Registration Dossier
Registration Dossier
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EC number: 805-675-2 | CAS number: 102340-61-4
Eye irritation
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:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- (2S,3R,4S,5S,6R)-2-{[(2R)-2,8-dimethyl-2-[(4S,8S)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-1-benzopyran-6-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol
- EC Number:
- 805-675-2
- Cas Number:
- 102340-61-4
- Molecular formula:
- C35H56O7
- IUPAC Name:
- (2S,3R,4S,5S,6R)-2-{[(2R)-2,8-dimethyl-2-[(4S,8S)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-1-benzopyran-6-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol
- 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)
Constituent 1
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.
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