Registration Dossier
Registration Dossier
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EC number: 500-018-3 | CAS number: 9005-64-5 1 - 6.5 moles 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:
- 1 971
- 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
- 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
Constituent 1
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.
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