Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 May 2011 to 12 May 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:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
Deviations:
no
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
Details on test material:
Name: Reactive Red F08-0146

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
< -4.4
Remarks on result:
other: pH and temp not specified
Details on results:
Analysis of the two-phase system
Measured concentrations in both phases of the test vessels are provided in Table 1 below. Reactive Red F08-0146 was not detected in the n-octanol phase; therefore less than the LOQ given in Table 1 below. The calculated Pow values are summarised in Table 2 below.

Any other information on results incl. tables

Table 1: Measured concentrations

Ratio of solvents
(n-Octanol: Water)

Measured concentration of

Reactive Red F08-0146in

n-octanol phase

(µg/ml)

Measured concentration of

Reactive Red F08-0146in

water phase

(µg/ml)

pH

1:1

< 0.25*
< 0.25

7250
7331

4.69

< 0.25
< 0.25

7308
7280

4.68

< 0.25
< 0.25

7226
7357

4.62

Mean (C)

< 0.25

7292

4.66

RSD%

-

1

-

Meas. test item (M)

< 6.25 µg

182 mg

-

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

182 mg

Recovery:

98 %

2:1

< 0.25*
< 0.25

11269
11372

4.50

< 0.25
< 0.25

10965
11115

4.50

< 0.25
< 0.25

11194
11215

4.47

Mean (C)

< 0.25

11188

4.49

RSD%

-

1

-

Meas. test item (M)

< 8.4 µg

185 mg

-

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

185 mg

Recovery:

99 %

*   Corresponds to the LOQ after the extraction

Table 1.: Measured concentrations (continued)

Ratio of solvents
(n-Octanol: Water)

Measured concentration of

Reactive Red F08-0146in

n-octanol phase

(µg/ml)

Measured concentration of

Reactive Red F08-0146in

water phase

(µg/ml)

pH

1:2

< 0.25*
< 0.25

5510
5563

4.68

< 0.25
< 0.25

5615
5627

4.67

< 0.25
< 0.25

5469
5519

4.67

Mean (C)

< 0.25

5550

4.67

RSD%

-

1

-

Meas. test item (M)

< 4.1 µg

186 mg

-

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

186 mg

Recovery:

100 %

*   Corresponds to the LOQ after the extraction

 

Table 2.: Calculated partition coefficient (Pow) and log Pow

Ratio of solvents
(n-Octanol: Water)

Partition coefficient

Log Partition coefficient

Pow

Log Pow

1:1

< 0.000034

< -4.5

2:1

< 0.000022

< -4.7

1:2

< 0.000045

< -4.4

Applicant's summary and conclusion

Conclusions:
In conclusion, the partition coefficient (Pow) of Reactive Red F08-0146 in a n octanol - water two-phase system was determined to be less than 4.5 * 10-5 using shake flask method. The log Pow is < -4.4.
Executive summary:

This study has been performed in accordance with the study plan, EU and OECD test guidance and the Principles of Good Laboratory Practice .

Summary of the results:

Partition coefficient (Pow) ofReactive Red F08-0146was determined using the shake-flask method:

Pow:< 4.5 *10-5

log Pow: < -4.4