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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Cas Number:
- 205825-52-1
- Molecular formula:
- C20H24
- IUPAC Name:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch no. 350321
Test system
- Vehicle:
- physiological saline
- Remarks:
- As it was not possible to get a solution/suspension with physiological saline 0.9% NaCl, the test item was moistened with a drop of physiological saline 0.9% NaCl (see 10.2) and was administered directly using open-chamber method.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test item was moistened with a drop of physiological saline 0.9% NaCl (see 10.2) and was
administered directly. - Number of animals or in vitro replicates:
- 3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive control treated with imidazole 20% in physiological saline 0.9% NaCl
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- None of the corneas treated with PARYFREE® DIMER showed any opacity of the tissue.
The following mean in vitro irritation score was calculated: -0.28
Therefore the test item was not classified.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the corneas treated with PARYFREE® DIMER showed any opacity of the tissue.
The test item was not classified for this endpoint.
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