Registration Dossier
Registration Dossier
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EC number: 930-447-5 | 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 GLP 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 treatment
- Score:
- 0.9
- Max. score:
- 1.2
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4-hours treatment
- Score:
- 6.6
- Max. score:
- 10.7
- Reversibility:
- not specified
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 vitro scores of the 30-minute and 4-hour treatments, the test item EPOXY RESIN T1800 (batch No. 81016) tested in its original form is classified as slightly irritant for the isolated calf cornea.
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