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EC number: 603-401-4 | CAS number: 1302-88-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted using a method similar to OECD Testing Guideline 473 and meets acceptable scientific standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- Study performed without metabolic activation using a non-standard cell lines (WI-38 - human embryonic lung cultures)
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FDA 71-45 (Sodium silicoaluminate)
- Physical state: Fine white powdered material
- Lot/batch No.: SR-1621
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: WI-38 - human embryonic lung cultures
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Not provided
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: Not provided
- Periodically "cleansed" against high spontaneous background: Not provided
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 1, 10 and 100 µg/ml
- Vehicle / solvent:
- - Vehicle: 0.85 saline
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Saline solution
- Positive controls:
- yes
- Positive control substance:
- triethylenemelamine
- Remarks:
- 0.1 µg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: 24 - 48 h
STAIN: acetic acid-orcein stain (20%)
NUMBER OF REPLICATIONS: 3 per concentration
NUMBER OF CELLS EVALUATED: 100 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy - Evaluation criteria:
- Evaluation of the genetic damage by identification of the aberrations (bridges, pseudochiasmata, multipolar cells, acentric fragments, etc) induced by the test substance.
- Statistics:
- Not provided
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: WI-38 - human embryonic lung cultures
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 250 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Acentric fragments:
- Negative control: 2%
- 1 µg/ml: 0%
- 10 µg/ml: 1%
- 100 µg/ml: one cell with an acentric fragment and one cell with a bridge (non significant).
- Positive control: four cells with pulverization together with the other aberrations. - Remarks on result:
- other: strain/cell type: WI-38 - human embryonic lung cultures
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item was considered to be non-mutagenic under the conditions of the test. - Executive summary:
The in vitro cytogenicity in mammalian cells of the read-across substance sodium silicoaluminate branded as FDA 71-45 was determined according to a method similar to the OECD Guideline for Testing of chemicals 473. Chromosome aberrations were evaluated in WI-38 - human embryonic lung cultures without metabolic evaluation.
The in vitro mammalian chromosome aberration test was performed with concentrations of 1, 10 and 100 µg/ml in a saline solution at 0.85%. Anaphase preparations were made by growing the WI-38 cells in presence of the test item. Cells were then suspended in acetic acid-orcein stain (20%) and put in slides to be evaluated. Evaluation of the genetic damage was made by identification of the aberrations induced by the test item.
Cytotoxicity was observed at a concentration of 250 µg/ml. No significant numbers of aberration were observed for each tested concentration.
The test item was considered to be non-mutagenic under the conditions of the test.
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