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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no data on test substance purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1951
Report date:
1951

Materials and methods

Objective of study:
other: hydrolysis
Principles of method if other than guideline:
The purpose of the study was to determine the hydrolysis of different sorbitan esters by lipase in vitro.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Sorbitan stearate
EC Number:
215-664-9
EC Name:
Sorbitan stearate
Cas Number:
1338-41-6
IUPAC Name:
1,4-anhydro-6-O-stearoyl-D-glucitol
Details on test material:
- Name of test material (as cited in study report): sorbitan monostearate, span 60
- Analytical purity: no data
Radiolabelling:
no

Administration / exposure

Route of administration:
other: in vitro application
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
24 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
2 mL
Positive control reference chemical:
corn oil (2 mL) and control runs (enzyme free)
Details on study design:
After preliminary trial runs the following type of mixture was subjected to the digestive influence of pancreatic lipase: 2 mL test substance, 50 mg bile salts, pancreatin, U.S.P. 200 mg and 15 mL water. The mixture was rendered slightly alkaline to phenolphtalein by the addition of N/20 sodium hydroxide and placed in an incubator for 24 hours at 37°C. Two experiments in each group were run. After the incubation period the free fatty acid liberated was titrated with N/20 sodium hydroxide, after the addition of 15 mL alcohol, using phenolphthalein soution as the indicator.

Results and discussion

Any other information on results incl. tables

Table 1: Free fatty acid content after in vitro hydrolysis of the test substance by lipase

 

mL N/20 NaOH

Weight of ester

Weight of fatty acid (g)

% fatty acid

Liberated fatty acid (g)

% fatty acid present in ester liberated

Corn oil

29.6

2

1.92

96.1

0.41

21.4

Test compound

5.7

2

1.48

74

0.08

5.4

Applicant's summary and conclusion