Registration Dossier
Registration Dossier
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EC number: 284-510-0 | CAS number: 84929-26-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Commiphora myrrha, Burseraceae.
Partition coefficient
Administrative data
Link to relevant study record(s)
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 05 2017 - October 09 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted according to an internationally recognised method, and under GLP. The test substance is adequately characterised. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient - HPLC Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7570 (Partition Coefficient, n-octanol / H2O, Estimation by Liquid Chromatography)
- Version / remarks:
- 1996
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on June 22, August 9 and 04-06 october 2016/ Signed on 13 March 2017
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
- Analytical method:
- high-performance liquid chromatography
- Type:
- log Pow
- Partition coefficient:
- ca. 4.7
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 1
- Type:
- log Pow
- Partition coefficient:
- ca. 4.9
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 2
- Type:
- log Pow
- Partition coefficient:
- ca. 5.3
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 3
- Type:
- log Pow
- Partition coefficient:
- ca. 5.7
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 4
- Type:
- log Pow
- Partition coefficient:
- ca. 5.8
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 5
- Type:
- log Pow
- Partition coefficient:
- ca. 5.9
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 6
- Type:
- log Pow
- Partition coefficient:
- ca. 5.9
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 7
- Type:
- log Pow
- Partition coefficient:
- ca. 7.3
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 8
- Type:
- log Pow
- Partition coefficient:
- ca. 7.3
- Temp.:
- 25 °C
- Remarks on result:
- other: signal 9
- Conclusions:
- The logarithmic partition coefficient (n-octanol/water) of the test item was calculated at each signal. 9 Signal of the test item were determined. The results were determined to be log Pow between 4.7 and 7.3 at 25 °C using the HPLC method.
- Executive summary:
The study was performed in order to determine the partition coefficient n-Octanol/Water of test item according to OCED 117 guideline, using the HPLC.
To calculate the linear regression eight chemicals for which log Pow has been reported were chosen from the list stated in the OECD 117 guideline. They were used to calibrate the elution time in units of log Pow
The partition coefficient was determined based on a calibration curve using 8 reference items.
The logarithmic partition coefficient (n-octanol/water) of the test item was calculated at each signal. 9 Signal of the test item were determined. The results were determined to be log Pow between 4.7 and 7.3 at 25 °C using the HPLC method.
Reference
To calculate the linear regression eight chemicals for which log Pow has been reported were chosen from the list stated in the OECD 117 guideline. They were used to calibrate the elution time in units of log Pow. The linear regression calculated fulfilled all quality criteria as given in the guideline.
Regression Coefficient (r): 0.9807.
The partition coefficient was determined based on a calibration curve using 8 reference items.
The logarithmic partition coefficient (n-octanol/water) of the test item was calculated at each signal. 9 Signal of the test item were determined. The results were determined to be log Pow between 4.7 and 7.3 at 25°C using the HPLC method.
Description of key information
The partition coefficient of test item was determined to be between 4.7 - 7.3 at 25°C.
Key value for chemical safety assessment
Additional information
A fully reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. It is considered as a key study.
To calculate the linear regression eight chemicals for which log Pow has been reported were chosen from the list stated in the OECD 117 guideline. They were used to calibrate the elution time in units of log Pow
The partition coefficient was determined based on a calibration curve using 8 reference items.
The logarithmic partition coefficient (n-octanol/water) of the test item was calculated at each signal. 9 Signal of the test item were determined. The results were determined to be log Pow between 4.7 and 7.3 at 25 °C.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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