Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-10-10 to 1991-03-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
yes
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
yes
Principles of method if other than guideline:
Based on the relatively high water solubility of the registered substance (> 500 g/l , see respective endpoint entry), a partition coefficient below the sensitivity range (log Pow 0 to 6) of the test method was expected. Therefore a preliminary test was performed to determine the solubility in n-octanol. The log Pow value estimated from the ratio of the maximum solubility of the substance in n-octanol and water was far below the sensitivity range of the test method.
From the determination of the surface tension of an aqueous solution of the substance (see respective endpoint entry), it was concluded that the substance must be regarded as a surface active material. From these two facts it was concluded that the main study could not be performed
GLP compliance:
yes
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent

Study design

Analytical method:
photometric method

Results and discussion

Partition coefficientopen allclose all
Type:
log Pow
Partition coefficient:
< -4.4
Temp.:
20 °C
pH:
>= 0 - <= 14
Remarks on result:
other: Estimate based on the ratio of the solubilities in n-octanol and water.
Type:
Pow
Partition coefficient:
21
Temp.:
20 °C
pH:
>= 0 - <= 14
Remarks on result:
other: Estimate based on the ratio of the solubilities in n-octanol and water.
Details on results:
pH not reported, however it is assumed that the measurement was being conducted within the neutral pH range.

Any other information on results incl. tables

Because the substance is a surface active material (see respective endpoint RSS) and because the estimated log Pow value < -4.4 is far out of range of the HPLC method (0 < log Pow < 6), the main study was not performed.

Applicant's summary and conclusion

Conclusions:
The partition coefficient was estimated to be log Pow < -4.4.