Registration Dossier

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
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 Type:
The influence of non-ionic detergents and other surfactants on human corneal permeability
Marsh R.J. and Maurice D.M.
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:

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan monolaurate, ethoxylated
EC Number:
EC Name:
Sorbitan monolaurate, ethoxylated
Cas Number:
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)
Details on test material:
- Name of test material (as cited in study report): Tween 20


Type of population:
- Sex: men and women
- Age: 20-46
Route of exposure:
Reason of exposure:
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.
- 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

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.