Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Partition coefficient
Administrative data
Link to relevant study record(s)
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
- Analytical method:
- high-performance liquid chromatography
- Key result
- Type:
- log Pow
- Partition coefficient:
- < 0.3
- Temp.:
- 25 °C
- Remarks on result:
- other: No data on pH.
- Conclusions:
- The log Pow of the test substance was determined to be < 0.30.
- Executive summary:
The objective of the study was to determine the partition coefficient (log Pow) of the test substance according to OECD guideline 117 and EU method A.8 using the HPLC simulation method using isocratic elution with a mobile phase of acetonitrile/water, 60:40 v/v. The test substance eluted as a single component exhibiting a retention time corresponding to a log Pow value of <0.30. As a definitive value for the partition coefficient has not been determined the 95% confidence range cannot be estimated.
Reference
The test substance eluted as a single peak with a retention time less than that of the lowest standard and less than that for the formamide. Therefore, a definitive result cannot be estimated from the standard graph and the result has been stated as less than the log Powfor the lowest standard used (2-butanone, log Pow = 0.30). It was possible to establish the calibration line with seven different calibration compounds.
There were only minimal differences between the replicates of retention times for each of the calibration and test substances, and between the two injection sequences. The resultant calculated values differed only to a small extent, therefore the results may be considered as acceptable for regulatory purposes.
The partition coefficient of the test substance was successfully evaluated using the HPLC simulation technique, with a mobile phase of acetonitrile/water, 60:40 v/v. The test substance eluted as a single component exhibiting a retention time corresponding to a log Pow value of <0.30. As a definitive value for the partition coefficient has not been determined the 95% confidence range cannot be estimated.
Description of key information
Key study: OECD guideline 117 and EC method A.8. GLP study.
log Pow < 0.30 at 25 ºC
Key value for chemical safety assessment
- Log Kow (Log Pow):
- 0.3
- at the temperature of:
- 25 °C
Additional information
Key study: OECD guideline 117 and EC method A.8. GLP study.
log Pow < 0.30 at 25 ºC
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