Registration Dossier

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance has a low potential for bioaccumulation based on log Kow <=3
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from October 18, 2007 to November, 5, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
yes
Remarks:
The deviation has no effect on the determination of log Pow of the test substance. See deviation.
GLP compliance:
yes (incl. certificate)
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water
Analytical method:
photometric method
Type:
log Pow
Partition coefficient:
-2.16
Temp.:
23 °C
pH:
9.1
Details on results:
Standard extended uncertainty 0.448.
Deviation:
A stock solution of the test substance should be prepared in n-octanol pre-saturated with water. Because of a low solubility of the test substance in this medium, the stock solution was prepared in water pre-saturated with n-octanol.
This deviation has no effect on the determination of log Pow of the test substance.

Executive summary:

The partition coefficient of the test substance was determined. The shake-flask method was used.

The test was performed according to the Method A.8, Partition coefficient, Directive 92/69/EEC, Published in OJ No L 383A, 1992.

Partition coefficient (log P) of the test substance - Humic acids, potassium salts - determined by shake-flask method is:

log Pow = -2.16 ± 0.45 (pH = 9.1, 23ºC)

The partition coefficient shows some suggestion of concentration dependency.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion