Registration Dossier
Registration Dossier
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EC number: 945-327-8 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study report from year 1974.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Reliability as reported in OECD SIDS (2004).
Data source
Reference
- Reference Type:
- other: Collection of data from published literature and company data.
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
- Principles of method if other than guideline:
- A cytogenetic assay on human embryonic lung cells (Wi-38) was performed. Mutations were quantified by counting anaphase aberrations. No metabolic activation.
- GLP compliance:
- no
- Type of assay:
- other: Cytogenetic assay on human embryonic lung cells (Wi-38). Mutations quantified by counting anaphase aberrations.
Test material
- Reference substance name:
- Silicic acid, calcium salt
- EC Number:
- 215-710-8
- EC Name:
- Silicic acid, calcium salt
- Cas Number:
- 1344-95-2
- Molecular formula:
- CaO3Si
- IUPAC Name:
- Silicic acid, calcium salt
Constituent 1
- Specific details on test material used for the study:
- Silene, synthetic amorphous calcium silicatel, hydrated, CAS 1344-95-2.
Method
Species / strain
- Species / strain / cell type:
- other: human embryonic lung cells (Wi-38)
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- Test concentrations used were 1, 10 and 100 µg/ml.
- Vehicle / solvent:
- Not specified.
Controlsopen allclose all
- Remarks:
- Not specified.
- Untreated negative controls:
- yes
- Remarks:
- 0.85 % saline
- Positive controls:
- yes
- Remarks:
- 0.1 µg/l triethylene melamine
Results and discussion
Test results
- Key result
- Species / strain:
- other: Human embryonic lung cells (Wi-38)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- Anaphase aberrations
- Cytotoxicity / choice of top concentrations:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Results from a cytogenetic assay with human embryonic lung cells, indicated no genotoxicity in vitro for synthetic amorphous calcium silicate.
- Executive summary:
The genotoxic potential of synthetic amorphous calcium silicate was tested in a cytogenetic assay with human embryonic lung cells (Wi-38). Mutations were quantified by counting anaphase aberrations. No genotoxicity in vitro for synthetic amorphous calcium silicate was indicated.
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