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Diss Factsheets

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 14 February 2008 and 31 March 2008.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted 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 relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)). Date of inspection: 21/08/2007. Date of signature: 23/04/2008
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Constituent 1
Details on test material:
Sponsor's identification :Hatcol 1760
Description : clear colourless slightly viscous liquid
Purity : >99%
Date received : 04 February 2008
Storage conditions :room temperature, in the dark

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
> 6.5
Temp.:
30 °C
pH:
7.1

Any other information on results incl. tables

Preliminary estimate

Approximate solubility in n-octanol:>411 g/l
Approximate solubility in water:      <1.00 x 10-2g/l
Approximate Pow:  >4.11 x 104
Log10Pow:  >4.61

Definitive test

Calibration

The retention times of the deadtime and the retention times, capacity factors (k) and log10Powvalues for the reference standards are shown in the following tables:

Table9.2

Dead Time

Retention Time (mins)

Mean Retention Time (mins)

Injection 1

Injection 2

Thiourea

2.545

2.549

2.547

Table9.3

Standard

Retention Time (mins)

Mean Retention Time (mins)

Capacity Factor (k)

Log10k

Log10Pow

Injection 1

Injection 2

Benzene

4.951

4.952

4.952

0.944

-2.50 x 10-2

2.1

Toluene

6.017

6.017

6.017

1.36

0.134

2.7

Naphthalene

6.835

6.834

6.835

1.68

0.226

3.6

Phenanthrene

10.282

10.280

10.281

3.04

0.482

4.5

Triphenylamine

18.514

18.510

18.512

6.27

0.797

5.7

DDT

23.571

23.565

23.568

8.25

0.917

6.5

Partitin coefficient of sample

The retention times, capacity factors and log10Powvalues determined for the sample are shown in the following table:

Table9.4

Injection

Retention(mins)

Capacity Factor (k)

Log10k

Log10Pow

1

31.401 to 69.398

>8.25

>0.917

>6.50

2

31.418 to 69.398

>8.25

>0.917

>6.50

Overall mean log10Pow:>6.50
Overall partition coefficient:      >3.16 x 106

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test material has been determined to be greater than 3.16E+06, log10 Pow >6.50.
Executive summary:

Method

The determination was carried out using the HPLC Method, Method A8 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Result

The partition coefficient of the test material has been determined to be greater than 3.16 x 106, log10Pow>6.50.