Registration Dossier
Registration Dossier
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EC number: 639-791-8 | CAS number: 3345-29-7
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
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene
- EC Number:
- 639-791-8
- Cas Number:
- 3345-29-7
- Molecular formula:
- C16H8F8
- IUPAC Name:
- 2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene
1
- Specific details on test material used for the study:
- Batch n. 340421
Date of analysis 26 November 19, 2021
Purity ≥98.00%
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.9% NaCl
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- 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
- Run / experiment:
- 2nd experiment (the first one was invalidi)
- Value:
- 0.66
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the evaluation criteria the test item PARYLENE HT® is not classified into UN GHS
Category.
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