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EC number: 952-608-9 | CAS number: -
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Octobre 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an internationally recognised method. No deviation was reported. Test substance is adequately specified. Therefore full validation applies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Version / remarks:
- Council Regulation (EC) No 2016/266 of 7. December 2015, Method A.24 “Partition Coefficient (n-
Octanol//Water), High Performance Liquid Chromatography (HPLC) Method - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UE A.24
- Version / remarks:
- Council Regulation (EC) No 2016/266 of 7. December 2015, Method A.24 “Partition Coefficient (n-
Octanol//Water), High Performance Liquid Chromatography (HPLC) Method - Deviations:
- no
- GLP compliance:
- no
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
Test material
- Reference substance name:
- Enzymatic hydrolyis products of Candida Saitoana
- EC Number:
- 952-608-9
- IUPAC Name:
- Enzymatic hydrolyis products of Candida Saitoana
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Yellow powder
- Storage In darkness at room temperature
- Batch: 19246
- Manufacturing date: September 2019
- Expiry date: September 2021
Constituent 1
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficient
- Key result
- Type:
- log Pow
- Partition coefficient:
- < 0.3
- Temp.:
- 20 °C
- pH:
- ca. 5
- Details on results:
- Due to the nature of the tests item which is an UVCB (substances of Unknown or Variable composition, Complex reaction products or Biological materials), a peak is measured between 1.35 and 1.84 minutes.
As the retention of the beginning of the peak was lower than the dead time and the retention time of the peak apex was equal to the dead time, the value of Log Pow was determined by using the regression equation on the Log k found thanks to the retention time of the end of the peak. If we consider that the linearity of calibration curve is still valid outside of the concentrations range used for calibration, the calculated < -0.51.
Even if the correlation coefficient r = 0.9862 is good, all measurements were lower than the retention time of the reference substance with the lowest partition coefficient (0.3) i.e.
2-butanone.
So, the partition coefficient n-octanol/water of the tests item is stated as lower than 0.3.
Applicant's summary and conclusion
- Conclusions:
- According to OECD method No. 117 and EU A.24, the partition coefficient n-octanol/water (Log Pow) of the test item is stated as lower than 0.3
- Executive summary:
A non-GLP study was conducted according to OECD 117 and EU. A.24 to determine the partition coefficient of the test item.
The study was performed using an HPLC/RI detector with a C18 column. Seven reference items with different retention times and uracil, for the determination of the dead time, were used to establish a calibration curve.
This calibration curve, log k versus log Pow, was obtained from the known Log Pow values (between 0.3 and 4) of the reference items as reported in the OECD117/EU-method A.24 and the capacity factor k, calculated from the retention time of the respective reference items and uracil. The calibration curve was validated considering the correlation coefficient higher than 0.9. All measurements showed that the substance was eluted at a retention time lower than the retention time of the reference substance with the lowest partition coefficient (0.3), i.e. 2-butanone. So, according to the OECD method 117/EU A.24, the partition coefficient n-octanol/water of the test item was stated as lower than 0.3.
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