Sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated)

Basic toxicokinetics

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

Test material information

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