Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 December 2008 to 10 March 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols with no deviations from standard test guidelines and/or minor methodological deficiences which do not affect the quality of the relevant results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
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 of test material (as cited in study report): INK BH11 M
- Substance type: dark red powder
- Lot/batch No.: MB-1A
- Storage condition of test material: room temperature in the dark

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficientopen allclose all
Type:
Pow
Partition coefficient:
< 0
Type:
log Pow
Partition coefficient:
< -4.35

Any other information on results incl. tables

The total weights (mg) and analysed concentration (mg/I) of the respective phases are shown in the following table:

 

 

 

Organic Phase

Aqueous Phase

Sample

Number

Total

Weight

(mg) (a)

Analysed

Concentration

(mg/L)

Weight

(mg)(b)

Analysed

Concentration

(mg/L)

Weight

(mg)t

pH

1

109

<0.403

<4.83 x 10-2

9.00 x 103

108

7.1

2

127

<0.403

<5.64 x 10-2

8.99 x 103

126

7.2

3

136

<0.403

<0.121

9.18 x 103

138

7.1

4

164

<0.403

<0.145

9.05 x 103

163

7.1

5

127

<0.403

<0.226

9.39 x 103

131

7.1

6

127

<0.403

<0.226

9.43 x103

132

7.1

 

(a)From analysis of the stock solution

(b)From analysis of the respective phase

 Sample Number Organic/Aqueous Volume Ratio  Partition Coefficient   Log10 Pow  Mean Partition Coefficient
1  10:1  <4.47 x 10^-5  <-4.35  <4.48 x 10^-5
10:1  <4.48 x 10^-5   <-4.35   <4.48 x 10^- 5
 20:1    <4.39 x 10^-5   <-4.36    <4.45 x 10^-5
 20:1   <4.45 x 10^-5   <-4.35   <4.45 x 10^- 5
 40:1   <4.29 x 10^-5   <-4.37   <4.29 x 10^- 5
 40:1   <4.27 x 10^-5   <-4.37    <4.29 x 10^-5

Overall Pow: <4.48 x 10.5 Log10 Pow : <-4.35

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the substance has been determined to be less than 4.48 x 10-5 at 20.8 ± 0.6°C, log10 Pow <-4.35.
Executive summary:

In a determination of general physico-chemical properties study (Harlan project number: 0959/0234) using the shake-flask method, Method A8 Partition Coefficient of Commission Regulation (EC) No 440/2008 of 30 May 2008, the substance has been shown to have apartition coefficient of less than 4.48 x 10 -5 at 20.8 ± 0.6°C, log10 Pow <-4.35