Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Aug 2017 to 30 Jan 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
not specified
Qualifier:
according to
Guideline:
other: EC Guideline A.24 (HPLC Method)
Deviations:
not specified
Qualifier:
according to
Guideline:
EPA OPPTS 830.7570 (Partition Coefficient, n-octanol / H2O, Estimation by Liquid Chromatography)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Remarks:
Health Care Inspectorate of the Ministry of Health, Welfare and Sport; Utrecht, The Netherlands
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 coefficientopen allclose all
Type:
log Pow
Partition coefficient:
4.3
Temp.:
35 °C
pH:
7
Type:
log Pow
Partition coefficient:
4.9
Temp.:
35 °C
pH:
7
Remarks on result:
other: Log Kow for trace (0.1%) impurity

Any other information on results incl. tables

Conclusion

The HPLC method at pH 7 was applied for the determination of the partition coefficient (Pow) of 4,4'-[isopropylidenebis(4,1-phenyleneoxy)]dianiline. The Pow and log Pow values of the test item at pH 7 are summarized below.

Test Item

Pow

log Pow

Peak area
(%)

Major peak

1.8 x 104

4.3

99.9

Impurity

8.0 x 104

4.9

0.11

Applicant's summary and conclusion