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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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.