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Partition coefficient

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Reference
Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental dates: October 19, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognized method, and under GLP. No significant deviation was reported. The test substance is adequately characterised. Therefore full validation applies.
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Version / remarks:
2004
Deviations:
yes
Remarks:
injection of reference substances individually
Qualifier:
according to
Guideline:
other: EU Method A.24 (Partition Coefficient - HPLC Method)
Version / remarks:
Regulation (EC) No. 440/2008 and No. 2016/266
Deviations:
yes
Remarks:
injection of reference substances individually
Qualifier:
equivalent or similar to
Guideline:
EU Method A.8 (Partition Coefficient - HPLC Method)
Version / remarks:
Regulation (EC) No. 440/2008
Deviations:
yes
Remarks:
injection of reference substances individually
GLP compliance:
yes (incl. certificate)
Remarks:
inspected on 20 & 21 June 2017 / signed on 04 September 2017
Type of method:
HPLC method
Partition coefficient type:
octanol-water
Specific details on test material used for the study:
The sample was tested as received.
Analytical method:
high-performance liquid chromatography
Key result
Type:
log Pow
Partition coefficient:
2.8
Temp.:
25 °C
pH:
5.5

Preliminary estimation

The calculated logKow value was 3.1.

Main study

All measured substances were used for the calibration curve.

Regression parameters of first calibration:

log Kow = 2.506 + 2.785 x log k

r2 = 0.9812

log Kow of the test item – 1st injection = 2.8

Regression parameters of second calibration:

log Kow = 2.501 + 2.792 x log k

r2= 0.9811

log Kow of the test item – 2nd injection = 2.8

The duplicate determinations fulfill the repeatability criteria of ± 0.1 log unit.

Therefore the average partition coefficient of the test item was determined to be: log Kow = 2.8

According to the sponsor, the test item is expected to be rather stable at pH 5 (ca 90% left after 5 days at 40°C).

Conclusions:
The substance has low potential to bioaccumulate in the environment, according to CLP classification criteria for aquatic chronic toxicity (log Kow <4).
Executive summary:

The partition coefficient of the test substance was measured under GLP according to the OECD 117/EU A24 guideline, HPLC method.

The system was calibrated twice with 10 reference substances, and the results for the duplicate determinations of the sample were interpolated from each linear regression. The mean value, rounded for accuracy, was retained.

The partition coefficient (log Kow) was measured at 2.8 (at 25°C and pH 5.5).

Description of key information

The substance has low potential for bioaccumulation, according to CLP classification criteria for aquatic chronic toxicity (log Kow <4).

Key value for chemical safety assessment

Log Kow (Log Pow):
2.8
at the temperature of:
25 °C

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. The result is retained as key data