Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt

Partition coefficient

Link to relevant study record(s)

Reference

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.04.2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study is required by REACH regulation 1907/2006

Qualifier:

according to guideline

Guideline:

OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)

Version / remarks:

OECD Guidelines for the Testing of Chemicals, Method No. 117, adopted 13. April 2004: “Partition Coefficient (n-octanol/water), High Performance Liquid Chromatog-raphy (HPLC) Method

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Method A.24 “Partition Coefficient (N-OCTANOL/WATER), HIGH PERFORMANCELIQUID CHROMATOGRAPHY (HPLC) METHOD

Version / remarks:

Commission Regulation (EU) 2016/266 of adopted 7 December 2015 amending Regu-lation EC No. 440/2008, Method A.24 “Partition Coefficient (N-OCTANOL/WATER), HIGH PERFORMANCELIQUID CHROMATOGRAPHY (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: Batch no: NA 2253
- Expiration date of the lot/batch:June 2019
- Purity test date: June 2016

Analytical method:

high-performance liquid chromatography

Key result

Type:

log Pow

Partition coefficient:

< 0.3

Temp.:

25 °C

pH:

ca. 5

Remarks on result:

other: based on conclusion

Details on results:

The test item consists of two peaks, which lie within the dead time of the method and not within the range of log POWs of the reference items. Therefore, the corresponding log POWs is stated as < 0.3 for peaks 1 and 2. It is thus concluded that the test item has a log POW of < 0.3.

Conclusions:

It is concluded that the test item has a log P O/W of < 0.3.

Executive summary:

The aim of the study was to determine the log P O/W of the test item using the HPLC method according to OECD 117, resp. EU A 24.

The study was performed using a HPLC with a C18 column. Six reference items with different retention times and thiourea for the determination of the dead time were used to produce a calibration curve, since retention time on hydrophobic columns and P_OWare correlated. The values obtained for the test item are the means ± standard deviations of three independent determinations The two peaks lie within the dead time of the method and not within the range of log P_OWs of the reference items. Therefore, the corresponding log P_OWs are stated as < 0.3 (the log P_OWof the reference with the lowest log P_OW2-Butanone) for peaks 1 and 2. It is thus concluded that the test item has a log P_OWof< 0.3.

Description of key information

Log P O/W according to OECD 117, resp. EU A. 24 (HPLC method)

Additional information

The aim of the study was to determine the log P O/W of the test item using the HPLC method according to OECD 117, resp. EU A 24.

The study was performed using a HPLC with a C18 column. Six reference items with different retention times and thiourea for the determination of the dead time were used to produce a calibration curve, since retention time on hydrophobic columns and P_OWare correlated. The values obtained for the test item are the means ± standard deviations of three independent determinations The two peaks lie within the dead time of the method and not within the range of log P_OWs of the reference items. Therefore, the corresponding log P_OWs are stated as < 0.3 (the log P_OWof the reference with the lowest log P_OW2-Butanone) for peaks 1 and 2. It is thus concluded that the test item has a log P_OWof < 0.3.