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Diss Factsheets

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-04-14 to 1999-04-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to EU test method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

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

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Reaktiv-Orange DYPR934

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
-6.1
Temp.:
20 °C
Details on results:
See below.

Any other information on results incl. tables

Determination of the saturation concentration of Reaktiv-Orange in n-octanol

For the determination of the n-octanol solubility four weighed portions (29.462 mg, 29.240 mg, 28.164 mg and 31.268 mg) of the test substance were added to 50 ml of n-octanol and stirred for 3 h at 20 °C.

Every solution was treated as follows:

One aliquot of about 8 mL were taken, centrifugated (15 min, 5000 rpm) and the centrifugates were filtered (Schleicher + Schüll 0.2 µm). 2 mL of n-octanol filtrates were extracted with 2 mL of distilled water, centrifugated (1 min, 5000 rpm) and the aqueous phase was investigated by HPLC.

Solubility in n-octanol:

Average 0.45 mg/L (corrected for purity of 56 %: 0.25 mg/L)

Standard deviation: 0.18 mg/L

The determination was performed as sum of both main components.

Final results:

Pow = 8.47 x 10-7

Log Pow = -6.07

Exp.

Stirring time (h)

Concentration

(mg/L)

Peak areas1)

Mean value

Peak areas1)

n-octanol solubility (mg/L)

Standard G1

 

1.2704

17.241

16.211

16.726

 

Exp.3

3

 

2.583

3.154

2.869

0.22

Standard H1

 

0.6588

8.419

7.886

8.153

 

Exp. 4

3

 

7.933

7.702

7.818

0.63

Standard I1

 

0.7376

8.288

12.035

10.162

 

Exp.5

3

 

5.133

5.839

5.486

0.40

Standard J1

 

0.7846

12.004

13.406

12.705

 

Exp.6

3

 

8.864

8.585

8.725

0.54

1)sum of main components

Applicant's summary and conclusion

Conclusions:
The n-octanol/ water partition coefficient of the test substance determined from its solubility in water and in n-octanol will be:
Log Pow = -6.07
Executive summary:

In a GLP compliant study the partition coefficient of Reactive-Orange DYPR 934 was determined from the ratio of the saturation concentrations of the test item in both n-octanol and water. The saturation of Reaktiv-Orange DYPR 934 in water was determined as to be 295.28 g/L (project EO 003 -99) while the determination of the saturation concentration of Reaktiv-Orange DYPR 934 in n-octanol was quantified by comparing integrated peak areas measured by injection of solutions with known amounts of the test substance (external standard method).

The n-octanol / water partition coefficient of the test substance determined from its solubility in water and in n-octanol will be:

Log Pow = -6.07