Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
GLP compliance:
yes (incl. QA statement)
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Constituent 1
Reference substance name:
Lecithins, hydrogenated
EC Number:
295-786-7
EC Name:
Lecithins, hydrogenated
Cas Number:
92128-87-5
Molecular formula:
not applicable - UVCB substance
IUPAC Name:
Lecithins, hydrogenated
Specific details on test material used for the study:
Batch number : 7598
Manufacturing date : July 28, 2017
Test item physical state: Slight yellow
Test item quantity received at test facility :150 g
Storage conditions : Ambient temperature (20 ±5°C), Hydroscopic and keep away from light

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
< 0.3
Temp.:
30 °C
pH:
> 2.5 - < 7.5

Applicant's summary and conclusion

Executive summary:

The partition coefficient was measured according to the OECD 117 guideline (HPLC method).

The partition coefficient (log Pow) of test item was considered to be lower than 0.3 at 30°C (pH 2.5 -7.5)