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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2006
Reference Type:
secondary source
Title:
Soluble Silicates. CAS No. 1344-09-8, 6834-92-0, 10213-79-3, 13517-24-3 and 1312-76-1.
Author:
OECD SIDS
Year:
2004
Bibliographic source:
SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Remarks:
RCC-Cytotest Cell Research GmbH
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sodium silicate solution (weight ratio 3.3)
Tradename: Natronwasserglas 37/40 PE
36% active ingredient, 64% water

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
CELL CULTURE DETAILS:
- Type and identity of media: Minimal Essential Medium supplemented with 10% fetal calf serum.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbital / ß-Naphthoflavone induced rat liver S9-mix
Test concentrations with justification for top dose:
19.5, 39.1, 78.1 & 156.3 µg active ingredient/mL
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
medium
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 300-400 µg/mL Ethylmethane sulfonate (-S9), 1.4-2.0 µg/mL Cyclophosphamide (+S9)
Details on test system and experimental conditions:
- Spindle inhibitor: 0.2 µg/ml Colcemid
- Stain: Giemsa
- No. of metaphases analyzed: 100
- Dosing: Cytotoxic concentrations were determined in a range-finder study with and without metabolic activation. 312.5 µg/ml was chosen as top concentration in the actual experiments.
- Number of replicates: 2
Evaluation criteria:
Breaks, fragments, deletions, exchanges, and chromosome disintegrations were recorded as structural chromosome aberrations. Gaps were recorded as well, but not included in the calculation of aberration rates. Only metaphases with characteristic chromosome numbers (22+-1) were included in the analysis. The mitotic index (% cells in mitosis) and the percentage of polyploid cells in 500 metaphase plates/culture were determined.

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
156.3 - 312.5 µg active ingredient/mL
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

PRECIPITATION CONCENTRATION:

156.3 µg active ingredient/ml (except experiment II after 18h preparation interval without S9 mix where precipitation occurred at 78.1 µg/ml and above)

Applicant's summary and conclusion