Registration Dossier
Registration Dossier
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EC number: 639-791-8 | CAS number: 3345-29-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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 guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: MatTek Corporation Protocol for: In Vitro EpiDermTM Skin Corrosion Test (EPI-200-SCT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm™; Version 07/27/2021
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- 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 No.: 340421
In vitro test system
- Test system:
- human skin model
- Remarks:
- reconstituted three-dimensional human skin model EpiDerm (MatTek). Human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Duration of treatment / exposure:
- 60 min and 3 minutes experiments
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Negative controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The test item has no non-specific MTT-reducing or colouring potential, therefore no additional controls were necessary.
The test item showed no corrosive effects.
The mean relative tissue viability (% negative control) was
>= 50% (93.3%) after 3 min treatment and >= 15% (96.7%) after 60 min treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is
classified as “non-corrosive“.
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