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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Colipa Program on optimization of existing in vitro eye irritation assays for entry into formal validation : technology transfer and intra/inter laboratory evaluation of epiocular assay for chemicals. Harbell et al. 2009. The toxicologist, 108, 1, 79
Principles of method if other than guideline:
In vitro test on reconstructed human epithelium cornea
GLP compliance:
no
Remarks:
but performed in quality environment

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: semi-solid
Details on test material:
yellow orange semi-solid
purity : 46.8%
For technical reasons (solubility and stability of mixtures), the commercial substance is tested (50% in mixture of triglyceride capric caprylic)

Test animals / tissue source

Species:
human

Test system

Vehicle:
other: paraffine oil
Controls:
yes, concurrent vehicle
Duration of treatment / exposure:
Treatment during 30 min or 1h30
Post-incubation during 2h or 18h
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: viability
Basis:
other: test item assay 1 (10%)
Score:
99.6
Irritation parameter:
other: viability
Basis:
other: test item assay 2 (100%)
Score:
93.7
Irritation parameter:
other: viability
Basis:
other: positive control
Score:
43.7
Irritation parameter:
other: viability
Basis:
other: negative control (liquid PBS)
Score:
9.8
Irritation parameter:
other: viability
Basis:
other: negative control (solid PBS)
Score:
18.4
Irritation parameter:
other: viability
Basis:
other: negative control (paraffin oil)
Score:
7
Irritation parameter:
other: vaibility
Basis:
other: positive control (liquid methyl acetate)
Score:
43.7
Irritation parameter:
other: viability
Basis:
other: positive control (solid methyl acetate)
Score:
35.9

Any other information on results incl. tables

Moistening (first treatment) : 30 minutes in CO2 steriliser

Treatment (liquids) : 30 minutes in CO2 steriliser

Treatment (solids) : 90 minutes in CO2 steriliser

Rinse : 12 minutes

Post-incubation : 120 minutes (liquids) or 18 hours (solids) in CO2 steriliser

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the test conditions used, Tocopheryl Glucoside at 10% and 100% was not irritant on human epithelium cornea in vitro test.
Executive summary:

The aim of the study was to evaluate the eye irritation potential of the test item Tocopheryl Glucoside.

The study was conduced on reconstructed human epithelium cornea.

Culture cells were exposed to test item at 10% and 100% during 30 min or 1h30 (for 10% and 100% test item concentrations respectively) and the viability was meseared using MTT coloration test.

In the test conditions used, the test item at 10% and 100%, corresponding to tocopheryl Glucoside concentration at 4,68 and 46,8%, was not irritant.