Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester

Hydrolysis

Administrative data

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2015-04-01 - 2015-04-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester

EC Number:

946-364-2

Molecular formula:

C43H78O8

IUPAC Name:

Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester

Test material form:

liquid

Details on test material:

- State of aggregation: yellow liquid
-Others: storage at room temperature, in the dark

Study design

Details on sampling:

Not applicable

Buffers:

Not applicable

Estimation method (if used):

Not applicable

Details on test conditions:

Not applicable

Results and discussion

Preliminary study:

Not applicable

Any other information on results incl. tables

Testing was not carried out using Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 for the following reasons:

• The test item as a whole was expected to be essentially insoluble in water. Therefore, the test solution concentration required, which would need to be less than half the water solubility, that would dissolve all the components, would be impractically low in order to perform the test. Also, a sufficiently sensitive analytical method was not available. Overall, these issues would make hydrolysis testing unfeasible.

• The test item is a complex mixture which the test method is not ideally suited to because each component that is unstable is likely to have its own hydrolytic rate. Also, if hydrolysis occurred many components would by hydrolyzed into the same structure as other components already present within the test item. It would then not be possible to distinguish between the original components and the hydrolysis product. The main functional groups within the components of the test item were ethers and esters. Ethers do not usually hydrolyze within environmentally relevant pH and temperature. Although esters can hydrolyze, especially in alkaline conditions, the test item components are considered to have a significantly reduced hydrolytic rate due to them being essentially insoluble in water. This is especially the case with the larger products that would be highly hydrophobic. The smaller products may be more susceptible to hydrolysis as they would have the potential to emulsify in water.

Applicant's summary and conclusion

Conclusions:

Method technically not feasible

Executive summary:

Testing was not carried out using Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 for the following reasons:

• The test item as a whole was expected to be essentially insoluble in water. Therefore, the test solution concentration required, which would need to be less than half the water solubility, that would dissolve all the components, would be impractically low in order to perform the test. Also, a sufficiently sensitive analytical method was not available. Overall, these issues would make hydrolysis testing unfeasible.

• The test item is a complex mixture which the test method is not ideally suited to because each component that is unstable is likely to have its own hydrolytic rate. Also, if hydrolysis occurred many components would by hydrolyzed into the same structure as other components already present within the test item. It would then not be possible to distinguish between the original components and the hydrolysis product. The main functional groups within the components of the test item were ethers and esters. Ethers do not usually hydrolyze within environmentally relevant pH and temperature. Although esters can hydrolyze, especially in alkaline conditions, the test item components are considered to have a significantly reduced hydrolytic rate due to them being essentially insoluble in water. This is especially the case with the larger products that would be highly hydrophobic. The smaller products may be more susceptible to hydrolysis as they would have the potential to emulsify in water.