Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06.01.2014 to 25.01.2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EU A.6.
Qualifier:
according to
Guideline:
other: OECD Guideline 105
Deviations:
no
Principles of method if other than guideline:
Based on the results of preliminary tests, the n-octanol/water partition coefficient was determined via the individual solubilities of the test item in n-octanol and water using the flask method (EU Method A.6 and OECD Guideline 105).
GLP compliance:
yes (incl. certificate)
Remarks:
Siemens AG, Prozess-Sicherheit, Industriepark Höchst, B 596 & B 598, D-65926 Frankfurt am Main, Germany
Type of method:
flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1 Kyobashi 1-Chome, Chuo-Ku, Tokyo 1048315, Japan/Batch No.: 130808
- Expiration date of the lot/batch: 07.08.2016
- Purity test date: 24.09.2013

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (10-30°C)

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:no

FORM AS APPLIED IN THE TEST (if different from that of starting material): solid

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
-2
Temp.:
20 °C
pH:
9

Applicant's summary and conclusion

Conclusions:
Based on the individual solubilities of the test item in n-octanol and water, the log Pow was calculated to be -2.0 at 20°C.
Executive summary:

The n-octanol/water partition coefficient was investigated in a study conducted according to OECD Guideline 105 and EU Method A.6 (flask method) based on preliminary tests. Based on the result obtained in the frame of the water solubility determination and the result of the n-octanol solubility determined within this study via HPLC, the log Pow was calculated to be -2.0 at 20°C. The recovery experiments with standard solutions indicated a sufficient accuracy of the analytical method.