Registration Dossier
Registration Dossier
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EC number: 937-130-0 | 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:
- March 16th 2011 to june 3rd 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Deviations:
- no
- Principles of method if other than guideline:
- The principle of this evaluation is based on the measurement of two factors: the opacity and the permeability of the treated corneas. The changes in these parameterrs correspond to the damages 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 April 7th 2010
Test material
- Reference substance name:
- Epoxy Resin T1600
- EC Number:
- 937-130-0
- IUPAC Name:
- Epoxy Resin T1600
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 30 MINUTES
- Score:
- 1.5
- Max. score:
- 3.8
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 6.5
- Max. score:
- 13.7
- 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 the study, according to the mean in vitro scores of 30-minutes and 4-hour treatments, the test item, EPOXY RESIN T1600, tested in its original form, is classified as Class 1, slightly irritant for the isolated calf cornea.
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