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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
1974
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

Constituent 1
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

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.