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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The registered substance is not classified as a genetic toxin.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 471.
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Target gene:
Histdine
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver post-mitochondrial fraction (S 9)
Test concentrations with justification for top dose:
Experiment 1 (all strains; with and without metabolic activation): 5, 15.81, 50, 158.1, 500, 1581 and 5000 μg/plate
Experiment 2 (all strains; with and without metabolic activation): The maximum test concentration of 5000 μg/plate was retained for all strains.
Experiment 3 (TA 100 and 102 only, without metabolic activation): Narrowed concentration intervals covering the range 1000-5000 μg/ml
Vehicle / solvent:
Methyl cellulose
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
mitomycin C
other: 2-aminoanthracene
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The substance showed no mutagenic activity in all strains with and without metabolic activation.
Executive summary:

The genetic toxicity of the substance was determined in accoridance with the OECD Guideline for Testing of Chemicals 471. A reverse bacterial mutation study was conducted on the substance, which was assayed for mutation in five histidine requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation. Three experiments at various test material concentrations showed a negative result for all strains with and without metabolic activation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

A study was conducted on the registered substance to determine the genetic toxicity of the substance. The genetic toxicity of the substance was determined in accoridance with the OECD Guideline for Testing of Chemicals 471. A reverse bacterial mutation study was conducted on the substance, which was assayed for mutation in five histidine requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation. Three experiments at various test material concentrations showed a negative result for all strains with and without metabolic activation.

A study was conducted on a structurally similar substance to the registered substance. The genetic toxicity of the test substance was determined via use of a guideline similar to the OECD Guideline for Testing of Chemicals 473, with the ammendment from OECD 473 being that no study was conducted in the presence of an external, metabolic activation system. The test was conducted using Human embryonic lung cells (Wi-38) to investigate the occurence of chromosome aberrations in the presence of the test substance. The results were negative in the absence of metabolic activation, therefore the substance is not classified as a genetic toxin.

The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.


Justification for selection of genetic toxicity endpoint
Study was conducted on the registered substance according to GLP standards and using OECD Testing Guideline 471.

Justification for classification or non-classification

No genetic toxicity was identified in an Ames test on the registered substance, or in a chromosome aberration test on a structurally similar substance.