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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:
From December 1 to 12, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. No deviation was reported. Test substance is adequately characterised with purity. Therefore full validation applies.
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Version / remarks:
1:1"Apr/I 2004
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Version / remarks:
Regulation (EC) No 440/2008
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss GLP compliance programme (inspected on November 15 and 16, 2006 / signed on March 29, 2007)
Type of method:
HPLC method
Partition coefficient type:
octanol-water
Specific details on test material used for the study:
Storage condition of test material: Refrigerator (between 0 and 10 °C under nitrogen)
Analytical method:
high-performance liquid chromatography
Key result
Type:
log Pow
Partition coefficient:
2.46
Temp.:
30 °C
pH:
6

Preliminary estimate

Approximate Pow: 2.19 x 103

Log10Pow estimate: 3.34

Definitive test

Regression parameters: log Pow = 3.1280 x log k + 2.2267 (r = 0.9909)

Table 4.7/1:Partition coefficient of sample

 

RT 1

RT 2

RT 3

RT 4

RT 5

Mean RT

STD

CV%

K

Log10K

Log10Pow

 

(min)

(min)

(min)

(min)

(min)

(min)

 

 

 

 

 

(To) Dead time

3.15

3.15

3.15

3.15

3.15

3.15

0.00

0.00%

0.01

-

-

ST 21 C 08

6.90

6.88

6.90

6.90

6.88

6.89

0.01

0.16%

1.188

0.075

2.46

 

RT = Retention time

Mean RT = = Mean retention time

STD = standard deviation

CV= coefficient of variation

Mean log10Pow: 2.46

Partition coefficient: 2.88 x 102

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 A8 guideline, HPLC method. The system was calibrated with 6 reference substances, and the result for the sample was interpolated from the linear regression.

Partition coefficient (log Pow) = 2.46 at 30°C.

Description of key information

The substance has low potential for bioaccumulation, according to Regulation (EC) No.1272/2008 (CLP) criteria for classification in aquatic chronic toxicity hazard class (log Kow <4).

It should also be of no concern for PBT assessment.

Key value for chemical safety assessment

Log Kow (Log Pow):
2.46
at the temperature of:
30 °C

Additional information

A fully reliable experimental study, conducted according to a recognized EC method (HPLC) and under GLP, is available. It is considered as a key study. The result is retained as key data.