Registration Dossier
Registration Dossier
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EC number: - | 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:
- 18/11/15 to 20/11/15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Items 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying items not requiring classification and labelling for eye irritation or serious eye damage
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: Light brown solid
- Details on test material:
- - Name of test material (as cited in study report): SPE1415
- Physical state: Light brown solid
- Analytical purity: Not supplied
- Lot/batch No.: 9
- Expiration date of the lot/batch: 20th February 2016
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: EpiOcular cornea epithelial model
- Strain:
- other: Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- A disc of the substance was applied to the tissue culture surface
- Duration of treatment / exposure:
- 6 hours
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Relative mean viability (%)
- Basis:
- other: Epiocular tissue
- Remarks on result:
- other: The treated tissues had a relative mean viability of 4.2% following an exposure period of 6 hours
- Irritant / corrosive response data:
- The treated tissues had a relative mean viability of 4.2% following an exposure period of 6 hours. A score of less than 60% gives a prediction of irritant.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance gave a response in an RHE assay which predicts as irritant.
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