Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Partition coefficient
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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- shake-flask method to: flask method
- Partition coefficient type:
- octanol-water
Test material
- 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
Constituent 1
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 |
| 2 | 10:1 | <4.48 x 10^-5 | <-4.35 | <4.48 x 10^- 5 |
| 3 | 20:1 | <4.39 x 10^-5 | <-4.36 | <4.45 x 10^-5 |
| 4 | 20:1 | <4.45 x 10^-5 | <-4.35 | <4.45 x 10^- 5 |
| 5 | 40:1 | <4.29 x 10^-5 | <-4.37 | <4.29 x 10^- 5 |
| 6 | 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
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