Pentasodium 2-(bis{halo-[(halo- sulfonatoaryl)diazenyl]-2-(sulfonatoalkoxy)anilino}-triazin-ylamino)alkanesulfonate

Partition coefficient

Administrative data

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 February 2011 – 27 April 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to OECD and EC guidelines and in compliance with GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)

Version / remarks:

(1995)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.8 (Partition Coefficient)

Version / remarks:

(Official Journal of the European Union no. L142, May 31, 2008)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

shake-flask method to: flask method

Partition coefficient type:

octanol-water

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): E-Y110
- Test substance storage: At room temperature protected from light
- Stability under storage conditions: Stable
- Description: Orange powder
- Batch: MB-1
- Expiry date: 23 December 2015

Study design

Analytical method:

high-performance liquid chromatography

Results and discussion

Partition coefficient

Partition coefficient 1

Type:

Pow

Partition coefficient:

< 0.001

Temp.:

20 °C

pH:

7.1

Partition coefficient 2

Type:

log Pow

Partition coefficient:

< -3.3

Temp.:

20 °C

pH:

7.1

Details on results:

The log Pow values were within the criterion range of ± 0.3 log units.

A small peak was detected in the pretreated samples from the blank mixture. The maximum contribution to the samples was 1.6%.

Any other information on results incl. tables

The results of the shake flask method are given in the Table below:

Main study – P_owof the test substance

Ratio n-octanol : buffer pH 7  [v:v]	Analysed concentration		Pow	Log Pow	pH
	n-octanol [g/l]	buffer pH 7 [g/l]	individual
1:1    1:2     2:1	< 0.000585 < 0.000587   < 0.000580 < 0.000592   < 0.000582 < 0.000590	0.718 0.713   0.552 0.540 0.967 1.06	< 8.14 x 10^-4 < 8.24 x 10^-4   < 1.05 x 10^-3 < 1.10 x 10^-3   < 6.02 x 10^-4 < 5.58 x 10^-4	< -3.1 < -3.1   < -3.0 < -3.0   < -3.2 < -3.3	7.1 7.1   7.1 7.1   7.1 7.1

The results on the recoveries of the test substance in the test samples are given in the Table below. The analysed concentration of the stock solution was 2.04 g/l. Based on this the nominal quantity of the test substance in the test samples was 4.08 mg.

Recoveries

Ratio n-octanol : buffer pH 7   [v:v]	Analysed quantity			Recovery     [%]
	n-octanol [mg]	buffer pH 7 [mg]	Total [mg]
1:1     1:2     2:1	< 0.00351 < 0.00352   < 0.00232 < 0.00237   < 0.00465 < 0.00472	4.31 4.28   4.41 4.32   3.87 4.23	4.31 4.28   4.42 4.32   3.87 4.23	106 105   108 106   95 104

Applicant's summary and conclusion

Conclusions:

The shake flask method was applied for the determination of the partition coefficient (Pow) of E-Y110. The Pow value of the test substance at neutral pH and 20°C was < 5.58 10^-4, which corresponds with a log Pow value of < -3.3.