Registration Dossier
Registration Dossier
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EC number: 930-384-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April to june 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study by a laboratory having a GPL certificate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Deviations:
- no
- Principles of method if other than guideline:
- The principle is based on the measurement of two factors; the opacity and the permeability of the treated corneas. The changes in these parameters correspond to the dammages induced to the tissues. The method used is adapted from that described by Gautheron P. & al. (1992) Fundam. APPL. Toxicol. 18 442-449
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate on january 27th 2009
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 30-minutes treatement
- Score:
- 0.3
- Max. score:
- 2.3
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4-hour treatment
- Score:
- 8.3
- Max. score:
- 13
- Reversibility:
- not specified
Any other information on results incl. tables
For each experiment, the acceptance criteria were fulfilled and the study was therefore considered to be valid.
No notable opaque spots or irregularities were observed on negative control corneas, either following the-minutes treatment or following the 4 -hour treatment.
Fluoresceine fixation was observed on test item-treated corneas, following both the 30 -minute and 4 -hour treatments
Following the 30 -minute treatement, the mean in vitro score was 0.3. Then following the 4 -hour treatment, the mean in vitro score was 8.3.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, according to both mean in vitroscores of the 30-minute and 4-hour treatments, the test item, Urethan Resin M2001 (batch N° 081128K), tested in its original form, is classified as slightly irritant for the isolated calf cornea.
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