Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 March 2011 to 25 March 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to EU & OECD test guidance in compliance with GLP and reported with a valid GLP certificate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Constituent 1
Details on test material:
Name: Reactive Orange F08-0314

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
< -4.5
Temp.:
20 °C
pH:
> 4.59 - < 4.66
Details on results:
Reactive Orange F08-0314 was not detected in the n-octanol phase.

Any other information on results incl. tables

Measured concentrations

Ratio of solvents

(n-Octanol : Water)

Measured concentration of Reactive Orange F08-0314 in n-octanol phase(μg/ml)

Measured concentration of Reactive Orange F08-0314 in water phase(μg/ml)

pH

1:1

<0.13*

<0.13

5212

5404

4.66

<0.13

<0.13

5432

5614

4.64

<0.13

<0.13

5570

5516

4.64

Mean (C)

<0.13

5458

4.65

RSD%

-

3

-

Meas. Test item (M)

<3.2μg

136mg

-

Total quantity of test item (Mo+Mw) in the two-phase system:

136 mg

Recovery:

102%

2:1

<0.13*

<0.13

7687

7337

4.60

<0.13

<0.13

7952

8104

4.60

<0.13

<0.13

8062

8124

4.59

Mean (C)

<0.13

7878

4.60

RSD%

-

4

-

Meas. Test item (M)

<4.3μg

130mg

-

Total quantity of test item (Mo+Mw) in the two-phase system:

130mg

Recovery:

97%

1:2

<0.13*

<0.13

4217

4138

4.62

<0.13

<0.13

4022

4492

4.63

<0.13

<0.13

4091

4424

4.63

Mean (C)

<0.13

4233

4.63

RSD%

-

4

-

Meas. Test item (M)

<2.1μg

142mg

-

Total quantity of test item (Mo+Mw) in the two-phase system:

142mg

Recovery:

106%

* Corresponds to the LOQ after the extraction

 

Calculated partition coefficient (Pow) and Log Pow

Ratio of solvents

(n-Octanol : Water)

Partition coefficient

Log Partition coefficient

Pow

Log Pow

1:1

<0.000024

<-4.6

2:1

<0.000016

<-4.8

1:2

<0.000030

<-4.5

 

Applicant's summary and conclusion

Conclusions:
In conclusion, the partition coefficient (Pow) of Reactive Orange F08-0314 in an n octanol - water two-phase system was determined to be less than 3.0 *.10-5 using shake flask method.
The log Pow is less than -4.5. The substance is not considered to have the propensity to bioaccumulate.
Executive summary:

This study has been performed in accordance with the study plan, Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Guideline No. 107, "Partition Coefficient (n-octanol/water): Shake Flask Method", adopted July 27, 1995 and Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Annex, Part A, Methods for the determination of physico-chemical properties, A.8 "Partition Coefficient", EEC Publication No. L142. and the Principles of Good Laboratory Practice (GLP). The study is reported with a valid GLP certificate.

 

The objective of the study was to determine the partition coefficient of the test item. The partition coefficient is the ratio of equilibrium concentrations of a dissolved test item in a two-phase system consisting of two largely immiscible solvents.

 

Summary of the results:

Partition coefficient (Pow) of Reactive Orange F08-0314 was determined using the shake-flask method.

Pow < 3.0 * 10-5

log Pow < -4.5