Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1958

Materials and methods

Objective of study:
other: enzymatic hydrolysis of propylene glycol distearate
Principles of method if other than guideline:
In vitro enzymatic hydrolysis of propylene glycol distearate by steapsin at 30°C.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Propylene Glycol-1-C14 Distearate (PGDS*); Propylene Glycol-1-C14 Distearate (PG*DS)
- Molecular weight (if other than submission substance): 342.56 g/mol
- Analytical purity: no data
- Impurities (identity and concentrations): analysis for free fatty acids and uncombined hydroxyl groups by acetylation in PGDS* showed none to be present. Analysis of PG*DS showed 0.08% free stearic acid and no uncombined hydroxyl groups.
- Locations of the label: PG*DS was tagged with C14 in the carbon-1 of the glycol fragment and PGDS* was tagged in the carboxyl C14 stearate moiety.
Radiolabelling:
yes

Test animals

Species:
other: in vitro; in glycerol-bile salts solution
Strain:
other: not applicable
Sex:
not specified

Administration / exposure

Details on study design:
IN VITRO HYDROLYSIS RATE OF PROPYLENE GLYCOL DISTEARATE
The method described by Balls and Matlock (Balls, A.K. and Matlock, M.B., 1938. J. Biol. Chem. 123, 679) was applied in the study with modifications. The percent of hydrolysis was calculated by titration of free fatty acids after 0, 5, 30 and 45 min and 1, 3 and 19.5 h.

Results and discussion

Metabolite characterisation studies

Details on metabolites:
After the in vitro hydrolysis of PGDS by steapsin, the in vitro study indicated that PGDS was capable of undergoing hydrolysis to yield free fatty acids.

Applicant's summary and conclusion