Registration Dossier
Registration Dossier
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EC number: 241-022-2 | CAS number: 16949-65-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Magnesium hexafluorosilicate hexahydrate
- Cas Number:
- 18972-56-0
- Molecular formula:
- MgSiF6·6H2O
- IUPAC Name:
- Magnesium hexafluorosilicate hexahydrate
Constituent 1
Test animals
- Species:
- other: Reconstructed Human Epidermis
- Strain:
- other: human derived epidermis keratinocytes as cell source and use of representative tissue and cytoarchitecture
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Control items
- Amount / concentration applied:
- 20mg
- Duration of treatment / exposure:
- An exposure time of 15 ± 0.5 minutes was allowed in a ventilated cabinet at room temperature. At the end of the exposure, each tissue was rinsed with approximately 25 mL of sterile D-PBS
- Observation period:
- A 42 hour recovery period was allowed by incubation at 37°C, 5% CO2 and saturated humidity
- Number of animals:
- 0
- Details on study design:
- Positive control item: 5% (w/v) sodium dodecyl sulphate (SDS) solution
Negative control item: D-PBS
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- ca. 88.5
- Remarks on result:
- other:
- Remarks:
- Basis: mean relative viability. Time point: no data. Max. score: 88.5. Reversibility: no data. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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