Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, no guideline followed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
HPLC method
GLP compliance:
yes
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
ca. 2.2
Temp.:
20 °C
Remarks on result:
other: no more detail
Details on results:
Dead volume= 2.6 mL
log P= 1.025*k + 1.184
r²=0.97

Applicant's summary and conclusion

Conclusions:
Log P of Lipacide UG is 2.2
Executive summary:

The aim of this study was to determine the coefficient partition of the item Lipacide UG, using HPLC method and according to the GLP principle.

HPLC uses analytical colums with a solid phase containing long hydrcocarbon chain (eg C8, C18) bounded to silice.

Chemicals are eluted with different speed from the column. Hydrosoluble products are eluted first, and liposoluble the latest, proportionally to their wter- hydroocarbon partition coefficient.

Partition coefficient is given from the capacity coefficient k:

k=(tR-t0)/t0

tR= retention time

t0= dead time

log P= a*k+b

a and b coefficient deduced from the standard curve.

this curve is determined using chemical standards (Phenol, alcool cynammique, benzoate de methyle, 2,3-dichloranilline, Benzoate de phényl, Benzoate de benzyl.

Log P of Lipacide UG is 2.2