at the temperature of:

20 °C