Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 February 2004
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.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
(Date of inspection: 02 December 2002 Date of signature: 13 February 2003)
Type of method:
HPLC 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): TIPX
- Substance type: Colourless liquid.
- Physical state: Liquid.
- Lot/batch No.: 042028.
- Storage condition of test material: Approximately 4ºC in the dark.

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
> 6.2
Temp.:
25 °C
Details on results:
log Pow of > 6.2 at 25°C.

Any other information on results incl. tables

log Pow of > 6.2 at 25°C.

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test material has been determined to be >1.59 x 106, log10 Pow >6.20.
Executive summary:

Partition Coefficient has been determined to be >1.59 x 106, log10Pow, >6.20 using the HPLC method, Method A8 of Commission Directive 92/69/EEC.