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Physical & Chemical properties

Partition coefficient

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Reference
Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.8 (Partition Coefficient - HPLC Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
HPLC method
Partition coefficient type:
octanol-water
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SOAP005-2
- Expiration date of the lot/batch: 15 October 2022

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient, stored under nitrogen in a desiccator

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Following receipt of the test item, it was found that the material readily absorbed moisture in the parent container. Consequently, on advice from the Sponsor, a sub-sample was dried overnight at 100°C and then stored in a desiccator under a headspace of nitrogen.
Analytical method:
high-performance liquid chromatography
Type:
log Pow
Partition coefficient:
> 6.2
Temp.:
25 °C
Remarks on result:
not determinable because of methodological limitations
Remarks:
no significant components of the test item were detected thus it was assumed that the partition coefficient of the compound is greater than that of the longest eluting standard assessed (DDT) with a log10Pow value greater than 6.2.
Details on results:
No significant components of the test item were detected in the chromatogram.
Conclusions:
The test item was determined to have a log10Pow value greater than 6.2.
Executive summary:

A study to determine the partition coefficient of the test item, Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl) aminoacetate], was conducted according to the OECD 117 guideline (Dunning 2018). The experimental determination of the partition coefficient is not applicable to surface active materials; however, an attempt was made to assess the property by the HPLC method since often the retention time of a material can provide a good indication of the partition coefficient. The partition coefficient was determined by the HPLC method. Six reference compounds were selected to have log10 Pow values between 1 and 6.2. Solutions of the test item were prepared and chromatographed, bracketed by samples of the reference mixture.

 No significant components of the test item were detected in the chromatogram. Therefore, it was assumed that the partition coefficient of the compound is greater than that of the longest eluting standard assessed (DDT) with a log10 Pow value greater than 6.2.

 The partition coefficient of the test item was determined to be > 6.2.

 The study is GLP-compliant and was conducted according to the standard guideline, therefore is considered reliable without restrictions and suitable as a key study for this endpoint.

Description of key information

The partition coefficient of the test item was determined to be > 6.2.

Key value for chemical safety assessment

Additional information

A study to determine the partition coefficient of the test item, Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl) aminoacetate], was conducted according to the OECD 117 guideline (Dunning 2018). The partition coefficient was determined by the HPLC method.

 No significant components of the test item were detected in the chromatogram. Therefore it was assumed that the partition coefficient of the compound is greater than that of the longest eluting standard assessed (DDT) with a log10 Pow value greater than 6.2.

The study is GLP-compliant and was conducted according to the standard guideline, therefore is considered reliable without restrictions and suitable as a key study for this endpoint.