Sorbitan monolaurate, ethoxylated

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (analytical purity of test substance not given, max. of 40% test substance evaluated).

Data source

Reference

Reference Type:

publication

Title:

The influence of non-ionic detergents and other surfactants on human corneal permeability

Author:

Marsh R.J. and Maurice D.M.

Year:

1971

Bibliographic source:

Exp Eye Res 11, 43-48

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

eye irritation

Principles of method if other than guideline:

The effect of the test substance on the corneal permeability to fluorescein was investigated in human subjects.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan monolaurate, ethoxylated

EC Number:

500-018-3

EC Name:

Sorbitan monolaurate, ethoxylated

Cas Number:

9005-64-5

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)

Details on test material:

- Name of test material (as cited in study report): Tween 20

Method

Type of population:

general

Subjects:

- Sex: men and women
- Age: 20-46

Route of exposure:

ocular

Reason of exposure:

intentional

Details on exposure:

In the main body of experiments saline drops were instilled into 1 eye and the experimental drops into the other 6 times in 1 hour. In the second group of experiments, in which the most effective detergents from the previous experiment were chosen, only 1 drop of various concentrations was instilled in each eye in order to approximate to normal clinical circumstances and to avoid the possibility of a cumulative action on the corneal surface.

Examinations:

- Other: The fluorescence of the anterior chambers of the 2 eyes was compared by means of the slit lamp fluorophotometer before and 1-2 hours after the instillation of the drops. Measurements were made with the fluorometer window focused in a region near the center of the anterior chamber.

Results and discussion

Results of examinations:

- Other: The test substance caused no untoward effect on the eye, even up to 40% concentration, but these drops were too sticky to be convenient. Increases in penetration averaging 5 times over controls were achieved with single drops containing the test substance at a level that did not cause ocular irritation.

Applicant's summary and conclusion

Conclusions:

The test substance did not cause ocular irritation in humans when tested in concentrations of 40%. Increases in penetration averaging 5 times over controls were achieved, offering a method of increasing the penetration of drugs for clinical use.