Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 December 2008 - 17 February 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid (not specified)
Details on test material:
Description: dark brown liquid
Storage conditions: room temperature, in the dark

Study design

Analytical method:
other: AAS (Atomic Absorption Spectroscopy)

Results and discussion

Partition coefficientopen allclose all
Type:
Pow
Partition coefficient:
< 0.013
Temp.:
20.5 °C
pH:
5.1
Type:
log Pow
Partition coefficient:
< -1.88
Temp.:
20.5
pH:
5.1

Any other information on results incl. tables

Table 2: Mean Absorbances for the Standard, Stock and Sample Solutions - Organic Phase

Solution

Mean Absorbance

Standard 0.00 mg/L

Standard 10.0 mg/L

Standard 30.0 mg/L

Standard 50.0 mg/L

Standard 100 mg/L

Standard 150 mg/L

Organic phase matrix blank

Sample 1

Sample 2

Sample 3

Sample 4

Sample 5

Sample 6

0.0013

0.0039

0.0071

0.0094

0.0130

0.0151

0.0019

0.0019

0.0015

0.0017

0.0017

0.0017

0.0021

 

Table 3: Mean Absorbances for the Standard, Stock and Sample Solutions - Aqueous Phase

Solution

Mean Absorbance

Standard 0.00 mg/L

Standard 10.0 mg/L

Standard 30.0 mg/L

Standard 50.0 mg/L

Standard 100 mg/L

Standard 150 mg/L

Aqueous phase matrix blank

Sample 1

Sample 2

Sample 3

Sample 4

Sample 5

Sample 6

Stock solution A

Stock solution B

0.0025

0.0060

0.0093

0.0121

0.0151

0.0177

0.0064

0.0163

0.0163

0.0156

0.0166

0.0167

0.0164

0.0162

0.0171

 

The total weights (mg) and analysed concentration (mg/L) of the respective phases are shown in the following table. The aqueous phase concentrations were corrected for the minor blank response obtained prior to any further calculations.

 

Table 4: The Total Weights (mg) and Analysed Concentration (mg/L)

Sample Number

Total Weight

(mg)*

Organic Phase

Aqueous Phase

Analysed Concentration (mg/L)

Weight

(mg)

Analysed Concentration (mg/L)

Weight

(mg)

pH

1

1050

<100

<22.0

8650

951

5.1

1

1100

<100

<23.0

8650

994

5.1

3

1620

<100

<17.0

7520

1280

5.1

4

1860

<100

<19.5

9240

1800

5.1

5

2580

<100

<13.5

9470

2560

5.1

6

2580

<100

<13.5

8830

2390

5.0

pH of stock solution: 5.0

Temperature: 20.5 ± 0.5 °C

*From analysis of the stock solution

From analysis of the respective phase

 

Table 5: The Partition Coefficient Determined For Each Sample

Sample

Number

Organic/Aqueous Volume Ratio

Partition Coefficient

Log Pow

1

2

2:1

<0.0116

<0.0116

<-1.94

<-1.94

3

4

1:1

 

<0.0133

<0.0108

<-1.88

<-1.97

5

6

1:2

<0.0106

<0.0113

<-1.98

<-1.95

Overall Pow: <0.0133        Log Pow: <-1.88

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test material has been determined to be <0.0133, Log Pow <-1.88 at 20.5 ± 0.5 °C, monitoring the metal content of the test material. The test substance is therefore not considered likely to bioaccumulate in the environment.
Executive summary:

The partition coefficient of the test material in n-octanol and water was determined in accordance with the standardised guideline EU Method A.8 using the shake-flask method.

The partition coefficient of the test material has been determined to be <0.0133, Log Pow <-1.88 at 20.5 ± 0.5 °C, monitoring the metal content of the test material using atomic absorption spectroscopy. The test substance is therefore not considered likely to bioaccumulate in the environment.